Pulse Oximeters - Premarket
`Notification Submissions [510(k)s]
`Guidance for Industry and
`Food and Drug Administration
`Staff
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`Document issued on: March 4, 2013
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`This document supersedes Non-invasive Pulse Oximeter General Guidance
`Document, September 7, 1992
`The draft of this document was issued on July 19, 2007.
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`For questions regarding this document contact Neel Patel at 301-796-5580 or
`neel.patel@fda.hhs.gov.
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`U.S. Department of Health and Human Services
`Food and Drug Administration
`Center for Devices and Radiological Health
`Office of Device Evaluation
`Division of Anesthesiology, General Hospital,
`Infection Control, and Dental Devices
`Anesthesiology and Respiratory Devices Branch
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`MASIMO 2005
`Apple v. Masimo
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`Preface
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`Public Comment
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`You may submit written comments and suggestions at any time for Agency consideration to the
`Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
`rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to
`http://www.regulations.gov. Identify all comments with the docket number listed in the notice of
`availability that publishes in the Federal Register. Comments may not be acted upon by the
`Agency until the document is next revised or updated.
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`Additional Copies
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`Additional copies are available from the Internet. You may also send an e-mail request to
`dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-
`827-8149 to receive a hard copy. Please use the document number (1605) to identify the
`guidance you are requesting.
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`Table of Contents
`1. INTRODUCTION................................................................................................................... 1
`2. SCOPE ..................................................................................................................................... 1
`3. DEVICE DESCRIPTION ...................................................................................................... 2
`4. DEVICE PERFORMANCE................................................................................................... 4
`4.1
`ACCURACY OF PULSE OXIMETERS............................................................................................................... 4
`4.2
`ALARMS ...................................................................................................................................................... 8
`4.3
`DISPLAY VALUES, OUTPUTS, AND INDICATORS ............................................................................................. 8
`4.4
`SATURATION PULSE INFORMATION SIGNAL .................................................................................................. 9
`5. SOFTWARE INFORMATION ............................................................................................. 9
`6. ELECTRICAL, MECHANICAL, AND ENVIRONMENTAL SAFETY ......................... 9
`7. ELECTROMAGNETIC COMPATIBILITY ...................................................................... 9
`8. BIOCOMPATIBILITY .......................................................................................................... 9
`9. CLEANING, DISINFECTION, AND STERILIZATION ................................................ 10
`9.1
`REUSE INSTRUCTIONS AND VALIDATION ................................................................................................ 10
`9.2
`STERILIZATION DOCUMENTATION ......................................................................................................... 10
`10. LABELING ........................................................................................................................... 10
`10.1
`INTENDED USE ......................................................................................................................................... 11
`10.2
`INSTRUCTIONS FOR USE .......................................................................................................................... 11
`10.3 DEVICE SPECIFICATIONS ......................................................................................................................... 11
`10.4 PACKAGE LABELING ............................................................................................................................... 12
`11. SUBMISSIONS FOR REPROCESSED SINGLE-USE SENSORS ................................. 12
`11.1
`IDENTIFICATION OF COMPONENTS AND USES ........................................................................................ 13
`11.2 PERFORMANCE TESTING ......................................................................................................................... 13
`11.3 CLEANING METHODS AND VALIDATION INFORMATION ........................................................................ 13
`11.4 DISINFECTION AND/OR STERILIZATION VALIDATION INFORMATION ................................................... 14
`11.5 DEVICES NOT PROVIDED STERILE .......................................................................................................... 14
`11.6 DEVICES PROVIDED STERILE .................................................................................................................. 14
`APPENDIX – LIST OF REFERENCES .................................................................................. 15
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`Pulse Oximeters - Premarket Notification
`Submissions [510(k)s]
`
`Guidance for Industry and
`Food and Drug Administration Staff
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`This guidance represents the Food and Drug Administration's (FDA's) current thinking on
`this topic. It does not create or confer any rights for or on any person and does not operate to
`bind FDA or the public. You can use an alternative approach if the approach satisfies the
`requirements of the applicable statutes and regulations. If you want to discuss an alternative
`approach, contact the FDA staff responsible for implementing this guidance. If you cannot
`identify the appropriate FDA staff, call the appropriate number listed on the title page of this
`guidance.
`
`1. Introduction
`FDA has developed this guidance document to assist industry in preparing premarket notifications
`(510(k)s) for pulse oximeters. These devices are intended for non-invasive measurement of the
`arterial blood oxygen saturation and pulse rate.
`
`FDA's guidance documents, including this guidance, do not establish legally enforceable
`responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
`be viewed only as recommendations, unless specific regulatory or statutory requirements are
`cited. The use of the word should in Agency guidances means that something is suggested or
`recommended, but not required.
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`2. Scope
`The scope of this document is limited to the Class II devices, Oximeter and Ear oximeter,
`classified under the following regulations:
`
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`21 CFR 870.2700 – Oximeter (product codes: DQA (Oximeter) and NLF (Oximeter,
`Reprocessed))
`An oximeter is a device used to transmit radiation at a known wavelength(s) through blood
`and to measure the blood oxygen saturation based on the amount of reflected or scattered
`radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
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`This guidance does not address oximeters in product codes MUD (tissue saturation
`oximeter), NMD (reprocessed tissue saturation oximeter), or MMA (fetal pulse oximeter).
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`21 CFR 870.2710 – Ear Oximeter (product code: DPZ (Ear oximeter))
`An ear oximeter is an extravascular device used to transmit light at a known wavelength(s)
`through blood in the ear. The amount of reflected or scattered light as indicated by this
`device is used to measure the blood oxygen saturation.
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`These classification regulations group together all oximeters intended to measure blood oxygen
`saturation. The regulations at 21 CFR 870.2700 and 870.2710 include devices using reflectance,
`transmittance, and fiber optic technologies, which are collectively referred to as pulse oximeters
`for the purpose of this guidance. The terms “transmittance” and “reflectance” refer to the sensor
`geometry and are not related to the principles of pulse oximetry and how the light is absorbed by
`hemoglobin.
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`This guidance document pertains to non-invasive pulse oximeters to measure arterial blood
`oxygen saturation (SpO2) and pulse rate based on the amount of transmitted, reflected and
`scattered light through various application sites (including, but not limited to finger, ear, foot,
`hand, forehead, back, and nose). These devices are limited to prescription use. These pulse
`oximeters may be continuous or spot-checking devices and either stand-alone or multi-parameter
`modules. These devices are typically labeled with a general indication for non-invasive
`measurement of blood oxygen saturation. A manufacturer that wishes to seek a specific clinical
`indication for use of a pulse oximeter, for example to screen for or diagnose a disease or
`condition, should submit clinical safety and effectiveness data to support the specific indication.
`A clinical evaluation of a new intended use of a legally marketed device may require an
`Investigational Device Exemption (IDE) under 21 CFR Part 812
`(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Howto
`MarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm) before the clinical study is
`initiated. Should an IDE be necessary, FDA suggests that manufacturers take advantage of the
`Pre-Submission Program (see “Draft Guidance for Industry and FDA Staff Medical Devices:
`The Pre-Submission Program and Meetings with FDA Staff,” issued July 13, 2012,1 which when
`final will represent FDA’s current thinking on this topic) to obtain input from FDA on their study
`plan.
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`3. Device Description
`We recommend you identify your device by the applicable regulation number and product code
`indicated in Section 2 above and include the information described below.
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`Intended Use
`We recommend you clarify if the device [and accessories] is intended:
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`1 Web addresses for all guidance documents referenced within can be found in the “List of References” at the end of
`this document.
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`• as a stand-alone device or a multi-parameter module;
`for use in spot-checking or continuous monitoring;
`•
`for single use or multi-use;
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`for out-of-hospital transport; or
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`for home use.
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`Device Design
`We recommend you identify and describe:
`• scientific principles underlying how the device achieves its intended use, i.e., the theory
`of operation (e.g. functional oxygen saturation or fractional oxyhemoglobin);
`• sensor configuration/geometry and recommended application sites;
`• design features; e.g., functions, alarms. In general, pulse oximeters intended for
`continuous monitoring should include high and low SpO2 and pulse rate alarms;
`• all patient interface accessories; e.g., patient cable, extender cables, sensors, bandages;
`• whether the device will be provided sterile; and
`• whether the device is a reprocessed single-use device.
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`We recommend you include high-level drawings, diagrams, or photographs of your device that
`can help explain the function or highlight new features that may affect safety and effectiveness,
`for example, changes to a sensor.
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`We recommend that you compare your device with a legally marketed predicate device (include
`the 510(k) number, if available) and provide information to show how your device is similar to
`and different from the predicate. Side by side comparisons, whenever possible, are desirable, for
`example, using a tabular format as shown below. For each identified difference, please provide
`further discussion of the difference compared to the predicate and why this difference will not
`significantly affect safety or effectiveness.
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`Table 1. Example Comparison of New and Predicate Devices
`Description
`Your Device
`Intended patient population, such as
`neonate, infant, pediatric, adult
`Intended application site, such as
`finger, ear, foot, hand, forehead, back,
`nose
`Performance Specifications (including
`use under motion and low perfusion
`conditions, if applicable, and any
`indices or signals provided to the user)
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`Predicate Device
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`Safety Specifications (e.g., electrical,
`mechanical, environmental)
`Features (e.g., alarms, display and
`indicators, modes)
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`4. Device Performance
`We recommend the device undergo performance testing as described in ISO 80601-2-61:2011
`Medical Electrical Equipment — Part 2-61: Particular requirements for basic safety and
`essential performance of pulse oximeter equipment or equivalent method. This should include,
`but not be limited to, testing identified in Sections 4.1 – 4.4 below.
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`4.1 Accuracy of Pulse Oximeters
`We recommend that you conduct the testing described in Clause 201.12.1 of ISO 80601-2-
`61:2011 or equivalent methods.
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`An oximeter operates as a system composed of a sensor, any extender or interface cable, and
`a specific oximeter monitor or module. We recommend you validate each system through
`appropriate testing, inspection, or analysis.
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`Grouping Sensors for Testing
`It may be appropriate to group certain sensors for testing if they are of similar design or
`equivalent performance. We consider sensors to be of similar design if they contain identical
`materials and electro-optical components and have equivalent sensor characteristics (e.g.,
`location of use). If you choose to group sensors for testing based on their similar design, we
`recommend you indicate that all sensors within each group contain identical materials and
`electro-optical components and describe the rationale for grouping. Generally, we believe
`that clip and adhesive sensors should not be grouped based on similar design because they
`differ in form, fit, and functional specifications. If you choose to group sensors for testing
`based on equivalent performance, we recommend you provide valid scientific evidence and
`statistical analysis to demonstrate that the results of testing are poolable.
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`Incorporating an Original Equipment Manufacturer’s Cleared Technology
`If your device incorporates an Original Equipment Manufacturer’s (OEM) oximeter that is
`legally marketed for the same intended use, we recommend you provide the following in lieu
`of accuracy studies:
`the 510(k) numbers for the submissions where each combination of oximeter, sensor,
`•
`and cable were cleared for use together; and
`testing that demonstrates that SpO2 and pulse rate values calculated by the OEM
`system are not corrupted during communication to your host device.
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`•
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`We recommend you conduct the above verification on the bench using a functional tester (see
`ISO 80601-2-61:2011 Section 201.3.209 for the definition and appropriate uses of a
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`functional tester) to span the range of saturation and pulse rate values to assure
`communication between the component and the host module.
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`Modifications to Oximeter Systems that Require a New 510(k)
`In accordance with 21 CFR 807.87(g), a pulse oximeter system “that has undergone a
`significant change or modification (from its currently cleared configuration) that could
`significantly affect the safety or effectiveness of the device” requires a new 510(k). To
`decide when to submit a new 510(k) for a change to an existing device, we recommend you
`refer to the FDA guidance titled “Deciding When to Submit a 510(k) for a Change to an
`Existing Device (K97-1),” issued January 10, 1997. FDA generally considers any one of the
`following modifications to be significant as they may have the potential to affect safety or
`effectiveness:
`• significant electro-optical sensor modifications (e.g., component or bandage material
`in the light path, extensive re-design where a device is miniaturized); or
`• significant SpO2 algorithm modifications.
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`We recommend you conduct in vivo (i.e., clinical) studies to determine the accuracy of SpO2
`(under laboratory and any labeled operating conditions (e.g., motion)) for new and modified
`systems. FDA will always consider alternatives to in vivo testing when the proposed
`alternatives are supported by an adequate scientific rationale. For example, when changes or
`modifications made do not affect the optical chain or signal processing path, then additional
`clinical studies may not be needed.
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`If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to
`obtaining 510(k) clearance of the device, the study must be conducted under the
`Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812. Generally, FDA
`believes pulse oximeters addressed by this guidance document are non-significant risk
`devices; therefore, the study would be subject to the abbreviated requirements of 21 CFR
`812.2(b). Please see the FDA Guidance titled, “Significant Risk and Nonsignificant Risk
`Medical Device Studies,” issued January 2006. In addition to the requirements of Section 21
`CFR 812.2(b), sponsors of such trials must comply with the regulations governing
`institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
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`4.1.1 In vivo testing for SpO2 accuracy under laboratory conditions
`We recommend you follow Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-
`61:2011 Procedure for invasive laboratory testing on healthy volunteers, or equivalent
`method to validate the SpO2 accuracy specifications of your pulse oximeter system by
`comparing each value from your system and a simultaneous value from co-oximetry of an
`arterial blood sample. We recommend you submit a detailed clinical report for this
`testing. Your report should describe the device configuration tested and include the
`following:
`test apparatus used, including means for arterial catheterization and blood
`•
`sampling, means for recording SpO2 values, and means for delivering medical
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`grade oxygen-nitrogen mixtures of varying fractional inspired oxygen (FiO2)
`levels;
`inclusion and exclusion criteria;
`•
`• number of subjects;
`• number of samples taken per subject;
`• specific conditions of testing, including laboratory conditions, subject motion, low
`pulse amplitude;
`type and frequency of motion for testing under motion conditions, if applicable;
`•
`• criteria and methods for determining stability of reference arterial blood oxygen
`saturation (SaO2) at the pulse oximeter sensor site;
`• desaturation profile, including target saturation plateaus and ranges; and
`formula used for determination of root mean square difference (Arms). (See
`•
`Clause 201.12.1.101.2.2 of ISO 80601-2-61:2011 for recommended formula.)
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`We recommend you conduct the study described in Clause 201.12.1.101.2 and Annex
`EE.2 of ISO 80601-2-61:2011 on 10 or more healthy subjects that vary in age and gender.
`Your data should include 200 or more data points (paired observations: pulse oximeter,
`co-oximeter). These data should be distributed as described in Annex EE.2.3.4(g).
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`Your study should have subjects with a range of skin pigmentations, including at least 2
`darkly pigmented subjects or 15% of your subject pool, whichever is larger.
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`We recommend you provide a line listing, a Bland-Altman plot, error plots (i.e., SaO2
`versus (SpO2-SaO2) for both individual test subjects and all subjects pooled), and
`rationale for any points excluded from analysis. Please include population mean bias
`2), within-subject variance (σ2), and upper 95% and
`(μ0), between-subject variance (σμ
`lower 95% limits of agreement. Please provide this information as outlined in Section 3
`of “Agreement Between Methods Of Measurement With Multiple Observations Per
`Individual” by Bland and Altman.2 If you note that the plots show noticeable outliers,
`please provide the following:
`• a discussion of the state of health, subject characteristics, test setup, test
`procedure, and any other factors that may have affected these data points; and
`• a discussion of how the outlier(s) do not raise safety and performance concerns
`regarding the accuracy of the device.
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`We recommend an Arms specification in conformance with Clause 201.12.1.101.1 of ISO
`80601-2-61:2011. We recognize that accuracy is, among other things, a function of
`patient characteristics, application site and sensor geometry. The table below outlines the
`typical Arms between measured values (SpO2) and reference values (SaO2) under normal
`conditions ranging from 70% to 100% SpO2.
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`2 See Bland and Altman. Agreement between methods of measurement with multiple observations per individual.
`Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582.
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`Table 3. Typical Arms Specification by Sensor Type
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`Sensor Type
`Transmittance, wrap and clip
`Ear clip
`Reflectance
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`Arms
`≤ 3.0 %
`≤ 3.5 %
`≤ 3.5 %
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`4.1.2 In vivo testing for SpO2 accuracy for neonates
`If your device is intended for use with neonates, we recommend you report performance
`of neonatal sensors on adult subjects as described in Section 4.1.1. Adult subjects are
`acceptable in this case due to the uncertainty of determining the accuracy of sensors
`intended for use in neonates. If the neonatal sensor is new or significantly changed
`compared to the predicate device, we recommend you provide testing on additional
`convenience arterial samples (See Annex EE.4.1, Invasive testing on patients, of ISO
`80601-2-61:2011) collected on neonates to verify safe form, fit, and function (clinical
`performance).
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`We recognize that neonatal clinical studies are more representative of the intended use
`than controlled laboratory studies in adults, that there will be inherently greater noise in
`the measurement of neonatal oxygen saturation values, and that convenience samples in
`this population may be clustered around 90% SaO2. Nonetheless, we recommend you
`provide data on a sufficient number of neonatal subjects and samples. We recommend
`that you justify the sample size and SaO2 range of data collected.
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`4.1.3 Testing for SpO2 accuracy for oximeters making motion
`performance claims
`We recommend testing in accordance with Clause 201.12.1.102 of ISO 80601-2-61:2011.
`One recommended approach is to use the methods described in Section 4.1.1
`incorporating subject motion. We recommend including a description of the
`characteristics of each motion including amplitudes, types, and frequencies of motion
`selected for testing in your test report.
`4.1.4 Testing for SpO2 accuracy under low perfusion for oximeters
`making low perfusion performance claims
`We recommend testing in accordance with Clause 201.12.1.103 of ISO 80601-2-61:2011.
`One recommended method is to verify the SpO2 accuracy under low perfusion conditions
`in vitro using a functional tester, set to the signal amplitude defined as low perfusion for
`the system (e.g., 0.3% modulation).
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`4.1.5 Testing for Pulse Rate Accuracy claims
`We recommend testing in accordance with Clause 201.12.1.104 of ISO 80601-2-61:2011.
`One recommended method is to test your system on the bench (using a functional tester)
`at the lowest pulse amplitude that the oximeter specifies as “normal.”
`4.1.6 Testing for Pulse Rate Accuracy for oximeters labeled with
`motion performance claims
`We recommend testing in accordance with Clause 201.12.1.102 of ISO 80601-2-61:2011.
`One potential approach is to use the methods described in Section 4.1.5 incorporating
`motion. We recommend including a description of the characteristics of each motion
`including amplitudes, types, and frequencies selected for testing.
`4.1.7 Testing for Pulse Rate Accuracy for oximeters labeled with low
`perfusion performance claims
`We recommend testing in accordance with Clause 201.12.1.103 of ISO 80601-2-61:2011.
`A recommended approach is to use the methods described in Section 4.1.5 with a
`functional tester, set to the signal amplitude defined as low perfusion for the system (e.g.,
`0.3% modulation).
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`4.2 Alarms
`We recommend you address the requirements of Clause 208 of ISO 80601-2-61:2011 or an
`equivalent method for visual and audible indicators and alarms of the monitor and any remote
`alarm unit.
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`4.3 Display values, outputs, and indicators
`We recommend you provide appropriate (e.g. clinical, bench) testing all of the data outputs,
`measurement values, and indicators that the device incorporates and displays on the monitor
`(e.g., perfusion index, signal strength, pulse amplitude). We recommend the test procedure
`include:
`the test method,
`•
`the objectives of the testing,
`•
`the equipment used, the tests specifications,
`•
`the standards to which conformance is demonstrated,
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`the pass/fail criteria, and
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`the summary of the results including an analysis explaining the significance of the
`•
`results.
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`Please also note Clause 201.12.4 of ISO 80601-2-61:2011 Protection against hazardous
`output for considerations regarding data update period and signal inadequacy.
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`4.4 Saturation pulse information signal
`If your device includes a variable-pitch auditory information signal to indicate the pulse
`signal, we recommend the pitch change follow Clause 201.103 of ISO 80601-2-61:2011 or
`equivalent method.
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`5. Software Information
`Please refer to “Guidance for the Content of Premarket Submissions for Software Contained in
`Medical Devices,” issued May 11, 2005, for a discussion of the software documentation that we
`recommend you provide. Please refer to the guidance “General Principles of Software
`Validation,” issued January 11, 2002, for software development practices. FDA generally
`considers pulse oximeters to be of “Moderate” level of concern for the purposes of software
`review.
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`If the device includes off-the-shelf software, we recommend you provide the additional
`information as recommended in the guidance, “Off-the-Shelf Software Use in Medical Devices,”
`issued September 9, 1999.
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`6. Electrical, Mechanical, and Environmental Safety
`We recommend you follow safety testing for Type BF or CF applied part as referenced in ISO
`80601-2-61:2011. Specifically, we recommend you address the requirements of Clauses 201.4 to
`201.11 and 201.13 to 201.16 of ISO 80601-2-61:2011.
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`7. Electromagnetic Compatibility
`Electromagnetic compatibility (EMC) is the ability of a device to operate properly in its intended
`environment of use without introducing excessive electromagnetic disturbances into that
`environment. We recommend you address the requirements of Clauses 201.17 and 202 of ISO
`80601-2-61:2011.
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`8. Biocompatibility
`We recommend that you provide a list of the patient-contacting materials in your device. You
`should evaluate the biocompatibility of the patient-contacting materials as described in the FDA
`guidance on the “Use of International Standard Organization (ISO) Standard ISO-10993,
`‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” issued May 1, 1995.
`We consider pulse oximeters devices with prolonged contact duration due to the potential for
`cumulative use. We consider the components that contact the patient to be surface contacting
`components with skin contact. We recommend testing include:
`irritation or intracutaneous reactivity;
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`• sensitization; and
`• cytotoxicity.
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`Materials are considered identical if they have the identical chemical formulation and identical
`manufacturing processes. If identical materials are used in a predicate device with the same type
`and duration of patient contact, you may identify the predicate device in lieu of performing
`biocompatibility testing.
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`9. Cleaning, Disinfection, and Sterilization
`We recommend you provide information on cleaning, disinfection, and sterilization for all pulse
`oximeters intended for reuse (both single patient and multi-patient).
`
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`9.1 Reuse Instructions and Validation
`For pulse oximeter systems and accessories intended for reuse, we recommend you evaluate
`the instructions for cleaning and, as appropriate, disinfection or sterilization.
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`If the device is intended to be cleaned, high-level disinfected, or sterilized by the user for
`multiple use, we recommend you demonstrate that the device can be cleaned, high-level
`disinfected, or sterilized according to the instructions provided in the device labeling; and
`that afterwards, the device continues to perform as intended.
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`In order to demonstrate that the labeled cleaning and disinfection or sterilization methods
`achieve the desired results, refer to the FDA guidance, “Labeling Reusable Medical Devices
`for Reprocessing in Healthcare Facilities,” issued April 1996, for additional
`recommendations.
`
` Sterilization Documentation
`9.2
`If the pulse oximeter system or accessories are provided sterile, we recommend you include
`the documentation described in “Updated 510(k) Sterility Review Guidance K90-1,” issued
`August 30, 2002.
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`You should also provide a description of the packaging system and the method used to
`validate that the packaging maintains sterility, but not the validation data itself (for more
`information on packaging testing, see ANSI/AAMI/ISO 11607-1-2:2006 Packaging for
`terminally sterilized medical devices – Parts 1 and 2). We recommend you identify the
`proposed shelf life and provide testing of aged samples to demonstrate that the sterility and
`device functionality are maintained over the expected shelf life.
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`10. Labeling
`The premarket notification must include labeling in sufficient detail to satisfy the requirements of
`21 CFR 807.87(e). Use the following suggestions for assistance in preparing labeling that
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`satisfies the requirements of 21 CFR 807.87(e).3 In addition, we recommend you conform to the
`labeling recommendations in Clause 201.7 of ISO 80601-2-61:2011.
`10.1 Intended Use
`The intended use should identify:
`• patient population(s);
`• spot checking or continuous monitoring;
`• application sites;
`• conditions of use such as motion and low perfusion, if applicable;
`• whether the device is intended for single use or reuse; and
`• environments of use.
`
`
`
`10.2 Instructions for Use
`As a prescription device, according to 21 CFR 801.109, the device is exempt from having
`adequate directions for lay use. Nevertheless, we recommend you provide clear and concise
`instructions that delineate the technological features of your device and how it is used on
`patients. Instructions should encourage local/institutional training programs designed to
`familiarize users with the features of the device and how to use it in a safe and effective
`manner. We recommend you conform to Clause 201.7 of ISO 80601-2-61:2011 for
`information to be included in the instructions for use. This includes but is not limited to:
`• all applicable safety information, warnings, cautions, and notes;
`• a description of your pulse oximeter system including the theory of operation
`(functional oxygen saturation or fractional oxyhemoglobin, etc.), sensor
`configuration/geometry, all features, alarms, and accessories;
`• an identification of whether the system and accessories are provided sterile or non-
`sterile;
`• device setup and operation information;
`instructions for the frequency of inspection of the application site for skin integrity;
`•
`instructions for the frequency of sensor relocation; and
`•
`• device service and maintenance information, including cleaning and disinfection
`instructions for reusable pulse oximeters and accessories (please also see Section 9.1
`above).
`
`
`
`10.3 Device Specifications
`We recommend you conform to Clauses 201.7.9.2.1.101, 201.7.9.2.14.101, and
`201.12.1.101.1 of ISO 80601-2-61:2011 for reporting device specifications in the labeling.
`
`3 Although final labeling is