INO Therapeutics/Ilkaria Premarket Notification
`
`510(k) Summary
`
`APR 15 20 10
`
`r,,3~~
`INOmax DS
`
`In accordance with 21 CFR 807.92 the following summary of information is provided:
`Date: December 18, 2009
`Submitter:
`[NO Therapeutics/Ikaria
`2902 Dairy Drive
`Madison, Wisconsin 53718
`
`Primary Contact Person: Larry Lepley
`Associate Director, Regulatory Affairs
`ff40 Therapeutics/Ikaria
`T: 608-226-3415
`F: 608-226-3402
`
`Secondary Contact Person: David Trueblood
`Director, Regulatory Affairs
`ffN0 Therapeutics/Ikaria
`T: 608-395-3910
`F: 608-226-3402
`
`Device: Trade Name:
`
`INOmax DS (Delivery System)
`
`Common/Usual Name: Nitric Oxide Administration Apparatus (primary)
`Nitric Oxide Administration Apparatus, Back-up System
`Nitric Oxide Analyzer
`Nitrogen Dioxide Analyzer
`
`Classification Names: Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric Oxide
`Backup Delivery, Class 11 -21 CFR 868.5165
`Product Code: MRN ( rimary), MRQ, MRP, MRQ
`
`Predicate Device s): K061901; INOrnax DS (Delivery System)
`
`Device Description: The INOmax D52 uses *a "dual-channel' design to ensure the safe
`delivery of llNOmax. The first channel has the delivery CPU, the
`flow controller and the injector module to ensure the accurate
`delivery of NO. The second channel is the monitoring system,
`which includes a separate monitor CPU, the gas cells (NO, NO 2,
`and 02 cells) and the user interface including the display and
`alarms. The dual-channel approach to delivery and monitoring
`permits INOmax delivery independent of monitoring but also
`allows the monitoring system to shutdown INOrnax delivery if it
`detects a fault in the delivery system such that the NO
`
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`Page 143 of 159
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`001
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`

`
`INO Therapeutics/Ikaria Premnarket Notification
`
`INOrnax DS
`
`concentration could become greater than 1 00 ppm.
`
`Intended Use: The INOmax DS delivery system delivers INOmaxg® (nitric
`oxide of inhalation) therapy gas into the inspiratory limb of the
`patient breathing circuit in a way that provides a constant
`concentration of nitric oxide (NO), as set by the user, to the
`patient throughout the inspired breath. It uses a specially
`designed injector module, which enables tracking of the ventilator
`waveforms and the delivery of a synchronized and proportional
`dose of NO. It may be used with most ventilators.
`The INOmax DS provides continuous integrated monitoring of
`inspired 02, NO 2, and NO, and a comprehensive alarm system.
`The INOmax DS incorporates a battery that pmovides up to 6
`hours of uninterrupted NO delivery in the absence of an external
`power source.
`The INOmax DS includes a backup NO delivery capability that
`provides a fixed flow of 250 mL/min of NO which along with
`user supplied 10 L/min of oxygen provides 20 ppm in the gas
`flow to a patients breathing circuit. It may also use the
`INOblender for backup.
`The target patient population is controlled by the drug labeling
`for INOmax and is currently neonates. The primary targeted
`clinical selling is the Neonatal Intensive Care Unit (NICU) and
`secondary targeted clinical setting, is the transport of neonates.
`
`Technology: All revisions of INOmax DS utilize component technology to
`deliver Nitric Oxide gas to the patient. The components consist of
`the Delivery System unit, the blender, a stand/cart and the NO gas
`tanks. In this revision the INOmax DS technological
`characteristic of design has changed with the inclusion of patient
`data storage and additional operation alarms. This modification of
`design does not affect the intent of INOmax DS in the delivery of
`NO gas for the target population of neonatal patients. The patient
`data storage was included for patient administration and the
`additional alarms were added to aid in the safe administration of
`the NO gas.
`The fundamental scientific technology remains the same in the
`concept of the INOmax DS. The proposed INOmax DS includes
`ergonomic changer related to two specific areas of use;
`data collection for the collection of patient
`-
`parameters/device usage
`additional notifications/alerts (visual and audible) to alert
`the user of operational events.
`These additional functions required the TNOmax DS to be
`modified to accommodate the additional components for data
`
`-
`
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`

`
`INO Therapeutics/Ikaria Premnarket Notification
`
`INOrnax DS
`
`transfer utilizing Infrared communication and the change in the
`Graphic User Interface (GUI) for visual notifications.
`Determination of Summary of Non-Clinical Tests:
`Substantial Eqiuivalence: The INOmax DS and its applications comply with voluntary
`standards as detailed
`in Section 9 and 17 of this premnarket
`submission.
`The hardware changes made to the INOmax DS, to implement the
`INOmax DS infrared features consisted of adding additional
`hardware to provide infrared communications to an INOmeter
`mounted on the INOmax DS gas cylinders. The new hardware
`did not change the original hardware which controlled all the
`original INOmax DS functions. The additional electrical
`connections to the original hardware were connections to the
`common power source and a serial data link connected to the
`battery and the monitoring processor. Thus, no extensive
`retesting of the original rNOmax DS was deemed necessary.
`
`The SVRS testing, the summary of which is described in
`appendix J of this submission, thoroughly tested all requirements
`of the software, including the NO delivery and gas monitoring
`performance. The successful completion of these tests
`demonstrated that the INOmax DS (Version 2) met the
`performance requirements of the original product and the new
`requirements of the revised device.
`
`The INOmax DS revision complies to "Guidance Document for
`Premarket Notification Submissions for Nitric Oxide Delivery
`Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide
`Analyzer" (January 24, 2000) FDA-I 157
`
`The results of testing verified that the additional communication
`of patient data through Infrared transmission and additional
`alarms did not alter the safety or effectiveness of the rNOmax DS
`operation.
`Summary of Clinical Tests:
`The subject of this premarket submission, INOmax DS, did not
`require clinical studies to support substantial equivalence.
`[NO Therapeutics/Ikaria considers the INOmax DS to be as safe,
`as effective, and performance is substantially equivalent to the
`predicate device(s).
`
`Conclusion:
`
`19
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`Page 145 of 159
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`

`
`Public Health Ser vice
`
`Food and Drug Administration
`10903 Newv Hapsire Avenue
`Docunent Contr ol Rooiiu -W066-G609
`Silver Spriing, Nil) 20993-0002
`
`4 ~DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`APR I 5 010
`
`Mr. Larry Lepley
`Associate Director, Regulatory Affairs
`2902 Dairy Drive
`Madison, Wisconsin 53718
`United States
`
`Re: K093922
`[NOmnax DS
`Trade/Device Name:
`Regulation Number: 21 CFR 868.5165
`Regulation Name: Nitric Oxide Administration Apparatus
`Regulatory Class: 11
`Product Code: MRN, MIRO, MRLP, MRQ
`Dated: March 15, 201 0
`Received: March 16, 20 10
`
`Dear Mr. Larry Lepley:
`
`We have reviewed your Section 5 1 0(k) premnarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the
`indications for use stated in the enclosure) to legally marketed predicate devices marketed in
`interstate commerce prior to, May 28, 1976, the enactment date of the Medical Device
`Amendments, or to devices that have been reclassified in accordance with the provisions of
`the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket
`approval application (PMA). You may, therefore, market the device, subject to the general
`controls provisions of the Act. The general controls provisions of the Act include
`requirements for annual registration, listing of devices, good manufacturing practice,
`labeling, and prohibitions against misbranding and adulteration. Please note: CDRH4 does
`not evaluate information related to contract liability warranties. We remind you, however,
`that device labeling must be truthful and not misleading.
`
`If your device is classified (see above) into either class LI (Special Controls) or class Ill
`(PMA), it may be subject to additional controls. Existing major regulations affecting your
`device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In
`addition, FDA may publish further announcements concerning your device in the Federal
`Rep~ister.
`
`004
`
`

`
`lPage 2 -Mr. Lepley
`
`Please be advised that FDA's issuance of ai substantial equivalence determination does not
`mean that FDA has made a determination that your device complies with other requirements
`of the Act or any Federal statutes and regulations administered by other Federal agencies.
`You must comply with all the Act's requirements, including, but not limited to: registration
`and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting
`(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
`practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
`and if applicable, the electronic product radiation control provisions (Sections 53) 1-542 of
`the Act); 21 CFR 1000-1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
`please go to
`II 5809.lti
`for
`lhttp:/!www.fda.qov/AboutFDA/Ceinters~iflices/CDRH/CDIRHOff-ices/ucmi
`the Center for Devices and Radiological l-ealth's (CDRH-'s) Office of Compliance. Also,
`please note the regulation entitled, "Misbranding by reference to premarket notification"
`(2I CFR Part 807.97). F-or questions regarding the reporting of adverse events under the
`MDR regulation (21 CFR Part 803), please go to
`for the CDRH-'s
`lhttp://wwwv.fda.~,)ov/MedicalDevices/Safety/ReportaProbleim/default.htmi
`Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`You may obtain other general information on your responsibilities under the Act from the
`Division of Small Manufacturers, Interniational and Consumer Assistance at its toll-free
`number (800) 638-2041 or (301) 796-7.100 or at its Internet address
`lhttp://www.fdaszov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely yours,
`
`-1~~~~~~~~~e
`
`Anthony D. Watson, B.S., M.S., M.B.A.
`Division Director
`Division of Anesthesiology, General Hospital,
`Infection Control and Dental Devices
`*Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`005
`
`

`
`[NO0 Therapeutics/Ikaria Premnarket Notification
`
`INOnmax DS
`
`5 1 0(k) Number (if known):
`
`Device Name:
`
`INOmax DS
`
`Indications for Use:
`
`The INOmax DS delivery system delivers INOmax0 (nitric oxide of inhalation)
`therapy gas into the inspiratory limb of the patient breathing circuit in a way that
`provides a constant concentration of nitric oxide (NO), as set by the user, to the
`patient throughout the inspired breath. It uses a specially designed injector
`module, which enables tracking of the ventilator waveforms and the delivery of a
`synchronized and proportional dose of NO. It may be used with most ventilators.
`
`The INOmax DS provides continuous integrated monitoring of inspired 02, NO 2,
`and NO, and a comprehensive alarm system.
`
`The INOmax DS incorporates a battery that provides up to 6 hours of
`uninterrupted NO delivery in the absence of an external power source.
`
`The INOmax DS includes a backup NO delivery capability that provides a fixed
`flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen
`provides 20 ppm in the gas flow to a patients breathing circuit. It may also use
`the INOblender for backup.
`
`The target patient population is controlled by the drug labeling for INOmax and is
`currently neonates. The primary targeted clinical selling is the Neonatal Intensive
`Care Unit (NICU) and secondary targeted clinical setting is the transport of
`neonates.
`
`Prescription Use x
`(Part 21 CFR 801 Subpar D)
`
`AND/OR
`
`Over-The-Counter Use_
`(Part 21 CFR 801 Sub~part CT)
`
`(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
`IF NEEDED)
`
`Concurrence of CDRH, Office of Device Evaluation (ODE)
`
`(Division sign-Off)
`Division of Anesthesiology, General Hospital
`Infection Control, Dental Devices
`
`510(k) Number: C g3'7j
`
`1 5
`
`006