DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - WO66-G609
`Silver Spring, MD 20993-0002
`
`February 16, 2017
`
`BTL Industries, Inc.
`David Chmel
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K163165
`Trade/Device Name: AM-100
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: NGX
`Dated: January 16, 2017
`Received: January 17, 2017
`
`Dear Mr. Chmel:
`
`We have reviewed your Section 510(k) premarket 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: CDRH 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 II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
`
`Please be advised that FDA's issuance of a 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 and Part 809; medical device reporting (reporting of
`
`LUMENIS EX1020
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`Page 2
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`- David Chmel
`
`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 531-542 of the Act); 21 CFR 1000-
`1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and
`Part 809), please contact the Division of Industry and Consumer Education at its toll-free number
`(800) 638-2041 or (301) 796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
`the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
`807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
`CFR Part 803), please go to
`http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
`796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely,
`
`Michael J. Hoffmann -S
`
`for
`
`Carlos L. Peña, PhD, MS
`Director
`Division of Neurological
`and Physical Medicine Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`LUMENIS EX1020
`Page 2
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`Page 1 of 1
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`36& 3XEOLVKLQJ 6HUYLFHV 

 ()
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`LUMENIS EX1020
`Page 3
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`

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`
`
`510(k) Summary
`
`
`
`General Information
`
`Sponsor:
`
`
`
`
`
`Applicant:
`
`
`
`
`
`Contact Person:
`
`
`
`Summary Preparation
`Date:
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`David Chmel
`BTL Industries, Inc.
`chmel@btlnet.com
`
`February 16, 2017
`
`Device Name
`
`
`
`Trade/Proprietary Name:
`
`AM-100
`
`Primary Classification Name:
`
`Stimulator, Muscle, Powered
`
`Classification Regulation:
`
`21 CFR 890.5850, Class II
`
`Classification Product Code:
`
`NGX
`
`
`
`Legally Marketed Predicate Devices
`
`The AM-100 is a state-of-the-art magnetic device with accessories, and is substantially
`equivalent to the current product that is already cleared for distribution in the USA under the
`following 510(k) Premarket Notification number:
`
` Torc Body (K131291)
`
`
`
`
`510(k) Summary - Page 1 of 6
`
`LUMENIS EX1020
`Page 4
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`

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`
`
`
`
`The HPM-6000 device was used as a reference device to support the determination of
`substantial equivalence. The HPM-6000 is cleared (K160992) as a PMS device because it
`elicits a muscle contraction.
`
`Product Description
`
`The AM-100 is a non-invasive therapeutic device. The device produces electromagnetic field
`that interacts with the tissues of the human body. By muscle stimulation, the AM-100 helps to
`strengthen and firm the abdomen, buttocks and thighs.
`
`The AM-100 is equipped with a color touch screen with wide view angle that significantly
`facilitates the use of the device. The on-screen information guides the user step-by-step
`through the entire therapy procedure. The therapeutic parameters are easily set using the
`touch screen, buttons and knob on the device. During the therapy the device keeps
`information about the applied therapy type, remaining therapy time and main therapy
`parameters on the screen.
`
`The AM-100 device has already been cleared by the FDA for muscle stimulation under the
`device name HPM-6000 (K160992).
`
`Indications for Use
`
`AM-100 is indicated to be used for:
`
`• Improvement of abdominal tone, strengthening of the abdominal muscles,
`
`development of firmer abdomen.
`
`
`
`• Strengthening, Toning and Firming of buttocks and thighs.
`
`Non-clinical Testing
`
`The AM-100 device has been thoroughly evaluated for electrical safety. The device has been
`found to comply with the following applicable medical device safety standards:
`
`
`
`IEC 60601-1
`
`Medical electrical equipment – Part 1: General requirements for basic
`safety and essential performance
`
`IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for
`basic safety and essential performance - Collateral standard:
`Electromagnetic compatibility – Requirements and tests
`
`IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
`basic safety and essential performance – Collateral standard: Usability
`
`IEC 60601-2-10 Medical Electrical Equipment – Part 2-10: Particular Requirements for
`the Basic Safety and Essential Performance of Nerve and Muscle
`Stimulators
`
`
`
`510(k) Summary – Page 2 of 6
`
`LUMENIS EX1020
`Page 5
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`

`

`IEC 62366
`
`Medical devices - Application of usability engineering to medical
`devices
`
`IEC 62304
`
`Medical device software – Software life cycle processes
`
`ISO 14971
`
`Medical devices – Application of risk management to medical devices
`
`Clinical testing
`
`The substantial equivalence determination for the AM-100 is not based on clinical testing.
`The device safety and efficacy was demonstrated by comparison of technical characteristics
`between the AM-100 and the predicate device.
`
`Summary of Clinical and Non-clinical testing
`
`Nonclinical test have been conducted to evaluate the AM-100 performance, and results
`confirm that the device performs as intended and in a similar manner compared to the
`predicate. Thus, the AM-100 is substantially equivalent to the predicate devices.
`
`Comparison with the Predicate Device
`
`510(k) number
`
`Not Assigned
`
`Device name
`
`AM-100
`
`K131291
`
`Torc Body
`
`Significant
`Difference
`
`Company name
`
`BTL Industries, Inc.
`
`Johari Digital HealthCare
`Ltd.
`
`Product Code
`and Regulation
`
`Physical Medicine
`
`Physical Medicine
`
`21 CFR 890.5850
`
`21 CFR 890.5850
`
`NGX – Stimulator, Muscle,
`Powered, Muscle
`Conditioning
`
`NGX – Stimulator, Muscle,
`Powered, Muscle
`Conditioning
`
`None
`
`510(k) Summary – Page 3 of 6
`
`LUMENIS EX1020
`Page 6
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`

`

`
`
`
`
`510(k) number
`
`Not Assigned
`
`K131291
`
`Device name
`
`Company name
`
`AM-100
`
`BTL Industries, Inc.
`
`Torc Body
`
`Johari Digital HealthCare
`Ltd.
`
`Significant
`Difference
`
`Indications for
`Use
`
`AM-100 is indicated to be
`used for:
` Improvement of
`abdominal tone,
`strengthening of the
`abdominal muscles,
`development of firmer
`abdomen.
` Strengthening, Toning
`and Firming of buttocks
`and thighs.
`
`TORC BODY is indicated to
`be used for:
` Improvement of abdominal
`tone, for strengthening of
`the abdominal muscles,
`for development of firmer
`abdomen.
` Strengthening, Toning and
`Firming of buttocks and
`thighs.
`
`None
`
`Primary Function Muscle stimulation
`
`Muscle stimulation
`
`None
`
`Principle of
`Action
`
`Initiating action potential of
`nerves results in muscle
`contraction
`
`Initiating action potential of
`nerves results in muscle
`contraction
`
`None
`
`Clinical Use
`
`Prescription use
`
`Home use
`
`Electrical
`Protection
`
`Class II, BF
`
`Class II, BF
`
`User Interface
`
`Touch screen
`
`Touch screen
`
`Firmware
`Controlled
`
`Yes
`
`Yes
`
`Type of Energy
`
`Magnetic field
`
`Electrical
`
`Magnetic Field
`Intensity
`
`Applicator 299-1: 0.5–1.8 T
`
`Applicator 299-2: 0.7–2.5 T
`
`N/A
`
`Not
`Significantly
`different
`
`None
`
`None
`
`None
`
`Not
`Significantly
`different
`
`N/A
`
`Type of Operation Continuous
`
`Continuous
`
`None
`
`Pulse Repetition
`Rate
`
`1 – 150 Hz
`
`1 - 200 Hz
`
`Not
`significantly
`different
`
`
`
`510(k) Summary – Page 4 of 6
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`

`
`
`
`
`510(k) number
`
`Not Assigned
`
`K131291
`
`Device name
`
`Company name
`
`AM-100
`
`BTL Industries, Inc.
`
`Torc Body
`
`Johari Digital HealthCare
`Ltd.
`
`Significant
`Difference
`
`Pulse Duration
`
`280 ± 20% µs
`
`290 µs
`
`Pulse Amplitude
`
`0 – 100%
`
`0 – 100%
`
`Current Strength
`
`N/A
`
`Up to 102 mA
`
`Induced Current
`in the Tissue
`
`28-30 mA
`
`28 mA
`
`Selection of
`parameters
`(Intensity, Time)
`
`Yes
`
`Yes
`
`Therapy Time
`
`Up to 60 min
`
`1 – 60 min
`
`Shape of
`Stimulation Pulse
`
`Symmetrical Biphasic Sine
`Wave
`
`Symmetrical Biphasic
`Square Wave
`
`Energy Source
`
`100 – 240 V AC, 50–60 Hz
`
`24 V DC Battery pack and
`
`Adaptor: 100 – 240 V AC,
`50–60 Hz
`
`None
`
`None
`
`N/A
`
`Not
`significantly
`different
`
`None
`
`None
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`System
`Dimensions
`(W×H×D)
`
`Ambient
`Temperature
`
`Environmental
`Specifications
`
`
`
` 500×970×580 mm
`
`152x102x203 mm
`
`(20×38×23 in)
`
`(6×4×8 in)
`
`-10°C to +55°C
`
`0°C to +44°C
`
`For indoor use only
`
`For indoor use only
`
`None
`
`Substantial Equivalence
`
`The AM-100 device has the same indications for use and similar technological characteristics
`and principles of operation as its predicate device.
`
`One of the technological differences between the subject and the predicate device includes
`type of energy used. However, the mechanism of action of the electrical stimulator and this
`
`
`
`510(k) Summary – Page 5 of 6
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`

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`kind of magnetic device is the same. Further, the predicate device is intended for a home
`use, while the subject device is intended for prescription use only. There are devices with a
`similar technology that are already cleared by the FDA as a prescription use devices. The
`AM-100 device and its predicate device differ in the shape of stimulation pulse, however that
`feature does not influence the muscle contraction stimulation. The last technological
`difference between the subject and the predicate device is pulse repetition rate. The pulse
`repetition rate of the subject device is within the range of the commonly used ones for
`devices intended for muscle stimulation.
`
`The energies coming out of the devices can not be directly compared due to the fact the
`predicate device is a contact one while the subject device is the non-contact device.
`Comparable are electrical currents induced directly in the targeted tissue.
`
`The current induced by the magnetic field (subject device) is almost identical compared to the
`predicate device.
`
`The technological differences between the AM-100 and the predicate device do not raise new
`types of safety or effectiveness questions.
`
`Conclusion
`
`Based upon the intended use and known technical information provided in this pre-market
`notification, the AM-100 device has been shown to be substantially equivalent to currently
`marketed predicate device.
`
`510(k) Summary – Page 6 of 6
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