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
`
`October 21, 2016
`
`BTL Industries, Inc.
`Jan Zarsky
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K160992
`Trade/Device Name: HPM-6000
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: IPF
`Dated: March 21, 2016
`Received: April 8, 2016
`
`Dear Jan Zarsky:
`
`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); medical device reporting (reporting of medical device-
`related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
`
`LUMENIS EX1021
`Page 1
`
`

`

`Page 2
`
`- Jan Zarsky
`
`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), 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 yours,
`
`William J.
`Heetderks -A
`
`Digitally signed by William J. Heetderks -
`A
`DN: c=US, o=U.S. Government, ou=HHS,
`ou=NIH, ou=People,
`0.9.2342.19200300.100.1.1=0010149848,
`cn=William J. Heetderks -A
`Date: 2016.10.21 16:12:18 -04'00'
`
`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 EX1021
`Page 2
`
`

`

`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`Food and Drug Administration
`Indications for Use
`
`Form Approved: OMB No. 0910-0120
`Expiration Date: January 31, 2017
`See PRA Statement below.
`
`510(k) Number (if known)
`K160992
`
`Device Name
`HPM-6000
`
`Indications for Use (Describe)
`The HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of
`medical diseases and conditions.
`
`The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or
`arms for rehabilitative purposes.
`
`Indications for Use for Muscle Stimulators:
`• Relaxation of muscle spasms
`• Prevention or retardation of disuse atrophy
`• Increasing local blood circulation
`• Muscle re-education
`• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
`• Maintaining or increasing range of motion
`
`Type of Use (Select one or both, as applicable)
`Prescription Use (Part 21 CFR 801 Subpart D)
`
`Over-The-Counter Use (21 CFR 801 Subpart C)
`
`CONTINUE ON A SEPARATE PAGE IF NEEDED.
`
`This section applies only to requirements of the Paperwork Reduction Act of 1995.
`*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
`The burden time for this collection of information is estimated to average 79 hours per response, including the
`time to review instructions, search existing data sources, gather and maintain the data needed and complete
`and review the collection of information. Send comments regarding this burden estimate or any other aspect
`of this information collection, including suggestions for reducing this burden, to:
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer
`Paperwork Reduction Act (PRA) Staff
`PRAStaff@fda.hhs.gov
`“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`information unless it displays a currently valid OMB number.”
`
`FORM FDA 3881 (8/14)
`
`Page 1 of 1
`
`PSC Publishing Services (301) 443-6740 EF
`
`LUMENIS EX1021
`Page 3
`
`

`

`
`
`510(k) Summary
`K160992/S001
`
`
`
`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
`
`Jan Zarsky
`Director
`BTL Industries, Inc.
`zarskyj@btlnet.com
`
`October 21, 2016
`
`
`
`Device Name
`Trade/Proprietary Name:
`Primary Classification Name:
`Classification Regulation:
`Classification Product Code:
`
`HPM-6000
`Stimulator, Muscle, Powered
`21 CFR 890.5850, Class II
`IPF
`
`Legally Marketed Predicate Devices
`The HPM-6000 is a state-of-the-art magnetic device with accessories, and is substantially
`equivalent to its predicate that is already cleared for distribution in the USA under the
`following 510(k) Premarket Notification number:
`
`
`0 – Page 1 of 6
`
`LUMENIS EX1021
`Page 4
`
`

`

`
`
`0 510(K) SUMMARY
`
`• Neotonus MS-101 Magnetic Muscle Stimulator System (K973929)
`
`Product Description
`The HPM-6000 is a non-invasive therapeutic device. The device produces electromagnetic
`field that interacts with the tissues of the human body, while mainly affected structures are
`muscular, collagenous, and neuronal tissue. The electromagnetic field is delivered in the
`subdermal, muscular or collagenous tissue area triggering the stimulation and relaxation. The
`subject device does not use electroconductive media.
`
`The HPM-6000 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.
`
`Intended Use
`The HPM-6000 device is intended to be used under medical supervision for adjunctive
`therapy for the treatment of medical diseases and conditions.
`
`The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk
`muscle excitation in the legs or arms for rehabilitative purposes.
`
`Indications for Use for Muscle Stimulators:
`• Relaxation of muscle spasms
`• Prevention or retardation of disuse atrophy
`•
`Increasing local blood circulation
`• Muscle re-education
`•
`Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
`• Maintaining or increasing range of motion
`
`Non-clinical Testing
`The HPM-6000 device has been thoroughly evaluated for electrical safety. The HPM-6000
`has been found to comply with the following applicable medical device safety standards:
`ISO 14971
`Medical devices – Application of risk management to medical devices
`IEC 62304
`Medical device software – Software life cycle processes
`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
`
`
`0 – Page 2 of 6
`
`LUMENIS EX1021
`Page 5
`
`

`

`
`
`0 510(K) SUMMARY
`
`IEC 62366
`
`ISO 10993-1
`
`ISO 10993-5
`
`IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
`basic safety and essential performance – Collateral standard: Usability
`Medical devices - Application of usability engineering to medical
`devices
`Biological evaluation of medical devices – Part 1: Evaluation and
`testing within a risk management process
`Biological evaluation of medical devices – Part 5: Tests for in vitro
`cytotoxicity
`Biological evaluation of medical devices – Part 10: Tests for irritation
`and skin sensitization
`
`ISO 10993-10
`
`Clinical testing
`The substantial equivalence determination for the HPM-6000 is not based on clinical testing.
`The device safety and efficacy was demonstrated by performance data and comparison of
`technical characteristics between the HPM-6000 and the predicate device.
`
`Summary of Clinical and Non-clinical testing
`Nonclinical test have been conducted to evaluate the HPM-6000 performance, and results
`confirm that the device performs as intended and in a similar manner compared to the
`predicate. Thus, the HPM-6000 is substantially equivalent to the predicate devices.
`
`Comparison with the Predicate Device
`
`510(k) number
`Device name
`
`
`Company name
`
`K160992
`HPM-6000
`
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Discussion
`
`Product Code
`and Regulation
`
`Intended Use
`
`Physical Medicine
`21 CFR 890.5850
`IPF – Stimulator, Muscle,
`Powered
`
`Physical Medicine
`21 CFR 890.5850
`IPF – Stimulator, Muscle,
`Powered
`
`The HPM-6000 device is
`intended to be used under
`medical supervision for
`adjunctive therapy for the
`treatment of medical diseases
`and conditions.
`The HPM-6000 device is
`indicated for use in stimulating
`neuromuscular tissue for bulk
`
`The Neotonus MS-101
`Magnetic Muscle Stimulator
`System is intended to be used
`under medical supervision for
`adjunctive therapy for the
`treatment of medical diseases
`and conditions.
`The Neotonus MS-101 is
`indicated for use in stimulating
`
`None
`
`None
`
`
`0 – Page 3 of 6
`
`LUMENIS EX1021
`Page 6
`
`

`

`510(k) number
`Device name
`
`
`Company name
`
`
`
`0 510(K) SUMMARY
`
`Discussion
`
`K160992
`HPM-6000
`
`
`BTL Industries, Inc.
`muscle excitation in the legs
`or arms for rehabilitative
`purposes.
`
`Indications for Use for Muscle
`Stimulators:
`• Relaxation of muscle
`spasms
`• Prevention or retardation
`of disuse atrophy
`• Increasing local blood
`circulation
`• Muscle re-education
`• Immediate post-surgical
`stimulation of calf
`muscles to prevent
`venous thrombosis
`• Maintaining or increasing
`range of motion
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`neuromuscular tissue for bulk
`muscle excitation in the legs or
`arms for rehabilitative
`purposes.
`Indications for Use for Muscle
`Stimulators:
`• Relaxation of muscle
`spasms
`• Prevention or retardation
`of disuse atrophy
`• Increasing local blood
`circulation
`• Muscle re-education
`• Immediate post-surgical
`stimulation of calf
`muscles to prevent
`venous thrombosis
`• Maintaining or increasing
`range of motion
`
`Electrical
`Protection
`
`Class II, BF
`
`Class II
`
`Interface
`
`Touch-screen
`
`Graphical Display
`
`Type of Energy
`
`Magnetic field
`
`Magnetic field
`
`Type of
`Applicator
`
`Number of
`Magnetic Coils
`in the Applicator
`
`Number of
`Applicators
`
`Color Touch
`Screen
`
`Single magnetic coil
`
`Single magnetic coil
`
`1
`
`2
`
`8.4 in
`21.3 cm
`800×400 pixel
`
`1
`
`1
`
`Unknown
`
`Type of Operation Continuous
`
`Continuous
`
`Pulse Repetition
`Rate
`
`1 – 150 Hz
`
`1 – 55 Hz
`
`
`0 – Page 4 of 6
`
`None
`
`Similar, not
`significantly
`different
`
`None
`
`None
`
`None
`
`None
`
`N/A
`
`None
`
`Similar
`Please see the
`discussion and
`
`LUMENIS EX1021
`Page 7
`
`

`

`510(k) number
`Device name
`
`K160992
`HPM-6000
`
`Company name
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Magnetic Field
`Intensity
`
`299-1 applicator: 0.5 – 1.8 T
`299-2 applicator: 0.7 – 2.5 T
`
`Up to 2.2 T
`
`Pulse Duration
`(±20 %)
`
`280 µs
`
`Pulse Amplitude
`
`0 – 100 %
`
`Therapy Time
`
`Up to 60 min
`
`Operating
`Temperature
`
`10–30 °C
`
` 275 µs
`
`0 – 100 %
`
`30, 60 min
`
`5–30 °C
`
`Operating
`Humidity
`
`30–75 %
`
`20–75 %
`
`0 510(K) SUMMARY
`
`Discussion
`
`conclusion
`below.
`
`Similar, not
`significantly
`different
`
`None
`
`None
`
`None
`
`Similar, not
`significantly
`different
`
`Similar, not
`significantly
`different
`
`Shape of
`Stimulation Pulse Sine, biphasic
`
`Sine, biphasic
`
`None
`
`Energy Source
`
`100 – 240 V AC, 50 – 60 Hz,
`max 14 A
`
`110 V AC, 50 – 60 Hz, 12 A
`
`None
`
`External
`Exchangeable
`Fuse
`
`Yes
`
`Yes
`
`None
`
`System
`Dimensions
`(W×H×D)
`
`500×970×580 mm
`
`500×580×230 mm
`
`(20×38×23 in)
`
`(20×23×9 in)
`
`System Weight
`
`33 kg (73 lb)
`
`28 kg (61 lb)
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`0 – Page 5 of 6
`
`LUMENIS EX1021
`Page 8
`
`

`

`510(k) number
`Device name
`
`K160992
`HPM-6000
`
`Company name
`
`BTL Industries, Inc.
`
`K973929
`Neotonus MS-101
`Magnetic Muscle
`Stimulator System
`Neotonus, Inc.
`
`Position
`
`Vertical – On castors
`
`Horizontal
`
`0 510(K) SUMMARY
`
`Discussion
`
`Similar, not
`important for
`the device
`safety and
`effectiveness
`evaluation
`
`The HPM-6000 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 predicate devices includes
`pulse repetition rate. Therefore, K952089, a powered muscle stimulator cleared under the IPF
`product code (predicate of the predicate or K952089) has been submitted to demonstrate that
`safety and effectiveness are not adversely affected. K952089 or Rich-Mar CM-II Muscle
`Stimulator has pulse repetition range rate of 2-200 Hz, compared to 0-150 Hz for HPM-6000,
`the subject device. The mechanism of action of the electrical stimulator and this kind of
`magnetic device is the same. The nerve gets stimulated by electrical current and while the
`method of delivery is the different (magnetic induction), it is still the same current delivered to
`the tissue that stimulates the nerve endings on a similar frequency.
`
`The technological differences between the HPM-6000 and predicate device, do not raise new
`types of safety or effectiveness questions.
`
`The non-clinical test results confirm that the depth of tissue penetration does not differ and
`pulse repetition rate works in a similar manner compared to the predicate. Thus, the HPM-
`6000 is substantially equivalent to the predicate devices.
`
`Substantial Equivalence
`Based upon the intended use and known technical information provided in this pre-market
`notification, the HPM-6000 device has been shown to be substantially equivalent to currently
`marketed predicate device.
`
`Conclusion
`Based on the aforementioned information, the HPM-6000 is safe and effective and
`substantially equivalent to the identified predicate device.
`
`0 – Page 6 of 6
`
`LUMENIS EX1021
`Page 9
`
`