(196 days)
No
The summary does not mention any AI or ML capabilities, and the device description focuses on electromagnetic field stimulation and user interface for setting parameters.
Yes
The device description clearly states "The HPM-6000 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body". The intended use also mentions "adjunctive therapy for the treatment of medical diseases and conditions" and "rehabilitative purposes".
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the HPM-6000 device is for "adjunctive therapy for the treatment of medical diseases and conditions" and for "stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes." This indicates a therapeutic, not a diagnostic, purpose.
No
The device description explicitly states it is a "non-invasive therapeutic device" that "produces electromagnetic field" and is "equipped with a color touch screen with wide view angle that significantly facilitates the use of the device." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the HPM-6000 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a therapeutic device used for stimulating neuromuscular tissue for rehabilitation purposes. This involves direct interaction with the patient's body for treatment, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a non-invasive therapeutic device that produces an electromagnetic field to interact with tissues. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to apply energy to the body for therapeutic effect.
In summary, the HPM-6000 is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for 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
Product codes
IPF
Device Description
The HPM-6000 is a non-invasive therapeutic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs or arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under medical supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical 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.
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
- Medical electrical equipment Part 1-2: General requirements for IEC 60601-1-2 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 62366 Medical devices - Application of usability engineering to medical devices
- ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines extending downwards, resembling a wave or a stylized body.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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
2
Indications for Use
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) |
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a sans-serif font. The squares are a dark blue color, while the text is a dark gray.
510(k) Summary K160992/S001
General Information
| Sponsor: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | Jan Zarsky
Director
BTL Industries, Inc.
zarskyj@btlnet.com |
| Summary Preparation
Date: | October 21, 2016 |
Device Name
| Trade/Proprietary Name: | HPM-6000 |
|---|---|
| Primary Classification Name: | Stimulator, Muscle, Powered |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | 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:
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Image /page/4/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
- Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) .
Product Description
The HPM-6000 is a non-invasive therapeutic 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
- Medical electrical equipment Part 1-2: General requirements for IEC 60601-1-2 basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters B, T, and L, respectively. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62366 | Medical devices - Application of usability engineering to medical
devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization |
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.
| 510(k) number | K160992 | K973929 | Discussion |
|---|---|---|---|
| Device name | HPM-6000 | Neotonus MS-101 | |
| Magnetic Muscle | |||
| Stimulator System | |||
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| Product Code | |||
| and Regulation | Physical Medicine | ||
| 21 CFR 890.5850 | |||
| IPF - Stimulator, Muscle, | |||
| Powered | Physical Medicine | ||
| 21 CFR 890.5850 | |||
| IPF - Stimulator, Muscle, | |||
| Powered | None | ||
| 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 | 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 | ||
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101 | |
| Magnetic Muscle | |||
| Stimulator System | |||
| Company name | BTL Industries, Inc. | Neotonus, 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 | 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 | None |
| Interface | Touch-screen | Graphical Display | Similar, not |
| significantly | |||
| different | |||
| Type of Energy | Magnetic field | Magnetic field | None |
| Type of | |||
| Applicator | Single magnetic coil | Single magnetic coil | None |
| Number of | |||
| Magnetic Coils | |||
| in the Applicator | 1 | 1 | None |
| Number of | |||
| Applicators | 2 | 1 | None |
| Color Touch | |||
| Screen | 8.4 in | ||
| 21.3 cm | |||
| 800x400 pixel | Unknown | N/A | |
| Type of Operation | Continuous | Continuous | None |
| Pulse Repetition | |||
| Rate | 1 – 150 Hz | 1 – 55 Hz | Similar |
| Please see the | |||
| discussion and | |||
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101 | |
| Magnetic Muscle | |||
| Stimulator System | |||
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| conclusion | |||
| below. | |||
| Magnetic Field | |||
| Intensity | 299-1 applicator: 0.5 - 1.8 T | ||
| 299-2 applicator: 0.7 - 2.5 T | Up to 2.2 T | Similar, not | |
| significantly | |||
| different | |||
| Pulse Duration | |||
| (±20 %) | 280 μs | 275 μs | None |
| Pulse Amplitude | 0 – 100 % | 0 - 100 % | None |
| Therapy Time | Up to 60 min | 30, 60 min | None |
| Operating | |||
| Temperature | 10-30 °C | 5-30 °C | Similar, not |
| significantly | |||
| different | |||
| Operating | |||
| Humidity | 30-75 % | 20-75 % | 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 | ||
| (20×38×23 in) | 500×580×230 mm | ||
| (20×23×9 in) | Similar, not | ||
| important for | |||
| the device | |||
| safety and | |||
| effectiveness | |||
| evaluation | |||
| System Weight | 33 kg (73 lb) | 28 kg (61 lb) | Similar, not |
| important for | |||
| the device | |||
| safety and | |||
| effectiveness | |||
| evaluation | |||
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101 | |
| Magnetic Muscle | |||
| Stimulator System | |||
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| Position | Vertical - On castors | Horizontal | Similar, not |
| important for | |||
| the device | |||
| safety and | |||
| effectiveness | |||
| evaluation |
Comparison with the Predicate Device
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Image /page/6/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "BTL" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is gray in color.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside, followed by the text "BTL Industries" in a gray, sans-serif font. The squares are blue, and the text is gray. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other, with the letters "BTL" inside the innermost square.
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.