(196 days)
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
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.
The provided text is a 510(k) Summary for the HPM-6000 device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (Neotonus MS-101 Magnetic Muscle Stimulator System) rather than providing detailed acceptance criteria and a study proving those criteria are met for the HPM-6000 itself.
Specifically, the document states:
"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."
Therefore, most of the requested information cannot be extracted directly from this document, as it describes a comparison study, not a study specifically designed to prove acceptance criteria for the HPM-6000 as a standalone device.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for the HPM-6000's performance in a standalone study. Instead, it compares the HPM-6000's characteristics to a predicate device to establish substantial equivalence.
| Characteristic | HPM-6000 Performance (Reported for comparison) | Predicate Device (Neotonus MS-101) | Acceptance Criteria (Not explicitly stated for HPM-6000 performance) |
|---|---|---|---|
| Primary Classification Name | Stimulator, Muscle, Powered | Stimulator, Muscle, Powered | Same as predicate |
| Classification Regulation | 21 CFR 890.5850, Class II | 21 CFR 890.5850, Class II | Same as predicate |
| Intended Use | As described in document | As described in document | Same as predicate |
| Electrical Protection | Class II, BF | Class II | Similar to predicate |
| Interface | Touch-screen | Graphical Display | Similar, not significantly different |
| Type of Energy | Magnetic field | Magnetic field | Same as predicate |
| Type of Applicator | Single magnetic coil | Single magnetic coil | Same as predicate |
| Number of Magnetic Coils | 1 | 1 | Same as predicate |
| Number of Applicators | 2 | 1 | No new safety/effectiveness concerns |
| Color Touch Screen | 8.4 in, 21.3 cm, 800x400 pixel | Unknown | N/A (not a direct comparison point) |
| Type of Operation | Continuous | Continuous | Same as predicate |
| Pulse Repetition Rate | 1 – 150 Hz | 1 – 55 Hz | Similar, demonstrated by comparison to another predicate (K952089) with 2-200 Hz range. |
| Magnetic Field Intensity | 299-1: 0.5 - 1.8 T; 299-2: 0.7 - 2.5 T | Up to 2.2 T | Similar, not significantly different |
| Pulse Duration (±20 %) | 280 µs | 275 µs | Same as predicate |
| Pulse Amplitude | 0 – 100 % | 0 - 100 % | Same as predicate |
| Therapy Time | Up to 60 min | 30, 60 min | Similar |
| 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 | Same as predicate |
| Energy Source | 100 - 240 V AC, 50 - 60 Hz, max 14 A | 110 V AC, 50-60 Hz, 12 A | Similar |
| External Exchangeable Fuse | Yes | Yes | Same as predicate |
| System Dimensions | 500×970×580 mm (20×38×23 in) | 500×580×230 mm (20×23×9 in) | Similar, not important for safety/effectiveness |
| System Weight | 33 kg (73 lb) | 28 kg (61 lb) | Similar, not important for safety/effectiveness |
| Position | Vertical - On castors | Horizontal | Similar, not important for safety/effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The substantial equivalence determination for the HPM-6000 is not based on clinical testing."
Therefore, there is no human test set described in this document. The "test" here refers to non-clinical testing and comparison of technical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no human test set or clinical study to establish "ground truth" for diagnostic performance was conducted. The ground truth for device safety and performance is based on engineering testing and comparison to established standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human test set with expert adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The HPM-6000 is a physical medical device (muscle stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A true "standalone" clinical performance study for the HPM-6000, as an algorithm, was not done. The document states "The substantial equivalence determination for the HPM-6000 is not based on clinical testing." Instead, the device's technical specifications and non-clinical performance (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation) were evaluated as a standalone product relative to established standards and then compared to a predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing performed, the "ground truth" would be engineering specifications, adherence to international standards (e.g., ISO, IEC), and measurements of physical parameters. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device that requires a training set.
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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
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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
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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 DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | Jan ZarskyDirectorBTL Industries, Inc.zarskyj@btlnet.com |
| Summary PreparationDate: | 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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- 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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| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability |
|---|---|
| IEC 62366 | Medical devices - Application of usability engineering to medicaldevices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritationand 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-101Magnetic MuscleStimulator System | |
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| Product Codeand Regulation | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle,Powered | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle,Powered | None |
| Intended Use | The HPM-6000 device isintended to be used undermedical supervision foradjunctive therapy for thetreatment of medical diseasesand conditions.The HPM-6000 device isindicated for use in stimulatingneuromuscular tissue for bulk | The Neotonus MS-101Magnetic Muscle StimulatorSystem is intended to be usedunder medical supervision foradjunctive therapy for thetreatment of medical diseasesand conditions.The Neotonus MS-101 isindicated for use in stimulating | None |
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101Magnetic MuscleStimulator System | |
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| muscle excitation in the legsor arms for rehabilitativepurposes.Indications for Use for MuscleStimulators:• Relaxation of musclespasms• Prevention or retardationof disuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis• Maintaining or increasingrange of motion | neuromuscular tissue for bulkmuscle excitation in the legs orarms for rehabilitativepurposes.Indications for Use for MuscleStimulators:• Relaxation of musclespasms• Prevention or retardationof disuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis• Maintaining or increasingrange of motion | ||
| ElectricalProtection | Class II, BF | Class II | None |
| Interface | Touch-screen | Graphical Display | Similar, notsignificantlydifferent |
| Type of Energy | Magnetic field | Magnetic field | None |
| Type ofApplicator | Single magnetic coil | Single magnetic coil | None |
| Number ofMagnetic Coilsin the Applicator | 1 | 1 | None |
| Number ofApplicators | 2 | 1 | None |
| Color TouchScreen | 8.4 in21.3 cm800x400 pixel | Unknown | N/A |
| Type of Operation | Continuous | Continuous | None |
| Pulse RepetitionRate | 1 – 150 Hz | 1 – 55 Hz | SimilarPlease see thediscussion and |
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101Magnetic MuscleStimulator System | |
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| conclusionbelow. | |||
| Magnetic FieldIntensity | 299-1 applicator: 0.5 - 1.8 T299-2 applicator: 0.7 - 2.5 T | Up to 2.2 T | Similar, notsignificantlydifferent |
| 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 |
| OperatingTemperature | 10-30 °C | 5-30 °C | Similar, notsignificantlydifferent |
| OperatingHumidity | 30-75 % | 20-75 % | Similar, notsignificantlydifferent |
| Shape ofStimulation 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 |
| ExternalExchangeableFuse | Yes | Yes | None |
| SystemDimensions(W×H×D) | 500×970×580 mm(20×38×23 in) | 500×580×230 mm(20×23×9 in) | Similar, notimportant forthe devicesafety andeffectivenessevaluation |
| System Weight | 33 kg (73 lb) | 28 kg (61 lb) | Similar, notimportant forthe devicesafety andeffectivenessevaluation |
| 510(k) number | K160992 | K973929 | Discussion |
| Device name | HPM-6000 | Neotonus MS-101Magnetic MuscleStimulator System | |
| Company name | BTL Industries, Inc. | Neotonus, Inc. | |
| Position | Vertical - On castors | Horizontal | Similar, notimportant forthe devicesafety andeffectivenessevaluation |
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.
§ 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).