HPM-6000U

K162010 · BTL Industries, Inc. · KPI · Dec 13, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162010
• Device Name: HPM-6000U
• Applicant: BTL Industries, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

HPM-6000U is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

Device Story

HPM-6000U is a non-invasive therapeutic device for pelvic floor muscle rehabilitation. It utilizes an electromagnetic field generated by a single coil within a chair-based applicator to induce action potentials in nerves, resulting in muscle contraction. The device is operated by a clinician in a clinical setting. The user interacts with a color touch screen to set therapeutic parameters, including pulse repetition rate (1-150 Hz) and amplitude (0-100%). The device provides continuous stimulation for a 30-minute session. By stimulating the pelvic floor musculature, the device aims to strengthen muscles and restore neuromuscular control, potentially benefiting patients suffering from urinary incontinence. The clinician monitors the therapy via the on-screen display, which shows the applied therapy type, remaining time, and main parameters.

Clinical Evidence

No clinical data. Substantial equivalence is demonstrated through comparison of technical characteristics and bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), and biological evaluation (ISO 10993-1, 5, 10).

Technological Characteristics

Non-invasive electromagnetic stimulator; chair-based applicator with single magnetic coil; magnetic field intensity 0.7-2.5 T; pulse repetition rate 1-150 Hz; pulse duration 280 μs; sine, biphasic pulse shape. Powered by 100-240 V AC. Complies with ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for women with urinary incontinence requiring rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Predicate Devices

• Neotonus Model 1000 Muscle Stimulator System (K973096)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 13, 2016

BTL Industries, Inc. % Jan Zarsky Director 47 Loring Drive Framingham, MA 01702

Re: K162010 Trade/Device Name: HPM-6000U Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI Dated: September 15, 2016 Received: September 16, 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) Not known K162010 Device Name HPM-6000U

Indications for Use (Describe)

HPM-6000U is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

Type of Use (Select one or both, as applicable)

X 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 blue squares, each rotated 45 degrees, with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.

## 510(k) Summary

### General Information

| Sponsor: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | Jan Žársky<br>Director<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation<br>Date: | July 19, 2016 |

#### Device Name

| Trade/Proprietary Name: | HPM-6000U |
|------------------------------|--------------------------------------------------------------|
| Primary Classification Name: | Stimulator, Electrical, Non-Implantable, For<br>Incontinence |
| Classification Regulation: | 21 CFR 876.5320, Class II |
| Classification Product Code: | KPI |

#### Legally Marketed Predicate Devices

The HPM-6000U is a non-invasive therapeutic device, 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:

Neotonus Model 1000 Muscle Stimulator System (K973096)

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## Product Description

The HPM-6000U is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.

The HPM-6000U 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

HPM-6000U is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

## Non-clinical Testing

The HPM-6000U device has been thoroughly evaluated for electrical safety. The HPM-6000U has been found to comply with the following applicable medical device safety standards:

| ISO 14971 | Medical devices - Application of risk management to medical<br>devices |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 | Medical device software - Software life cycle processes |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility – Requirements and<br>tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation<br>and testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the logo is the text "BTL Industries" in a gray, sans-serif font.

### Clinical testing

The substantial equivalence determination for the HPM-6000U is not based on clinical testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the HPM-6000U and the predicate device.

### Comparison with the Predicate Device

| 510(k) number | Not Assigned | K973096 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | HPM-6000U | Neotonus Model 1000<br>Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Product Code<br>and Regulation | Gastroenterology-Urology<br>Devices<br>21 CFR 876.5320<br>KPI - Stimulator, Electrical,<br>Non-Implantable, For<br>Incontinence | Gastroenterology-Urology<br>Devices<br>21 CFR 876.5320<br>KPI - Stimulator, Electrical,<br>Non-Implantable, For<br>Incontinence |
| Intended Use | HPM-6000U is intended to<br>provide entirely non-<br>invasive electromagnetic<br>stimulation of pelvic floor<br>musculature for the<br>purpose of rehabilitation of<br>weak pelvic muscles and<br>restoration of<br>neuromuscular control for<br>the treatment of urinary<br>incontinence in women. | Neotonus Model 1000 Muscle<br>Stimulator System is intended<br>to provide entirely non-<br>invasive electromagnetic<br>stimulation of pelvic floor<br>musculature for the purpose<br>of rehabilitation of weak pelvic<br>muscles and restoration of<br>neuromuscular control for the<br>treatment of urinary<br>incontinence in women. |
| Primary Function | Stimulation of pelvic floor<br>musculature | Stimulation of pelvic floor<br>musculature |
| Principle of<br>Action | Initiating action potential of<br>nerves results in muscle<br>contraction | Initiating action potential of<br>nerves results in muscle<br>contraction |
| Type of Energy | Magnetic field | Magnetic field |
| Energy Source | 100 - 240 V AC, 50 - 60<br>Hz, max 14 A | 110 V AC, 50 - 60 Hz,<br>max 12 A |
| Type of Coil | Single magnetic coil | Single magnetic coil |
| Number of | 1 | 1 |
| 510(k) number | Not Assigned | K973096 |
| Device name | HPM-6000U | Neotonus Model 1000<br>Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Magnetic Coils<br>in the Applicator | | |
| Type of<br>Applicator | Chair | Chair |
| Number of<br>Applicators | 1 | 1 |
| Patient Position<br>during Therapy | Sitting position | Sitting position |
| Position of Coil | Center of applicator seat | Center of applicator seat |
| Type of<br>Operation | Continuous | Continuous |
| Magnetic Field<br>Intensity | 0.7 - 2.5 T | Up to 2.2 T |
| Pulse Repetition<br>Rate | 1 - 150 Hz | 1 – 55 Hz |
| Step of<br>Frequency<br>Setting | 1 Hz | 1 Hz |
| Pulse Duration | 280 μs (± 20%) | 275 μs |
| Pulse Amplitude | 0 – 100 % | 0 - 100 % |
| Shape of<br>Stimulation<br>Pulse | Sine, biphasic | Sine, biphasic |
| Therapy Time | 30 min | 30 min |
| Operating<br>Temperature | +10 to +30 °C (50 - 86 °F) | +10 to +30 °C (50 - 86 °F) |
| Interface | Touch-screen | Graphical Display |
| Firmware<br>controlled | Yes | Yes |
| Environmental<br>Specifications | For indoor use only | For indoor use only |
| Clinical Use | Prescription Use | Prescription Use |
| 510(k) number | Not Assigned | K973096 |
| Device name | HPM-6000U | Neotonus Model 1000<br>Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| External<br>Exchangeable<br>Fuse | Yes | Yes |
| Main Unit<br>Dimensions<br>(W×H×D) | 500×970×580 mm<br>(20×38×23 in) | 580×170×320 mm<br>(23×7×12.5 in) |
| Applicator<br>Dimensions<br>(W×H×D) | 730x730x730 mm<br>(29x29x29 in) | 700x1250x785 mm<br>(27.5x49x31 in) |
| System Weight | 46 kg (101 lb) | 42.5 kg |
| Position | Vertical - On castors | Horizontal |
| Electrical<br>Protection | Class II, BF | Class II |

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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters BTL inside them. To the right of the logo is the text "BTL Industries" in a simple, sans-serif font.

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### Substantial Equivalence

Based upon the intended use and known technical information provided in this pre-market notification, the HPM-6000U device has been shown to be substantially equivalent to currently marketed predicate device. Thorough Substantial Equivalence Discussion is provided in Section 12.

### Conclusion

Based on the aforementioned information, the HPM-6000U is safe and effective and substantially equivalent to the identified predicate device.