HPM-6000UF

K181497 · BTL Industries, Inc. · KPI · Nov 14, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181497
• Device Name: HPM-6000UF
• Applicant: BTL Industries, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Nov 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

HPM-6000UF 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 male and female urinary incontinence.

Device Story

HPM-6000UF is a non-invasive therapeutic device for pelvic floor muscle rehabilitation. It uses an electromagnetic field generator to induce neuromuscular tissue stimulation, triggering muscle contraction. The system consists of a console with a color touch-screen and an applicator chair containing an air-cooled coil. The device is operated by a clinician in a professional setting; the user follows on-screen, step-by-step guidance to set therapy parameters. The patient sits on the applicator chair, which can be adjusted for positioning. The electromagnetic field interacts with pelvic tissues to provide stimulation and tonization. This process aims to strengthen pelvic muscles and restore neuromuscular control, potentially benefiting patients suffering from urinary incontinence. Clinical safety regarding thermal effects on the testes in males was documented.

Clinical Evidence

Clinical study conducted to assess thermal safety in males. Results documented no meaningful rise in scrotal surface temperature during treatment, supporting safety for the male population.

Technological Characteristics

System console and applicator chair; electromagnetic field generator; air-cooled coil; color touch-screen interface; 100-240 V AC power source; magnetic field intensity 0.7–2.5 T; pulse repetition rate 1–150 Hz; pulse width 280 μs (± 20%); dual-phase rectangular pulses; firmware-controlled; moderate level of concern software.

Indications for Use

Indicated for male and female patients requiring rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

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

• HPM-6000U (K162010)
• InToneMV (K134020)

Submission Summary (Full Text)

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November 14, 2018

BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, MA 01752

Re: K181497

> Trade/Device Name: HPM-6000UF Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: September 21, 2018 Received: September 26, 2018

Dear David 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Glenn B. Bell -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K181497

Device Name HPM-6000UF

Indications for Use (Describe)

HPM-6000UF 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 male and female urinary incontinence.

| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

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

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# 510(k) Summary

## General Information

| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation<br>Date: | November 13, 2018 |

#### Device Name

| Trade/Proprietary Name: | HPM-6000UF |
|------------------------------|-------------------------------------------|
| Primary Classification Name: | Nonimplanted electrical continence device |
| Common Name: | Pelvic floor muscle stimulator |
| Classification Regulation: | 21 CFR 876.5320, Class II |
| Classification Product Code: | KPI |

## Legally Marketed Predicate Devices

The HPM-6000UF is a non-invasive therapeutic device, and is substantially equivalent to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:

Primary predicate - HPM-6000U (K162010) Secondary predicate - InToneMV (K134020)

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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL". The squares are arranged in a triangular pattern. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.

#### Product Description

The HPM-6000UF 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-6000UF 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 stepby-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-6000UF 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 male and female urinary incontinence.

#### Side Effects

The intended use may be accompanied by various side effects such as muscular pain, temporary muscle spasm, temporary joint or tendon pain, temporary increase of local circulation, increased sensitivity during intercourse, and local erythema or skin redness.

#### Non-clinical Testing

The HPM-6000UF is identical in design to the HPM-6000U predicate. Therefore, no nonclinical testing was needed.

#### Clinical testing

In order to demonstrate safety of the HPM-6000UF in the treatment of males (specifically, thermal safety to the testes), a clinical study has been conducted. The clinical study documented no meaningful rise in scrotal surface temperature during treatment, and that the HPM-6000UF device is safe in the male population.

#### Technological Characteristics

The HPM-6000UF is identical in design to the HPM-6000U predicate device. The only difference relative to this predicate device is to expand the indications for use statement.

The HPM-6000UF device and its predicates are comprised of a system console and applicator. The system consists of the electromagnetic field generators, computer, and the touch-screen control panel. Applicator Chair is designed for non-invasive therapy of urinal incontinence. The coil is located in the middle of the seat and air cooled. Running

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Image /page/5/Picture/1 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is simple and modern, and the colors are muted.

therapy is indicated by illuminated segments in armrests. For precise patient positioning prior to the therapy, the seat height can be electronically adjusted by a remote control.

The HPM-6000UF device is using a maqnetic field in order to induce neuromuscular tissue stimulation. The InToneMV predicate device is stimulating neuromuscular tissue via the direct current flow. In both cases there is an induction of electrical stimulus in the neuromuscular tissue resulting in the muscle contraction.

The HPM-6000UF device is intended for professional use as a prescription use only, while the InToneMV predicate device is intended also for a home use. The energy source of the HPM-6000UF device is electric power grid instead of battery source by the InToneMV predicate device. Further, the HPM-6000UF is equipped with larger colorful touch-screen control panel to increase user comfort.

The technological differences between the HPM-6000UF device and the predicate devices do not raise any new types of safety or effectiveness questions.

| 510(k) number | Not Assigned | K162010 | K134020 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | HPM-6000UF | HPM-6000U | InToneMV |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | InControl Medical,<br>LLC |
| Product Code<br>and Regulation | Gastroenterology-<br>Urology Devices<br>21 CFR 876.5320<br>KPI - Stimulator,<br>Electrical, Non-<br>Implantable, For<br>Incontinence | Gastroenterology-<br>Urology Devices<br>21 CFR 876.5320<br>KPI - Stimulator,<br>Electrical, Non-<br>Implantable, For<br>Incontinence | Gastroenterology-<br>Urology Devices<br>21 CFR 876.5320<br>KPI - Stimulator,<br>Electrical, Non-<br>Implantable, For<br>Incontinence |
| Intended Use | HPM-6000UF is<br>intended to provide<br>entirely non-invasive<br>electromagnetic<br>stimulation of pelvic floor<br>musculature for the<br>purpose of rehabilitation<br>of weak pelvic muscles<br>and restoration of<br>neuromuscular control<br>for the treatment of male<br>and female urinary<br>incontinence. | HPM-6000U is intended<br>to provide entirely non-<br>invasive<br>electromagnetic<br>stimulation of pelvic<br>floor musculature for the<br>purpose of rehabilitation<br>of weak pelvic muscles<br>and restoration of<br>neuromuscular control<br>for the treatment of<br>urinary incontinence in<br>women. | InToneMV is intended<br>to provide electrical<br>stimulation and/or visual<br>biofeedback (via<br>manometry) for<br>treatment of male and<br>female urinary and fecal<br>incontinence. |

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| | | K181497<br>Page 4 of 5 |
|-----------|---------------------------|------------------------|
| | 510(K) SUMMARY | |
| | | |
| | K134020 | |
| | InToneMV | |
| J | InControl Medical,<br>LLC | |
| ies, Inc. | | |

| 510(k) number | Not Assigned | K162010 | K134020 |
|---------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Device name | HPM-6000UF | HPM-6000U | InToneMV |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | InControl Medical,<br>LLC |
| Clinical Use | Prescription Use | Prescription Use | Clinic or home use,<br>under direction of<br>physician |
| Applicable<br>Patients | Male and Female | Woman | Male and Female |
| Primary Function | Muscle stimulation | Muscle stimulation | Muscle stimulation |
| Principle of Action | Initiating action potential<br>of nerves results in<br>muscle contraction | Initiating action potential<br>of nerves results in<br>muscle contraction | Initiating action potential<br>of nerves results in<br>muscle contraction |
| Type of Energy | Magnetic field | Magnetic field | Electrical |
| Energy Source | 100 - 240 V AC, 50 - 60<br>Hz, max 14 A | 100 - 240 V AC, 50 -<br>60 Hz, max 14 A | 4/5 AA nickel metal<br>hydride battery |
| Number of output<br>channels | 1 | 1 | 1 |
| Magnetic Field<br>Intensity | 0.7 – 2.5 T | 0.7 – 2.5 T | N/A |
| Pulse Repetition<br>Rate | 1 – 150 Hz | 1 — 150 Hz | 0 - 50 Hz |
| Pulse Width | 280 $ μ $ s (± 20%) | 280 $ μ $ s (± 20%) | 200 $ μ $ s |
| Shape of<br>Stimulation Pulse | Dual phase, rectangular<br>pulses | Dual phase, rectangular<br>pulses | Dual phase, rectangular<br>pulses |
| Therapy Time | Up to 30 min | Up to 30 min | Up to 30 min |
| Interface | Touch-screen | Touch-screen | Buttons accompanied<br>by simple screen |
| Firmware<br>controlled | Yes | Yes | Yes |
| 510(k) number | Not Assigned | K162010 | K134020 |
| | | | |
| Device name | HPM-6000UF | HPM-6000U | InToneMV |
| | | | |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | InControl Medical,<br>LLC |
| Software Level of<br>Concern | Moderate | Moderate | Moderate |
| Environmental<br>Specifications | For indoor use only | For indoor use only | For indoor use only |
| Feedback | By Patient | By Patient | Manometric air pressure |
| Operating<br>Temperature | +10 to +30 °C<br>(50 - 86 °F) | +10 to +30 °C<br>(50 – 86 °F) | Unknown |
| Main Unit | 500 × 970 × 580 mm | 500 × 970 × 580 mm | 122 x 61 x 30 mm |
| Dimensions | | | |
| (W×H×D) | (20 × 38 × 23 in) | (20 × 38 × 23 in) | (4.8 x 2.4 x 1.1 in) |
| Applicator | 730 x 730 x 730 mm | 730 x 730 x 730 mm | 196 x 58 x 99 mm |
| Dimensions<br>(W×H×D) | (29 x 29 x 29 in) | (29 x 29 x 29 in) | (7.7 x 2.3 x 3.9 in) |
| System Weight | 46 kg (101 lb) | 46 kg (101 lb) | Unknown |

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Image /page/7/Picture/1 description: The image contains the logo for BTL Industries. The logo consists of three overlapping blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a dark gray sans-serif font. The logo is simple and modern, and the text is clear and easy to read.

510(K) SUMMARY

## Substantial Equivalence

Based upon the intended use and known technical information provided in this pre-market notification, the HPM-6000UF device has been shown to be substantially equivalent to currently marketed predicate devices.

## Conclusion

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