Pelvic Floor Muscle Stimulator

K230767 · Nanjing Vishee Medical Technology Co., Ltd. · KPI · Sep 21, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230767
• Device Name: Pelvic Floor Muscle Stimulator
• Applicant: Nanjing Vishee Medical Technology Co., Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Sep 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) 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

MagBelle AF180 is a non-invasive therapeutic device for pelvic floor muscle rehabilitation. It consists of a main unit with a color touch screen and a chair applicator. The device generates an electromagnetic field that penetrates pelvic tissues to trigger muscle stimulation. It supports three modes: magnetic stimulation, Kegel biofeedback training, and a combined mode. Clinicians select therapy parameters via the touch screen, buttons, and knobs. The device provides real-time feedback on therapy type, remaining time, and parameters. Used in hospitals/clinics under licensed practitioner supervision. The device benefits patients by strengthening pelvic floor muscles and restoring neuromuscular control, aiding in the treatment of urinary incontinence.

Clinical Evidence

Clinical study conducted on 100 male and female patients (ages 22-70) in a hospital setting to validate Kegel biofeedback functionality. Pelvic floor muscle strength was assessed using the modified Oxford Grading Scale and compared against measurements from the subject device and the reference device (MyOnyx System). Results showed comparable performance between the subject device and the reference device in evaluating pelvic floor muscle conditions.

Technological Characteristics

Magnetic coil stimulation; field strength 0.7-2.5 T; pulse repetition 1-150 Hz; pulse width 340 μs (±20 μs); biphasic sine pulse shape. Interface: touch screen. Power: 100-240 V AC, 50-60 Hz. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (nerve/muscle stimulators).

Indications for Use

Indicated for male and female patients 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

• HPM-6000UF (K181497)

Reference Devices

• MyOnyx System (K201014)

Submission Summary (Full Text)

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September 21, 2023

Nanjing Vishee Medical Technology Co., Ltd. Lisa Tan Regulatory Affairs Building 9, No.19, Ningshuang Road, Yuhuatai District Nanjing, Jiangsu 210012 China

Re: K230767

> Trade/Device Name: Pelvic Floor Muscle Stimulator Regulation Number: 21 CFR§ 876.5320 Regulation Name: Non-Implanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: August 17, 2023 Received: August 21, 2023

Dear Lisa Tan:

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. Although this letter refers to your product as a device, please be aware 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Angel A. Soler-garcia -S

For Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230767

Device Name Pelvic Floor Muscle Stimulator

### Indications for Use (Describe)

Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K230767 Page 1 of 4

### 510 (k) Summary

#### Submitter Information 1.

| | 510 (k) submitter: | Nanjing Vishee Medical Technology Co., Ltd. |
|----|---------------------------|------------------------------------------------------------------------------------------|
| | Address: | Building 9, No.19, Ningshuang Road, Yuhuatai<br>District, Nanjing, Jiangsu 210012, China |
| | Applicant Contact Person: | Mr. Kai Qiu<br>Phone: [phone]<br>Email : [e-mail] |
| | Correspondent Contact: | Mrs. Lisa Tan<br>Phone: [phone]<br>Email : [e-mail] |
| | Preparation date: | September 12, 2023 |
| 2. | Device Name | |

| Trade Name of the Device: | Pelvic Floor Muscle Stimulator |
|----------------------------|--------------------------------------------|
| Common Name: | Nonimplanted electrical continence device |
| Classification Name: | Non-Implanted Electrical Continence Device |
| Classification Regulation: | 21 CFR 876.5320 |
| Device Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KPI |

#### 3. Predicate and Reference Devices

| | 510(k) Number | Trade Name of the Device |
|------------|---------------|--------------------------|
| Predicate: | K181497 | HPM-6000UF |
| Reference: | K201014 | MyOnyx System |

The predicate device was never subjected to a design related recall.

#### Device Description 4.

The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation.

MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped

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with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).

#### ਨ. Indications For Use

Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely noninvasive 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 & Predicate<br>Device(s): | K230767 (Subject Device) | K181497 (Predicate<br>Device) | K201014 (Reference<br>Device) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Pelvic Floor Muscle<br>Stimulator | HPM-6000UF | MyOnyx System |
| Indication for Use | Pelvic Floor Muscle<br>Stimulator (model: MagBelle<br>AF180) is intended to provide<br>entirely non-invasive<br>electromagnetic stimulation<br>of pelvic floor musculature<br>for the purpose of<br>rehabilitation of weak pelvic<br>muscles and restoration of<br>neuromuscular control for the<br>treatment of male and female<br>urinary incontinence. | HPM-6000UF is intended to<br>provide entirely non-invasive<br>electromagnetic stimulation<br>of pelvic floor musculature<br>for the purpose of<br>rehabilitation of weak pelvic<br>muscles and restoration of<br>neuromuscular control for the<br>treatment of male and female<br>urinary incontinence. | The MyOnyx System is<br>indicated for acute and ongoing<br>treatment of stress, urge, or<br>mixed urinary incontinence,<br>where urinary control may be<br>improved through electrical<br>stimulation that strengthens the<br>pelvic floor muscles or inhibits<br>the detrusor muscle through<br>reflexive mechanisms. The<br>system also uses EMG-based or<br>pressure-based biofeedback to<br>help control and strengthen the<br>pelvic floor muscles in the<br>treatment of urinary<br>incontinence. |
| Function | Pelvic floor muscle<br>stimulation | Pelvic floor muscle<br>stimulation | Pelvic floor muscle stimulation |
| Prescription Use<br>Only | Yes | Yes | Yes |
| Type of energy | Magnetic field | Magnetic field | Electrical |
| Power source | 100-240 V AC, 50-60 Hz,<br>max 12 A | 100-240 V AC, 50-60 Hz,<br>max 14 A | Max 140mA @ 5Vdc<br>(700mW) |
| Therapy Process | Specific therapy mode is<br>selected by the clinician<br>based on the patient's<br>symptoms. | Specific therapy mode is<br>selected by the clinician<br>based on the patient's<br>symptoms. | Specific therapy mode is<br>selected by the clinician based<br>on the patient's symptoms |
| Kegel Exercise<br>Mode | Present | Absent | Present |
| Applicator | Chair | Chair | Vaginal and Anal probes |

### Comparison of the Technological Characteristics with Predicate and Reference Devices: 6.

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| Stimulation source | Magnetic coil | Magnetic coil | Current |
|-----------------------------------------|------------------------------|---------------------------|------------------------------------------------------------------------|
| Magnetic field<br>strength | 0.7-2.5 T | 0.7-2.5 T | Not Applicable |
| Pulse repetition rate | 1-150 Hz | 1-150 Hz | 5-80 Hz |
| Pulse width | $340 \mu s \ (\pm 20 \mu s)$ | $280 \mu s \ (\pm 20 \%)$ | 150-400 μs |
| Variation of Pulse<br>intensity (dB/dt) | Up to 24 mT/ μs±20% | Up to 28 mT/ μs±20% | Not Applicable |
| Pulse amplitude<br>adjustment | 0-100% | 0-100% | Not Applicable |
| Pulse shape | Sine, biphasic | Sine, biphasic | Symmetrical, rectangular,<br>bipolar, biphasic |
| Interface | Touch screen | Touch screen | LCD |
| Firmware controlled | Yes | Yes | Yes |
| Applicator<br>dimensions<br>(WxHxD) | 28x48x28 in. | 29x29x29 in. | 28 mm diameter (Vaginal<br>Probe) and 19.6 mm diameter<br>(Anal probe) |
| Treatment<br>Environment | Hospital/Clinics only | Hospital/Clinics only | Under medical supervision<br>only |

As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.

## 7. Non-Clinical Testing

Below is a list of the tests that were performed and successfully completed for the subject device per the below guidance and standards:

- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Electrical Safety testing according to IEC 60601-1: 2020 Medical electrical equipment - O Basic safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General O requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- IEC 60601-2-10:2016 Particular requirements for the basic safety and essential O performance of nerve and muscle stimulators
- o Software Verification and Validation Testing according to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

Additionally, performance bench data was submitted for device performance and durability of the subject device. This data included:

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- o Service life verification test
- o Stimulation Coil Surface Temperature Rise Test
- 0 Maximum Magnetic Field Strength Test
- o Cybersecurity testing

All pre-determined acceptance criteria were met.

#### Clinical Data Summary 8.

To verify the Kegel Biofeedback functionality, the sponsor tested the subject device in 100 urinary incontinence patients (male and female, age range: 22-70) in a hospital set-up. All the patients' pelvic floor muscles strength was tested manually by a clinician by using modified Oxford Grading Scale. Then, the patients' pelvic floor muscle strength was measured by using the subject device. Thus, the Kegel biofeedback mode of the subject device was calibrated to identify the values of the biofeedback signal corresponding to normal and weak pelvic floor muscle strength. The pelvic floor muscle strength measured by the subject device was also compared to the pelvic floor muscle strength measured by a reference device, K201014 (MyOnyx System). Pelvic floor muscle conditions evaluated by both the subject and the reference devices were found to be comparable to each other.

#### 9. Conclusions

Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.