Unicare (K-UNICARE-USA)

K230983 · Tenscare, Ltd. · KPI · Oct 20, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230983
• Device Name: Unicare (K-UNICARE-USA)
• Applicant: Tenscare, Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Oct 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Device Story

Unicare is a battery-powered, single-channel, home-use electrical muscle stimulator. It delivers electrical stimulation to pelvic floor muscles via a reusable vaginal probe or optional self-adhesive skin electrodes. The device operates by generating symmetrical bi-phasic rectangular waveforms at specific frequencies and pulse widths to facilitate neuromuscular re-education. Users control stimulation intensity via manual push-buttons on the unit. The device is intended for OTC use by women to treat urinary incontinence. By strengthening pelvic floor muscles, the device aims to improve continence and reduce incontinence symptoms. It is a non-implanted device designed for personal use in a home environment.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and nerve/muscle stimulator performance standards (IEC 60601-2-10), alongside software verification and validation.

Technological Characteristics

Battery-powered (3.7V 80 mAh Li-ion) single-channel stimulator. Delivers symmetrical bi-phasic rectangular pulses. Max output 99.0 mA (+/- 10%) at 500Ω. Includes reusable vaginal probe and self-adhesive electrodes. 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 women with stress, urge, or mixed urinary incontinence requiring pelvic floor muscle rehabilitation and maintenance of urinary continence.

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

• Perfect PFE (K191312)

Submission Summary (Full Text)

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October 20, 2023

TensCare Ltd Saskia Eldridge-Hinmers Regulatory Affairs Associate 9 Blenheim Road Epsom. Surrev KT19 9BE United Kingdom

Re: K230983 Trade/Device Name: Unicare (K-UNICARE-USA) Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: April 12, 2023 Received: September 20, 2023

Dear Saskia Eldridge-Hinmers:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Jessica K. Nguyen -S

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

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# Indications for Use

510(k) Number (if known) K230983

Device Name Unicare (K-UNICARE-USA)

Indications for Use (Describe)

Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K230983 Page 1 of 3

# 510 (k) Summary

#### Submitter Information 1.

| 510 (k) submitter: | TensCare Ltd. | |
|---------------------------|------------------------------------------------|--|
| Address: | 9 Blenheim Road, Epsom, | |
| | Surrey, KT19 9BE, United Kingdom | |
| | Phone: [phone] | |
| | Fax: [phone] | |
| Applicant Contact Person: | Saskia Eldridge-Hinmers | |
| | Regulatory Affairs Associate | |
| | Phone: [phone] | |
| | Email : [e-mail] | |
| American Representative: | Mr. Scott A Bednar | |
| | QA/RA Consulting Group, Inc. | |
| | 3335 Tuscarawas Road, Beaver | |
| | Pennsylvania 15009 | |
| | Phone: [phone] | |
| | Email : [e-mail] | |
| Preparation date: | October 17, 2023 | |

#### 2. Device Name

| Trade Name of the Device: | Unicare (K-UNICARE-USA) |
|---------------------------|-------------------------------------------|
| Common Name: | Nonimplanted electrical continence device |
| Regulation Name: | Nonimplanted electrical continence device |
| Regulation Number: | 21 CFR 876.5320 |
| Device Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KPI |

#### 3. Predicate Devices

| 510(k) Number: | K191312 |
|---------------------------|-------------|
| Trade Name of the Device: | Perfect PFE |

The predicate device has not been subject to a design related recall.

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#### Device Description 4.

Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.

#### 5. Indications For Use

Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

| Device & Predicate<br>Device(s): | K230983 (Subject Device) | K191312 (Predicate Device) |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Unicare | Perfect PFE |
| Indication for Use | Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women. | Perfect PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women. |
| Function | Pelvic floor muscle stimulation | Pelvic floor muscle stimulation |
| Prescription Use<br>Only/OTC | OTC | OTC |
| Power source | Rechargeable Li-ion 3.7V 80 mAh | 2xAA batteries |
| Maximum Output<br>Current (500Ω load) | 99.0 mA +/- 10% | 90mA |
| Maximum current<br>density/electrode<br>(mA/cm²) | 23.35 mA/cm² | 21.4 mA/cm² |
| Maximum average<br>power density/electrode<br>(mW/cm²) @ 500Ω | 11.9 mW/cm² | 15.34 mW/cm² |
| Output waveform type | Symmetrical Bi-phasic rectangular | Asymmetrical Bi-phasic rectangular |
| Stimulation frequencies | Stress: 50Hz<br>Urge: 10Hz<br>Mixed: half Stress program & half Urge program<br>Tone: 35Hz | Stress: 50Hz<br>Urge: 10Hz<br>Mixed: half Stress program & half Urge program<br>Tone: 35Hz |

#### 6. Comparison of the Technological Characteristics with Predicate Device:

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| Pulse width | Stress: 300µs | Stress: 300µs |
|-----------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| | Urge: 200µs<br>Mixed: half Stress program & half Urge program | Urge: 200µs<br>Mixed: half Stress program & half Urge program |
| | Tone: 250µs | Tone: 250µs |
| Vaginal probe Electrode surface area (per individual electrode) | 4.24 cm² | 4.24 cm² |
| Treatment duration | Maximum 20 min | 10 or 20 min<br>(default = 20 min) |
| Treatment Environment | Home use | Home use |

As evidenced by the above table, both the subject and the predicate devices have the same 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:

- o Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical 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 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

Additionally, battery service life and performance verification test data were submitted to establish performance and durability of the subject device.

All pre-determined acceptance criteria were met.

#### Conclusions 8.

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