Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

K231166 · Zmi Electronics , Ltd. · KPI · Jan 18, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K231166
• Device Name: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
• Applicant: Zmi Electronics , Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jan 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Device Story

Levina Incontinence Stimulation Electrodes are reusable, non-sterile probes for vaginal or rectal insertion; used by patients in home settings. Probes connect to compatible, FDA-cleared electrical stimulators to deliver electrical stimulation to pelvic musculature or provide electromyography (EMG) feedback. Device facilitates rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for urinary incontinence treatment. Patients operate the device; cleaning required before/after each use with water and mild soap. Output consists of electrical stimulation or EMG signals processed by the external stimulator unit to guide patient therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -10, -17, -18, and -23. Performance testing included visual inspection, size measurement, impedance testing, and mechanical stability testing (cycling, bending, tensile strength) per IEC 60601-1 and ANSI AAMI EC53:2013/(R)2020.

Technological Characteristics

Materials: Medical Grade PC and stainless steel. Sensing/Actuation: Electrical stimulation/EMG feedback via mucosal contact. Dimensions: Vaginal probes (8-10 cm length, 3.16-3.4 cm diameter, 2.8-6 cm² surface area); Anal probes (7-12.5 cm length, 1.2-2.8 cm diameter, 3-6.3 cm² surface area). Connectivity: Wired connection to external stimulator. Sterilization: Non-sterile; reusable. Standards: ISO 10993 series, IEC 60601-1, ANSI AAMI EC53.

Indications for Use

Indicated for patients with urinary incontinence or weak pelvic floor muscles requiring rehabilitation or restoration of neuromuscular control via electromyography feedback or electrical stimulation.

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

• Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) (K222528)

Submission Summary (Full Text)

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January 18, 2024

ZMI Electronics Ltd. Lawrence Liu Regulatory Affairs Section Manager 6F-1, 286-4, Shin Ya Road Kaohsiung, 806 Taiwan

Re: K231166

Trade/Device Name: Levina Incontinence Stimulation Electrodes Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HIR Dated: December 18, 2023 Received: December 18, 2023

Dear Lawrence Liu:

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 (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.

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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).

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.

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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

Enclosure

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## Indications for Use

510(k) Number (if known) K231166

Device Name

Levina Incontinence Stimulation Electrodes

Indications for Use (Describe)

Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">☑</div> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">☑</div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Section 5: 510(k) Summary

### 1. Submitter Information

Applicant Name: ZMI Electronics Ltd. Address: 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Contact Person

Name: Lawrence Liu Title: Regulatory Affairs Manager Phone: [phone] Ext 351 Fax: [phone] E-mail: [e-mail] Date Summary Prepared: January 17, 2024

#### 2. General Device Informaion

Device Name: Levina Incontinence Stimulation Electrodes Common / usual name: Stimulator, Electrical, Non-implantable, For Incontinence Model: PFR-XX Regulation Number: 21 CFR 876.5320 Classification Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: KPI Subsequent Product Code: HIR (Obstetrical and Gynecological Diagnostic Devices)

#### 3. Predicate Device Information Primary Predicate

510K Number: K222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

#### 4. Device Description

Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.

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### 5. Indication of Use

Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

#### 6. Comparison to the PredicateDevice

The following features are compared among the predicate devices and our models.

| Technological<br>Characteristics | Subject Device | Primary Predicate | Comparison & Impact |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ZMI Electronics Ltd. | Well-Life Healthcare Ltd. | - |
| Name / Model | Levina Incontinence Stimulation<br>Electrodes<br>PFR-XX | Well-Life Probe Electrode for<br>Stimulation/EMG Probe (Model:<br>SA) | - |
| US FDA Listed | K231166 | K222528 | - |
| Product Code | KPI & HIR | KPI & HIR | Identical |
| Regulation<br>Number | 876.5320 | 876.5320 | Identical |
| Regulation<br>Name | Nonimplanted electrical<br>continence device | Nonimplanted electrical<br>continence device | Identical |
| Regulatory<br>Class | Class II | Class II | Identical |
| Indication for<br>Use | to provide electromyographic<br>feedback from pelvic<br>musculature or electrical<br>stimulation to pelvic musculature<br>for the purpose of rehabilitation<br>of weak pelvic floor muscles and<br>restoration of neuromuscular<br>control during the treatment of<br>urinary incontinence. | to provide electromyographic<br>feedback from pelvic<br>musculature or electrical<br>stimulation to pelvic musculature<br>for the purpose of rehabilitation<br>of week pelvic floor muscles and<br>restoration of neuromuscular<br>control during the treatment of<br>urinary incontinence. | Identical |
| Prescriptive or<br>Over-The-<br>Counter Use | Prescription and OTC Use | Prescription and OTC Use | Identical |
| Electrode<br>Placement | Vaginal or Rectal | Vaginal or Rectal | Identical |
| Environment<br>of Used | Home | Home | Identical |
| Target<br>Population | Patients with incontinence or<br>weak pelvic floor muscles | Patients with incontinence or<br>weak pelvic floor muscles | Identical |
| Standards | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-18<br>ISO 10993-17<br>ISO 10993-23 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | Identical |
| Materials | Medical Grade PC,<br>Stainless Steel | ABS,<br>Stainless Steel | Similar;<br>Levina probes are made of<br>materials suitable for high<br>temperature disinfection. |
| Contact<br>Duration | Intermittent mucosal contact<br>< 30 min/session -Stim<br>< 1 hour/session - EMG<br>not exceeding hr combined<br>Stim/EMG | Intermittent mucosal contact<br>< 30 min/session -Stim<br>< 1 hour/session - EMG<br>not exceeding hr combined<br>Stim/EMG | Identical |
| Electrode<br>Surface Area | Vaginal Probes: 2.8 – 6 cm²<br>Anal Probes: 3 – 6.3 cm² | Vaginal Probes: 4.25 – 7.87 cm²<br>Anal Probes: 1.93 – 3.77 cm² | Different;<br>The range of electrode<br>surface area are within the<br>within the normal range for other |
| | | | K231101<br>Page 3 of |
| | | | cleared devices of this<br>device type |
| Probe Length | Vaginal Probes: 8 - 10 cm<br>Anal Probes: 7 – 12.5 cm | Not publicly available | Different;<br>The range of probe lengths<br>are within the normal range<br>for other cleared devices of<br>this device type |
| Probe<br>Diameter | Vaginal Probes: 3.16 - 3.4 cm<br>Anal Probes: 1.2 – 2.8 cm | Not publicly available | Different;<br>The range of probe<br>diameters are within the<br>normal range for other<br>cleared devices of this<br>device type |
| Usage<br>Conditions | Reusable-Single Patient | Reusable-Single Patient | Identical |
| Sterility | Not sterilized | Not sterilized | Identical |
| Reprocessing-<br>Cleaning | Cleaning: washed with soap or<br>neutral detergent (at or near<br>pH7.0) and water after each use<br>and dried thoroughly. | Cleaning: washed with soap and<br>water after each use and dried<br>thoroughly. | Similar |

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K231166

The differences in technological characteristics do not raise different questions of safety and effectiveness.

### 7. Non-clinical Testing

A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:

- 1) The biocompatibility evaluation for the Levina Incontinence Stimulation Electrodes was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- ISO 10993-18 Chemical characterization of medical device ●
- ISO 10993-17 Establishment of leachable substances ●
- ISO 10993-5 Tests for in vitro cytotoxicity ●
- ISO 10993-10 Tests for irritation and skin sensitization ●
- ISO 10993-23 Tests for irritation
- 2) Recommendations and requirements outlined in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed for reprocessing and cleaning instructions in the labeling.
- 3) Performance Bench Testing was conducted to verify the performance to specifications of the proposed device and included the following:
- Subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD to comply ● with 21 CFR 898.
- Visual Inspection
- Size Measurement ●
- Impedance Testing ●

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- 4) Performance Bench Testing Stability Testing was performed to verify the stability to product life of the proposed device and included the following:
- Probe and Lead Wire Connector Stability with Cycling Test ●
- · Lead Wire Bending Test
- Lead Wire Tensile Test
- Tensile strength of cable connection test per ANSI AAMI EC53:2013/(R)2020 related test ● methods for lead wire strength of cable connection test.

#### 8. Conclusion

Based upon the information presented above, the Levina Incontinence Stimulation Electrodes have the same intended use and similar technological characteristics as the predicate devices Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) (K222528). The differences between the subject devices and the predicate devices do not raise different questions in safety and effectiveness. The performance testing provided supports a determination of substantial equivalence to the predicate device. Therefore, it can be concluded that Levina Incontinence Stimulation Electrodes are substantially equivalent to the predicate device.