K Number

Device Name

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

Manufacturer

ZMI Electronics Ltd.

Date Cleared

2024-01-18

(268 days)

Product Code

KPI HIR

Regulation Number

876.5320

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K222528

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and safety of an electrode for electrical stimulation and EMG feedback, with no mention of AI or ML capabilities.

Therapeutic

Yes

The device is intended for "rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence," which falls under therapeutic use.

Diagnostic

Yes

The device is intended to provide "electromyography feedback from pelvic musculature," which is a diagnostic function to assess the activity of the pelvic floor muscles.

SaMD (Software as a Medical Device)

The device description clearly states it is an electrode probe for electrical stimulation and EMG feedback, which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Levina Electrodes Function: The Levina Incontinence Stimulation Electrodes are used directly on or in the body (in vivo) to provide electrical stimulation and receive electromyography (EMG) feedback from pelvic muscles. They are a therapeutic and diagnostic tool used in situ, not for analyzing samples taken from the body.

The description clearly states the device's purpose is for "electrical stimulation to pelvic musculature" and "electromyography feedback from pelvic musculature," which are both in-vivo applications.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

KPI, HIR

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pelvic musculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The probes are used directly by the patients for home care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
1. 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.
1. 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
1. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222528

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
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).(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K231166

Device Name

Levina Incontinence Stimulation Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)

| 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: +886-7-8150053 Fax: +886-7-8150057 E-mail: mail@zmi-electronics.com

Contact Person

Name: Lawrence Liu Title: Regulatory Affairs Manager Phone: +886-7-8150053 Ext 351 Fax: +886-7-8150057 E-mail: lawrence@zmi-electronics.com 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

5. Indication of Use

6. Comparison to the PredicateDevice

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

| Technological

Characteristics	Subject Device	Primary Predicate	Comparison & Impact
Manufacturer	ZMI Electronics Ltd.	Well-Life Healthcare Ltd.	-
Name / Model	Levina Incontinence Stimulation
Electrodes
PFR-XX	Well-Life Probe Electrode for
Stimulation/EMG Probe (Model:
SA)	-
US FDA Listed	K231166	K222528	-
Product Code	KPI & HIR	KPI & HIR	Identical
Regulation
Number	876.5320	876.5320	Identical
Regulation
Name	Nonimplanted electrical
continence device	Nonimplanted electrical
continence device	Identical
Regulatory
Class	Class II	Class II	Identical
Indication for
Use	to provide electromyographic
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.	to provide electromyographic
feedback from pelvic
musculature or electrical
stimulation to pelvic musculature
for the purpose of rehabilitation
of week pelvic floor muscles and
restoration of neuromuscular
control during the treatment of
urinary incontinence.	Identical
Prescriptive or
Over-The-
Counter Use	Prescription and OTC Use	Prescription and OTC Use	Identical
Electrode
Placement	Vaginal or Rectal	Vaginal or Rectal	Identical
Environment
of Used	Home	Home	Identical
Target
Population	Patients with incontinence or
weak pelvic floor muscles	Patients with incontinence or
weak pelvic floor muscles	Identical
Standards	ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-18
ISO 10993-17
ISO 10993-23	ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23	Identical
Materials	Medical Grade PC,
Stainless Steel	ABS,
Stainless Steel	Similar;
Levina probes are made of
materials suitable for high
temperature disinfection.
Contact
Duration	Intermittent mucosal contact