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.

AI/ML Overview

The provided text describes the 510(k) summary for the Levina Incontinence Stimulation Electrodes. However, it does not describe studies involving AI, human readers, or image analysis for diagnostics. The device is a physical electrode used for electrical stimulation and EMG feedback in treating urinary incontinence.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-powered diagnostic device, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes of AI assistance, are not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

Indications for Use: Identical.
Technological Characteristics: Similar, with minor differences in materials, electrode surface area, probe length, and diameter, which are deemed not to raise new questions of safety or effectiveness.
Non-clinical Performance Testing: Primarily focused on biocompatibility, reprocessing instructions, and electrical/mechanical integrity (e.g., visual inspection, size measurement, impedance testing, stability tests like cycling, bending, and tensile strength of lead wires).

Given this, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI-driven diagnostic as requested. The "performance" for this device relates to its physical and functional integrity, not to diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for an AI system. No ground truth establishmen or adjudication methods as they relate to diagnostic interpretation are present in the document.

Summary of what can be extracted from the document:

Device Name: Levina Incontinence Stimulation Electrodes
Intended Use: 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.
Key Comparison Points for Substantial Equivalence:
- Identical: Product Code, Regulation Number, Regulation Name, Regulatory Class, Indication for Use, Prescriptive or Over-The-Counter Use, Electrode Placement, Environment of Use, Target Population, Usage Conditions, Sterility.
- Similar (with justification for equivalence): Materials (medical grade PC, Stainless Steel vs. ABS, Stainless Steel), Reprocessing-Cleaning.
- Different (with justification for equivalence): Electrode Surface Area, Probe Length, Probe Diameter. These differences are described as being "within the normal range for other cleared devices of this device type."

Regarding "Acceptance Criteria" for this specific device:

The acceptance criteria here are implicitly met through the non-clinical testing demonstrating the device's physical and electrical safety and performance in line with recognized standards and similarity to the predicate. The "study" proving this involves the specific bench testing outlined:

1. A table of acceptance criteria and the reported device performance:

For this type of device (electrodes), the "acceptance criteria" are not reported as specific numerical cutoffs for diagnostic performance, but rather as successful completion of required testing for safety and functional integrity.

Acceptance Criterion (Type of Test)	Reported Device Performance
Biocompatibility Evaluation:
ISO 10993-18 Chemical characterization	Conducted and deemed compliant (implied by clearance)
ISO 10993-17 Establishment of leachable substances	Conducted and deemed compliant (implied by clearance)
ISO 10993-5 Tests for in vitro cytotoxicity	Conducted and deemed compliant (implied by clearance)
ISO 10993-10 Tests for irritation and skin sensitization	Conducted and deemed compliant (implied by clearance)
ISO 10993-23 Tests for irritation	Conducted and deemed compliant (implied by clearance)
Reprocessing & Cleaning Validation:	Followed FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (implied successful validation). Instruction for cleaning after each use with water and mild soap or neutral detergent.
Performance Bench Testing:
Subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005 (to comply with 21 CFR 898)	Conducted and deemed compliant (implied by clearance)
Visual Inspection	Passed (implied by clearance)
Size Measurement	Verified to specifications (Vaginal: 8-10 cm L, 3.16-3.4 cm D, 2.8-6 cm² SA; Anal: 7-12.5 cm L, 1.2-2.8 cm D, 3-6.3 cm² SA)
Impedance Testing	Passed (implied by clearance)
Stability Testing:
Probe and Lead Wire Connector Stability with Cycling Test	Passed (implied by clearance)
Lead Wire Bending Test	Passed (implied by clearance)
Lead Wire Tensile Test	Passed (implied by clearance)
Tensile strength of cable connection test per ANSI AAMI EC53:2013/(R)2020	Passed (implied by clearance)

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI diagnostic with a test set of data. The testing involves actual device units. The number of samples for each bench test is not specified in this summary, but typically involves a representative sample size per standard requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic interpretation is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic AI. The "ground truth" for this device is its adherence to physical specifications, material properties, and electrical integrity, verified by standard bench testing and material analyses.

8. The sample size for the training set: Not applicable. This is not an AI diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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 (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

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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

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5. Indication of Use

6. Comparison to the PredicateDevice

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

TechnologicalCharacteristics	Subject Device	Primary Predicate	Comparison & Impact
Manufacturer	ZMI Electronics Ltd.	Well-Life Healthcare Ltd.	-
Name / Model	Levina Incontinence StimulationElectrodesPFR-XX	Well-Life Probe Electrode forStimulation/EMG Probe (Model:SA)	-
US FDA Listed	K231166	K222528	-
Product Code	KPI & HIR	KPI & HIR	Identical
RegulationNumber	876.5320	876.5320	Identical
RegulationName	Nonimplanted electricalcontinence device	Nonimplanted electricalcontinence device	Identical
RegulatoryClass	Class II	Class II	Identical
Indication forUse	to provide electromyographicfeedback from pelvicmusculature or electricalstimulation to pelvic musculaturefor the purpose of rehabilitationof weak pelvic floor muscles andrestoration of neuromuscularcontrol during the treatment ofurinary incontinence.	to provide electromyographicfeedback from pelvicmusculature or electricalstimulation to pelvic musculaturefor the purpose of rehabilitationof week pelvic floor muscles andrestoration of neuromuscularcontrol during the treatment ofurinary incontinence.	Identical
Prescriptive orOver-The-Counter Use	Prescription and OTC Use	Prescription and OTC Use	Identical
ElectrodePlacement	Vaginal or Rectal	Vaginal or Rectal	Identical
Environmentof Used	Home	Home	Identical
TargetPopulation	Patients with incontinence orweak pelvic floor muscles	Patients with incontinence orweak pelvic floor muscles	Identical
Standards	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-18ISO 10993-17ISO 10993-23	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23	Identical
Materials	Medical Grade PC,Stainless Steel	ABS,Stainless Steel	Similar;Levina probes are made ofmaterials suitable for hightemperature disinfection.
ContactDuration	Intermittent mucosal contact< 30 min/session -Stim< 1 hour/session - EMGnot exceeding hr combinedStim/EMG	Intermittent mucosal contact< 30 min/session -Stim< 1 hour/session - EMGnot exceeding hr combinedStim/EMG	Identical
ElectrodeSurface Area	Vaginal Probes: 2.8 – 6 cm²Anal Probes: 3 – 6.3 cm²	Vaginal Probes: 4.25 – 7.87 cm²Anal Probes: 1.93 – 3.77 cm²	Different;The range of electrodesurface area are within thewithin the normal range for other
			K231101Page 3 of
			cleared devices of thisdevice type
Probe Length	Vaginal Probes: 8 - 10 cmAnal Probes: 7 – 12.5 cm	Not publicly available	Different;The range of probe lengthsare within the normal rangefor other cleared devices ofthis device type
ProbeDiameter	Vaginal Probes: 3.16 - 3.4 cmAnal Probes: 1.2 – 2.8 cm	Not publicly available	Different;The range of probediameters are within thenormal range for othercleared devices of thisdevice type
UsageConditions	Reusable-Single Patient	Reusable-Single Patient	Identical
Sterility	Not sterilized	Not sterilized	Identical
Reprocessing-Cleaning	Cleaning: washed with soap orneutral detergent (at or nearpH7.0) and water after each useand dried thoroughly.	Cleaning: washed with soap andwater after each use and driedthoroughly.	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
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 ●

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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.

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.

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).