Indication for Use - Stimulation: The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. Indication for Use - Sensing: The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

Device Description

The Reusable Vaginal and Rectal Electrodes are identical to the predicate devices except for the addition of "multi-patient use" and reuse instructions. There were no design changes required or made to allow for this change.

AI/ML Overview

This submission pertains to the Reusable Vaginal and Rectal Electrodes manufactured by Empi, Inc. The core change from predicate devices is the addition of "multi-patient use" and reuse instructions, indicating that the device itself is not new, but rather its usage paradigm has been expanded.

Therefore, the acceptance criteria and study information provided in the original document focus on validating the reuse aspect rather than the inherent performance of the electrode itself.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance is based on validating the sterilization process and reuse instructions to ensure the device remains safe and effective for multi-patient use.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Sterilization Efficacy	Validate the sterilization process to ensure electrodes are safe for multi-patient use.	"Non-clinical tests were performed to validate the sterilization process and instructions."
Reuse Instructions	Validate that the reuse instructions are adequate to maintain the device's safety and effectiveness.	"Non-clinical tests were performed to validate... the reuse instructions." Device is "reusable if reuse instructions are followed."
Design Integrity for Reuse	No design changes required or made to allow for multi-patient use.	"There were no design changes required or made to allow for this change [multi-patient use and reuse instructions]."

2. Sample Size for Test Set and Data Provenance

The document does not provide details on the sample size used for any specific tests. It only states that "Non-clinical tests were performed."

Sample Size for Test Set: Not specified.
Data Provenance: The tests were "Non-clinical," implying laboratory or bench testing rather than human subject data. Country of origin not specified, but the submission is to the U.S. FDA, suggesting testing likely occurred in the U.S. or under U.S. regulatory standards. The data is prospective for demonstrating the new reuse claim.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. For non-clinical tests validating sterilization and reuse instructions, "experts" in the sense of medical professionals establishing clinical ground truth are not relevant. The ground truth would be established by scientific methods for sterility, material integrity, and functionality after sterilization cycles, typically by microbiologists, materials scientists, or engineers. The document does not specify these roles.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data by multiple experts. The described tests are non-clinical validations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is designed to assess the impact of an AI algorithm on human reader performance, which is not relevant to validating the reuse of an electrode.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an AI algorithm was not done. This device is an electrode, not an AI algorithm. The core functionality of the device (stimulation/sensing) was already established by predicate devices. The study focused on the "standalone" aspect of its reusability through non-clinical validation.

7. Type of Ground Truth Used

The ground truth used was based on scientific validation of sterilization processes and materials science principles to ensure safety and functionality after multiple uses and reprocessing. This would involve:

Microbiological testing: To confirm sterility (e.g., Sterility Assurance Level, SAL).
Material integrity testing: To ensure the electrode material and electrical properties are maintained after reprocessing cycles.
Engineering validation: To ensure the device remains functional and safe for electrical stimulation/sensing.

8. Sample Size for the Training Set

Not applicable. This device is a physical electrode, not an AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K9172054

SUMMARY OF SAFETY AND EFFECTIVENESS Reusable Vaginal and Rectal Electrodes Date of Summary May 30, 1997

AUG 1 4 1997

Page 1 of 1

General Provisions A.

Submitter's Name:	Empi, Inc.
Submitter's Address:	599 Cardigan RoadSt. Paul, Minnesota 55126-3965
Contact Person:	Carolyn M. Steele HustenRegulatory Affairs Manager
Classification Name:	Non-Implanted Electrical Continence Device21 CFR Part 876.5320
Proprietary Name:	Innova® ComfortPulse Vaginal Electrodes (Smalland Standard)Innova® Rectal Electrode
Common Name:	Pelvic Floor Stimulation Device

Name of Predicate Devices B.

• Empi, Inc. Minnova Pelvic Floor Stimulation System	K970307
• Empi, Inc. ComfortPulse Regular and Small Electrode	K964577
• Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode	K952688
• Empi, Inc. Innova Rectal Stimulation Electrode	K954272

C. Device Description

Intended Use D.

Indication for Use - Stimulation:

The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed.

Indication for Use - Sensing:

The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

Non-Clinical and Clinical Test Summary E.

Non-clinical tests were performed to validate the sterilization process and instructions.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles a human figure in profile, with three parallel lines extending from the head, representing the department's focus on health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 1997

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager EMPI, Inc. 599 Cardigan Road … St.Paul, Minnesota 55126-3965 Re : K972054

Innova® ComfortPulse Vaginal Electrodes (Small and Standard) Innova® Rectal Electrode ` Dated: May 30, 1997 Received: June 2, 1997 Requlatory Class: II 21 CFR §876.5320/Product Code: 78 KPI

Dear Ms. Husten:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclosure) to 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). You may, therefore, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h. William Lyr

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972054--

510(k) Number: (if known): Unknown at time of submission Device Name: Reusable Vaginal and Rectal Electrodes Indications for Use:

Indication for Use - Stimulation:

The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indication for Use - Sensing:

The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel H.P.

(Division Sign-Off) (Division Sigil-Krif)
Division of Reproductive, Abdominai, ENT, and Radiological Devices 510(k) Number .

P Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use ________

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).