The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

Device Description

The Small Vaginal and Rectal Stimulation Electrode is identical in design to the predicate rectal electrode device except for the addition of vaginal use for stimulation. There were no design changes required or made to allow for this change.

AI/ML Overview

Innova Small Vaginal and Rectal Stimulation Electrode - Study Summary

This document describes the acceptance criteria and the supporting clinical study for the Innova Small Vaginal and Rectal Stimulation Electrode.

Note: The provided documentation primarily focuses on establishing substantial equivalence for a medical device (510(k) submission) rather than presenting a detailed performance study with explicit acceptance criteria and corresponding results in a typical scientific paper format. Therefore, some information requested (e.g., specific performance metrics with numerical targets, detailed ground truth establishment for training sets) is not explicitly present in the provided text and will be inferred or marked as "Not explicitly stated."

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state quantitative acceptance criteria or detailed performance metrics. The primary objective of the clinical study was to establish "equivalence" to currently marketed stimulation electrodes. This implies a non-inferiority or comparative effectiveness approach, rather than meeting specific performance thresholds.

Acceptance Criteria (Inferred from document)	Reported Device Performance
Functional Equivalence: The electrode, when used vaginally, performs similarly to currently marketed stimulation electrodes for pelvic floor stimulation in the treatment of urinary incontinence and assessment of EMG activity.	The clinical study "confirmed the suitability of performance of this electrode" and established "equivalence between this electrode used vaginally and the currently marketed stimulation electrodes."
Safety: The device is safe for its intended use (vaginal and rectal stimulation).	Not explicitly detailed, but implied by regulatory clearance and the statement about re-use instructions for safety.
Intended Use Compliance: The device can be used vaginally and rectally for pelvic floor stimulation and EMG activity assessment.	Supported by device description and intended use statement.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not explicitly stated. The documentation mentions "A Clinical study was performed," but the number of participants is not provided.
Data Provenance: Not explicitly stated. The document is from Empi, Inc. in St. Paul, Minnesota, USA, suggesting the study likely took place in the USA. The study is described retrospectively in the 510(k) submission as having been "performed."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. Given the context of a medical device for urinary incontinence and EMG activity, it is reasonable to infer that the ground truth for the clinical study would have been established by medical professionals, likely including urologists, gynecologists, physical therapists specializing in pelvic floor dysfunction, or other relevant clinicians.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated.

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

MRMC Study: Not explicitly mentioned or indicated. The study's focus was on establishing equivalence of the device itself rather than the improvement of human readers with AI assistance.

6. Standalone Performance Study

Standalone Performance: Not applicable in this context. This device is a physical electrode used in conjunction with other equipment and by clinicians, not a standalone algorithm. The "suitability of performance" was confirmed in a clinical setting with human involvement.

7. Type of Ground Truth Used

Type of Ground Truth: Clinical assessment and outcomes. The study aimed to confirm "suitability of performance" and "equivalence" in the context of treating urinary incontinence and assessing EMG activity. This would likely involve clinical evaluations of patient outcomes, symptom improvement, and/or physiological measurements (EMG readings) from the device compared to predicate devices.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device is a physical medical electrode, not an AI/ML algorithm that requires a training set.

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

Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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1983206

Cost Effective Health Care Solutions

SUMMARY OF SAFETY AND EFFECTIVENESS Innova Small Vaginal and Rectal Stimulation Electrode

Date of Summary: September 11, 1998 Page 1 of 1

Empi. Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA

612-415-9000 FAX 612-415-7305

General Provisions	FAX
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® Small Vaginal and Rectal StimulationElectrode
Common Name:	Pelvic Floor Stimulation Device

B. Name of Predicate Devices

•	Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode	K952688
•	Empi, Inc. Innova Rectal Stimulation Electrode	K954272
•	Innova® ComfortPulse™ Vaginal Electrodes (Small and Std.)	K964577
•	Innova® Vaginal Electrode	K940091

C. Device Description

D. Intended Use

E. Non-Clinical and Clinical Test Summary

A Clinical study was performed to establish equivalence between this electrode used vaginally and the currently marketed stimulation electrodes. This study confirmed the suitability of performance of this electrode.

3 1998 NOV

NOV 3

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the twin snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a semi-circular fashion around the left side of the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOVI

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager Empi, Incorporated 599 Cardigan Road St. Paul, Minnesota 55126-4099 Re: K983206 Empi Small Vaginal and Rectal Stimulation Electrode Dated: September 11, 1998 Received: September 14, 1998 Regulatory Class: II 21 CFR §876.5320/Product Code: 78 KPI

Dear Ms. Steele 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 indications for use stated in the enclosure) 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, market the device, 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 II (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 requirements, as set forth in the Quality System Regulation (OS) 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 the Electronic Product 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 questions on the promotion 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/cdr/dsmaldsmamain.html".

Sincerely yours

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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Empi, Inc. 510(k) Submission Small Vaginal/Rectal Stimulation Electrode Page 3

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinid G. Logom

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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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).