The Vaginal Stimulation/EMG Probe - Tampon, is intended 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.

Device Description

Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Vaginal Stimulation/EMG Probe - Tampon". It outlines the device's characteristics, intended use, and its substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific acceptance criteria or quantitative performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy, precision, etc.). Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices. The "reported device performance" in this context refers to the comparative characteristics, which are implicitly accepted as meeting the required performance since the predicate devices are already cleared.

Characteristic Category	Acceptance Criteria (Implicit for Substantial Equivalence to Predicate)	Reported Device Performance (Vaginal Stimulation/EMG Probe - Tampon)
Intended Use	Same as predicate devices	"Intended 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." (Identical to predicates)
Technological Characteristics	Similar to predicate devices, with justifiable differences	- Number of Electrodes: 2-Stimulation/EMG
		- Usage Conditions: Reusable - single patient use
		- Electrode Orientation: Circular
		- Body Material: Acrylonitrile-Butadiene-Styrene copolymer (ABS)
		- Probe Length: 2.3 inches nominal (Shorter than predicates, justified for improved patient mobility)
		- Probe Diameter: 0.841 inch nominal (Similar to predicates, but slightly different from 0.750" and 1.0")
		- Electrode Material: Stainless steel
		- Electrode Placement: Vaginal
		- Device Connector: Attached cord with 3.5 mm stereo phono plug
		- Contact Duration: Intermittent mucosal contact (<30 min/session - Stim, <1 hour/session - EMG, not exceeding 1 hr combined Stim/EMG) (Identical to predicates)
Material Biocompatibility	Meets established biocompatibility standards	"Materials used to fabricate Vaginal Stimulation/EMG Probe - Tampon, are considered biocompatible and appropriate for their intended use." (Based on ISO 10993, G95-1, USP, and in vitro/in vivo evaluations).
Manufacturing Process	Identical to predicate devices	"The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices."

2. Sample Size Used for the Test Set and Data Provenance:

This document is a 510(k) summary, which is a premarket notification to the FDA. It does not describe a clinical study with a traditional "test set" or "sample size" in the context of performance evaluation against individual cases. Instead, the "test" or assessment here is one of substantial equivalence to predicate devices. The data provenance is primarily from documentation of the predicate devices and material evaluations. No patient-specific data from a clinical trial test set is presented.

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

Not applicable. This is not a study requiring expert-based ground truth for a test set of clinical images or patient data. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the compliance of the new device with recognized standards for materials and manufacturing.

4. Adjudication Method for the Test Set:

Not applicable. There is no adjudication method described as this is not a study assessing performance against a gold standard for a test set of medical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. This document does not describe an MRMC comparative effectiveness study. The focus is on substantial equivalence based on technological characteristics and intended use, not on measuring human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical probe, not an algorithm or AI system. Its function is to facilitate electromyographic feedback and electrical stimulation, which inherently involves human interaction (patient and clinician).

7. The Type of Ground Truth Used:

The primary "ground truth" used for this submission is the established safety and effectiveness of the predicate devices. This is supplemented by:

Biocompatibility standards and test results: Based on ISO 10993, FDA General Program Memorandum #G95-1, and United States Pharmacopeia (USP) guidelines, utilizing in vitro or in vivo laboratory evaluations and biomaterial history. This constitutes a "standards-based" ground truth for material safety.
Manufacturing process equivalence: The "ground truth" is that the manufacturing process is identical to that of already cleared devices, implying similar quality control and product integrity.
Material composition: The use of identical raw material components as predicate devices serves as a ground truth for material consistency.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a 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

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the Hollister logo. The logo consists of a geometric symbol to the left of the word "Hollister". The geometric symbol is a stylized cross or asterisk shape, formed by intersecting bars. The word "Hollister" is written in a bold, sans-serif font.

Hollister Incorporated 2000 Ho!lister Drive Libertyville, Illinois 60048-3781

1/3

Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

510(k) Summary

JUN 2 5 1997

1. Submitter's name, Address and Contact Person

Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Ph (847)680-2849 (847)918-3860 Fax -

Date Summary Prepared - April 24, 1997

2. Name of Device:

Vaginal Stimulation/EMG Probe - Tampon

3. Name of Predicate Device(s)

Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602

4. Description of Device

5. Statement of Intended Use

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a plus sign with additional arms. To the right of the shape is the word "Hollister" in a serif font.

Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

6. Statement of Technological Characteristics of the Device

The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.

ElectrodeCharacteristics	Vaginal Stimulation/EMG Probe - Tampon	Vaginal Stimulation/EMG Probe-Small	Vaginal Stimulation/EMG Probe - Standard
Number of Electrode	2-Stimulation/EMG	2-Stimulation/EMG	2-Stimulation/EMG
Usage Conditions	Reusable - single patientuse	Reusable - single patientuse	Reusable - single patientuse
ElectrodeOrientation	Circular	Circular	Circular
Body Material	Acrylonitrile-Butadiene-Styrene copolymer(ABS)	Acrylonitrile-Butadiene-Styrene copolymer(ABS)	Acrylonitrile-Butadiene-Styrene copolymer(ABS)
Probe Length	2.3 inches nominal	4.8 inches nominal	4.8 inches nominal
Probe Diameter	0.841 inch nominal	0.750 inch nominal	1.0 inch nominal
Electrode Material	Stainless steel	Stainless steel	Stainless steel
Electrode Placement	Vaginal	Vaginal	Vaginal
Device Connector	Attached cord with 3.5mm stereo phono plug	Attached cord with 3.5mm stereo phono plug	Attached cord with 3.5mm stereo phono plug
Contact Duration	Intermittent mucosalcontact<30 min/session - Stim<1 hour/session - EMGnot exceeding 1 hrcombined Stim/EMG	Intermittent mucosalcontact<30 min/session - Stim<1 hour/session - EMGnot exceeding 1 hrcombined Stim/EMG	Intermittent mucosalcontact<30 min/session - Stim<1 hour/session - EMGnot exceeding 1 hrcombined Stim/EMG
Indications for Use	Electrical stimulation of thepelvic floor muscles for thetreatment of urinaryincontinence. EMG sensingof the pelvic floor muscles	Electrical stimulation of thepelvic floor muscles for thetreatment of urinaryincontinence. EMG sensingof the pelvic floor muscles	Electrical stimulation of thepelvic floor muscles for thetreatment of urinaryincontinence. EMG sensingof the pelvic floor muscles

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the Hollister logo. On the left is a black geometric design that resembles a stylized snowflake or cross. To the right of the design is the word "Hollister" in a serif font.

Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

7. Biocompatibility

The biocompatibility of the Vaginal Stimulation/EMG Probe - Tampon, in nonsterilized configurations was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as:

-- ISO 10993, International Standards Organization (ISO) Standard
-- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
-- United Stated Pharmacopeia (USP)

Material biocompatibility issues have been addressed based upon biomaterial history or in separate in vitro or in vivo laboratory evaluations using licensed commercial reference laboratories. Specific test methodology has been chosen, where appropriate, from test protocols established or recommended by the aforementioned agencies or organizations. Product use conditions have been mimicked in testing procedures where possible. These evaluations have been contracted either by Hollister or the suppliers of the materials.

Based upon the results of this assessment, the materials used to fabricate Vaginal Stimulation/EMG Probe - Tampon, are considered biocompatible and appropriate for their intended use.

8. Conclusion

Based upon the information presented above it is concluded that the proposed Vaginal Stimulation/EMG Probe - Tampon, is safe and effective for its intended use and is substantially equivalent to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN 2 5 997

Mr. Joseph S. Tokarz Manager. Regulatory Affairs Hollister, Inc. . . . . . . . . . . . . . . . 2000 Hollister Drive Libertyville, Illinois 60048

Re: K971541 Vaginal Stimulation/EMG Probe - Tampon Dated: April 24, 4997 ....... - - -Received: April 28, 1997 Regulatory class: II 21 CFR §876.5320/Product code: 78 KPI 21 CFR §884.1425/Product code: 85 HIR

Dear Mr. Tokarz:

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 (Special Controls) or 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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) 594-4616. 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/cdrh/dsmamain.html".

Sincerely yours,

Kiliai Yi

Lillian Xia, Ph.D.

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

{4}------------------------------------------------

Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

Statement of Intended Use

510(k) Number (if Known): Device Name:

K971541 Vaginal Stimulation/EMG Probe - Tampon_

Intended Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use __

(Optional Format 1-2-96)

. and Radiological Devices
510(k) Number K971541

Page 6

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).