The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

Device Description

The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.

AI/ML Overview

The provided text describes a 510(k) submission for the Hollister InCare Pressure Biofeedback Vaginal and Anal Pressure Probes, which are accessories to the InCare Pelvic Floor Therapy devices. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K891774).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it indicates the overarching acceptance criterion is substantial equivalence to the predicate device (K891774) in terms of intended use, manufacturing processes, labeling, and product performance.

Acceptance Criteria Category	Reported Device Performance	Comments
Intended Use	"equivalent in intended use"	The new device and the predicate device are both intended to "provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence."
Manufacturing Processes	"equivalent in manufacturing processes"	No specific details on manufacturing process equivalence are provided, but the statement implies a comparison was made. The primary change described is the use of a silicone bladder.
Labeling	"equivalent in... labeling"	No specific details on labeling equivalence are provided, but the statement implies a comparison was made.
Product Performance	"equivalent in product performance"	This is the key area for a "study." The document states "product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance." Crucially, no specific performance metrics, measurement methods, or quantitative results are provided.
Biocompatibility	"considered biocompatible and appropriate for its intended use"	Biocompatibility assessment of the silicone bladder was conducted based on "United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices." This is a specific criterion met.

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

The document does not provide any information regarding the sample size used for the performance tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states "product performance test results demonstrate...equivalence."

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

This information is not provided in the document. The nature of the device (pressure probes for biofeedback) suggests that "ground truth" would likely involve instrument calibration against known pressures or direct comparison of measurements between the new and predicate devices, rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the likely nature of the performance tests (instrument physical characteristics or comparison of readings), an adjudication method as described (e.g., 2+1, 3+1) is unlikely to be relevant or applicable to this type of device submission.

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

An MRMC comparative effectiveness study is not applicable and was not done. This device is a biofeedback probe, not an AI-assisted diagnostic tool for which human reader performance would be a primary efficacy endpoint. The submission is for a physical device, an accessory to a therapy system.

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

A standalone algorithm performance study is not applicable and was not done. This device is a physical probe, and there is no mention of a standalone algorithm for its function. Its purpose is to measure pressure and provide biofeedback for human-guided rehabilitation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. However, for a device like a pressure probe, the "ground truth" for performance would most likely involve:

Calibration against known, standardized pressure sources.
Direct comparative measurements between the new device and the predicate device, or a highly accurate reference standard, under controlled conditions.
Biocompatibility testing against established regulatory standards (USP, G95-1, ISO 10993-1).

It is highly unlikely that expert consensus, pathology, or outcomes data would be directly used as "ground truth" for the performance of a pressure-measuring probe itself. Such data would be relevant for the overall biofeedback therapy effectiveness, but not for the performance of the probe as an accessory.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical probe, not an AI/machine learning model that requires a training set.

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

This information is not provided and is not applicable, as there is no training set for this type of device.

Summary

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Hollister Incorporated 2000 Hollister Drive Libertyville, Illino s 60048-3781

MAR 5 2002

Hollister

Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

510(k) Summary

1. Sponsor's name. Address and Contact Person

Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Contact Person Cindy Roberts Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)918-3497 Ph: Fax: (847)918-3860

Date Summary Prepared -- November 5, 2001

2. Name of Device:

InCare Pressure Biofeedback Vaginal Pressure Probe InCare Pressure Biofeedback Anal Pressure Probe

3. Name of Predicate Device(s)

InCare Pressure Biofeedback Vaginal Pressure Probe -- 510(k) #K891774 InCare Pressure Biofeedback Anal Pressure Probe - 510(k) #K891774

4. Description of Device

5. Statement of Intended Use

The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

6. Statement of Technological Characteristics of the Device

The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are used as an accessory with the InCare Pelvic Floor Therapy devices to provide pressure biofeedback from pelvic floor musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence. To meet the changing needs of

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Hollister

Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

Hollister's customers the InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe has been constructed with a silicone bladder.

The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774 - 8/23/89) are equivalent in intended use, manufacturing processes and labeling as a biofeedback therapy device for the treatment of urinary incontinence. Furthermore, product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance.

Biocompatibility assessment of the silicone bladder has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices. Based upon the results of this assessment, the silicone bladder material is considered biocompatible and appropriate for its intended use.

7. Conclusion

Based on information presented above and in the body of this premarket notification the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe with silicone bladder are substantially equivalent to devices currently in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 5 2002

Ms. Cindy Roberts Global Regulatory Affairs Analyst Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781

Re: K013653

Trade/Device Name: InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe Non-Latex probe bladder Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: 85 HIR Dated: February 14, 2002 Received: February 19, 2002

Dear Ms. Roberts:

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 (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. 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 (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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

b. Statement of Intended Use

KOI 3653 510(k) Number (if Known): InCare Pressure Biofeedback Vaginal and Anal Pressure Probes Device Name:

Intended Use:

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 11.0136 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V OR Prescription Use (Per 21 CFR 801.109)

Over-the-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).