The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

Device Description

The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.

The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Hollister Incorporated InCare Pelvic Floor Therapy System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain the information requested in the prompt regarding:

A table of acceptance criteria and reported device performance: This is not a study assessing performance against pre-defined criteria.
Sample size used for the test set and data provenance: No new clinical study data is presented.
Number of experts used to establish ground truth and their qualifications: Not applicable, as no new ground truth was established for a test set.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does provide:

The core of this document is a statement of "substantial equivalence" to predicate devices, which means that the device has the same intended use and similar technological characteristics to devices already legally marketed.

Here's a summary of the relevant details from the provided text:

Device Name: InCare Pelvic Floor Therapy System
Intended Use:
- Electrical stimulation component: To provide electrical stimulation for the rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
- Biofeedback components: To provide electromyography or pressure biofeedback from pelvic musculature for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
Predicate Devices:
- InCare Pelvic Floor Therapy Systems (K930530/c, K961872, K974048)
- Elpha 2000 Conti Device (K964738)
Technological Characteristics (briefly described as justification for equivalence): The proposed system is an office-based instrument combining an instrumentation unit and a personal computer, with separate functions for "data manipulation and presentation" (PC) and "patient therapy" (instrumentation unit). The key update in this 510(k) is an "expanded stimulation parameter of 10 Hz and updated clinician application software."
Conclusion of the 510(k): "Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices."

In essence, this document is a regulatory submission for market clearance based on similarity to existing devices, not a scientific study proving performance against specific acceptance criteria.

Summary

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MAR 1 9 2002

Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 Telephone: 847.680.1000 Facsimile: 847.918.3860

K013612
PAGE 1 OF 2

Hollister Incorporated InCare Pelvic Floor Therapy System

Safety and Effectiveness Summary

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 Fax: (847) 918-3860

Date Summary Prepared - November 2, 2001

2. Name of Device:

InCare Pelvic Floor Therapy System.

3. Name of Predicate Device(s)

1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048
1. Elpha 2000 Conti Device, K964738

4. Description of Device

The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

5. Statement of Intended Use

The electrical stimulation component of the InCare Pelvic Floor Therapy System provides r it e clource. band it is that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

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Hollister

Hollister Incorporated InCare Pelvic Floor Therapy System

6. Statement of Technological Characteristics of the Device

The proposed InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

7. Conclusion

Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices.

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MAR 1 9 2002

Mr. Joseph S. Tokarz Manager Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K013612 Trade/Device Name: InCare PRS9500 Pelvic Floor Therapy System Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Product Code: 78 KPI Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Product Code: 85 HIR Regulatory Class: II Dated: February 13, 2002 Received: February 27, 2002

Dear Mr. Tokarz:

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 I mis letter will anow you to begin nationing , "
notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Drice 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 II you desire specific advice for your de rest on 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on by responsibilities under the Act may be obtained from the Division of Small Manufacturers, your responsibilition and Consumer 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

Nancy 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 Pelvic Floor Therapy System

Statement of Intended Use

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

013612

InCare Pelvic Floor Therapy Stimulation/Biofeedback Device

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-the-Counter-Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal,	Page 6

and Radiological Devices 510(k) Number

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).