A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse.

The specific indications for use by pessary style are as follows:

Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion..
Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient.

Device Description

Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone elastomers and are available in the following styles:
Cube Pessarv
Dish Pessary
Gellhorn Pessary
Ring Pessary
Mar-Land Pessary
Hodge Pessary
Oval Pessary
Gehrung Pessary
Fitting Set
Cube Pessary with Drainage
Dish Pessary with Support
Gellhorn Pessary with Drainage
Ring Pessary with Support
Mar-Land Pessary with Support t
Hodge Pessary with Support
Shaatz Pessary
Donut Pessary

AI/ML Overview

This document is a 510(k) summary for the Mentor EvaCare™ Vaginal Pessaries, submitted to the FDA in 1999. It details the device's substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, most of the requested information cannot be extracted from this document.

However, based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or report specific device performance metrics in the format of a table. It is a submission for substantial equivalence based on prior predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set or associated sample size, country of origin, or study design (retrospective/prospective) is mentioned for this 510(k) submission. The submission relies on biocompatibility testing of component materials and substantial equivalence to predicate devices, not on a new clinical study with a test set for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new clinical study with a test set and ground truth establishment by experts is described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No new clinical study requiring an adjudication method for a test set is described.

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:

Not applicable. This device is a silicone vaginal pessary, not an AI-assisted diagnostic tool, and therefore, no MRMC comparative effectiveness study involving AI or human readers would be relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. As noted above, this is a physical medical device, not an algorithm, so standalone performance testing in this context is irrelevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. No new clinical study requiring ground truth establishment is detailed in this 510(k) submission for performance evaluation.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning model.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, there is no ground truth establishment for a training set discussed.

In summary: This 510(k) document is a regulatory submission for a physical medical device, the Mentor EvaCare™ Vaginal Pessary. It focuses on demonstrating substantial equivalence to predicate devices already on the market and mentions prior biocompatibility testing of materials. It does not describe a new clinical study involving acceptance criteria, performance metrics, test sets, training sets, or expert ground truth establishment as would be required for a novel diagnostic device or AI algorithm.

Summary

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

DEC 1 3 1999

Mentor EvaCare™ Pessary 510(k) Notification

510(k) SUMMARY Mentor EvaCare™ Vaginal Pessaries

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: K993308

Donna A. Crawford Contact Person: Manager, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111

Telephone: (805) 879-6304 (805) 681-6004 FAX:
Date Prepared: September 30, 1999

Device Name and Classification:

Proprietary Name:	Mentor EvaCare™ Vaginal Pessaries
Common Name:	Vaginal Pessary
Classification Name:	Vaginal Pessary
Classification:	Class II (21 CFR § 884.3575)
Product Code:	85 HHW

Manufacturer:

Mentor Urology 1615 West River Road North Minneapolis, MN 55411

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

510(k) SUMMARY Mentor EvaCare™ Vaginal Pessaries

Substantial Equivalence Claim:

Mentor EvaCare™ Vaginal Pessaries are substantially equivalent to preamendment devices and pessaries manufactured by:

Milex Products, Inc. ● Inflat-o-Ball K904026
. DesChutes Medical Products, Inc.
- Pelvx Donut, Pelvx Cube K974117 Pelvx Incontinence Ring K974116
- Pelvx Ring, Pelvx Ring with Support K974115
Bioteque America, Inc. . Pessary Flexible Silicone Donut Ring K920747 Flexible Silicone Gellhorn K920187

Device Description:

Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone elastomers and are available in the following styles:

Cube Pessarv ●
Dish Pessary ●
Gellhorn Pessary ●
Ring Pessary . ●
Mar-Land Pessary .
. Hodge Pessary
Oval Pessary .
Gehrung Pessary ●
Fitting Set .
. Cube Pessary with Drainage
Dish Pessary with Support ●
Gellhorn Pessary with Drainage ●
Ring Pessary with Support ●
Mar-Land Pessary with Support t
. Hodge Pessary with Support
Shaatz Pessary -.
Donut Pessary ، .

Indications For Use:

A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse.

The specific indications for use by pessary style are as follows:

Donut Pessary: Support of third degree prolapse, cystocele and rectocele.

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

Support of first or mild degree prolapse. Ring Pessary with Ring Pessary: support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and cystocyle.
Shaatz Pessary: Support of first or mild second degree prolapse and cystocele.
Mar-Land Pessary: Control of stress urinary incontinence and minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, uterine retroversion or incompetent cervix, stress urinary incontinence.
Gehrung Pessary: Support of cystocele and rectocele, support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient

Summary of Testing:

Mentor has previously performed biocompatibility testing on the pessary component materials.

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

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1999

Ms. Donna A. Crawford Manager, Corporate Requlatory Affairs MENTOR Corporation 201 Mentor Drive Santa Barbara, CA 93111

Re: K993308 Mentor EvaCare™ Vaginal Pessaries Dated: October 25, 1999 Received: November 23, 1999 Regulatory Class: II 21 CFR 884.3575/Procode: 85 HHW

Dear Ms. Crawford:

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 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, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act include requirements for annual registration, ilsting 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 requlations 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 (QS) for Medical Devices: General requlation (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 requiation 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K 9g 3308

Mentor EvaCare™ Vaginal Pessary (various styles) Device Name:

Indications For Use:

A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse.

Please refer to the attached page for a listing of indications for use for each pessary style.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number	K993308/5001

Prescription Use (Per 21 CFR 801.109)

OR Over the Counter Use

(Optional Format 1-2-96)

{5}------------------------------------------------

INDICATIONS FOR USE

Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion..
Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient.

Regulation Number and Section

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).