MENTOR EVACARE VAGINAL PESSARIES

K993308 · Mentor Corp. · HHW · Dec 13, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K993308
• Device Name: MENTOR EVACARE VAGINAL PESSARIES
• Applicant: Mentor Corp.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Dec 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Mentor EvaCare™ Vaginal Pessaries are removable medical-grade silicone elastomer devices designed to support pelvic organs. Available in multiple styles (e.g., Ring, Cube, Gellhorn, Hodge, Dish, Donut, Oval, Shaatz, Mar-Land, Gehrung), they are inserted into the vagina by a clinician to treat conditions including uterine prolapse, cystocele, rectocele, and stress urinary incontinence. The device acts as a mechanical support structure. Clinicians use a fitting set to determine the appropriate size for the patient. By providing structural support to the pelvic floor, the pessary helps alleviate symptoms associated with pelvic organ prolapse and incontinence, potentially improving patient quality of life and avoiding or delaying surgical intervention.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed on the silicone elastomer materials.

Technological Characteristics

Medical-grade silicone elastomers. Multiple form factors (Ring, Cube, Gellhorn, Hodge, Dish, Donut, Oval, Shaatz, Mar-Land, Gehrung). Mechanical support device. Non-powered. No software or electronics.

Indications for Use

Indicated for patients with uterine prolapse, cystocele, rectocele, stress urinary incontinence, uterine retroversion, or incompetent cervix. Specific indications vary by style: Donut (3rd degree prolapse, cystocele, rectocele); Ring (1st/2nd degree prolapse, cystocele); Dish (stress incontinence, minor prolapse); Oval (1st/2nd degree prolapse, cystocele); Shaatz (1st/2nd degree prolapse, cystocele); Mar-Land (stress incontinence, minor prolapse); Hodge (1st/2nd degree prolapse, cystocele, stress incontinence, incompetent cervix, retroversion); Gehrung (cystocele, rectocele, 2nd/3rd degree prolapse); Gellhorn (2nd/3rd degree prolapse, procidentia); Cube (3rd degree prolapse, procidentia, cystocele, rectocele). Fitting set used for sizing.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] [phone] 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

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#### 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.

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- 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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)

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# 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.