MTI ST#1 SILICONE PESSARY

K020512 · Medical Technology and Innovations, Inc. · HHW · May 16, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020512
• Device Name: MTI ST#1 SILICONE PESSARY
• Applicant: Medical Technology and Innovations, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.

Device Story

MTI ST#1 Silicone Pessary is a vaginal device for treating genuine stress urinary incontinence. Geometrically shaped to support the bladder and align the urethra between device legs when inserted. Used by patients under prescription; removed daily before sleep. Device provides mechanical support to restore normal bladder function.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by biocompatibility data demonstrating the device is nonirritating and nontoxic, and comparison to legally marketed predicate devices.

Technological Characteristics

Silicone material. Geometrically shaped vaginal pessary. Mechanical support principle. Class II device.

Indications for Use

Indicated for patients with genuine stress urinary incontinence. Prescription use only. Not for use during sleep; must be removed daily.

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

• DesChutes Medical Products, Inc. PelvX Incontinence Ring (K974116)
• Milex Silicone Gehrung Folding Pessary (510(k) number unknown)

Submission Summary (Full Text)

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MAY 1 6 2002

### 510(k) SUMMARY, K020512

## Medical Technology & Innovations, Inc.

#### MTI ST#1 Silicone Pessary

#### March 14, 2002

#### Submitter Information:

| Submitter's Name: | Larry W. James, P.A.<br>Senior VV – Research & Development<br>Medical Technology & Innovations, Inc.<br>1072 N.W. High Point Drive<br>Lee's Summit, MO 64081 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Device Name: | |

MTI ST#1 Silicone Pessary Proprietary name:

Vaginal pessary Common Name:

Classification Name: Vaginal pessary

#### Predicate Device Equivalence:

Substantial equivalence is claimed to the DesChutes Medical Products, Inc. Pelvx Incontinence Ring, cleared for commercial distribution per K974116, and to the Milex Silicone Gehrung with Knob Pessary, 510(k) number unknown.

#### Device Description:

The MTI ST#1 Silicone Pessary is geometrically shaped such that when inserted in the patient's vagina, the urethra is aligned between the legs of the device and the bladder is fully supported, thus allowing the bladder to function normally.

P.

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#### Intended Use:

The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.

#### Device Classification:

Class II, 21 CFR 884.3575, Product Code HHW

#### Predicate Devices:

DesChutes Medical Products, Inc. PelvX Incontinence Ring, K974116

Milex Silicone Gehrung Folding Pessary, 510(k) number unknown

#### Comparison of Technological Characteristics:

The MTI ST#1 Silicone Pessary has the same technological characteristics as the predicate devices.

#### Summary of Device Evaluation:

Information on this and similar devices demonstrates that the MTI ST#1 Silicone Pessary performs as intended. Biocompatibility data demonstrates that the device is nonirritating and nontoxic.

#### Conclusions:

Based on the above, we concluded that the MTI ST#1 Silicone Pessary is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 6 2002

Larry W. James, P.A. Senior Vice President Research and Development Medical Technology & Innovations. Inc. 3725 Investment RIVIERA BEACH FL 33404

# Re: K020512

Trade/Device Name: MTI ST#1 Silicone Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: 85 HHW Dated: February 14, 2002 Received: February 15, 2002

Dear Mr. James:

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. Iisting 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.

Image /page/2/Picture/11 description: The image shows a partial view of a circular seal or emblem. The words "DEPARTMENT OF HEALTH" are visible, arranged along the curve of the circle. To the right of the text, there is a stylized graphic element, possibly part of a larger design within the seal. The image is in black and white, with the text and graphic elements appearing in solid black against a white background.

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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 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), 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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K020512

Device Name:

MTI ST#1 Silicone Pessary

## Indications for Use:

The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the used in the The MTTST#1 Slicone Pessaly is litended in procurption intended to be used while
treatment of genuine stress unnary incontinence. It is not intentional to be used while treatment of genume stress unnary incontinent. In the surfore going to bed.

*Prescription Use*

Ethel C. Segman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 020512 510(k) Number ________________________________________________________________________________________________________________________________________________________________