TIPI

K060526 · Contipi , Ltd. · HHW · Jun 9, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060526
• Device Name: TIPI
• Applicant: Contipi , Ltd.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females. Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.

Device Story

Intra-vaginal device for mid-urethral support; inserted via tampon-like applicator; expands to provide mild tension on vaginal walls; flexible arms maintain support during body movement; removed via pull string. Single-use, disposable; worn up to 8 hours. Available in multiple sizes. Used by women suffering from stress urinary incontinence to reduce urine leakage. Clinical benefit demonstrated by reduction in pad weight and improved quality of life scores.

Clinical Evidence

Prospective study of 50 participants. Objective endpoint: 94% of participants achieved >70% reduction in pad weight (mean reduction 86±9%, p<0.001). Subjective endpoints: 92% reported feeling dry; Quality of Life (QoL) leak score improved from 21.26 to 5.3. Adverse event rate was 6.6%. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Intra-vaginal pessary; soft, flexible material; flexible arms for support; multiple sizes; single-use; disposable; tampon-like applicator; biocompatible per ISO 10993-1.

Indications for Use

Indicated for temporary management of genuine (mild, moderate, severe) stress urinary incontinence in females. Contraindicated in patients with vaginal infection, lacerations, urinary tract infections, severely atrophic vagina, recent vaginal surgery, difficulty inserting a tampon, abnormal vaginal bleeding, during menstruation, during coitus, or during pregnancy.

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

• Johnson & Johnson - Introl ® - Bladder Neck Support (K930618 and K965040)

Submission Summary (Full Text)

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K060524
page 1 of 2

### 510(k) Summary

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 15-May-06

JUN - 9 2006

| ConTIPI Ltd. | |
|---------------------|-------------------------|
| 99 Hahistadrut Ave. | Tel - 011-972-4-8470113 |
| Haifa 31250 ISRAEL | Fax - 011-972-4-8490824 |

| Official Contact -- | Nir Sinai - Project Manager |
|-----------------------------|-------------------------------------------------------------------------|
| Proprietary or Trade Name - | |
| Common/Usual Name - | Intra-vaginal stress incontinence device |
| Classification Name -- | Vaginal pessary |
| Device -- | |
| Predicate Devices -- | Johnson & Johnson - Introl ® - Bladder Neck Support K930618 and K965040 |

JUN - 6 2002Device Description --

a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time.

It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.

| Indications for Use -- | indicated for temporary management of genuine (mild, moderate and severe) stress urinary incontinence in females. |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | designed to be used by any woman, who suffers from stress urinary incontinence. |
| Environment of Use -- | No limitations |

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1K060526
Page 1 of 2

#### Non-Confidential Summary of Safety and Effectiveness

## Page 2 of 2 15-May-06

| Contraindications -- | Patients should not use if: |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vaginal infection or lacerations are present Urinary tract infections Severely atrophic vagina Recovering from recent vaginal surgery Have difficulty inserting a vaginal tampon |

- Abnormal vaginal bleeding .
- During monthly menstruation period .
- During coitus .
- Consult your doctor regarding use during pregnancy ◆

## Clinical Testing Effectiveness and Safety --

A fifty (50) participant safety and efficacy study was performed. It measured objective and subjective end-points.

Objective Efficacy end-point

- Reduction in pad weight Objective at least a 70% reduction .
- 94% of participants obtained % reduction of over 70% (p<0.001), mean % reduction . 86±9% (with high range of 59-98%), and a specific frequency distribution showed that 80% of patients had >80% reduction of A pad weight.

Subjective Efficacy end-points

- Participant's perception of being dry .
- . 92% considered themselves dry when compared to the first week and the last few days of use
- Leak Score Quality of Life (QoL) questionnaire the total score, decreasing from 21.26 to ● 5.3, pre-trial vs. post-trial, respectively.

Safety Testing

- We monitored all participants for any problems and adverse events. ●
- . The number of reported adverse events was 6.6% which is lower than other predicate study results.
- Biocompatibility testing per ISO 10993-1 has been demonstrated. .

#### Substantial Equivalence -

The device based upon a comparison to the predicate and clinical testing has been demonstrated that it is substantially equivalent.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 9 2006

ConTIPI Ltd. % Mr. Paul E. Dryden Regulatory Consultant ProMedic. Incorporated 6329 W. Waterview Ct. MCCORDSVILLE IN 46055-9501

Re: K060526

Trade/Device Name: Vaginal Pessary Regulation Number: 21 CFR § 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: May 15, 2006 Received: May 16, 2006

Dear Mr. Dryden:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The seal also includes the years "1906-2006" and the phrase "Protecting and Promoting Public Health" written in cursive. The logo is black and white.

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#### Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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# Indications for Use Statement

Page 1 of 1

510(k) Number: K060526

Device Name:

Indications for Use:

Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.

Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Vaginal Pessary device

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________