MODIFICATION TO URESTA PESSARY

K083769 · Eastmed, Inc. · HHW · Jan 14, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083769
• Device Name: MODIFICATION TO URESTA PESSARY
• Applicant: Eastmed, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Jan 14, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The urestaTM Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising.

Device Story

The uresta™ Pessary is a vaginal device designed to manage stress urinary incontinence in adult women. It is inserted vaginally to provide support and reduce involuntary urine loss caused by physical activities like coughing, laughing, or exercising. The device is manufactured from a non-latex thermoplastic elastomer rubber. It functions as a mechanical support device. No specific clinical setting is mandated, and it is intended for use by the patient. The device does not involve electronic processing, software, or algorithms.

Clinical Evidence

Bench testing only; biocompatibility testing was conducted to support the safety of the new thermoplastic elastomer material.

Technological Characteristics

Vaginal pessary constructed from non-latex thermoplastic elastomer rubber. Mechanical support device; no energy source, connectivity, or software components.

Indications for Use

Indicated for adult women over 18 years of age experiencing involuntary urine loss during physical activity (stress urinary incontinence).

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

• uresta™ Pessary (K081385)
• Instead Softcup Feminine Protection Cup (K971303)

Submission Summary (Full Text)

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K083769
Page 1 of 2

EastMed Inc.

uresta" Pessary Special 510(k)

| Manufacturer Name: | EastMed Inc. |
|--------------------|----------------------------------------------------------------------|
| Contact Name: | Karen Farrell |
| Title: | VP, Regulatory Affairs & Health Education |
| Postal Address: | 1721 Lower Water Street<br>Suite 301<br>Halifax, Nova Scotia B3J 1S5 |
| Phone Number: | 902-421-5692 |
| Fax: | 902-421-5695 |
| Date: | December 17, 2008 |

# 510(k) Summary of Safety and EffectivenesgAN 1 4 2009

| Device Proprietary Name: | urestaTM Pessary |
|------------------------------|------------------|
| Device Common or Usual Name: | Vaginal Pessary |
| Classification Name: | Pessary, Vaginal |
| Classification Code | HHW |
| Classification Panel | General Hospital |
| Regulation Number | 884.3575 |

### Predicate Device:

Substantial equivalence is claimed to the following devices:

- uresta™ Pessary, K081385, EastMed Inc. �
- Instead Softcup Feminine Protection Cup, K971303, Ultrafem Inc. o

### Description of the Device

The uresta™ Pessary has been modified to be manufactured using an alternate non-latex thermoplastic elastomer rubber. No other changes have been made to the device.

#### Intended Use of the Device

The urestaTM Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising.

#### Performance

EastMed Inc. has undertaken biocompatibility testing to support the safety of the new material.

#### Substantial Equivalence

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uresta™ Pessary Special 510(k)

K083769
Page 2 of 2.

16

EastMed Inc.

### i Conclusion

.

Based on the information provided in this 510(k) premarket notification, the modified uresta™ Pessary is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine. The symbol features a staff with two snakes coiled around it, and a pair of wings at the top.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN 1 4 2009

EastMed, Inc. c/o Ms. Roshana Ahmed Manager, Regulatory Affairs (Devices) CanReg, Inc. 4 Innovation Drive Dundas, Ontario CANADA L9H 7P3

K083769 Re:

Trade/Device Name: uresta™ Pessary Regulation Number: 21 CFR §884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: HHW Dated: December 17, 2008 Received: December 18, 2008

Dear Ms. Ahmed:

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, the refore, 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 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.

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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 that I Dr. I 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 os 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 11 you t 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240.276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Inay consumer on International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EastMed Inc.

uresta™ Pessary Special 510(k)

## Indications for Use Statment

510(k) Number:

K 083769

Device Name:

uresta™ Pessary

Indication for Use:

This device is for use in adult women, over 18 years of age, who experience involuntary urine loss with physical activity (stress urinary incontinence).

X Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Office of Device Evaluation

510(k)_

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K083109