PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

K012277 · Sims Portex , Ltd. · HHW · Feb 11, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K012277
• Device Name: PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
• Applicant: Sims Portex , Ltd.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.

Device Story

Ring-shaped vaginal pessary; constructed from PVC or Polythene; available in various sizes. Device provides mechanical support to vaginal wall/urethra to treat uterine prolapse and stress incontinence. Intended for single-patient use; supplied non-sterile. Insertion and removal performed by trained clinicians; requires periodic removal for cleaning and vaginal inspection to prevent tissue embedding, ulceration, or fistula formation.

Clinical Evidence

No clinical data provided. Biological safety assessment performed in accordance with ISO 10993, Part 1:1994. Bench testing included visual and dimensional inspections.

Technological Characteristics

Materials: PVC or Polythene. Form factor: Ring-shaped, various sizes. Principle: Mechanical vaginal support. Sterilization: Non-sterile. No published standards; safety verified via visual and dimensional testing and ISO 10993 biological evaluation.

Indications for Use

Indicated for patients requiring vaginal support for uterine prolapse, correction of uterine displacements, or alleviation of stress incontinence via anterior vaginal wall pressure on the urethra.

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

• PelvXGellhorn Vaginal Pessary (K002329)

Submission Summary (Full Text)

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## ייד בגווע א

## FEB 1 1 2002

## 510(k) SUMMARY

The Summary of Safety and Effectiveness on the Portex Ring Pessary reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

| Applicant | Claire Mullins<br>SIMS Registration Manager<br>SIMS Portex Ltd<br>Hythe<br>Kent CT21 6JL<br>UK |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 44 1303 260551 |
| Facsimile | 44 1303 266761 |
| Date | 12th July 2001 |
| Name | Portex Ring Pessary |
| Classification | Class II device with Product Code 85 HHW |
| Predicate | PelvXGellhorn Vaginal Pessary<br>K002329 |
| Description | A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending. |
| Intended Use | Portex Ring Pessaries provide vaginal support to prevent the uterus from descending.<br>Designed to ease uterine prolapse.<br>Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra. |
| Contraindications | (PRECAUTIONS)<br>Inspection of the vagina using a speculum is recommended prior to insertion or<br>replacement of a ring pessary.<br>Ring Pessaries should be removed and reinserted as prescribed by the attending clinician.<br>The Portex ring Pessaries are supplied non-sterile and are reusable for single patient use.<br>Re-use of this device in another patient may result in cross infection. |
| Caution | (WARNINGS)<br>Insertion and removal of Ring Pessaries should only be performed by competent trained<br>personnel.<br>After removal of Ring Pessary an inspection of the vagina should be performed to check<br>for ulceration, bleeding, infection.<br>Ring Pessaries should be removed and checked as prescribed by competent trained<br>personnel to prevent embedding in the vaginal tissue or fisula formation. |
| Technological<br>Characteristics | There are no published standards for these particular types of products, and as such tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use. Such tests include – Visual and Dimensional |
| Data Submitted | The biological safety assessment of the Wallace Endometrial has been performed in<br>accordance with the International Standard ISO 10993, Part 1:1994, "Biological<br>Evaluation of medical Devices: Evaluation and Testing." In addition to ISO 10993 the<br>selection of tests, taking into consideration the particular application of the product. |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, possibly representing health and well-being.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB | | 2002

Mr. Steven Ogilvie Director, Regulatory Affairs and Scientific Affairs Sims Portex Limited Hythe, Kent CT21 6JL UNITED KINGDOM

Re: K012277

Trade/Device Name: Sim's Portex Vaginal Ring Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: 85 HHW Dated: November 7, 2001 Received: November 13, 2001

Dear Mr. Ogilvie:

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 (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.

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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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Page Page Ca of

510(k) Number (if known): K (1 גבר 77

Device Name: Sim's Pocter Ring Pessa

Indications For Use:

Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use*

Nancy C. Snazkon

(Division Sia 510(k) Numb (Optional Format 3-10-98)