MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

K063223 · CooperSurgical, Inc. · HDW · Jan 23, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K063223
• Device Name: MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
• Applicant: CooperSurgical, Inc.
• Product Code: HDW · Obstetrics/Gynecology
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5350
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The subject device is intended to completely cover the cervix and used with spermicide to prevent pregnancy.

Device Story

Milex Wide-Seal contraceptive diaphragm is a shallow silicone cup with a flexing rim; available in Omniflex (flat/coil) or Arcing styles. Device is placed over the cervix by the user and coated with spermicidal cream or gel to prevent pregnancy. It acts as a physical barrier to sperm. Sizes range from 60mm to 95mm. Used by women as a method of contraception.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility, cleaning validation, and functional/mechanical bench testing. Historical usage data noted with over 500,000 units distributed since 1962.

Technological Characteristics

Silicone contraceptive diaphragm with flexing rim. Available in Omniflex (flat/coil) or Arcing styles. Sizes: 60mm-95mm. Mechanical barrier device. No electronic components or software.

Indications for Use

Indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception, in conjunction with an approved spermicidal gel or cream.

Regulatory Classification

Identification

A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

Predicate Devices

• Ortho McNeil Diaphragm

Submission Summary (Full Text)

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**CooperSurgical**

23

510 (k) Summary

JAN 23 2008

## Date Prepared [21 CFR 807.92(a)(1)]

Revised January 18, 2008

## Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary (Regulatory / Quality Consultant) on behalf of CooperSurgical, Inc.

Contact Information:

Joseph Azary Telephone: [phone] Facsimile: [phone] 543 Long Hill Avenue Shelton, CT 06484

Sponsor / Manufacturer: CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611.

FDA Registration:

CooperSurgical, Inc. is registered with FDA under Establishment Registration# 1216677.

## Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade name: Wide-Seal Diaphragms including Omniflex Diaphragms and Arcing Diaphragms

Common / Classification Name: Contraceptive Diaphragm

Classification: Classification of this device would fall under the responsibility of the Division of Obstetrics and Gynecology. Class II, Product Code: HDW, 21 CFR 884.5350

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## Predicate Device [21 CFR 807.92(a)(3)]

The following predicate device has been identified:

- . Ortho McNeil Diaphragm - Preamendment
The Milex Diaphragm has been on the market since 1962 prior to the FDA Medical Device Amendments. The U.S. Patent for the Milex Diaphragm is dated May 29, 1962.

The subject device is substantially equivalent to the predicate device. The main difference is the material composition. The Milex Wide-Seal Diaphragms are composed of Silicone and the Ortho Diaphragms are composed of Natural Rubber.

## Description of the Device [21 CFR 807.92(a)(4)]

## Summary of the Device / Operation / Characteristics

The Milex Wide-Seal contraceptive diaphragm is a shallow cup with a flexing rim. The diaphragm is composed of silicone.

The diaphragm is placed over the cervix and coated with spermicidal cream or gel to prevent pregnancy.

The diagrams are offered in the following sizes:

- 60mm .
- 65mm .
- 70mm .
- . 75mm
- . 80mm
- . 85mm
- 90mm .
- . 95mm

The diaphragms are offered in two styles:

- Omniflex (Flat or Coil Style that folds in one place only). ●
- . Arcing (Folds in any place to form an arc or bow for insertion)

#### Intended Use [21 CFR 807.92(a)(5)]

The subject device is intended to completely cover the cervix and used with spermicide to prevent pregnancy.

## Technological Characteristics [21 CFR 807.92(a)(6)]

CooperSurgical Inc. believes that the subject device is substantially equivalent to the predicate device.

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# Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subjected to and passed a variety of biocompatibility tests, cleaning validation, and functional / mechanical testing. Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962.

## Conclusion [21 CFR 807.92(b)(3)]

We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas G. Williams Vice President, Regulatory Affairs and Business Assurance CooperSurgical, Inc. 95 Corporate Drive TRUMBULL CT 06611

K063223 Re:

Trade/Device Name: Milex Wide-Seal Contraceptive Diaphragm Regulation Number: 21 CFR §884.5350 Regulation Name: Contraceptive diaphragm and accessories Regulatory Class: II Product Code: HDW Dated: December 28, 2007 Received: January 2, 2008

Dear Mr. Williams:

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 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 vour 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 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

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

KOG3223 510(k) Number (if known):

Device Name: Milex Wide-Seal Contraceptive Diaphragm

Indications For Use:

Milex Wide-Seal Silicone Diaphragms, in conjunction with an approved spermicidal gel or cream are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Helen Reiner

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number

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