ORTHO ALL-FLEX DIAPHRAGM

{0}------------------------------------------------ ## 510(k) Summary | Submitter Name: | Johnson & Johnson Produtos Profissionais Ltda. (JJPP) | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | Rod. Presidente Dutra km 154<br>São José dos Campos São Paulo<br>SP-Brasil<br>12240-908 | | Establishment Registration Number | 3004903580 | | Phone Number: | 011 55+12+3932.1737 | | Fax Number: | 011 55+12+3932 1975 | | Contact Person: | Nancy M.R.B. Lopes M.Sc. | | Date Prepared: | 19 November 2007 | | Device Trade Name: | ORTHO® ALL-FLEX® Diaphragm | | Common Name | Diaphragm | | Classification Name, | Contraceptive diaphragm and accessories | | Number & | 884.5350 | | Product Code: | HDW | | Predicate Devices: | Milex Silicone Diaphragm, Cooper Surgical, Inc.<br>ORTHO® ALL-FLEX® Diaphragm (Latex), Ortho Women's Health<br>Global Pharmaceutical Supply Group - A division of Johnson & Johnson | | Device Description<br>and Statement of<br>Intended Use | Description: The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is a<br>molded, buff-colored, shallow silicone rubber cup with a flexible rubber<br>covered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginal<br>diaphragm contains a distortion-free, dual spring-within-a-spring that<br>provides unique arcing action no matter where the rim is compressed. It<br>is appropriate for use not only where ordinary diaphragms are indicated,<br>but also in patients with mild cystocele, rectocele or retroversion.<br>Intended Use: The ORTHO® ALL-FLEX® Diaphragm, in conjunction with<br>an appropriate spermicide, is indicated for the prevention of pregnancy<br>in women who elect to use diaphragms as a method of contraception. | {1}------------------------------------------------ | Summary of<br>Technological<br>Characteristics | When inserted into the vagina, the ORTHO® ALL-FLEX® Diaphragm<br>functions as a mechanical barrier that prevents sperm from entering the<br>cervical canal. The spring within the perimeter of the device causes the<br>device to create a seal against the vaginal wall; covering the cervix and<br>preventing sperm from entering the cervical canal. The silicone cup also<br>serves as a repository for spermicide. | | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | A table comparing the ORTHO® ALL-FLEX® Diaphragm to the predicate<br>devices is attached. | | | Conclusion | The information discussed above demonstrates that the ORTHO® ALL-<br>FLEX® Diaphragm is substantially equivalent to the predicate devices. | | | Declarations | This summary includes only information that is also covered in the<br>body of the 510(k). This summary does not contain any puffery or unsubstantiated<br>labeling claims. This summary does not contain any raw data, i.e., contains only<br>summary data. This summary does not contain any trade secret or confidential<br>commercial information. This summary does not contain any patient identification information. | | {2}------------------------------------------------ | Feature | ORTHO® ALL-FLEX®<br>Diaphragm | ORTHO® ALL-FLEX®<br>Diaphragm | Milex Wide-Seal Silicone<br>Diaphragm | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K080040 | N/A Grandfathered | K063223 | | Manufacturer | Johnson & Johnson<br>Produtos Profissionais<br>Ltda. -<br>A division of Johnson &<br>Johnson | Ortho Women's Health<br>Global Pharmaceutical<br>Supply Group - A division<br>of Johnson & Johnson | Cooper Surgical, Inc. | | Classification # &<br>Product Code | 884.5350 | 884.5350 | 884.5350 | | | HDW | HDW | HDW | | Intended Use | The ORTHO® ALL-<br>FLEX® Diaphragm, in<br>conjunction with an<br>appropriate spermicide,<br>is indicated for the<br>prevention of pregnancy<br>in women who elect to<br>use diaphragms as a<br>method of contraception | The ORTHO® ALL-<br>FLEX® Diaphragm, in<br>conjunction with an<br>appropriate spermicide, is<br>indicated for the<br>prevention of pregnancy in<br>women who elect to use<br>diaphragms as a method<br>of contraception | The Milex® Diaphragm, in<br>conjunction with an<br>appropriate spermicide, is<br>indicated for the prevention<br>of pregnancy in women who<br>elect to use diaphragms as a<br>method of contraception | | Mode of Action | Mechanical<br>contraceptive barrier | Mechanical contraceptive<br>barrier | Mechanical contraceptive<br>barrier | | Reusable | Yes | Yes | Yes | | Material of Construction | Medical Grade Silicone | Natural Latex Rubber | Medical Grade Silicone | | Standard of Conformity | ISO 8009:2004(E) | ISO 8009:2004(E) | ISO 8009:2004(E) | ## Summary of Technical Characteristics {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and two wavy lines below representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Johnson & Johnson Produtos Profissionais Ltda. c/o Mr. William F. Greenrose President Oserve America, Inc. 220 River Road CLAREMONT NH 03743 AUG 2 5 2008 Re: K080040 Trade/Device Name: Ortho® All-Flex® Diaphragm Regulation Number: 21 CFR §884.5350 Regulation Name: Contraceptive diaphragm and accessories Regulatory Class: II Product Code: HDW Dated: August 12, 2008 Received: August 12, 2008 Dear Mr. Greenrose: 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/3/Picture/10 description: The image is a circular seal with the text "FDA Centennial" in the center. Above the text is a stylized logo with the letters "FDA". The seal also contains the text "1906-2006" at the top. The seal is surrounded by a dotted border. Protecting and Promoting Public Health {4}------------------------------------------------ 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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/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 {5}------------------------------------------------ ## 4.1 Indications for Use Statement K080040 510(k) Number (if known): Device Name: ORTHO® ALL-FLEX® Diaphragm Indications for Use: The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) Prescription XXX Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) _ (Revision Sign-Off) Division St Division of Reproductive, Abdomina and Radiological Devic 510(k) Number Section 4.0 CONFIDENTIAL