DUREX SYNTHETIC POLYISOPRENE MALE CONDOM

K072169 · Ssl Americas, Inc. · MOL · Jun 19, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072169
• Device Name: DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
• Applicant: Ssl Americas, Inc.
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Device Story

Synthetic polyisoprene male condom; shaped, teat-ended, lubricated sheath. Designed for OTC use for contraception and STI prevention. Material offers consistency and absence of natural rubber latex proteins. Device shares design, shape, and silicone lubricant with 'Zeus' odour masker with predicate Durex Ultra Comfort Latex Rubber Condom. Performance validated via physical testing (ASTM D3942-03, ISO 4074:2002, ASTM D6324-05), biocompatibility (ISO 10993), and viral penetration studies. Clinical evidence includes a randomized, crossover, home-use study comparing the device to the predicate, demonstrating no significant difference in clinical breakage or slippage.

Clinical Evidence

Clinical investigation (2007) conducted as a randomized, crossover, home-use study (n=not specified) comparing subject device to predicate (K980319). Primary endpoints: clinical breakage and slippage. Results showed no significant difference between subject and control condoms. Additional evidence includes biocompatibility testing per ISO 10993 and viral penetration studies.

Technological Characteristics

Synthetic polyisoprene rubber sheath; shaped, teat-ended; silicone lubricant with 'Zeus' odour masker. Conforms to ASTM D3942-03, ISO 4074:2002, and ASTM D6324-05. Material identical to Biogel Skinsense PI surgical gloves. Non-latex, protein-free.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals using male condoms.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• Durex Ultra Comfort Latex Rubber Condom (K980319)
• Biogel Skinsense PI surgeons glove (K050184)

Submission Summary (Full Text)

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K072169

Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission

JUN 1 9 2008

## 1.4: 510(k) SUMMARY

#### A. Submitter Information

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: [phone] Fax: [phone]

## B. Contact Person

Chris Robinson - Head of Regulatory Compliance, SSL Americas.

## C. Date Prepared

9 July 2007

## D. Proprietary Name

Durex synthetic polyisoprene male condom. (Trade name to be determined later)

E. Common Name Synthetic male condom

#### F. Classification Name

Condom non-latex ( 21 CFR 884.5300, Product code M-OL)

#### G. Predicated Device

Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319] Biogel Skinsense PI surgeons glove [510(k) Number K050184]

## H. Description of the Device

This condom is made of a synthetic polyisoprene rubber sheath, which completely I his condom is made or lead of the membrane. This device is a shaped, teat ended, lubricated condom. Synthetic polyisoprene is the synthetic form of natural lubricated condom. Bylinene perfisen as natural rubber, a material commonly used for poryisoprono raover of condoms made by SSL from synthetic polyisoprene have been shown to have similar performance properties as natural rubber latex condoms and conform to the relevant physical test requirements of national and international connomi to tare referant patural rubber latex male condoms, ISO 4074:2002, and Volunary Sandards of the synthetic condom standard ASTM D6324-05.

#### I. Intended Use of the Device

This synthetic polyisoprene condom has the same intended use as the predicate This syntherie perfisoprene consisted for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission

Physical test data, biocompatibility data, safety and clinical data included in the 510K application indicate that the differences between this condom and the predicate condom device does not adversely affect the safety and effectiveness of the device in its intended use.

#### J. Technological Characteristics

This condom has many similar characteristics as the predicate condom identified. The condoms described in K980319 are Durex manufactured, shaped natural rubber latex male condoms with silicone lubricant containing 'Zeus' odour masker. The synthetic polyisoprene condom is the same shape and design and uses the same silicone lubricant with 'Zeus' odour masker as the predicate device. The physical properties of the synthetic polyisoprene condom conform to relevant sections of domestic and international regulations: ASTM D3942-03, ISO 4074:2002 and ASTM D6324-05. Physical testing and final release testing revealed results in conformance with required specifications.

The synthetic polyisoprene material used to manufacture these condoms is also the same material used for the production of the predicate device, Biogel Skinsense PI surgical gloves, which are currently marketed in the USA.

The advantages of synthetic polyisoprene over natural rubber latex are the consistency of the synthetically derived material in comparison with the typical variation found in natural polyisoprene, low levels of impurities in the synthetic material and absence of natural rubber latex proteins.

## K. Clinical and non clinical performance data.

Physical testing of the condom demonstrates that it meets performance standards for natural rubber condoms, which have been safely marketed worldwide for many vears. This condom has also been tested in line with the requirements of the ISO10993 standard on Biological Evaluation of Medical Devices, FDA Guidance Memorandum G95-1 (1995) and FDA guidance for testing of male condoms made from new material. Results of all these biocompatibility studies support the safety of the device. Additional viral penetration studies have also been conducted with acceptable results. A consumer user evaluation study was undertaken on the Durex synthetic polyisoprene condom in comparison with Durex natural rubber and polyurethane condoms in the UK and Italy during 2004 with favourable results for the new condom.

Subsequently a clinical investigation was conducted in 2007, in line with US FDA guidelines for clinical studies on synthetic condoms (Testing Guidance for Male Condoms made from New Material, June 29, 1995). The study was a randomised, cross over, home use study using the predicate device, ( K980319 Durex Ultra Comfort condom) as the control condom. The study found no significant difference between the study condom and control condom with respect to clinical breakage or clinical slippage.

The Durex synthetic polyisoprene condom has already been launched in other markets worldwide with a low incidence of consumer complaints in these countries. In conclusion it is considered that the Durex synthetic polyisoprene condom is as safe

and effective, and performs at least as well as the predicate condom.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 9 2008

Mr. Chris Robinson Regulatory Affairs Manager Head of Regulatory Compliance SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K072169

Trade/Devices Name: SSL Synthetic Polyisoprene Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: May 16, 2008 Received: May 23, 2008

Dear Mr. Robinson:

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 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

NancyCbrogdon

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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Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission

# l.3 Indications for Use

510(k) Number (if known): Not known. KVZZ/ 4 9 Device Name: Durex synthetic polyisoprene male condom Indications for Use:

The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

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

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