Skyn Original Polyisoprene Lubricated Male Condom

K160399 · Ansell Healthcare Products, LLC · MOL · Jul 25, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160399
• Device Name: Skyn Original Polyisoprene Lubricated Male Condom
• Applicant: Ansell Healthcare Products, LLC
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Jul 25, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Skyn Original Polyisoprene Lubricated Male Contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STI's).

Device Story

Skyn Original Polyisoprene Lubricated Male Condom is a synthetic polyisoprene rubber sheath; features integral ring at open end and reservoir tip at closed end. Designed for over-the-counter use by individuals for contraception and STI prevention. Device incorporates silicone gel lubricant containing fragrance oil as masking agent to minimize substrate odor. Dimensions: length >180mm, width 53±2mm, thickness 0.065-0.075mm. Device functions as physical barrier to prevent exchange of bodily fluids. User applies device to penis prior to intercourse. Benefits include pregnancy prevention and reduced STI transmission risk.

Clinical Evidence

Bench testing only. Performance testing followed ISO 23409:2011 and FDA guidance for non-latex condoms. Mechanical properties and shelf-life (5 years) met specifications. Biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity) showed passing results.

Technological Characteristics

Material: Synthetic polyisoprene rubber. Lubricant: Silicone gel with fragrance oil. Dimensions: >180mm length, 53±2mm width, 0.065-0.075mm thickness. Design: Fitted sheath with integral ring and reservoir tip. Conforms to ISO 23409:2011. Non-electronic, mechanical barrier device.

Indications for Use

Indicated for contraception and reduction of risk of pregnancy and transmission of STIs 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

• Lifestyles Lubricated Polyisoprene Latex Male Condom (K070800)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2016

Ansell Healthcare Products, LLC. Robert Mahler Director, Regulatory Affairs 111 Wood Avenue South, Suite 210 Iselin, NJ 08830

Re: K160399

> Trade/Device Name: Skyn Original Polyisoprene Lubricated Male Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: June 21, 2016 Received: June 23, 2016

Dear Robert Mahler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160399

#### Device Name

Skyn Original Polyisoprene Lubricated Male Condom

Indications for Use (Describe)

The Skyn Original Polyisoprene Lubricated Male Contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STI's).

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary (K160399)

#### Submitter:

Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830, USA

#### Contact Person:

Robert S. Mahler Director Regulatory Affairs for the Americas Phone: [phone] [e-mail]

#### Date Prepared:

July 25, 2016

#### Device Name:

| Proprietary Name: | Skyn Original Polyisoprene Lubricated Male Condom |
|----------------------------|---------------------------------------------------|
| Common Name: | Condom, Synthetic |
| Classification Name: | Condom |
| Classification Regulation: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | MOL |
| Classification Panel: | Obstetrics/Gynecology |

#### Predicate Device:

K070800 - Lifestyles Lubricated Polyisoprene Latex Male Condom

#### Reason for 510(k) Submission:

The subject device is a modified version of predicate device (K070800). Lubricant coating of subject device contains fragrance oil to improve the aroma and minimize the odor profile of the device for the end user. The fragrance oil has not been utilized previously in the predicate device.

#### Device Description:

The Skyn Original Polyisoprene Lubricated Male Condom is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with fragrance oil. Fragrance oil acts as a masking agent to minimize odor originated from condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length >180mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.

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## Indications for Use:

The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

## Technological Characteristics:

The technological characteristics of the Skyn Original Polyisoprene Lubricated Male Condom are identical to the predicate device. The only difference is addition of fragrance oil to the lubricant coating of subject device. This difference does not represent a new technology as it does not raise different questions of safety or effectiveness as compared to the predicate device.

### Performance Data:

Performance testing conducted to assess the addition of fragrance oil to the condom lubricant followed ISO 23409:2011, "Male Condoms – Requirements and test methods for condoms made from synthetic materials," and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device. Shelf-life testing demonstrated the device met its five year shelf-life specification. In addition, biocompatibility tests conducted to assess the addition of fragrance oil to the condom lubricant (cvtotoxicity, sensitization, irritation, and acute systemic toxicity) had passing results. The remainder of the performance testing outlined in the guidance document was deemed not needed to support the addition of fragrance oil to the condom lubricant.

#### Conclusion:

The subject and predicate devices have the same intended use and fundamental technological characteristics. The subject device is different from the predicate device in that it contains fragrance oil. However, the difference does not raise new types of questions and can be assessed by biocompatibility testing and performance testing. Performance data demonstrated that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.