Skyn Original Polyisoprene Lubricated Male Condom - Flavored

K171172 · Ansell Healthcare Products, LLC · MOL · Aug 2, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171172
• Device Name: Skyn Original Polyisoprene Lubricated Male Condom - Flavored
• Applicant: Ansell Healthcare Products, LLC
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Aug 2, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

Device Story

Male contraceptive and prophylactic device; synthetic polyisoprene rubber sheath; features integral ring at open end and reservoir tip at closed end. Lubricated with silicone gel containing flavor oils (Mango, Coconut, Passion Fruit, Cherry) to provide aroma/flavor. Used by individuals for pregnancy prevention and STI risk reduction. Device conforms to ISO 23409:2011 standards.

Clinical Evidence

Bench testing only. Testing followed ISO 23409:2011 and FDA guidance for non-latex condoms. Results confirmed mechanical properties equivalent to predicate. Biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity) passed. Shelf-life testing supported a 3-year duration.

Technological Characteristics

Material: Synthetic polyisoprene rubber. Dimensions: 190±10mm length, 53±2mm width, 0.065-0.075mm thickness. Lubricant: Silicone gel with flavor oils. Conforms to ISO 23409:2011. Shelf-life: 3 years.

Indications for Use

Indicated for individuals seeking contraception and protection against sexually transmitted infections (STIs).

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

• Skyn Original Polyisoprene Male Condom (K160399)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with lines above them that could represent hair or wings.

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

August 2, 2017

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

Re: K171172

Trade/Device Name: Skyn Original Polyisoprene Lubricated Male Condom - Flavored Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: July 7, 2017 Received: July 12, 2017

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.

{1}------------------------------------------------

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.

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

{2}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K171172

#### Device Name

Skyn Original Polyisoprene Lubricated Male Condom - Flavored

#### Indications for Use (Describe)

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{3}------------------------------------------------

#### 510k Summary

### Submitter:

Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830, USA Phone: [phone] [e-mail]

#### Contact Person:

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

#### Date Prepared:

August 1, 2017

#### Device Name:

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

### Predicate Device:

K160399 – Skyn Original Polyisoprene Male Condom

### Reason for 510(k) Submission:

The subject device is a modified version of predicate device (K160399). The new lubricant coating of subject device contains flavor oils to improve the aroma and minimize the odor profile of the device for the end user. Four variants would be available; Mango, Coconut, Passion Fruit, and Cherry. The flavor oils have not been utilized previously in the predicate device.

### Device Description:

The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive

{4}------------------------------------------------

and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. 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 190±10mm, 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 3 year shelf-life.

## Indications for Use:

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

## Technological Characteristics:

The technological characteristics of the Skyn Original Polyisoprene Lubricated Male Condom are identical to the predicate device. The only difference is replacement of flavor oil for the fragrance masking agent to the lubricant coating of subject device. This difference in technological characteristics 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 flavor 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. Shelflife testing demonstrated the device met its three-year shelf-life specification. In addition, biocompatibility tests conducted to assess the addition of flavor oil to the condom lubricant (cytotoxicity, 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 flavor oil to the condom lubricant.

### Conclusion:

Performance data demonstrated that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.