Trojan Supra Lubricated Polyurethane Male Condom

K171639 · Church & Dwight Co., Inc. · MOL · Aug 1, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171639
• Device Name: Trojan Supra Lubricated Polyurethane Male Condom
• Applicant: Church & Dwight Co., Inc.
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Aug 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

Device Story

Trojan Supra Lubricated Polyurethane Male Condom is a straight-walled, non-textured, nipple-end sheath made of polyurethane. It is intended for over-the-counter use by males to prevent pregnancy and sexually transmitted infections. The device features a reservoir tip and is coated with a dimethylpolysiloxane lubricant. It is used as a physical barrier during sexual intercourse. The current submission updates the labeling to allow the use of personal lubricants specifically labeled as compatible with polyurethane condoms, replacing a previous warning against all additional lubricants. The device is identical in design, dimensions, and materials to the predicate device.

Clinical Evidence

Bench testing only. Compatibility testing of the polyurethane condom with personal lubricants was performed according to ASTM D7661-10.

Technological Characteristics

Material: Polyurethane with dimethylpolysiloxane lubricant and hydrated amorphous silica dusting agent (< 20 mg/unit). Dimensions: 190 mm length, 58 mm nominal flatwidth, 0.04 mm thickness. Design: Straight-walled, non-textured, reservoir tip. Shelf-life: 5 years. Testing standard: ASTM D7661-10 for lubricant compatibility.

Indications for Use

Indicated for use by males to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

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

• TROJAN SUPRA Polyurethane Condom (K100767)

Submission Summary (Full Text)

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Public Health Service

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

August 1, 2017

Church & Dwight Co., Inc. Lisa Burns Regulatory Affairs Manager 500 Charles Ewing Blvd. Ewing, NJ 08628

Re: K171639

Trade/Device Name: Trojan Supra Lubricated Polyurethane Male Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: June 1, 2017 Received: June 2, 2017

Dear Lisa Burns:

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.

# Charles Viviano -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) K171639

Device Name

Trojan Supra Lubricated Polyurethane Male Condom

Indications for Use (Describe)

The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

| 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:

| Submitter Name: | Church & Dwight Co., Inc. | Device &<br>Predicate<br>Device(s): | K171639 | K100767 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628<br>Phone: [phone]<br>E-mail: [e-mail] | Condom | | |
| Contact Person: | Lisa Burns<br>Regulatory Affairs Manager<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Tel: [phone]<br>Fax: [phone] | Condom<br>Material | Same as the<br>predicate | Emulsified polyurethane<br>containing<br>polyoxyethylene<br>alkylether emulsifier |
| Date Prepared: | August 1, 2017 | Nominal<br>Width | Same as the<br>predicate | 58 mm |
| Device Trade Name: | TROJAN SUPRA™ Lubricated Polyurethane Male<br>Condom | Nominal<br>Length | Same as the<br>predicate | 190mm |
| Device Common Name: | Polyurethane Condom | Nominal<br>Thickness | Same as the<br>predicate | 0.04 mm |
| Product Code: | MOL | Lubricant | Same as the<br>predicate | Dimethylpoly<br>siloxane (400<br>mg/unit max) |
| Classification: | Class II, Condom (21 CFR § 884.5300) | Color<br>Additives | Same as the<br>predicate | Non-colored |
| Predicate Device: | K100767: TROJAN SUPRA Polyurethane Condom | Dusting<br>agent | Same as the<br>predicate | Hydrated<br>amorphous<br>silica < 20<br>mg/unit |
| Shape | Same as the<br>predicate | Straight<br>walled with a<br>reservoir tip at<br>the closed end<br>and ring at the<br>open end | | |
| Texture | Same as the<br>predicate | Non-textured | | |
| Burst<br>properties | Same as the<br>predicate | Burst volume<br>9.4 dm3<br>Burst pressure<br>10.31 kPa | | |

The predicate device has not been subject to a design-related recall.

### Reason for 510(k) Submission:

The subject device is identical to the predicate device (K100767). The purpose of this submission is to change the personal lubricant compatibility statement in the labeling.

### Description of Device:

The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.

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#### Intended use of the Device:

The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections. The IFU statement is similar to the predicate device.

#### Comparison of Technological Characteristics:

There is no difference in the technological characteristics of the subject 510(k) condom and the predicate condom. Both the 510(k) subject condom and the predicate condom have the same design, dimensions, and materials. The 510(k) subject condom labeling is the same except for the device labeling has been revised to replace the existing warning of: "DO NOT USE WITH ANY ADDITIONAL PERSONAL LUBRICANTS, as they may damage the condom." This warning is being replaced with: "May be used with

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personal lubricants labeled compatible with polyurethane condoms."

#### Performance Testing:

#### Compatibility Testing of Polyurethane Condoms with Cleared Personal Lubricants:

Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10.

The results did not support that all personal lubricants are compatible with polyurethane condoms. However, a personal lubricant cleared by FDA with labeling for use with polyurethane condoms would be permissible to use.

#### Substantial Equivalence:

Based on the Compatibility Testing of Polyurethane Condoms with Current Commercial Lubricant, Trojan Supra Lubricated Polyurethane Male Condoms are substantially equivalent to the predicate device.