Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant

K180104 · Church & Dwight Co., Inc. · HIS · Mar 14, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180104
• Device Name: Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
• Applicant: Church & Dwight Co., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

Natural rubber latex condom; bulbous shape; 11 rows of continuous ribs on shaft; 9 rows of continuous ribs on bulb; silicone-based lubricant with sensory ingredients for warming, cooling, or tingling sensation. Used by individuals for contraception and STI prevention. Device provides physical barrier; lubricant enhances user experience. No electronic or software components.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (ISO 10993-5, -10, -11) and physical testing (airburst specifications per ASTM D3492-16). Shelf life established via physical testing per 21 CFR 801.435.

Technological Characteristics

Natural rubber latex sheath; silicone-based lubricant; bulbous shape; 185 mm length; 54 mm flat-width (shaft), 65 mm flat-width (bulb). Meets ASTM D3492-16. Biocompatibility per ISO 10993. No software or electronic components.

Indications for Use

Indicated for individuals seeking contraception and protection against 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™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (K131887)

Submission Summary (Full Text)

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#### 510(k) SUMMARY:

| Submitter Name: | Church & Dwight Co., Inc. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628 |
| Contact Person: | Joelle Reinson<br>Senior Regulatory Specialist<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | January 15, 2018 |
| Device Trade Name: | Trojan™ Chain Reaction Natural Rubber Latex Condom<br>With Sensate Lubricant |
| Device Common Name: | Natural Rubber Latex Condom |
| Product Code: | HIS (condom) |
| Regulatory Class: | Class II |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Predicate Device: | K131887: TROJAN™ Jaguar Male Natural Rubber Latex<br>Condom with Warming and Tingling Lubricant |
| | The predicate device has not been subject to a design<br>related recall |

#### Description of Device:

The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a silicone-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming, cooling, and/or tingling. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.

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### Intended Use of the Device:

The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

### Predicate Device Comparison:

The subject and predicate device have the same intended use. The subject and predicate device are similar in natural rubber latex formulation, design and dimensions but differ in the formulation of their lubricant systems. This difference in technological characteristics does not raise different questions of safety and effectiveness.

### Summary of Performance Testing: Biocompatibility:

Biocompatibility testing was performed on the Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices.

| Test Performed | ISO Standard |
|------------------------------------------|--------------|
| Cytotoxicity ISO Elution Method | ISO 10993-5 |
| Rabbit Vaginal Irritation | ISO 10993-10 |
| Rabbit Penile Irritation | ISO 10993-10 |
| Primary Rabbit Skin Irritation | ISO 10993-10 |
| Guinea Pig Maximization<br>Sensitization | ISO 10993-10 |
| Acute Systemic Toxicity | ISO 10993-11 |

The results of testing demonstrate that the subject device is biocompatible.

# Physical Testing Data:

Three (3) lots of Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).

# Shelf Life:

Stability of the Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant was established from results of physical testing data using a protocol that followed 21 CFR §801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435.

# Conclusion:

Based on the results of the testing and safety data described above, the Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is as safe and effective as the predicate device. The performance data support a determination of substantial equivalence.

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Image /page/2/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2018

Church & Dwight Co., Inc. Joelle Reinson Senior Regulatory Specialist 500 Charles Ewing Boulevard Ewing, NJ 08628

Re: K180104

> Trade/Device Name: Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 15, 2018 Received: January 16, 2018

Dear Joelle Reinson:

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. Iisting 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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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