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 Description

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, specifically a natural rubber latex condom. The document describes the device, its intended use, comparison to a predicate device, and performance testing.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Important Note: The device described is a medical device (condom) and the performance testing focuses on biocompatibility, physical strength (airburst), and shelf-life, which are typical for such devices. This is not a software/AI-based device, therefore, many of the questions related to AI performance, human reader studies, ground truth for AI, etc., are not applicable to this document. The answers will reflect this.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
- Cytotoxicity (ISO 10993-5)	"The results of testing demonstrate that the subject device is biocompatible." (Specific values/pass/fail stated as 'biocompatible' rather than numerical)
- Rabbit Vaginal Irritation (ISO 10993-10)	"The results of testing demonstrate that the subject device is biocompatible."
- Rabbit Penile Irritation (ISO 10993-10)	"The results of testing demonstrate that the subject device is biocompatible."
- Primary Rabbit Skin Irritation (ISO 10993-10)	"The results of testing demonstrate that the subject device is biocompatible."
- Guinea Pig Maximization Sensitization (ISO 10993-10)	"The results of testing demonstrate that the subject device is biocompatible."
- Acute Systemic Toxicity (ISO 10993-11)	"The results of testing demonstrate that the subject device is biocompatible."
Physical Testing (Airburst):
- Meet airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms)	"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)." (Specific quantitative airburst values or thresholds are not provided in this summary, but the report explicitly states the criteria were met).
Shelf Life/Stability:
- Establish expiration date based on physical testing data following 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."

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility: The specific number of animals (rabbits, guinea pigs) used for the tests is not detailed in this summary, but standard ISO 10993 protocols would involve a defined minimum number of animals. The data provenance would be laboratory testing conducted for C&D Co.
Physical Testing (Airburst): "Three (3) lots" of condoms were tested. The exact number of condoms per lot is not specified, but implied to be sufficient for ASTM testing. Data provenance is laboratory testing.
Shelf Life: Testing was ongoing to support 36-month initial dating, with real-time stability through five years. The sample size for this ongoing testing is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable as the device is a physical medical device (condom), not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device lies in objective physical and biological test results (e.g., cell viability for cytotoxicity, physical airburst pressure, etc.) against established ASTM and ISO standards.

4. Adjudication Method for the Test Set

This question is not applicable as the tests performed are objective, laboratory-based physical and biological assays with defined pass/fail criteria according to international standards (ISO, ASTM). There is no "adjudication" between multiple human reviewers of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

This question is not applicable. MRMC studies are relevant for imaging or diagnostic devices where human readers interpret outputs, often with and without AI assistance, to assess changes in diagnostic accuracy. This is a physical condom, not an AI diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The device is a physical condom, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on:

International Standards: Specific criteria defined in ISO 10993 series for biocompatibility and ASTM D3492-16 for physical condom properties (like airburst).
Laboratory Measurements: Objective measurements derived from these standardized tests, which are interpreted directly against the standard's specifications (e.g., a certain pressure must be withstood, a certain level of cell viability or irritation score must not be exceeded).

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY:

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628
Contact Person:	Joelle ReinsonSenior Regulatory SpecialistChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Tel: (609) 806.1671Fax: (609).403.7415
Date Prepared:	January 15, 2018
Device Trade Name:	Trojan™ Chain Reaction Natural Rubber Latex CondomWith 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 LatexCondom with Warming and Tingling Lubricant
	The predicate device has not been subject to a designrelated recall

Description of Device:

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Intended Use of the Device:

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 MaximizationSensitization	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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.