Trojan™ Chain Reaction™ Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

Device Description

The Trojan™ Chain Reaction™ Personal Lubricant is a non-sterile anhydrous, clear silicone-based (Dimethicone, Dimethiconol) personal lubricant with sensate that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

AI/ML Overview

The document describes the Trojan™ Chain Reaction™ Personal Lubricant (K161544) and its substantial equivalence to a predicate device, the Trojan™ Tingly Warmth Personal Lubricant (K120706). The acceptance criteria for the new device are established through a comparison of its technological characteristics and performance testing against the predicate device and relevant standards.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Trojan™ Chain Reaction™ Personal Lubricant)
Intended Use	For penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.	Identical to Predicate Device: "Trojan™ Chain Reaction™ Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms."
Biocompatibility	Meet standards for cytotoxicity, acute systemic toxicity, primary rabbit skin irritation, rabbit vaginal irritation, rabbit penile irritation, and guinea pig maximum sensitization according to ISO 10993 standards.	Passed: Biocompatibility testing performed in accordance with ISO 10993 (specific parts mentioned in the document: -5:2009 for Cytotoxicity, -11:2006 for Acute Systemic Toxicity, -10:2010 for Irritation and Sensitization). The lubricant is biocompatible based on the results.
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms.	Passed: Condom Compatibility Testing performed according to ASTM D7761-10 (with modification to include pre-lubricated and un-lubricated dry condoms). Tested with three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms. "Condom compatibility testing demonstrates that Chain Reaction™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms."
Shelf Life	Maintain specifications (viscosity, odor, color, appearance, microbial limits, absence of pathogens) for an expected shelf life.	2 Years: "Chain Reaction™ Personal Lubricant has a two year (24 month) shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count (USP <61> and <1111>, Total Yeast and Mold count (USP <61> and <111)), and Absence of Pathogens (USP <62>). The results were satisfactory for all parameters."
Appearance	Clear and colorless	Clear and colorless (consistent with predicate, K120706 describes "Viscous liquid, clear")
Odor	Characteristic odor – no malodor	Characteristic odor – no malodor (predicate has "Menthol")
Viscosity	400 – 800 cps	400 – 800 cps (predicate has 528 – 566 cp, within the range, so considered acceptable)
Total Microbial Count	<100 cfu/g (per USP <61> and <1111>)	<100 cfu/g (consistent with predicate)
Fungal/Yeast/Mold Limits	<10 cfu/g (per USP <61> and <1111>)	<10 cfu/g (consistent with predicate)
Absence of Pathogens	Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans per USP <62>)	Absent (consistent with predicate)
Sterility	Non-sterile	Non-sterile (consistent with predicate)
Base Type	Silicone	Silicone (consistent with predicate)
Primary Ingredients	Dimethicone, Dimethiconol, Sensate	Dimethicone, Dimethiconol, Sensate (consistent with predicate)

2. Sample size used for the test set and the data provenance

The document does not explicitly state "test sets" in the context of human data. The testing described is primarily for physical and chemical properties, biocompatibility, and condom compatibility.

Biocompatibility Testing: The sample sizes are not specified but would typically involve a small number of animals (e.g., rabbits, guinea pigs) for each test as per ISO 10993 standards. The data provenance would be from laboratory studies conducted by the manufacturer or contracted labs. Specific country of origin is not mentioned but assumed to be from a reputable testing facility. The nature of these tests is prospective, meaning the device was specifically manufactured and tested for these criteria.
Condom Compatibility Testing: "Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested." This refers to the types of condoms used, not a sample size of device units. The number of lubricant units tested on these condoms is not explicitly stated, but common practice would involve multiple samples (e.g., replicates) per condom type as per ASTM D7761-10. This is also prospective lab testing.
Shelf Life Testing: The document mentions an "accelerated stability study." This type of study involves multiple samples stored under controlled conditions over time to predict long-term stability. The exact number of samples is not provided, but it would be a prospective study conducted in a lab environment.
Specifications Testing (Appearance, Odor, Viscosity, Microbial): These are routine quality control and stability tests. Sample sizes are not specified but would follow internal quality procedures and pharmacopeial standards (e.g., USP).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (experts establishing ground truth for human-reviewed test sets) is not applicable to this device. This product is a personal lubricant, and its evaluation focuses on physical, chemical, and biological compatibility properties, rather than diagnostic accuracy or clinical interpretation by human experts. The "ground truth" is established by laboratory measurements, adherence to codified standards (ISO, ASTM, USP), and comparison to a legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods involving multiple reviewers (like 2+1, 3+1) are typically used in clinical studies for diagnostic devices where human interpretation is a critical component and there's a need to resolve disagreements among experts. The testing for a personal lubricant relies on objective measurements and established standards, not subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC comparative effectiveness study is used for diagnostic algorithms or medical imaging devices to assess the performance of humans, potentially with AI assistance, across multiple readers and cases. The Trojan™ Chain Reaction™ Personal Lubricant is not a diagnostic device and does not involve AI assistance or human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a personal lubricant, not an algorithm or AI system. Its performance is inherent in its physical and chemical properties when used as intended, not through an automated analytical process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Established Standards and Methods: Compliance with internationally recognized standards such as ISO 10993 for biocompatibility, ASTM D7761-10 for condom compatibility, and USP <61>, <62>, <1111> for microbial limits.
Laboratory Measurements: Objective, quantifiable results from analytical tests (e.g., viscosity, pH, microbial counts, chemical composition).
Predicate Device Equivalence: Direct comparison to the established safety and effectiveness profile of a legally marketed predicate device (Trojan™ Tingly Warmth Personal Lubricant). The "ground truth" for the predicate device itself would have been established through similar testing and regulatory review.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this product. The development and testing of a personal lubricant involve chemical formulation and engineering, not machine learning model training.

9. How the ground truth for the training set was established

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

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

August 31, 2016

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

Re: K161544

Trade/Device Name: Trojan™ Chain Reaction™ Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 2, 2016 Received: June 3, 2016

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. 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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Benjamin R. Fisher -S

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

510(k) Number (if known) K161544

Device Name

Trojan™ Chain Reaction™ Personal Lubricant

Indications for Use (Describe)

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

Residential Use (Part 21 CFR 201.326) - Subject to Discretion	Over-The-Counter Use (21 CFR 201.66) - Subject to Discretion
----------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

510(k) Summary - K161544

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628
Contact Person:	Lisa BurnsManager, Regulatory AffairsChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Tel: (609) 806.1997Fax: (609) 403.7411
Date Prepared:	August 30, 2016
Device Trade Name:	Trojan™ Chain Reaction™ Personal Lubricant
Device Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR § 884.5300)
Product Code:	NUC (lubricant, personal)
Classification:	Class II
Predicate Device:	Trojan™ Tingly Warmth Personal Lubricant (K120706),Church & Dwight Co., Inc.
Indications for Use:	Trojan™ Chain Reaction™ Personal Lubricant is apersonal lubricant for penile and/or vaginal application,intended to lubricate and moisturize, to enhance the easeand comfort of intimate sexual activity and supplement thebody's natural lubrication. This product is compatiblewith natural rubber latex and polyisoprene condoms. Notcompatible with polyurethane or other condoms.

Device Description:

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

polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

The specifications for the subject lubricant include the following:

. Appearance
Odor ●
Viscosity
Total microbial count (total aerobic microbial count (TAMC) < 100 cfu/g per USP <61> and <1111>)
Fungal/yeast/mold limits (total combined yeast and mold count (TYMC) < ● 10 cfu/g per USP <61> and <1111>>
Absence of pathogenic organisms (Pseudomonas aeruginosa, ● Staphylococcus aureus, Candida albicans per USP <62>)

The Chain Reaction™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packed in a carton.

Intended Use Comparison:

The subject and predicate device have identical indications for use - for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Therefore, the intended use of the subject and predicate device are the same.

Technological Characteristics Comparison:

The following table compares the key technological characteristics of the subject and predicate device:

Device & Predicate Device(s):	K161544	K120706
Condom Compatibility	Natural rubber latexand polyisoprene	Natural rubber latexand polyisoprene
Base Type	Silicone	Silicone
Primary Ingredients	Dimethicone	Dimethicone
	Dimethiconol	Dimethiconol
	Sensate	Sensate
Biocompatible	yes	yes
Appearance	Clear and colorless	Viscous liquid, clear
Odor	Characteristic odor – nomalodor	Menthol
Viscosity	400 – 800 cps	528 – 566 cp
Total Microbial Count	<100 cfu/g	<100 cfu/g

{5}------------------------------------------------

Fungal/Yeast/Mold Limits	<10 cfu/g	<10 cfu/g
Absence of PathogenicOrganisms	absent	absent
Sterility	Non-sterile	Non-sterile
Shelf-life	2 years	2 years

The subject and predicate device have different technological characteristics, including different formulation and specifications. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.

Biocompatibility:

Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009. The subject lubricant is biocompatible based on the results of the following biocompatibility studies:

Test Performed	Standard
Cytotoxicity	ISO 10993-5:2009
Acute Systemic Toxicity	ISO 10993-11:2006
Primary Rabbit Skin Irritation	ISO 10993-10:2010
Rabbit Vaginal Irritation	ISO 10993-10:2010
Rabbit Penile Irritation	ISO 10993-10:2010
Guinea Pig Maximum Sensitization	ISO 10993-10:2010

Condom compatibility:

Condom Compatibility Testing was performed with Chain Reaction™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)- subject lubricant.

Condom compatibility testing demonstrates that Chain Reaction™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.

Shelf Life:

Chain Reaction™ Personal Lubricant has a two year (24 month) shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor,

{6}------------------------------------------------

color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count (USP <61> and <1111>, Total Yeast and Mold count (USP <61> and <111>), and Absence of Pathogens (USP <62>). The results were satisfactory for all parameters.

Substantial Equivalence:

The subject device is substantially equivalent to the predicate device. Both the subject and predicate device have identical intended uses and comparable technological characteristics. In addition, non-clinical performance data, biocompatibility testing, and shelf life testing further demonstrate that the subject device is substantially equivalent to the predicate device.

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.