TINGLY WARMTH 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™ LUBRICANTS Tingly Warmth Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a personal lubricant, not a device that relies on algorithms or AI for performance. Therefore, many of the requested categories related to algorithm performance, ground truth, experts, and multi-reader studies are not applicable.

Here's a breakdown of the acceptance criteria and supporting studies as described in the document for the TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993)	Non-cytotoxic	Non-cytotoxic
	Rabbit Vaginal Irritation (ISO 10993)	Non-irritating	Non-irritating
	Rabbit Penile Irritation (ISO 10993)	Non-irritating	Non-irritating
	Acute Systemic Toxicity (ISO 10993)	Non-systemically toxic	Non-systemically toxic
	Guinea Pig Maximization (ISO 10993)	Non-sensitizing	Non-sensitizing
	Primary Rabbit Skin Irritation (ISO 10993)	Non-irritating	Non-irritating
Condom Compatibility	ASTM D7761-10 (modified for pre-lubricated and un-lubricated dry condoms)	Compatible with natural rubber latex and polyisoprene condoms	Compatible with commercially available natural rubber latex and polyisoprene condoms
Shelf-life	Accelerated aging study (to be verified by real-time aging study)	2-year shelf-life	2-year shelf-life (based on accelerated aging)
Substantial Equivalence	Comparison to Predicate Device (K-Y® Brand Intrigue™ Intense Warming Sensation)	Equivalent in technology, intended use, safety, and effectiveness	Equivalent in technology, intended use, safety, and effectiveness

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

Biocompatibility: The specific number of animals/samples used for each biocompatibility test (e.g., number of rabbits, guinea pigs) is not specified in the summary. The tests are general biological evaluation tests as per ISO 10993.
Condom Compatibility: The document states that "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." The number of individual condoms tested per brand is not specified.
Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA 510(k) submission, it's regulated for the US market. The studies appear to be prospective tests specifically conducted for this submission.

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

This question is not applicable as the device is a personal lubricant, and its performance is evaluated through laboratory and non-clinical (biocompatibility, condom compatibility, shelf-life) testing, not by expert interpretation of data like medical images.

4. Adjudication Method for the Test Set

This question is not applicable. The tests performed are objective laboratory and physical property evaluations, not subjective assessments requiring adjudication among multiple readers.

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 question is not applicable as the device does not involve AI or human interpretation of data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical product (lubricant), not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements and standardized test methods.
- For biocompatibility: Standardized ISO 10993 assays with pass/fail criteria (e.g., non-cytotoxic, non-irritating).
- For condom compatibility: ASTM D7761-10 (modified) with criteria for compatibility.
- For shelf-life: Results from accelerated aging studies (and later real-time studies) according to established stability protocols.

8. The Sample Size for the Training Set

This question is not applicable as there is no "training set" for this type of device. The product is a physical chemical formulation, not an algorithm that requires training data.

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

This question is not applicable for the reasons stated in point 8.

Summary

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510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

Submitter Name: Submitter Address:

Contact Person:

Date Prepared: Device Trade Name:

Device Common Name:

Product Code:

Classification:

Predicate Device:

Intended Use:

Device Description:

II. 510(k) Summary

Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543

Emily Perez Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543 Tel: (609) 688-5347 Fax: (609) 497-7179

October 2, 2012

TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant

Personal Lubricant

NUC - Condom (21 C.F.R. § 884.5300)

Class II

K-Y® Brand Intrigue™ Intense Warming Sensation (K072360)

Tingly Warmth 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.

OCT 4 2012

October 2, 2012

(revised)

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510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

Technological Characteristics:

There is no difference in the fundamental technological characteristics of the TROJANTS Tingly Warmth Personal Lubricant and the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal Lubricant. TROJANTM LUBRICANTS Tingly Warmth Personal Lubricant is composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. The proposed device is substantially equivalent to the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal equivanced under 510(k) # K072360. Three of the four ingredients, dimethicone, dimethiconol and vanillyl butyl ether, in TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant are identical to those in the predicate device. The additional ingredient, menthol, does not raise new questions of safety or effectiveness.

Biocompatibility:

Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.

Testing Performed	Results
Cytotoxicity	Non-cytotoxic
Rabbit Vaginal Irritation	Non-irritating
Rabbit Penile Irritation	Non-irritating
Acute Systemic Toxicity	Non-systemically toxic
Guinea Pig Maximization	Non-sensitizing
Primary Rabbit Skin Irritation	Non-irritating

Testing Performed:

Condom Compatibility:

Condom Compatibility Testing was performed using TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant and ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" which was modified to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested.

Condom compatibility testing results demonstrate that the TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with commercially available natural rubber latex condoms and polyisoprene condoms.

(continued)

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Shelf-life:

TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant has a two-year shelf-life based on the results of an accelerated aging study.

. A Real-time aging study is being performed in order to verify results of the accelerated aging study.

Substantial Equivalence:

Based on non-clinical performance data, biocompatibility review and testing and safety data, the proposed device is substantially equivalent to K-Y® Brand Intrigue™ Intense Warming Sensation in technology, intended use, safety and effectiveness.

Conclusion:

The results from laboratory testing and non-clinical evaluations of human use testing show that the proposed device performs equivalently to the predicate device and is safe for use as a personal lubricant.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Emily Perez Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street PRINCETON NJ 08543

OCT - 4 2012

Re: K120706

Trade/Device Name: TROJAN™ LUBRICANTS TINGLY WARMTH Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 29, 2012 Received: August 31, 2012

. Dear Ms. Perez:

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 medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Tucker

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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Confidential August 29, 2012

510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

I. Indications For Use

510(k) Number (if known): K120706

Device Name: TROJAN™ LUBRICANTS TINGLY WARMTH Personal Lubricant

INDICATIONS FOR USE:

TINGLY WARMTH 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 componently with natural rubber latex
supplement the body's natural lubrication. This product is compons supplement the body s natural fabrication. This polyurethane or other condoms.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use × (21 C.F.R. 801 Subpart C)

Tomi McWhay

ductive, Gastro-Renal, and

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.