The Trojan XOXO Thin condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Description

The Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Thin condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a straight wall nipple end shape consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom). The Trojan™ XOXO™ Thin condom has a nominal length of 180 ± 10 mm, a nominal thickness of 0.07 ± 0.01 mm, and a nominal flat- width of 52 ±2 mm, measured 30 mm from the open end.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant. It states that the device is substantially equivalent to a legally marketed predicate device (Trojan™ (TM-TBD) Latex Condom with Lubricant, K912901).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

First, it's crucial to understand that this document describes a medical device (condom), not an AI or software device. Therefore, the questions related to AI-specific elements like "test set," "ground truth," "MRMC study," "standalone algorithm performance," and "training set" are not applicable to this submission. The "device" in this context is a physical product.

Acceptance Criteria and Device Performance (Physical Testing):

The document explicitly states that the Trojan™ XOXO™ Thin condom was tested against the specifications of ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms). This ASTM standard defines the acceptance criteria for male condoms, which typically include properties like burst volume and pressure, tensile strength, elongation, freedom from holes, and dimensions.

While the document doesn't list the specific numerical acceptance criteria from ASTM D3492-08 in a table, it does state the device's performance relative to that standard.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Defined by ASTM D3492-08)	Reported Device Performance
Physical Testing:
Burst volume	Met specifications
Burst pressure	Met specifications
Tensile strength	Met specifications
Elongation	Met specifications
Freedom from holes	Met specifications
Dimensions (Length, Thickness, Flat-width)	Met specifications
Biocompatibility:
Cytotoxicity (ISO 10993-5)	Passed
Acute Systemic Toxicity (ISO 10993-11)	Passed
Primary Rabbit Skin Irritation (ISO 10993-10)	Passed
Rabbit Vaginal Irritation (ISO 10993-10)	Passed
Rabbit Penile Irritation (ISO 10993-10)	Passed
Guinea Pig Maximum Sensitization (ISO 10993-10)	Passed
Shelf Life:
3-year (36 month) shelf-life	Met (based on accelerated stability)

Study Details:

Sample size used for the test set and the data provenance:
- Physical Testing: "Three (3) lots of Trojan™ XOXO™ Thin condom were tested and met specifications of ASTM D3492-08".
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of rabbit subjects, guinea pigs, cell cultures) are not provided in this document. These would be defined within the respective ISO standards.
- Data Provenance: The document does not explicitly state the country of origin, but it implies internal testing by Church & Dwight Co., Inc. and/or a contracted lab following international standards (ASTM, ISO). It is retrospective in the sense that the testing was completed before the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of AI. For a physical device like a condom, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and ISO standards (e.g., laboratory measurements for dimensions, burst tests, biological responses). The "experts" would be the qualified laboratory technicians and scientists performing the tests and interpreting the results according to the standard protocols. Their qualifications are inherent in their ability to perform validated tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None in the sense of expert adjudication for an AI output. The adjudication for a physical device test involves meeting predefined numerical specifications or observed biological responses as per the established test methods.
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:
- Not applicable. This device is a physical condom, not an AI system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical condom, not an AI system. The performance is the intrinsic performance of the physical product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the physical characteristics and biocompatibility of the condom is based on objective, standardized measurements and observations as defined by:
  - ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) for physical properties.
  - ISO 10993 series (e.g., ISO 10993-5, -10, -11) for biological evaluation of medical devices (biocompatibility).
The sample size for the training set:
- Not applicable. There is no "training set" for a physical device in the AI sense. The manufacturing process of condoms involves quality control checks throughout production, but this is not analogous to an AI training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI training set. The "ground truth" for ensuring manufacturing quality aligns with general quality system regulations (21 CFR Part 820) and specifications derived from standards like ASTM D3492-08.

Summary

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

August 26, 2016

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

Re: K161545

Trade/Device Name: Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS 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

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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 (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.

Joyce M. Whang -S

for

Benjamin 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) K161545

Device Name

Trojan(TM) XOXO(TM) Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant

Indications for Use (Describe)

The Trojan XOXO Thin condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of 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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II. 510(k) Summary - K161545

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628
Contact Person:	Lisa BurnsRegulatory Affairs ManagerChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Tel: (609) 806.1997Fax: (609) 403.7411
Date Prepared:	June 2, 2016
Device Trade Name:	Trojan™ XOXO™ Thin Male Natural Rubber LatexCondom with Silicone and Aloe Vera OE Lubricant
Device Common Name:	Natural Rubber Latex Condom with Lubricant
Product Code:	HIS – Condom (21 CFR § 884.5300)
Classification:	Class II
Predicate Device:(K912901)	Trojan™ (TM-TBD) Latex Condom with Lubricant[Secondary Brand name HER PLEASURE™ added whenintroduced on market]
Indications for Use:	The Trojan XOXO Thin condom is used forcontraception and for prophylactic purposes (to helpprevent pregnancy and the transmission of sexuallytransmitted infections).

Device Description:

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Standard Specifications for Rubber Contraceptives (Male condom). The Trojan™ XOXO™ Thin condom has a nominal length of 180 ± 10 mm, a nominal thickness of 0.07 ± 0.01 mm, and a nominal flat- width of 52 ±2 mm, measured 30 mm from the open end.

The Trojan™ XOXOTM Thin condom is packaged in a primary foil. Multiple individually foiled condoms may be packaged in a carton.

Technological Characteristics:

The Trojan™ XOXO™ Thin condom is a straight wall nipple end condom with lubricant. The predicate and 510(k) subject device are both smooth walled with similar dimensions and contain a silicone based lubricant. The Trojan™ XOXO™ Thin condom is made from a pre-vulcanized natural rubber latex. The purpose and technological function of the pre-vulcanized natural rubber latex in the latex condom formulation is the same as the current natural rubber latex. The Trojan™ XOXO™ Thin condom has an additional ingredient to the silicone based lubricant versus the plain silicone lubricant on the predicate device. This difference does not raise different questions of safety or effectiveness as all condoms must demonstrate biocompatibility and physical testing.

Biocompatibility:

Biocompatibility testing was performed to evaluate the biocompatibility of the Trojan™ XOXO™ Thin condom in accordance with ISO 10993-1. Biological Evaluation of Medical Devices, 2009 and the device is considered safe for consumers based on the results of the biocompatibility testing.

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

Physical Testing:

Three (3) lots of Trojan™ XOXO™ Thin condom were tested and met specifications of ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).

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Shelf Life:

The Trojan™ XOXO™ Thin condom has a three year (36 month) shelf-life based on the results of an accelerated stability study protocol created with reference to 21 CFR 801.435. Five year (60 month) expiration dating will be verified with real-time stability according to 21 CFR 801.435.

Substantial Equivalence:

The Trojan™ XOXO™ Thin Condom has the same intended use as the predicate device. Based on performance data and biocompatibility review and testing and safety data, Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant is substantially equivalent to the predicate device in technology, intended use, safety and effectiveness.

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.