Trojan™ Azul Personal Lubricant (H2O Sensitive Touch 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. This product is not compatible with polyurethane condoms.

Device Description

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water).

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.

AI/ML Overview

This document, K180764, is a 510(k) Premarket Notification for a personal lubricant, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant). It is not a medical imaging AI device, and therefore does not contain information related to AI model training, testing, or human reader studies.

The acceptance criteria and performance data provided in this document pertain to the physical, chemical, and biological properties of the personal lubricant, and its compatibility with condoms, as well as its shelf life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria, as this document is for a non-AI medical device.

However, I can extract the acceptance criteria and performance data relevant to this specific device (personal lubricant) as presented in the document.

Acceptance Criteria and Reported Device Performance (for Trojan™ Azul Personal Lubricant):

Parameter	Acceptance Criteria (K180764 / Subject Device)	Reported Device Performance (K180764 / Subject Device)
Appearance	Clear Gel	Clear Gel
Color	Clear and colorless	Clear and colorless
Odor	Characteristic odor	Characteristic odor
pH	5.9-6.9	5.9-6.9
Viscosity	1500-7500	1500-7500
Osmolality	250 - 550 (S001)	250 - 550 (S001)
Antimicrobial Effectiveness	Meets Requirement	Meets Requirement
Total Aerobic Microbial Count (TAMC)	< 100 cfu/g	< 100 cfu/g
Total Yeast and Mold Count (TYMC)	< 10 cfu/g	< 10 cfu/g
Absence of Pathogenic Organisms	Absent	Absent
Biocompatibility	(Implied to meet ISO 10993 standards)	Testing performed and results summarized below.
Condom Compatibility	Compatible with NRL and polyisoprene condoms; Not compatible with polyurethane condoms	Compatible with NRL and polyisoprene condoms; Not compatible with polyurethane condoms
Shelf Life	Validated shelf life	Validated shelf life

Study Proving the Device Meets Acceptance Criteria (as described in the document):

The performance data to demonstrate substantial equivalence to the predicate device was derived from non-clinical testing.

Biocompatibility:
- Tests performed:
  - Cytotoxicity with Agarose Overlay (ISO 10993-5)
  - Rabbit Vaginal Irritation Study (ISO 10993-10)
  - Acute Systemic Toxicity Study (ISO 10993-11)
  - Guinea Pig Maximization Sensitization Study (ISO 10993-10)
- Results: Not explicitly detailed beyond stating "the following biocompatibility testing was performed... in accordance with ISO 10993." The implication is that the device met the criteria for these tests.
Condom Compatibility:
- Methodology: A modification of ASTM D7661 (Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) was used.
- Results: "Laboratory test results demonstrated that the proposed device is compatible with leading commercial brands of natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms." This matches the acceptance criteria.
Shelf Life:
- Methodology: Validated shelf life based on results of an accelerated aging stability study.
- Evaluation parameters: Odor, Color, Viscosity, Osmolality, and pH. Microbial evaluation was conducted via USP testing.
- Results: "results were met for all parameters."

Addressing the specific questions asked for an AI device (which are not applicable to this document):

Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for this product is established through laboratory testing (analytical, chemical, biological).
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, ground truth is based on established laboratory analytical methods, biological tests, and international standards (e.g., ISO, ASTM, USP).
The sample size for the training set: Not applicable (no AI training set).
How the ground truth for the training set was established: Not applicable.

Summary

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August 1, 2018

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

Re: K180764

Trade/Device Name: Troian™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Regulation Number: 21 CFR& 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 27, 2018 Received: June 28, 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, 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.

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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 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,

Sharon M. Andrews -S

for

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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TrojanTM Azul Personal Luricant (H2O Sensitive Touch Personal Lubricant)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180764

Device Name

Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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March 22, 2018

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) SUMMARY:

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628Phone: 609-806 1200
Contact Person:	Joelle ReinsonSenior Regulatory Affairs SpecialistChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Email: Please addTel: (609) 806.1671Fax: (609) 403.7415
Date Prepared:	July 31, 2018
Device Trade Name:	Trojan™ Azul Personal Lubricant (H2O Sensitive TouchPersonal Lubricant)
Device Common Name:	Personal Lubricant
Product Code:	NUC (lubricant, personal)
Classification:	Class II, Condom (21 CFR § 884.5300)
Predicate Device:	K141034: TROJAN™ Azul Personal Lubricant (H2OSensitive Touch Personal Lubricant)

Description of Device:

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The following parameters are included as part of the device specifications:

Appearance ●
o Color
Odor ●
pH
Viscosity ●
SymOcide pH Assay
Osmolality
Antimicrobial effectiveness ●
Total Aerobic Microbial Count (TAMC) ●
Total Yeast and Mold Count (TYMC) ●
Absence of Pathogenic Organisms (at minimum Pseudomonas ● aeruginosa, Staphylococcus aureus, and Candida albicans)

Device & Predicate Device(s):	K180764	K141034
Indication for Use	Trojan Azul personallubricant (H2O sensitivetouch personal lubricant) isa personal lubricant forpenile and/or vaginalapplication, intended tolubricate and moisturize, toenhance to ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latexand polyisoprene condoms.This product is notcompatible withpolyurethane condoms.	Azul personal lubricant is a personallubricant for penile and/or vaginalapplication, intended to lubricate andmoisturize, to enhance to ease andcomfort of intimate sexual activity andsupplement the body's natural lubrication.This product is compatible with naturalrubber latex and polyisoprene condoms.This product is not compatible withpolyurethane condoms.
General Device Characteristics
Sponsor	Church & Dwight Co., Inc.	Church & Dwight Co., Inc.
Regulation Number	884.5300	884.5300
Product Code	NUC	NUC
Device Class	II	II
Condom Compatibility	NRL and polyisoprene	NRL and polyisoprene

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Base Type	Water	Water
Primary Ingredients	Deionized Water	Deionized Water
	Glycerin, USP	Glycerin, USP
	Symocide pH(Phenoxyethanol,Hydroxyacetophenone,Caprylyl Glycol, Water)	Methylparaben, NF
	Hydroxyethyl-Cellulose	Hydroxyethyl Cellulose (Natrosol 250HX PHARM)
	Sodium Hyaluronate	Sodium Hyaluronate
	Sodium Citrate, USP	Sodium Citrate, USP
	Sodium Chloride, USP	Sodium Chloride, USP
	Citric Acid, USP	Citric Acid, USP
	Sodium Hydroxide	Sodium Hydroxide
	Vitamin E TPGS(Tocophersolan)	Vitamin E TPGS
	Veragel 200	Aloe
	Standardized (AloeBarbadensis LeafExtract)







Appearance	Clear Gel	Clear Gel
Color	Clear and colorless	Clear and colorless
Odor	Characteristic odor	Characteristic odor
pH	5.9-6.9	5.9-6.9
Viscosity	1500-7500	1500-7500
Osmolality	250 - 550 (S001)	250 - 550 (S001)
Antimicrobial effectiveness	Meets Requirement	Meets Requirement
TAMC	< 100 cfu/g	< 100 cfu/g
TYMC	<10 cfu/g	<10 cfu/g
Absence of pathogenic organisms	Absent	Absent

The indication for use statement of the subject device is identical to that of the predicate device.

The only difference in the technological characteristics between the subject and predicate device is the inclusion of Symocide instead of Methylparaben. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions as compared to the predicate device. These differences can be address through non-clinical testing.

Performance Data:

The performance testing results are summarized below.

Biocompatibility:

The following biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices.

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Test Performed	Standard
Cytotoxicity with Agarose Overlay	ISO 10993-5
Rabbit Vaginal Irritation Study	ISO 10993-10
Acute Systemic Toxicity Study	ISO 10993-11
Guinea Pig Maximization Sensitization Study	ISO 10993-10

Condom Compatibility:

The results for laboratory testing used a modification of the methodology found in ASTM D7661; Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Laboratory test results demonstrated that the proposed device is compatible with leading commercial brands of natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.

Shelf Life:

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) has a validated shelf life based on results of an accelerated aging stability study. Evaluation of Odor, Color, Viscosity. Osmolality, and pH was conducted. Microbial evaluation was conducted via USP testing and results were met for all parameters

Substantial Equivalence:

Based on the results of performance testing, the Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is substantially equivalent to the predicate device, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant), K141034.

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.