Azul 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 Azul 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. 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 methylparaben. This medical device is designed to meet product specifications which include: Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness. The Azul 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 and preservation.

AI/ML Overview

The document describes the Azul Personal Lubricant and its supporting studies for 510(k) premarket notification. However, it does not provide specific acceptance criteria or a study with a table of reported device performance values compared to those criteria. The provided information focuses on the device's characteristics, intended use, and a summary of various studies conducted to demonstrate its safety and compatibility.

Here's an analysis of the requested information based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document lists "product specifications" (Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness) for which the device is "designed to meet." However, the specific acceptance criteria (e.g., pH range, maximum microbial count) and the actual reported performance values are not detailed in a table format.

The document also mentions "Condom compatibility" results but does not quantify them against acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a single "test set" in the context of validating a device's performance against detailed acceptance criteria using a specific sample size. Instead, it describes several types of studies performed:

Biocompatibility studies:
- In vitro cytotoxicity study
- Rabbit vaginal irritation study
- Rabbit penile irritation study
- Acute systemic toxicity study
- Guinea pig maximization sensitization study
- Primary rabbit skin irritation study
- Sample Size: Not specified for any of these individual studies.
- Data Provenance: Not explicitly stated, but these are typically conducted in a laboratory setting. The country of origin is not mentioned. These would be considered prospective studies for the purpose of this submission.
Shelf life - Stability and shelf life testing:
- Sample Size: Not specified.
- Data Provenance: In vitro study, typically laboratory-based. The country of origin is not mentioned. This would be a prospective study.
Condom compatibility testing:
- Sample Size: Not specified (e.g., number of condoms tested, number of lubricant applications).
- Data Provenance: Laboratory testing using a modification of ASTM D7661. The country of origin is not mentioned. This would be a prospective study.

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

Not applicable or not specified. The studies described are primarily
laboratory-based chemical, physical, and biological (animal) tests, not human-reader-based assessments requiring expert ground truth establishment in the way, for example, a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications is not relevant to the types of studies reported for this personal lubricant.

4. Adjudication Method for the Test Set

Not applicable. Given the nature of the studies (laboratory tests, animal studies), there is no mention of an adjudication method involving multiple human assessors or an "adjudication method" in the context of clinical or diagnostic review.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study, which typically evaluates the performance of human readers with and without AI assistance, was not conducted as this device is a personal lubricant and not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No. This device is a personal lubricant, not an algorithm or AI system. Therefore, a standalone performance study in that context was not performed. The performance studies described (biocompatibility, stability, condom compatibility) assess the device's inherent properties.

7. Type of Ground Truth Used

The "ground truth" for the studies described is based on established scientific methodologies for assessing chemical properties, physical properties, biocompatibility (animal models), and material compatibility (e.g., ASTM standards).

Biocompatibility: In vitro assay results (cytotoxicity) and observed biological responses in animal models (irritation, systemic toxicity, sensitization).
Shelf life: Measured physical, chemical, and microbiological parameters over time under specified conditions (e.g., accelerated aging).
Condom compatibility: Physical property changes or damage to condoms measured according to a modified ASTM standard.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The studies described are traditional device testing.

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

Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Summary

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Pg. I of 3 K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

Confidential July 21, 2014 - Revised Page 2 of 26

II. 510(k) Summary Azul Personal Lubricant

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628
Contact Person:	Joseph CicconeSenior Manager, Regulatory AffairsChurch & Dwight Co., Inc.500 Charles Ewing BoulevardEwing, NJ 08628Tel: (609) 806.1994Fax: (609) 403.7411
Date Prepared:	July 21, 2014
Device Trade Name:	Azul Personal Lubricant
Device Common Name:	Personal Lubricant
Product Code:	NUC - Condom (21 CFR § 884.5300)
Classification:	Class II
Predicate Devices:	Lifestyles Natural (K122054)Aloe Cadabra Lubricant (K124044)
Device Description:	The Azul Personal Lubricant is a hydrous, clear water-based personallubricant with aloe and vitamin E that is compatible with natural rubberlatex and polyisoprene condoms. This product is not compatible withpolyurethane condoms. The lubricant formula is thickened using sodiumhyaluronate and hydroxyethylcellulose. It contains a pH buffer system tomaintain a slightly acidic pH of 5.9 to 6.9, and is preserved usingmethylparaben. This medical device is designed to meet productspecifications which include:
	Color/appearance
	Odor�
	pl-l
	Viscosity
	Methylparaben assay�
	Osmolality
	Total aerobic microbial count●
	Total yeast and mold count●
	Absence of pathogenic organisms
	Antimicrobial effectiveness
	The Azul Personal Lubricant is packaged in a polyethylene terephthalate(PET) bottle with a screw on, flip top polypropylene (PP) closure. Aninduction seal will be placed over the bottle for tamper resistance andpreservation.
Intended Use:	The intended use is as a personal lubricant compatible with naturalrubber latex and polyisoprene condoms. Not compatible withpolyurethane condoms.
Indications for Use:	Azul Personal Lubricant is a personal lubricant for penile and/or vaginalapplication, intended to lubricate and moisturize, to enhance the ease andcomfort of intimate sexual activity and supplement the body's naturallubrication. This product is compatible with natural rubber latex andpolyisoprene condoms. This product is not compatible withpolyurethane condoms.
Technological Characteristics:	Azul Personal Lubricant contains similar ingredients as legally marketedwater-based personal lubricants that are compatible with natural rubberlatex and polvisoprene condoms. This product is not compatible withpolyurethane condoms.
Summary of Studies:
	Biocompatibility studies - Performed on the final 510(k)-subjectdevice. These studies include in vitro cytotoxicity study; rabbitvaginal irritation study; rabbit penile irritation study; acute systemictoxicity study; guinea pig maximization sensitization study; primaryrabbit skin irritation study. Based on the results of these studies. AzulPersonal Lubricant is considered safe for consumer use.

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Image /page/0/Picture/6 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in a bold, sans-serif font, with the tagline "BRAND CONDOMS" underneath in a smaller font. To the right of the wordmark is an image of a Trojan warrior's head, complete with a helmet. The logo is simple, recognizable, and conveys a sense of strength and protection.

Church & Dwight Co.. Inc.

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Image /page/1/Picture/3 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in bold, sans-serif font, with the tagline "BRAND CONDOMS" in smaller font below. To the right of the wordmark is an image of a Trojan helmet.

CHURCH & DWIGHT CO., INC.

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Shelf life - Stability and shelf life testing was performed on the Azul Personal Lubricant to validate the stability of the device during its intended shelf life of 2 years. Accelerated aging was performed in accordance with accepted standards for medical devices to simulate longterm storage. To evaluate stability, this in vitro study used sealed and unsealed sample bottles to simulate actual device usage.

Condom compatibility - The results for laboratory testing using 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 polyurethanc condoms.

Substantial Equivalence:

The proposed device is substantially equivalent to the predicate devices. Lifestyles Natural and Aloe Cadabra in technology, intended use, safety.

Image /page/2/Picture/6 description: The image shows the word "TROJAN" in bold, sans-serif font. To the right of the word is a stylized image of a Trojan helmet. Below the word "TROJAN" are the words "BRAND CONDOMS" in a smaller font.

CHURCH & DWIGHT CO., INC.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2014

Church & Dwight Co., Inc. Joseph Ciccone Senior Manager, Regulatory Affairs 500 Charles Ewing Boulevard Ewing, NJ 08628

K141034 Re:
Trade/Device Name: Azul Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 21, 2014 Received: April 22, 2014

Dear Joseph Ciccone,

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

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Page 2 - Joseph Ciccone

(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.

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" (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 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.

Image /page/4/Picture/8 description: The image shows the name "Benjamin R Fisher -S" in a bold, sans-serif font. The letters "R" and "F" are stylized with a decorative pattern, possibly indicating a logo or design element. The text is horizontally aligned and appears to be part of a title or heading.

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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K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

Confidential July 2, 2014 Page 1 of 26

I. Indications for Use

510(k) Number (if known): N/A

・

Device Name: Azul Personal Lubricant

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (21 CFR 801 Subpart D) OR

Over-The-Counter (OTC)X (21 CFR 801 Subpart C)

Beniamin R.F. 2014 1-5:06:53 -04'00'

CHURCH & DWIGHT CO., INC.

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.