Aqua Lube Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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, polyisoprene, and polyurethane condoms.

Device Description

Aqua Lube® is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. This product is a clear, non-greasy, high-viscosity, liquid. This product may be used with or without a condom during intimate sexual activity.

AI/ML Overview

This document describes the safety testing and substantial equivalence of the Aqua Lube® Personal Lubricant (K110325) to predicate devices. It is not a study proving the device meets specific performance criteria in a clinical setting as would typically be described for a diagnostic or AI-based device. Instead, it focuses on laboratory tests to demonstrate safety and compatibility.

Therefore, many of the requested elements for a study on "acceptance criteria" and "device performance" in the context of an AI or diagnostic device are not applicable to this 510(k) submission for a personal lubricant.

However, I can extract the relevant information regarding the acceptance criteria and how the device proved to meet them in the context of the provided document.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Safety Testing	Biocompatibility:		Met acceptance requirements for all tests
	Cytotoxicity	(Absence of cytotoxic effects)
	Irritation	(Absence of irritant effects)
	Sensitization	(Absence of sensitization)
	Systemic Toxicity	(Absence of systemic toxic effects)
Product Compatibility	Latex Condom Compatibility	Does not affect mechanical or physical integrity of condoms	Does not affect the mechanical or physical integrity of natural rubber latex, polyisoprene, and polyurethane condoms
Technological Characteristics	Substantial Equivalence to predicate devices	Similar intended use, similar formulations	Substantially equivalent to K-Y Personal Lubricant and ForPlay Personal Lubricant

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

Sample Size: Not specified for individual tests. The document broadly states "laboratory studies" and "studies on latex condom compatibility." For biocompatibility and toxicity studies, it refers to "the proposed devices" (plural, likely implying multiple samples of Aqua Lube were tested).
Data Provenance: The studies were conducted by "outside laboratories." The country of origin is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective, as they were conducted specifically for the purpose of demonstrating safety and equivalence for this submission.

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

Not applicable. This is a laboratory-based safety and compatibility assessment, not a clinical study involving expert interpretation of diagnostic output or ground truth establishment based on human review. The "ground truth" or "reference standard" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility and condom compatibility.

4. Adjudication Method for the Test Set

Not applicable. This is not a study where human adjudication of results would be relevant. The outcome of the laboratory tests (e.g., cytotoxicity assay results, physical property measurements of condoms) are objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This type of study is used for diagnostic or AI-assisted interpretation, where human readers evaluate cases with and without AI assistance. This document describes laboratory safety and compatibility testing for a personal lubricant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical product (personal lubricant), not an algorithm or AI. The tests performed are inherent to the product itself.

7. The Type of Ground Truth Used

The "ground truth" or reference standard for these tests are the established scientific and regulatory methods for evaluating:

Biocompatibility: Standardized assays (e.g., ISO standards for cytotoxicity, irritation, sensitization, systemic toxicity) with predefined pass/fail criteria.
Condom Compatibility: Standardized methods to assess the mechanical and physical integrity of condoms after exposure to the lubricant (e.g., burst pressure, tensile strength tests) with established acceptance limits for material degradation.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.

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

Not applicable, as there is no training set for this type of product.

Summary

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DEC - 8 2011

K110325
Pg. 1 of 2

ATTACHMENT 10-Re 510(k) Pre-Market Notification Aqua Lube® Personal Lubricant

510(k) SUMMARY

Mayer Laboratories, Inc. 1950 Addison Street, Suite 101 Berkeley, CA 94704-1182 USA

Contact Person

Submitter

『

David P. Mayer, President (510) 229-5300 telephone fax (510) 848-5763 davidm@mayerlabs.com email

Date Prepared

February 1, 2011

Aqua Lube® (TX 407)

Personal Lubricant

Proprietary Name

Common Name

Classification Name

Predicate Device

Description of Device

Condom Class II (21 CFR § 884.5300) Product Code: NUC, Lubricant, patient, vaginal, latex compatible

K-Y® Personal Lubricant (K955648) ForPlay Personal Lubricant (K051688)

Indications For Use

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ATTACHMENT 10-Rev.

510(k) Pre-Market Notification
Aqua Lube® Personal Lubricant

Technological Characteristics

The Aqua Lube formula is proprietary. The product however, has no exceptional technological characteristics. Aqua Lube Personal Lubricant consists mainly of water and water-soluble ingredients similar to other lubricants currently on the U.S. market and substantially equivalent to the predicate devices.

Substantial Equivalence

Aqua Lube is substantially equivalent to predicate devices currently marketed in the United States, including K-Y Personal Lubricant and ForPlay Personal Lubricant. Aqua Lube and the predicate devices have the same intended use and have similar formulations. The safety of the ingredients and of the finished products based on laboratory studies is substantially equivalent.

Safety Testing

Biocompatibility and Toxicity studies on Aqua Lube Personal Lubricant were conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs). The proposed devices were evaluated, for their potential to cause cytotoxicity, irritation, sensitization, and systemic toxicity and the results of testing showed that this formula meets acceptance requirements for all tests. Additionally, studies on latex condom compatibility were conducted. According to the data, Aqua Lube does not affect the mechanical or physical integrity of natural rubber latex, polyisoprene, and polyurethane condoms. Therefore, Aqua Lube is safe to use with latex condoms and non-latex condoms.

Conclusion

Laboratory and safety testing conducted on Aqua Lube personal lubricant has provided scientific evidence that this product is safe for its intended use, and that it is substantially equivalent to predicate devices.

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Image /page/2/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-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

DEC - 8 2011

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

Mr. David P. Maver President Mayer Laboratories, Inc. 1950 Addison Street. Suite 101 BERKELEY CA 94704

Re: K110325

Trade/Device Name: Aqua Lube® (TX-407) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 21, 2011 Received: November 23, 2011

Dear Mr. Mayer:

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 of medical device-related

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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/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,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 11-Rev.1 510(k) Pre-Market Notification Aqua Lube® Personal Lubricant CONFIDENTIAL

INDICATIONS FOR USE STATEMENT

510(k) Number

KI10325

Device Name

Aqua Lube®

Indications for Use

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

Julius Kanne

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110325

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.