Aqua Lube® Natural 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

Aqua Lube® Natural Personal Lubricant is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. Aqua Lube® Natural Personal Lubricant consists of two models: "Regular" and "Warming." This product is a clear, non-greasy, high-viscosity, liquid. This product is composed primarily of organic aloe, hydroxyethycellulose, sorbitol, and tocopherols (vitamin E). The Warming model contains the same ingredients as the Regular model plus the additional ingredient organic peppermint oil. Aqua Lube® Natural Personal Lubricant causes a warming response. This product may be used with or without a condom during intimate sexual activity. This product is packaged in a tube made of low density polyethylene with a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0 oz. Each tube is packaged in a paperboard carton, which constitutes the device's individual carton.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aqua Lube® Natural Personal Lubricant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Rabbit Vaginal Irritation	Non-Irritating	Non-Irritating
Acute Systemic Toxicity	Non-systemically toxic	Non-systemically toxic
Sensitization Guinea Pig Maximization	Non-sensitizing	Non-sensitizing
Condom Compatibility (Natural Rubber Latex)	No effect on mechanical/physical integrity	Does not affect
Condom Compatibility (Polyisoprene)	No effect on mechanical/physical integrity	Does not affect
Condom Compatibility (Polyurethane)	(No specific "acceptance" criterion, but noted incompatibility)	Did affect
Shelf Life (Warming Model)	Minimum 24 months stability	Confirmed 24 months
Shelf Life (Regular Model)	Minimum 14 months stability	Confirmed 14 months

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

The document does not specify the exact sample sizes for the individual tests (Cytotoxicity, Irritation, Toxicity, Sensitization). However, it does state that "Biocompatibility testing was conducted on Aqua Lube® Natural Personal Lubricant per ISO 10993 series," which implies standard biological testing methods for medical devices.

Provenance: The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The studies were conducted in compliance with Good Laboratory Practices (GLPs), which are a set of principles for conducting non-clinical laboratory studies.

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

This information is not provided in the document. The studies listed (e.g., cytotoxicity, irritation, sensitization) are laboratory tests with objective endpoints, rather than subjective evaluations that typically require human expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The tests described are primarily objective laboratory assessments, not requiring an adjudication method like those used for interpreting ambiguous results in image-based diagnostics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance. The Aqua Lube device is a personal lubricant, not a diagnostic tool.

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

No, a standalone algorithm performance study was not done. This concept is relevant for AI algorithms, which are not applicable to a personal lubricant.

7. The Type of Ground Truth Used

The ground truth for the device's performance relies on objective laboratory measurements and standardized testing protocols:

Biocompatibility: Results were based on measurable biological responses (e.g., cell viability for cytotoxicity, observable tissue reactions for irritation, systemic effects for toxicity, immune responses for sensitization) defined by the ISO 10993 series.
Condom Compatibility: Results were based on mechanical and physical integrity testing of condoms as defined by ASTM D7661-10.
Shelf Life: Results were based on real-time stability data, indicating the maintenance of product characteristics over time.

8. The Sample Size for the Training Set

This information is not applicable. The Aqua Lube device is a physical product, not an AI model requiring a "training set."

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

This information is not applicable. As stated above, this is not an AI model.

Summary

{0}------------------------------------------------

510(k) SUMMARY

Submitter	Mayer Laboratories, Inc.1950 Addison Street, Suite 101Berkeley, CA 94704-1182 USA
Contact Person	David P. Mayer, President(510) 229-5300 (telephone)(510) 848-5763 (fax)davidm@mayerlabs.com (email)	AUG 1 2013
Date Prepared	July 26, 2013
Proprietary Name	Aqua Lube® Natural Lubricants
Common Name	Personal Lubricant
Classification Name	CondomClass II (21 CFR § 884.5300)Product Code: NUC
Predicate Device	Glycerin & Paraben Free Astroglide® (K072647)
Description of Device	Aqua Lube® Natural Personal Lubricant is a non-sterile, water-based, personal lubricant designed to supplement the body's ownnatural lubrication fluids. Aqua Lube® Natural Personal Lubricantconsists of two models: "Regular" and "Warming." This product isa clear, non-greasy, high-viscosity, liquid. This product is composedprimarily of organic aloe, hydroxyethycellulose, sorbitol, andtocopherols (vitamin E). The Warming model contains the sameingredients as the Regular model plus the additional ingredientorganic peppermint oil. Aqua Lube® Natural Personal Lubricantcauses a warming response.
	This product may be used with or without a condom during intimatesexual activity.
	This product is packaged in a tube made of low density polyethylenewith a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0oz. Each tube is packaged in a paperboard carton, which constitutesthe device's individual carton.

{1}------------------------------------------------

Intended Use

Aqua Lube Natural 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Technological Characteristics

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

Product Safety

Biocompatibility testing was conducted on Aqua Lube® Natural Personal Lubricant per 1SO 10993 series, in compliance with Good Laboratory Practices (GLPs). The proposed devices were evaluated for their potential to cause cytotoxicity, irritation, sensitization, and acute systemic toxicity. The results of testing showed that the device meets acceptance requirements for all tests, as summarized in the following table:

Testing Performed	Results
Cytotoxicity	Non-cytotoxic
Rabbit Vaginal Irritation	Non-Irritating
Acute Systemic Toxicity	Non-systemically toxic
Sensitization Guinea Pig Maximization	Non-sensitizing

Condom Compatibility

Studies on condom compatibility were conducted according to the ASTM D7661-10. Both models of Aqua Lube® Natural Personal Lubricant demonstrated they do not affect the mechanical or physical integrity of natural rubber latex and polyisoprene condoms. The studies did show both models did affect polyurethane condoms. Therefore, Aqua Lube® Natural Personal Lubricant is compatible with natural rubber latex condoms and polyisoprene condoms. Aqua Lube Natural Personal Lubricant is not compatible with polyurethane condoms.

Shelf Life Data

Real time stability data confirms a minimum shelf life of 24 months for the Aqua Lube® Natural Lubricants - Warming Model and 14 month stability for Aqua Lube® Natural Personal Lubricant - Regular Model.

Substantial Equivalence

Aqua Lube Natural Personal Lubricant and the predicate device have the same intended use. Both are water-based personal lubricants and they have comparable physical parameters. The Aqua Lube Natural Personal Lubricant is substantially equivalent to predicate device regarding safety and effectiveness.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/15 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human figures standing below the eagle.

Public Health Service

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

August 1, 2013

Maver Laboratories, Inc. % David P. Mayer President and CEO 1950 Addison Street, Suite 101 Berkeley, CA 94704-1182

Re: K130345

Trade/Device Name: Aqua Lube® Natural Personal Lubricant

Aqua Lube Natural Personal Lubricant has two variants

l) Regular

Warming

Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 18, 2013 Received: June 28, 2013

Dear David P. 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.

{3}------------------------------------------------

Page 2 - David P. Mayer

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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number	K130345
Device Name	Aqua Lube® Natural Personal Lubricant
	Aqua Lube Natural Personal Lubricant has two variants1) Regular2) Warming
Indications for Use	Aqua Lube® Natural Personal Lubricant is a personallubricant, for penile and/or vaginal application,intended to moisturize and lubricate, to enhance theease and comfort of intimate sexual activity andsupplement the body's natural lubrication. This productis compatible with natural rubber latex andpolyisoprene condoms. This product is not compatiblewith polyurethane condoms.

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 CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130345 510(k) Number_

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.