A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.

Device Description

The CVS Personal Lubricant & Moisturizer formula is non-sterile. clear, non- staining, non-greasy, aqueous gel intended for use as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms as demonstrated in condom compatibility testing. This device is not a contraceptive or spermicide, nor does it contain any such component. CVS Personal Lubricant & Moisturizer is packaged in PETE bottles with a foil seal and polypropylene cap.

AI/ML Overview

This document describes the premarket notification for the CVS Personal Lubricant & Moisturizer, a device that is not an AI/ML product. Therefore, it does not include information on acceptance criteria or studies involving AI/ML performance.

The provided text details the device description, intended use, comparison of technological characteristics with a predicate device (Astroglide), and non-clinical studies conducted to demonstrate substantial equivalence. These non-clinical studies serve as the "performance data" for this type of medical device, ensuring its safety and effectiveness for its stated intended use.

Here's an analysis of the information provided, tailored to what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, the concept of "acceptance criteria" is related to demonstrating substantial equivalence to a predicate device through physical, chemical, and functional characteristics, rather than diagnostic performance metrics.

Feature / Test Category	Acceptance Criteria (Implied by Predicate Comparison and Standards)	Reported Device Performance (CVS Personal Lubricant & Moisturizer)
Composition	Substantially similar ingredients to predicate (Astroglide)	Contains: water, glycerin, propylene glycol, polyquaterium 15, methylparaben and propylparaben. Substantially similar to Astroglide in ingredient list.
Intended Use	Same intended use as predicate device	Personal lubricant for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. Compatible with latex condoms. Not a contraceptive or spermicide. (Identical to predicate's stated use).
Physical Characteristics	Non-sterile, clear, non-staining, non-greasy, aqueous gel (as described for the device). "Perceptual qualities" comparable to predicate.	Non-sterile, clear, non-staining, non-greasy, aqueous gel. "Test results rated CVS Personal Lubricant & Moisturizer (a 10 of 10 rating) as comparable to Astroglide" on the basis of perceptual qualities, physical and chemical properties.
Condom Compatibility	Must not adversely affect tensile strength, elongation, or burst pressure of latex condoms (standard for lubricants claiming compatibility).	When applied to latex condoms, it "does not adversely affect tensile strength, elongation or burst pressure, when compared to untreated condoms."
Shelf-Life Stability	Maintain product integrity and safety over time (typically a specified period under accelerated conditions).	Successfully passed 90-day accelerated stability.
Preservative Effectiveness	Must meet requirements of USP <1227> Antimicrobial Effectiveness Test.	Formulation with the preservative system has "successfully passed the requirements of the USP <1227> Antimicrobial Effectiveness Test."
Container Type	Similar to predicate for ease of use and safety.	Plastic (PETE bottles with a foil seal and polypropylene cap). Similar to predicate (Plastic).
Sterility	Non-sterile, as per device description and predicate.	Non-sterile.

2. Sample size used for the test set and the data provenance:

Non-Clinical Studies: The document does not specify exact sample sizes for the Stability, Preservative Effectiveness, or Condom Compatibility tests in terms of number of product units or condoms. These tests would typically follow established test protocols with defined sample sizes by relevant standards (e.g., ISO, ASTM, USP).
- Data Provenance: The studies were conducted by Lake Consumer Products, Inc., as part of their submission to the FDA. The data provenance is internal to the manufacturer. It is retrospective in the sense that the data was generated specifically for this 510(k) submission, not as part of a post-market surveillance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a personal lubricant, not a diagnostic AI/ML device requiring expert interpretation of medical images or data. Ground truth here refers to objective measurements against established physical, chemical, or biological standards.

4. Adjudication method for the test set:

Not applicable for this type of device. Performance is determined by objective laboratory testing against established standards and comparison to a predicate device, not by expert adjudication of diagnostic outcomes.

5. 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 is not an AI/ML device and therefore no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance evaluation comes from:

Predicate Device Comparison: The chemical composition and intended use are compared directly to an existing legally marketed device (Astroglide, K935299).
Established Standards:
- Preservative Effectiveness: USP <1227> Antimicrobial Effectiveness Test.
- Condom Compatibility: Industry-standard tests for tensile strength, elongation, and burst pressure of latex condoms (implied by the statement "does not adversely affect tensile strength, elongation or burst pressure"). These tests have predefined acceptance limits.
Internal Laboratory Testing: Stability, perceptual qualities, physical, and chemical properties were assessed through internal testing, likely against predetermined specifications or direct comparison to the predicate.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device. There is no "training set."

9. How the ground truth for the training set was established:

Not applicable as this is not an AI/ML device.

Summary

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APR 4 - 2007

510(k) SUMMARY

Submitter:	Lake Consumer Products, Inc.
	1 Pharmacal Way
	Jackson, WI 53037

Contact Person: Mary L. Wundrock Vice President- Laboratory Services mwundrock@pharmacalway.com Phone: (262) 677-4121 Ex 7110 Fax: (262) 677-9006
September 6, 2006 Date Submitted:

Proprietary Name: CVS Personal Lubricant & Moisturizer

Personal Lubricant Common Name:
Predicate Name: Astroglide 510(k) Number: K935299

Classification Name:

21 CFR 880.6375 Patient Vaginal Lubricant Product Code MMS Class I

21 CFR880.5300 Lubricant, Patient, Vaginal, Latex Compatible Product Code NUC Class II

Description of Device:

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Intended Use:

CVS Personal Lubricant & Moisturizer is intended as a personal lubricant for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. The lubricous nature of the product helps supplement the body's natural lubricating fluids, thereby reducing friction. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide, nor does it contain any such component.

Comparison of Technological Characteristics:

CVS Personal lubricant & Moisturizer contains water, glycerin, propylene glycol, polyquaterium 15, methylparaben and propylparaben. CVS Personal Lubricant & Moisturizer is substantially similar to the predicate device.

A summary comparison of the features of CVS Personal Lubricant & Moisturizer and the predicate device Astroglide is provided in Table 1.

Features	CVS PersonalLubricant &Moisturizer	Predicate Device-Astroglide
Labeled CondomCompatible	Yes	Yes
Personal Lubricant	Yes	Yes
Contains Water	Yes	Yes
Contains Glycerin	Yes	Yes
ContainsPropylene Glycol	Yes	Yes
ContainsPolyquaternium 15	Yes	Yes
ContainsMethylparaben	Yes	Yes
ContainsPropylparaben	Yes	Yes
Sterile	No	No
Container type	Plastic	Plastic

TABLE 1

CVS Personal Lubricant & Moisturizer is substantially equivalent to the following device that is currently in commercial distribution:

Astroglide, BioFilm Inc., K935299

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Substantial Equivalence:

CVS Personal Lubricant & Moisturizer is substantially similar to the predicate device, Astroglide. The products have the same intended use and technological characteristics. No new safety or effectiveness issues have been raised through testing. Both products are intended for use as personal lubricants, safe to use with condoms, water-soluble and for over-the-counter (OTC) use.

Summary of Performance Data:

Non-Clinical Studies

Stability- CVS Personal Lubricant & Moisturizer has successfully passed 90 day accelerated stability.

Preservative Effectiveness-CVS Personal Lubricant & Moisturizer formulation with the preservative system has successfully passed the requirements of the USP <1227> Antimicrobial Effectiveness Test.

Comparison with Predicate Device- CVS Personal Lubricant & Moisturizer was compared to Astroglide on the basis of perceptual qualities, physical and chemical properties, ingredient list review, label claims and packaging. Test results rated CVS Personal Lubricant & Moisturizer (a 10 of 10 rating) as comparable to Astroglide.

Condom Compatibility Testing- CVS Personal Lubricant & Moisturizer, when applied to latex condoms does not adverselv affect tensile strength, elongation or burst pressure, when compared to untreated condoms.

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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 with its wings spread, and three human figures in profile facing the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

Ms. Mary L. Wundrock Vice President - Laboratory Services Lake Consumer Products, Inc. 1 Pharmacal Way, P.O. Box 198 JACKSON WI 53037

FEB 2 4 2014

Re: . K062682 Trade/Device Name: CVS Personal Lubricant & Moisturizer Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): March 21, 2007 Received (Date on orig SE ltr): March 22, 2007

Dear Ms. Wundrock:

This letter corrects our substantially equivalent letter of April 4, 2007.

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

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Page 2 -

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 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 contact 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. 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,

Benjamin R. Fisher -S

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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Indications for Use Statement:

KC62682 510(k) Number:

Device Name: CVS Personal Lubricant & Moisturizer

Indications for Use:

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

Over-The-Counter Use (Part 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)

David A. Bergman

Division Sien-Division of Reproductive, and Radiological Dev 510(k) Number

4-1

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.