The Clay-Park Labs Lubricating Jelly is intended for personal lubrication when vaginal dryness causes discomfort and as a lubricant for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

Device Description

The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle of glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

AI/ML Overview

This document is a 510(k) summary for the Clay-Park Labs Lubricating Jelly, a patient lubricant. It focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria and a study proving performance against those criteria in the way one would for a diagnostic or AI-powered medical device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device is safe for intended use.	Confirmed through substantial equivalence to a legally marketed predicate device (K-Y® Lubricating Jelly).
Effectiveness/Performance: Device performs as intended.	Confirmed through substantial equivalence to a legally marketed predicate device (K-Y® Lubricating Jelly).
Stability: Device maintains properties over shelf-life.	Stability confirmed for 36 months via long-term stability study and preservative effectiveness test (USP method <51>).
Technological Characteristics: Comparable to predicate.	"The technological characteristics of the Clay-Park Labs Lubricating Jelly are identical to those of the predicate device."
Intended Use: Matches predicate device.	Identical intended use as the predicate device (personal lubrication for vaginal dryness, insertion of medical devices).

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

Not applicable. This submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data (stability testing), not a challenge set performance evaluation. The "test set" in this context would refer to samples used in the stability study.
Data provenance: Not specified beyond the company's internal testing.

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

Not applicable. Ground truth in the context of device performance (stability, formulation) is established through analytical testing and adherence to recognized standards like USP <51>, not expert consensus on interpretations.

4. Adjudication method for the test set:

Not applicable. There was no "test set" requiring adjudication in the sense of expert review or consensus.

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 device is a manual medical lubricant, not an diagnostic or AI-powered device.

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

Not applicable. This device is a manual medical lubricant, not an algorithm.

7. The type of ground truth used:

For stability and preservative effectiveness: Analytical testing results against predetermined specifications and USP method <51> standards.
For substantial equivalence: Comparative analysis of technological characteristics and intended use against the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The primary "study" supporting the Clay-Park Labs Lubricating Jelly's performance and safety is the demonstration of substantial equivalence to the K-Y® Lubricating Jelly predicate device, combined with a 36-month long-term stability study and a preservative effectiveness test in accordance with USP method <51>.

Substantial Equivalence: The submission asserts that the technological characteristics of the Clay-Park Labs Lubricating Jelly are "identical to those of the predicate device" (K-Y® Lubricating Jelly) and that its intended use is also the same. This implies that since the predicate device is legally marketed and generally accepted as safe and effective for its intended use, a device with identical characteristics and intended use is also considered safe and effective.
Stability and Preservative Effectiveness: A 36-month long-term stability study was conducted to confirm the product's stability throughout its labeled shelf-life. Concurrently, a preservative effectiveness test, performed according to United States Pharmacopeia (USP) method <51>, confirmed that the preservatives (chlorhexidine gluconate and methylparaben) were effective in inhibiting microbial growth over time. These tests are critical in ensuring the product maintains its properties and remains safe for use over its shelf-life.

Summary

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K012203

AUG 2 7 2001

510(k) Summary

General Information on Submitter I.

Name:	Clay-Park Labs, Inc.
Address:	1700 Bathgate Ave.
	Bronx, NY 10457
Telephone:	(718) 960-9976
Fax:	(718) 960-0111
Contact Person:	Candis Edwards
Date Prepared:	July 11, 2001

II. General Information on Device

Name: Clav-Park Labs Lubricating Jelly

Classification Name: Patient Lubricant

Predicate Device III.

K-Y® Lubricating Jelly

IV. Description of Device

V. Intended Use

VI. Technological Characteristics of Device Compared to Predicate Device

The technological characteristics of the Clay-Park Labs Lubricating Jelly are identical to those of the predicate device.

VII. Summary of Performance Data

Stability of the Clay-Park Labs Lubricating Jelly was confirmed throughout its labeled shelf-life (36 months) by a 36 month long-term stability study and a preservative effectiveness test in accordance with USP method <51>.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.

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

FEB 2 4 2014

Clay-Park Labs, Inc. % Mr. Gary L. Yingling, Esq. Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Second Floor WASHINGTON DC 20036-1221

Re: K012203

Trade/Device Name: Clay-Park Labs Lubricating Jelly Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): July 12, 2001 Received (Date on orig SE Itr): July 13, 2001

Dear Mr. Yingling:

This letter corrects our substantially equivalent letter of August 27, 2001.

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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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 (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 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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510(k) Number: KO12203

Clay-Park Labs Lubricating Jelly Device Name:

Indications for Use:

The Clay-Park Labs Lubricating Jelly is indicated for personal lubrication when vaginal dryness The Clay Pant Laos Lacerousing and for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IN NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use V

Nancy C. Broadron
(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Dev 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.