Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.

K-Y® Brand Ultra Gel™ is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for lubrication, and moisturization purposes. It is also compatible with latex condoms.

Personal Lubricant compatible with latex condoms, helps enhance intimacy.

Device Description

K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

AI/ML Overview

This K-Y® Brand Ultra Gel™ Personal Lubricant 510(k) summary does not contain the level of detail typically found in a clinical study report for a diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device through pre-clinical and limited clinical testing, rather than establishing specific performance metrics against a defined acceptance criterion with a dedicated study.

However, based on the provided text, I can infer the "acceptance criteria" relate to performance as safe and effective, and "substantially equivalent" to the predicate device. The "study" refers to the body of testing conducted to support this claim.

Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:

Acceptance Criteria and Device Performance for K-Y® Brand Ultra Gel™ Personal Lubricant

This submission focuses on demonstrating substantial equivalence of K-Y® Brand Ultra Gel™ Personal Lubricant to its predicate device, K-Y® Brand LIQUID Personal Lubricant. The acceptance criteria are implicitly met by demonstrating safety, non-irritation, and comparable performance to the predicate device, particularly in terms of lubricity and consumer satisfaction.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from submission)	Reported Device Performance
Safety:
Non-irritating	Preclinical biocompatibility studies demonstrated the formulation was non-irritating. Human irritation studies under occluded and repetitive conditions showed the formulation was non-sensitizing and only mildly irritating.
Non-sensitizing	Human irritation studies demonstrated the formulation was non-sensitizing.
No significant pharmacotoxic effects	Preclinical biocompatibility studies demonstrated no significant pharmacotoxic effects.
Not associated with system toxicity	Preclinical biocompatibility studies demonstrated no system toxicity.
Compatibility:
Compatible with latex condoms	Demonstrated compatibility with latex condoms according to ASTM D 3492 standards.
Performance (Compared to Predicate/Marketed Products):
More lubricious than predicate (K-Y® Brand LIQUID Personal Lubricant)	Demonstrated to be more lubricious in laboratory coefficient of friction testing.
Preferred texture/consistency (compared to other commercially marketed vaginal moisturizer)	In consumer-use testing, the proposed formulation rated significantly higher for texture/consistency compared to another commercially marketed vaginal moisturizer.
Preferred moisturizing properties (compared to other commercially marketed vaginal moisturizer)	In consumer-use testing, the proposed formulation rated significantly higher for moisturizing properties compared to another commercially marketed vaginal moisturizer.
Substantial Equivalence:
Same intended use as predicate	Confirmed: "Both devices have the same intended use." Both are personal lubricants to supplement natural lubrication, relieve friction, and enhance intimate sexual activity.
Similar formulations to predicate	Confirmed: "Both devices have... similar formulations." The new product consists mainly of water-soluble ingredients similar to other lubricants on the market.
Safe for intended use	Overall conclusion from laboratory, preclinical, and clinical testing is that the product is safe for its intended use.

2. Sample Sizes Used for Test Set and Data Provenance

Due to the nature of this 510(k) summary, specific sample sizes for each test are not explicitly provided.

Preclinical Biocompatibility Studies: Conducted by outside laboratories. Data provenance not specified (e.g., country of origin). These would typically be prospective animal or in vitro studies.
Human Irritation Studies: Involved human subjects. Details on number of subjects, country of origin, or retrospective/prospective nature are not provided. These are typically prospective clinical trials.
Consumer-Use Testing: Involved consumers. Specific sample size, country of origin, or retrospective/prospective nature are not provided. These are typically prospective user studies.
Condom Compatibility Testing: Conducted according to ASTM D 3492 standards. This is lab-based testing; human subjects are not involved for this specific test.

3. Number of Experts and Qualifications for Ground Truth

Not applicable in the context of this 510(k) summary. "Ground truth" as understood in AI/imaging devices (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by laboratory measurements, biological responses, and consumer feedback against defined criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory analyses (e.g., coefficient of friction, biocompatibility, ASTM standards) and direct human or consumer responses (irritation, consumer preference). There is no "test set" requiring adjudication by multiple experts in the sense of a diagnostic interpretation.

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

No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of AI assistance on human performance. K-Y® Brand Ultra Gel™ is a personal lubricant, not a diagnostic device.

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

No. This concept applies to AI algorithms. K-Y® Brand Ultra Gel™ is a physical product, not an algorithm. Its performance is evaluated through physical and biological interactions, as well as user experience.

7. Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as follows:

Preclinical Biocompatibility (Non-irritation, non-sensitizing, no toxicity): Laboratory measurements and biological assays (e.g., cytotoxicity tests, sensitization tests, systemic toxicity tests) following established GLP guidelines.
Human Irritation Studies: Direct human response/observation by trained medical professionals (e.g., dermatologists or clinical researchers) assessing skin reactions.
Condom Compatibility: Adherence to the specified ASTM D 3492 standard, which involves physical testing methods to evaluate material integrity and performance.
Lubricity: Objective laboratory measurement of the coefficient of friction.
Consumer-Use Testing (Texture/Consistency, Moisturizing Properties): Subjective consumer feedback and preference ratings, likely via questionnaires or surveys, quantified statistically.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. K-Y® Brand Ultra Gel™ is a chemical formulation, not an AI model.

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

Not applicable. There is no training set for this type of product.

Summary

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510(k) SUMMARY

Submitter	Personal Products Company Division of McNeil-PPC Inc.199 Grandview RoadSkillman, New Jersey 08558-9418
Contact Person	Marylou PanicoMgr. Regulatory Affairs(908) 904-3709 telephone(908) 904-3748 telefax
Date Prepared	May 29, 2002
Proprietary Name	K-Y® Brand Ultra Gel™Personal Lubricant
Common Name	Personal Lubricant
Classification Name	Condom 21CFR § 884.5300 Product Code 85HIS
Predicate Device	K-Y® Brand LIQUID Personal Lubricant

Description of Device

Intended Use

Technological Characteristics

K-Y® Brand Ultra Gel™ formula is proprietary. The product however, has no exceptional technological characteristics, consisting mainly of water-soluble ingredients similar to other lubricants currently on the US market.

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510(k) SUMMARY (continued)

Substantial Equivalence

This product has been shown in laboratory testing to be substantially equivalent to its predecessor, the currently marketed K-Y® Brand LIQUID Personal Lubricant. Both devices have the same intended use and similar formulations. One differentiating feature is that K-Y® Brand Ultra Gel™ contains vitamin E and is more lubricious, as demonstrated in laboratory coefficient of friction testing.

Preclinical Testing of Formulation

Preclinical biocompatibility studies on K-Y® Brand Ultra Gel™ Personal Lubricant were conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs). These studies demonstrated that this formulation was non-initating, did not produce any significant pharmacotoxic effects and was not associated with system toxicity.

Clinical Testing

In Human Irritation studies under conservative occluded and repetitive conditions, this formulation was non-sensitizing and only mildly irritating.

Consumer-Use Testing conducted to evaluate performance of the proposed formulation as compared to another commercially marketed vaginal moisturizer, demonstrated that the proposed formulation rated significantly higher for texture/consistency and moisturizing properties.

Laboratory, Preclinical and Clinical testing conducted on K-Y® Brand Ultra Gel™ Personal Lubricant has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicate device, K-Y® Brand LIQUID Personal Lubricant.

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Image /page/2/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 or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.

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

FEB 2 4 2014

Ms. Marylou Panico Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558

Re: K020827

Trade/Device Name: K-Y® Brand Marque Ultra Gel™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): March 12, 2002 Received (Date on orig SE ltr): March 14, 2002

Dear Ms. Panico:

This letter corrects our substantially equivalent letter of June 12, 2002.

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. Iisting 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) INDICATIONS FOR USE FORM (Replica of FDA Form)

510(k) Number (if known):

Device Name: K-Y Brand ® Ultra Gel™ Personal Lubricant Indications For Use: Personal Lubricant compatible with latex condoms, helps enhance intimacy

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-the-Counter-Use V (per 21 CFR 801.109)

Girard G. Geyson

JUN 12 2002

02-0827

00-000003

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.