Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

AI/ML Overview

The provided text describes the 510(k) summary for the K-Y® Brand WARMING Jelly Personal Lubricant. It outlines preclinical and clinical testing to demonstrate safety and substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Not a contact sensitizing agent; no systemic toxicity	This product was not found to be a contact sensitizing agent, nor was it associated with systemic toxicity.
Human Repeated Insult Patch Test	No evidence of contact sensitization	No evidence of contact sensitization was elicited.
Consumer Perception (Warming Sensation)	Positive perception of warming sensation	75.50% of participants rated the product as "Excellent, Very Good or Good" for "Warms on Contact." In an In Home Consumer Use Study, 91.67% of 245 reported responses were positive for "Warms on Contact."
Consumer Perception (Enhances Intimacy)	Positive perception of enhanced intimacy	In an In Home Consumer Use Study, 85.01% of 245 reported responses were positive for "Enhances Intimate Sexual Activity."
Irritation (Vaginal/Vulvar)	No irritation determined by gynecological examination	It was concluded that the product did not cause irritation as determined by final gynecological examination.
Serious Adverse Events	No serious adverse events	No serious adverse events, including allergic reactions, were reported during the course of the Consumer Perception Study or the In Home Consumer Use Study.
Discomfort	Minimal to no discomfort	In the In Home Consumer Use Study, 0.078% of responses reported "experienced discomfort" (from 245 reported responses).
Condom Compatibility	Compatible with latex condoms (as per ASTM D 3492)	Compatible with latex condoms as defined by ASTM D 3492.

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes the tests and then reports the positive (or negative, where appropriate) outcomes as evidence of safety and performance. I've inferred the acceptance criteria based on the reported results.

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

Human Repeated Insult Patch Test: The sample size is not explicitly stated, but the test compared the product to the currently marketed K-Y® Brand Warming LIQUID.
Consumer Perception Study (Warming): The total number of participants is not explicitly stated. It mentions "75.50% of the participants felt the product warmed well."
In Home Consumer Use Study:
- Female subjects: Consented female subjects received speculum examinations at baseline and following the last coital episode. The exact number of subjects is not explicitly stated but is implied to be at least 245 based on the reported responses.
- Reported Responses: 245 reported responses for various criteria.
- Data Provenance: The studies are described as "Human Clinical Testing" and "Preclinical Testing of Formulation," implying prospective human studies conducted by an "outside laboratory." The country of origin is not explicitly stated, but the submission is to the FDA in the US.

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

In Home Consumer Use Study (Gynecological Examinations): The study involved "gynecological examinations at baseline and following the last coital episode." It then states, "It was concluded that the product did not cause irritation as determined by final gynecological examination." This implies a medical professional (likely a gynecologist) performed these examinations. The number of such experts and their specific qualifications (e.g., years of experience) are not specified in this document.
Other studies (Human Repeated Insult Patch Test, Biocompatibility): The "ground truth" here would be laboratory analysis and expert interpretation of those results. The number and qualifications of experts involved in these analyses are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for any of its human studies. The results appear to be reported based on the observations and findings of the individuals conducting the tests and assessments. For the In Home Consumer Use Study, the "conclusion" about irritation was "determined by final gynecological examination," suggesting a single expert's assessment or the consensus of a study team.

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 associated with diagnostic imaging or interpretative tasks where multiple human readers assess cases with and without AI assistance. The K-Y® Brand Warming Jelly is a personal lubricant, and the studies focused on safety, biocompatibility, and consumer perception, not diagnostic effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A (Not Applicable). This device is a personal lubricant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this product. The testing performed evaluates the product's direct interaction with the human body and user perception.

7. The Type of Ground Truth Used

Biocompatibility: Laboratory test results (e.g., contact sensitization, systemic toxicity measurements) interpreted against established scientific standards (ISO 10993 and G93-1).
Human Repeated Insult Patch Test: Clinical observation by trained professionals for skin reactions, comparing the test product to a predicate.
Consumer Perception Studies: Self-reported subjective experience of participants (e.g., rating warming, feedback on intimacy enhancement, discomfort).
In Home Consumer Use Study (Irritation): Objective medical assessment via "gynecological examinations" by a qualified professional.
Condom Compatibility: Laboratory testing results based on ASTM D 3492.

8. The Sample Size for the Training Set

N/A (Not Applicable). This device is a personal lubricant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data science. The "formulation" of the product is proprietary and developed through chemical and material science processes, not through a data-driven training set.

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

N/A (Not Applicable). As explained above, there is no "training set" for this product. The ground truth for its development and testing is established through standard preclinical and clinical methodologies for medical devices, focusing on safety, biocompatibility, and intended use performance.

Summary

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APR ~ 5 2004

K040164
Page 1 of 2

510(k) SUMMARY

Submitter	Personal Products Company Division of McNeil-PPC Inc.199 Grandview RoadSkillman, New Jersey 08558-9418
Contact Person	Marylou P. CarlsonMgr. Regulatory Affairs(908) 904-3709 phone(908) 904-3748 fax
Date Prepared	January 23, 2004
Proprietary Name	K-Y® BrandWARMING Jelly Personal Lubricant
Common Name	Personal Lubricant
Classification Name	Condom: 21CFR § 884.5300 Product Code 85HISPatient Lubricant: 21CFR 880.6375 Product Code MMS
Predicate Device	K-Y® Brand Warming LIQUID Personal Lubricant

K-Y® Brand JELLY Personal Lubricant

Description of Device

Intended Use

Intended OSE condom. The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for SEXUAL activity. This noticall may be carey appatible with latex condoms. K-Y® Brand purpose of fubrication, and monearizante. In of imparting a warming sensation when applied to the genital area.

Regulatory Status

Per 21CFR, 880.6375, Patient lubricant is defined as Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or themed purposes that is about to the recessory to a condom, (a Class II medical device) the therapedia device. When accuse Class II Medical Device requiring 510(k) clearance.

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K040164
page 2 of 2

510(k) SUMMARY (continued)

Technological Characteristics

The K-Y® Brand WARMING Jelly Personal Lubricant formula is proprietary. The product, has The R-1 & Bland W/HGMI . Conny seristics and consists mainly of safe water-soluble no exceptional technological character. K-Y® Brand personal lubricants currently on the market.

Substantial Equivalence

Substantial Equivalence
K-Y® Brand WARMING Jelly Personal Lubricant has been shown, in laboratory tests, to be K-Y® Brand WARNING Jeny Personal Barrently marketed K-Y® Brand Warming LIQUID Personal substantally equivalent to the same intended use with a variation in formula ingredients. Lubrican. Both devices have the same mique feature of the K-Y® Brand WARMING lubricant products.

Preclinical Testing of Formulation

Precimical Testing of Formation
Biocompatibility studies according to International Standard ISO 10993 and General Program Blocompationity studies abouring to and WARMING Jelly were conducted by an outside Memoratiouin G93-1 on X-1 & Blails W Practices (GLPs). Results form these studies, laboratory, in compulatice with Cood Laboratory - Pashered to be a contact sensitizing agent, nor was it associated with systemic toxicity.

Human Clinical Testing

Human Chilital Testillie
In a Human Repeated Insult Patch Test (Modified Draize Procedure), this product was In a Human Repeared misun Paten 1000 Torming LIQUID for its potential for contact compared to the currently markets its I & TV Wanning List of contact sensitization was elicited.

A Consumer Perception Study evaluated both male and female participant's experience of A Consumer Petception Stady overance count to their genitals during an on-site visit. Overall warmin with a single application or the product as Excellent, Very Good or Good for "Warms on 75.50% of the participans face the product & incomed or reported during the course of this study.

An In Home Consumer Use Study was conducted to evaluate both consumer perception of An in Home Collisumer OSC Study was collection of the product through vulvo/vaginal warning schud activity as well well well we. Consented female subjects received speculum examinations at baseline and following the last coital episode. The study was gyneological exammations at baseme and 10.6 for Investigational Device Exemption and conducted in compunated with acy results for this study concluded that in 245 reported responses, 91.67% were positive for "Warms on Contact" and 85.01% were positive for Itesponses, 91.07% were positively to "responded positively to "experienced discomfori". Ennunces Intimate " and 0.078 roopeneuse, (with a minimal of two sexual intercourse Auditionally, ance two weeks of nome tool (with reported. Gynecological examinations encounters) there were no sorrous ac. stregular erythema of the inner thigh area at baseline, which was not present at the return visit. It was concluded that the product did not cause irritation as determined by final gynecological examination.

Preclinical and Clinical testing have provided scientific evidence that this product is safe for its intended use.

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Re: K040164 Trade/Device Name: K-Y® Brand Warming Jelly Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): January 23, 2004 Received (Date on orig SE ltr): January 26, 2004

Dear Ms. Carlson:

This letter corrects our substantially equivalent letter of April 5, 2004.

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 (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/Resourcesfor You/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

510(k) Number (if known): K040164

Device Name: K-Y® Brand Warming Jelly

Indications For Use:

Personal Lubricant I croomax Lubrican
For vaginal/penile and condom application during sexual intimacy

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brydon

(Division Sign-Of)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040164

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.