Warming Jelly 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 not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Device Description

Warming Jelly Personal Lubricant is a clear, odorless, non-sterile, water-soluble jelly for use as a personal lubricant. The product imparts a mild warming sensation when applied to the genitalia. Warming Jelly Personal Lubricant can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms as defined by ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Warming Jelly Personal Lubricant is not a contraceptive or spermicide.

AI/ML Overview

The provided documentation describes the non-clinical performance testing of the "Warming Jelly Personal Lubricant" device, primarily to demonstrate its safety and substantial equivalence to a predicate device. It does not detail a study focused on establishing specific performance criteria that would typically be associated with diagnostic or AI-assisted devices (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria relate to standard safety and quality control assessments for personal lubricants.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity evaluation (ISO 10993-5:2009)	Confirmed safe for proposed indication
	Maximization Test for Delayed Type Hypersensitivity (ISO 10993-10:2010)	Confirmed safe for proposed indication
	Vaginal Irritation Test (ISO 10993-10:2010)	Confirmed safe for proposed indication
	Acute System Toxicity Test (ISO 10993-11:2006)	Confirmed safe for proposed indication
Condom Compatibility	ASTM D7661-10 Standard Test Method	Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. (This is a stated characteristic, not a performance target to be met, but rather an outcome that needs to be disclosed for safe use).
Stability	Shelf life	12 months (currently available stability data confirms)
Quality Control Release	Appearance/color	Evaluated in lot release testing
	Odor	Evaluated in lot release testing
	Viscosity	Evaluated in lot release testing
	Microbiological safety (standard plate count, absence of gram negative bacteria, absence of Pseudomonas, absence of Staphylococcus, yeast and mold count, absence of Candida albicans)	Evaluated in lot release testing
	pH	Evaluated in lot release testing
	Osmolality	Evaluated in lot release testing
	Water activity	Evaluated in lot release testing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical trials or AI/diagnostic device validation where specific patient cohorts are used. The testing described is non-clinical, involving laboratory and material compatibility assessments for a personal lubricant.

Therefore, "sample size" would refer to the number of samples of the lubricant tested for each criterion. This information is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is also not applicable as these are laboratory non-clinical tests, not human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The "ground truth" for these tests is established by standardized laboratory methods (e.g., ISO, ASTM) and analytical measurements, not by expert consensus on clinical cases. The document does not mention human experts establishing ground truth for these non-clinical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation tasks where multiple human readers assess cases and discrepancies need resolution. The described tests are laboratory-based and follow established protocols without the need for such adjudication.

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

This information is not applicable. The device is a personal lubricant, not an AI or diagnostic tool, so such a study would not be performed for this product.

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

This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.

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

As described in point 3, the "ground truth" for the non-clinical tests is established by adhering to standardized testing methodologies (e.g., ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility) and quantifiable analytical measurements for quality control parameters (pH, viscosity, etc.). There isn't a "ground truth" in the clinical sense of a diagnosis or outcome.

8. The sample size for the training set

This information is not applicable. This is a non-AI/non-diagnostic device; therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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R123770
pg. 1 of 2

APR 0 9 2013

SiO (K)Summary

Submitter:

Wisconsin Pharmacal Company, LLC N168 W22223 Main Street Jackson, WI 53037

Contact Person:

John Nyqaard inyqaard@pharmacalway.com (262) 677-7112

Date Submitted:

December 6, 2012

Proprietary Names:

Warming Jelly Personal Lubricant

Common Name:

Personal Lubricant

Classification Name:

21 CFR 884.5300 Lubricant, Personal, Vaginal Product Code: NUC Class: Review Panel: Obstetrics/Gynecology

Predicate Device:

Device Name: K-Y® Brand Warming Jelly Personal Lubricant 510(k) Number: K040164 Product Code: MMS and HIS

Intended Use:

Description of Device:

Warming Jelly Personal Lubricant is a clear, odorless, non-sterile, water-soluble jelly for use as a personal lubricant. The product imparts a mild warming sensation when applied to the qenitalia. Warming Jelly Personal Lubricant can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms as defined by ASTM D7661 - 10

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K123770
pg. 2 of 2

Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Warming Jelly Personal Lubricant is not a contraceptive or spermicide.

Technological Characteristics of the Device:

The Warming Jelly Personal Lubricant formula is proprietary and consists of watersoluble ingredients similar to the identified predicate device.

Warming Jelly Personal Lubricant is substantially equivalent to the identified previously cleared warming jelly personal lubricant predicate with respect to its design and materials, principles of operation, function, formulation, and intended use.

Summary of Non-Clinical Performance Testing:

Biocompatibility Testing: The following biocompatibility testing performed on Warming Jelly Personal Lubricant confirms it is safe for its proposed indication:

Cytotoxicity evaluation Direct Contact Method according to ISO 10993-5: 2009 .
. Maximization Test for Delayed Type Hypersensitivity test according to ISO 10993-10:2010
. Vaginal Irritation Test according to ISO 10993-10:2010
. Acute System Toxicity Test according to ISO 10993-11:2006

Condom Compatibility Testing: Condom compatibility testing as defined by ASTM D7661-10 Standard Test Method demonstrates that Warming Jelly Personal Lubricant is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Stability Testing: Currently available stability data confirms a shelf life of 12 months for Warming Jelly Personal Lubricant.

Quality Control Release Testing: Lot release testing of Warming Jelly Personal Lubricant includes evaluation of appearance/color, odor, viscosity, microbiological safety (standard plate count, absence of gram negative bacteria, absence of Pseudomonas, absence of Staphylococcus, yeast and mold count, absence of Candida albicans), pH, osmolality and water activity.

Conclusion: Based on the information presented in this 510(k) notification, Warming Jelly Personal Lubricant is safe and effective for OTC use for its proposed indications and is substantially equivalent in intended use, formulation, safety, and technological characteristics to the identified predicate device and other similar warming lubricants.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a person embracing another, composed of three wavy lines.

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

April 9, 2013

Wisconsin Pharmacal Company, LLC % Mr. John Nygaard Director, Quality and Regulatory 1 Pharmacal Way JACKSON WI 53037

Re: K123770

Trade/Device Name: Warming Jelly Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 5, 2013 Received: March 7, 2013

Dear Mr. Nygaard:

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. Ilsting 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.

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.

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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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

HerbertPLerner -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

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3.0 Indications for Use Statement

Indications for Use

510(k) Number (if known): K123770

Device Name: Warming Jelly Personal Lubricant

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Pöderner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K123770

Image /page/4/Picture/16 description: The image shows a logo for a company called "Pharmacal". The logo features the company name in a stylized font, with the word "Pharmacal" stacked on top of the word "personal care". The logo is surrounded by six circles, each with a small stem extending outward. The circles are arranged in a circular pattern around the company name.

Page 1 of 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.