Me Again® Long Lasting Vaginal Moisturizer 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, and polyurethane condoms.

vH Essentials® Long Lasting Vaginal Moisturizer 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, and polyurethane condoms.

Device Description

Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Long Lasting Vaginal Moisturizer" (marketed as Me Again® and vH Essentials®). It describes the device, its intended use, and provides evidence of its substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study designed to demonstrate that the device meets specific performance acceptance criteria, as one would typically find for a complex diagnostic or therapeutic device.

Instead, the summary focuses on demonstrating substantial equivalence to previously cleared predicate devices for personal lubricants/vaginal moisturizers. This is a common pathway for Class II devices. The "performance data" presented is primarily related to safety (biocompatibility) and product integrity (stability) rather than a comparative effectiveness or diagnostic accuracy study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to the information provided.

I will address the questions to the extent possible given the content:

Acceptance Criteria and Device Performance for Polichem SA Long Lasting Vaginal Moisturizer

The primary objective of the studies described in the 510(k) summary is to demonstrate substantial equivalence to predicate devices by ensuring the new device meets safety and basic functional requirements consistent with its classification as a personal lubricant/vaginal moisturizer. There are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar metrics that would be present for a diagnostic or therapeutic device.

The performance data listed addresses biocompatibility, stability, and compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device and the 510(k) submission, "acceptance criteria" are implied by compliance with recognized standards and successful completion of tests. There are no quantitative "performance metrics" in the traditional sense for this type of device submission's "performance data."

Category	Implied Acceptance Criterion	Reported Device Performance
Biocompatibility	Device materials are non-cytotoxic, non-irritating, and non-sensitizing for vaginal application.	- Cytotoxic evaluation following EN ISO 10993-5 rule: Performed (implies acceptable results). - Delayed hypersensitivity test (GPMT) according to ISO 10993-10:2010: Performed (implies acceptable results). - Acute Vaginal Irritation hybrid test: Performed (implies acceptable results). - Acute Systemic Toxicity hybrid test: Performed (implies acceptable results).
Stability	Device maintains its properties for the claimed shelf life.	- Stability data confirms: A shelf life of 24 months.
Compatibility	Condom compatibility is tested and clearly labeled.	- Recent condom compatibility testing per ASTM D7661-10 demonstrates: Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (This results in a clear labeling instruction rather than a "failure" of the device itself).

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

The document does not specify the sample sizes used for the biocompatibility, stability, or compatibility tests. These types of tests typically follow recognized standards (e.g., ISO, ASTM), which specify sample sizes. The data provenance is not explicitly stated beyond indicating the performing entity ("Polichem SA") and the submission to the FDA. It is prospective testing for the specific device.

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. The studies performed are laboratory-based tests (biocompatibility, stability, ASTM compatibility), not clinical studies involving expert interpretation of patient data or images to establish a "ground truth." The "ground truth" for these tests is the objective outcome of the test itself (e.g., cytotoxicity present/absent, irritation present/absent, shelf life determined, material compatibility).

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

This question is not applicable, as these were laboratory tests, not studies requiring expert adjudication of clinical or imaging data.

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 question is not applicable. This device is a personal lubricant/vaginal moisturizer, not an AI-powered diagnostic or decision-support tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant to this submission.

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

This question is not applicable. The device is a physical product, not an algorithm or software. No standalone algorithm performance study was done.

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

As mentioned in #3, the "ground truth" for the tests described is the objective result of standardized laboratory testing according to established protocols (e.g., ISO, ASTM standards for biocompatibility and material testing). There is no "expert consensus," "pathology," or "outcomes data" in the context of device performance demonstration here, beyond the demonstration of safety and stability.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This question is not applicable, as there is no "training set" for this device.

Summary

{0}------------------------------------------------

Page 1/2

K112217 510(k) Summary

Polichem SA Long Lasting Vaginal Moisturizer

4.0 510(k) Summary

Submitter:

Wisconsin Pharmacal Company, LLC US Agent for Polichem SA 1 Pharmacal Way Jackson, WI 53037

Contact Person:

John Nygaard Quality Assurance Manager jnygaard@pharmacalway.com (262) 677-7112

Date Submitted:

Proprietary Names:

Me Again® Long Lasting Vaginal Moisturizer and vH Essentials® Long Lasting Vaginal Moisturizer

Common Name:

Personal Lubricant

Classification Name:

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

Predicate Devices:

Device Name: Replens Long-Lasting Vaginal Moisturizer 510(k) Number: K101241 Product Code: NUC

Device Name: CVS Personal Lubricant & Moisturizer 510(k) Number: K062682 Product Code: NUC, MMS

Intended Use:

Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of

OCT 16 2012

{1}------------------------------------------------

K112217 510(k) Summary

suitable where metal-to-metal contact and lubrication is required. This product is

intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Description of Device:

Technological Characteristics of the Device:

Long Lasting Vaginal Moisturizer is substantially equivalent to the identified previously cleared vaginal moisturizer predicates with respect to its design and materials, principles of operation, function, formulation, and intended use.

Summary of Performance Data:

Biocompatibility Testing: The following biocompatibility testing has been performed on Long Lasting Vaginal Moisturizer:

Cytotoxic evaluation following the EN ISO 10993-5 rule .
Delayed hypersensivity test Guinea-Pig Maximisation Test (GPMT) according . to ISO 10993-10:2010
Acute Vaginal Irritation hybrid test .
Acute Systemic Toxicity hybrid test ●

Stability Data: Stability data confirms a shelf life of 24 months for Long Lasting Vaginal Moisturizer.

Compatibility Testing: Recent condom compatibility testing conducted per ASTM D7661-10 demonstrates that Long Lasting Vaginal Moisturizer is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Conclusion: Long Lasting Vaginal Moisturizer is substantially equivalent to its proposed predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Polichem SA
% Mr. John Nygaard
Quality Assurance Manager
Wisconsin Pharmacal Company
1 Pharmacal Way
JACKSON WI 53037

OCT 16 2012

Re: K112217

Trade/Device Name: Me Again® Long Lasting Vaginal Moisturizer vH Essentials® Long Lasting Vaginal Moisturizer

Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 20, 2012 Received: September 24, 2012

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, 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 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

{3}------------------------------------------------

Page 2 -

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 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,

Benjamin K. Twitchell

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

{4}------------------------------------------------

K112217 Indications for Use Form

Indications for Use

510(k) Number: K112217

Device Name: Me Again® Long Lasting Vaginal Moisturizer

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

/Concurrence of CDRH, Office of Device Evaluation (ODE)

Hryu'h Khan

tive, Gastro-Renal, and

Page 1 of 1

{5}------------------------------------------------

K112217 Indications for Use Form

Polichem SA Long Lasting Vaqinal Moisturizer

Indications for Use

510(k) Number: K112217

Device Name: vH Essentials® Long Lasting Vaginal Moisturizer

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorga Th Khan

n Sian-Off Reproductive, Gastro-Renal, 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.