The device 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 compatible with natural rubber latex and polyisoprene condoms.

Device Description

Vaginal Moisturizing Gel is identical to the predicate device except that it is presented in 8 pre-filled applicators for easy use.

Vaginal Moisturizing Gel is intended for use as a personal lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the product specification:
• Appearance
• Color
• Odor
• pH
• Viscosity
• Osmolality
• Antimicrobial effectiveness
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans)

Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18

AI/ML Overview

This document describes the FDA's decision to clear the "Vaginal Moisturizing Gel" for marketing and provides a summary of the device's characteristics and supporting data. However, it does not include detailed acceptance criteria or a study proving the device meets them in the format requested. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria.

Therefore, I cannot populate the table and answer the questions directly as the information is not present within the provided text.

Based on the document, I can extract the following relevant information regarding the device:

Device Name: Vaginal Moisturizing Gel
Intended Use: 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. Compatible with natural rubber latex and polyisoprene condoms.
Predicate Device: Internal Hydrating Gel (K141718)
Key claim for substantial equivalence: Identical to the predicate device except for packaging (8 pre-filled applicators) and has identical technological characteristics.

Here's an analysis of what is provided and why it doesn't fit the request:

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

Not Available: The document lists "product specifications" (Appearance, Color, Odor, pH, Viscosity, Osmolality, Antimicrobial effectiveness, TAMC, TYMC, Absence of Pathogenic Organisms) for the device and states it has a pH of 4.5-5.0. However, it does not provide any specific acceptance criteria (e.g., minimum/maximum values, thresholds, statistical targets) for these parameters, nor does it report the actual performance values obtained from testing against these criteria.

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

Not Available: The document mentions "non-clinical testing" for condom compatibility and biocompatibility studies. However, it does not provide any sample sizes for these tests or the provenance of the data.

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)

Not Applicable/Not Available: This type of information (expert consensus, ground truth establishment) is typically relevant for diagnostic devices or AI-driven systems where human interpretation is involved. For a personal lubricant, ground truth generally refers to objective physical, chemical, and biological properties, often established through standardized laboratory methods rather than expert consensus on interpretation. The document does not mention any experts involved in establishing ground truth for the performance tests.

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

Not Applicable/Not Available: Adjudication methods are typically used in clinical trials or studies where multiple readers/evaluators assess data and disagreements need to be resolved. This is not reported for the non-clinical tests summarized.

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 personal lubricant, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

Not Applicable: As stated above, this is not an AI-driven device.

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

Objective Laboratory Measurements: The "ground truth" for this device would be established through objective laboratory measurements for parameters like pH, viscosity, osmolality, microbial counts, and chemical analysis of extractables/leachables, as well as standardized physical testing for condom compatibility (ASTM D7661-10). These are not explicitly categorized as "ground truth" in the document but represent the objective standards against which the device was tested.

8. The sample size for the training set

Not Applicable: This device is not an AI/ML device that requires a training set.

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

Not Applicable: As above, no training set is involved.

Summary of available information related to performance/testing:

The document states:

Biocompatibility Data: A study of extractable and leachable materials from the new applicator was conducted according to USP <661>. Extracts were analyzed using infrared analysis, GC-MS, and ICP-MS. Risk analysis showed that ethanol extractable materials were in amounts much lower than the tolerable intake of any component.
Performance Testing - Non-Clinical: The device was tested for condom compatibility according to ASTM D7661-10 and found to be compatible with natural rubber latex and polyisoprene condoms.
Product Specifications: pH of 4.5-5.0 and a shelf life of 18 months.

In conclusion, while the document confirms certain tests were performed and their outcomes (e.g., compatible with condoms, extractables below tolerable limits), it does not provide the detailed "acceptance criteria" and "reported device performance" in a quantitative table format that your request envisions, nor does it contain the specific sample sizes, expert involvement, or AI-related study details. The FDA's clearance is based on the device being "substantially equivalent" to an existing predicate rather than meeting a set of novel, explicitly defined performance acceptance criteria in this document.

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 1, 2015

Combe Incorporated Pushpa Rao, Ph.D., D.A.B.T., R.A.C. Sr. Director Global Regulatory Affairs/Product Safety 1101 Westchester Avenue White Plains, NY 10604

Re: K150615

Trade/Device Name: Vaginal Moisturizing Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 9, 2015 Received: March 10, 2015

Dear Pushpa Rao,

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.

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Page 2 - Pushpa Rao, Ph.D., D.A.B.T., R.A.C.

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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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 vours.

Joyce M. Whang -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150615

Device Name Vaginal Moisturizing Gel

Indications for Use (Describe)

The device is a personal lubricant, for penial 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 compatible with natural rubber latex and polyisoprene condoms.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Owner:	Combe Incorporated1101 Westchester AvenueWhite Plains, NY 10604
Contact Person	Pushpa Rao, Ph.D., D.A.B.T., R.A.C.Sr. Director Global Regulatory Affairs/Product SafetyEmail: prao@combe.comPhone: (914) 461-4458Fax: (914) 697-7764
Name of Device	Trade name – Vaginal Moisturizing Gel Classificationname - Personal lubricant Citation: 21 CFR 884.5300Product Code: NUC Class: II
Predicate Device	Internal Hydrating Gel (K141718)
Device Description	Vaginal Moisturizing Gel is identical to the predicate device exceptthat it is presented in 8 pre-filled applicators for easy use.Vaginal Moisturizing Gel is intended for use as a personal lubricant.This product is compatible with natural rubber latex and polyisoprenecondoms. This device is not compatible with polyurethane condoms.The following parameters are included as part of the productspecification:• Appearance• Color• Odor• pH• Viscosity• Osmolality• Antimicrobial effectiveness• Total Aerobic Microbial Count (TAMC)• Total Yeast and Mold Count (TYMC)• Absence of Pathogenic Organisms (at minimum Pseudomonasaeruginosa, Staphylococcus aureus, and Candida albicans)Vaginal Moisturizing Gel has a pH of 4.5-5.0 and a shelf life of 18
Indications forUse	The device is a personal lubricant, for penile and/or vaginal application,intended to moisturize and lubricate, to enhance the ease and comfort ofintimate sexual activity, and supplement the body's natural lubrication.This product is compatible with natural rubber latex and polyisoprenecondoms.
TechnologicalCharacteristics	The proposed device, Vaginal Moisturizing Gel has the identicaltechnological characteristics as the predicate device.
BiocompatibilityData	Biocompatibility of the new applicator was supported with a study ofextractable and leachable materials from the applicator. The newapplicator was subjected to extractable testing according to USP <661>:Physicochemical Tests for Plastics. Extracts were also analyzed usinginfrared analysis, gas chromatography coupled with mass spectrometry(GC-MS), and inductively coupled plasma mass spectroscopy. Extractedmolecules were only detected after aggressive extraction with ethanol asdetermined by GC-MS. Risk analysis showed that ethanol extractablematerials were in amounts much lower than the tolerable intake of anycomponent.
Performance Testing-Non- Clinical	The proposed device was tested for condom compatibility according toASTM D7661-10 and found to be compatible with natural rubber latexand polyisoprene condoms.
Conclusions	Based on the results of non-clinical testing, the proposed device,Vaginal Moisturizing Gel, is substantially equivalent to the predicatedevice.

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510(k) Summary

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.