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 and polyisoprene condoms. Not compatible with polyurethane condoms.

Device Description

Vaginal Moisturizing Gel is a non-sterile, water based, colorless, transparent viscous gel. It is identical to the predicate devices except that it is packaged for use in tube sizes of either 5 or 50 grams (0.18oz. /1.8 oz.). Tubes are comprised of a laminate structure. The larger 50 gram size will utilize a flip-top cap while the smaller 5 gram size will utilize a screw on cap.

This device 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 device 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)

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Vaginal Moisturizing Gel. This is a medical device submission, and the content focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a diagnostic or AI-powered device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training was established) are not applicable to this type of submission or the information provided.

However, I can extract the acceptance criteria and reported device performance from the "Physical/Chemical" and "Micro" sections, as these represent the specifications the device must meet.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "reported device performance" in the sense of a measured outcome from a study for each parameter. Instead, it lists the "Acceptance range" or "Acceptance criteria" for various characteristics, which the device is asserted to meet. The accompanying statements about "Conclusion" and "Performance Testing" imply that the device does meet these criteria.

Characteristic	Acceptance Criterion	Reported Device Performance (Assumed to meet criteria)
Physical/Chemical
Appearance	Clear translucent	Clear translucent
pH	4.0 - 5.0	4.0 - 5.0
Viscosity	55,000 - 100,000 cps	55,000 - 100,000 cps
Osmolality (mOsm/kg)	1273 ± 9	1273 ± 9
Micro
Total plate count	<100 cfu/g	<100 cfu/g
Yeast and mold	< 10 cfu/g	< 10 cfu/g
Pseudomonas aeruginosa	Negative	Negative
Staphylococcus aureus	Negative	Negative
Candida albicans	Negative	Negative
Performance
Coefficient of Friction	0.186	0.186
Shelf Life
50g tube shelf life	36 months	Meets specifications over 36 months
5g tube shelf life	18 months	Meets specifications over 18 months

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

This information is not provided in the document. The submission focuses on device characteristics and substantial equivalence, not a clinical trial or performance study with a distinct "test set" as typically understood for diagnostic devices. Performance is demonstrated through meeting specified physical, chemical, and microbiological parameters, and shelf-life testing.

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 to this type of device and submission. "Ground truth" established by experts is typically relevant for diagnostic devices (e.g., image interpretation), not for a personal lubricant where physicochemical properties and microbiological purity are key.

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

This information is not applicable to this type of device and submission. Adjudication methods are used in studies involving expert review of cases, which is not described here.

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. This is a personal lubricant, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.

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

This information is not applicable. This is a personal lubricant, not an algorithm, so standalone performance in that context is irrelevant.

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

For the physical/chemical and microbiological characteristics, the "ground truth" is established by standard laboratory testing methods to determine if the device meets its predefined specifications. For condom compatibility, "ground truth" would be established by testing the device's interaction with condom materials as per relevant standards (implied by the claim of compatibility). For shelf-life, "ground truth" is established through accelerated aging and real-time stability studies where the device's characteristics are measured over time. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these parameters.

8. The sample size for the training set

This information is not applicable. This is a personal lubricant; it does not involve a "training set" in the context of machine learning or AI development. The device's formulation and manufacturing process are developed, not "trained" on data.

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

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

Summary

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

July 21, 2017

Combe Incorporated Richard Grabarz, M.S., R. A. C. Sr. Manager Regulatory Affairs 1101 Westchester Avenue White Plains, NY 10604

Re: K171855

Trade/Device Name: Vaginal Moisturizing Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 19, 2017 Received: June 21, 2017

Dear Richard Grabarz:

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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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.

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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Indications for Use

510(k) Number (if known) K171855

Device Name Vaginal Moisturizing Gel

Indications for Use (Describe)

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)

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510(k) Summary

Submitter:	Combe Incorporated1101 Westchester AvenueWhite Plains, NY 10604Phone: 800-873-7400Electronic: www.combe.com/contact	Device & PredicateDevice(s):General DeviceCharacteristics	K171855	K150615	K141718
Official Correspondent:	Richard S. Grabarz, M.S., RACSr. Manager Regulatory AffairsEmail: rgrabarz@combe.comPhone: (914) 461-4467Fax: (914) 697-7717	Sponsor	Combe	Combe	Combe
Date Prepared:	July 20, 2017	Indication for Use	The device is apersonal lubricant,for penile and/orvaginal application,intended tomoisturize andlubricate, to enhancethe ease and comfortof intimate sexualactivity, andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexand polyisoprenecondoms. Notcompatible withpolyurethanecondoms.	The device is apersonal lubricant,for penile and/orvaginalapplication,intended tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity, andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubberlatex andpolyisoprenecondoms.	The device is apersonal lubricant,for penile and/orvaginalapplication,intended tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity, andsupplement thebody's naturallubrication. Thisproduct iscompatible withpolyisoprenecondoms only.
Device Proprietary Names:	Vaginal Moisturizing Gel	Formulation	Same (see DeviceDescription)	Identical	Identical
Device Common Name:	Personal Lubricant	Condom Compatibility	Natural rubber latexand polyisoprenecondoms	Natural rubberlatex andpolyisoprenecondoms	Polyisoprenecondoms only
Classification:	21 CFR 884.5300 (Condom)	Base Type	Water	Water	Water
Regulatory Class:	II	Packaging	Laminate tube	Single use pre-filled applicatorwith twist off cap	Laminate tubewith screw-onplastic syringe
Product Code:	NUC (lubricant, personal)	Amount of lubricant inpackage (g)	5 and 50	5.9	28
Predicate Device:	Internal Hydrating Gel (K141718) and VaginalMoisturizing Gel (K150615)

The predicate devices have not been subject to a design-related recall.

Device Description:

Appearance ●
Color
Odor
pH ●
Viscosity ●
Osmolality ●

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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)

Comparison of Indication for Use and Technological Characteristics:

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Applicator Length (mm)
Barrel	N/A	N/A	118.49 ± 1.02
Plunger	N/A	N/A	124.90 ± 1.01
Applicator Width/ Diameter (mm)
Barrel	N/A	N/A	11.18 ± 0.75
Plunger	N/A	N/A	14.22 ± 0.75
Tube Length(mm)
Tube	58.8/127.0	66.68 ± 1	104.775
Neck	3.86/5.89	63.00 ± 1	5.56
Tube Width (mm)
Tube	15.875/28.178	19.00 ± 0.2	22.225
Neck	3.937/6.350	14.00 ± 0.2	6.350
Neck base	N/A	6.42 ± 0.2	N/A
Package color	N/A	Aqua exterior	Natural
Material Syringe	N/A	N/A	LDPE
Tube Material
Tube	LDPE	LDPE	LDPE
Tube Body	Foil Laminate	Foil Laminate	Foil Laminate

Physical/Chemical	Acceptance range	Acceptance range	Acceptance range
Appearance	Clear translucent	Clear translucent	Clear translucent
pH	4.0 - 5.0	4.0 - 5.0	4.0 - 5.0
Viscosity	55,000 - 100,000	55,000 - 100,000	55,000 – 100,000
	cps	cps	cps
Osmolality (mOsm/kg)	1273 ± 9	1273 ± 9	1273 ± 9
Micro
Total plate count	<100 cfu/g	<100 cfu/g	<100 cfu/g
Yeast and mold	< 10 cfu/g	< 10 cfu/g	< 10 cfu/g
Pseudomonas aeruginosa	Negative	Negative	Negative
Staphylococcus aureus(coagulase positive)	Negative	Negative	Negative
Candida albicans	Negative	Negative	Negative
Performance: Coefficient ofFriction	0.186	0.186	0.186
Storage conditions	Room temp	Room temp	Room temp

The subject device indication for use statement is similar to the primary predicate device (K141718), except that the subject device claims to be compatible with natural rubber latex condoms.

The subject device differs from the K141718 predicate device in the following ways:

The subject device is provided in two sizes, a 5 & 50 gram laminate tube, while the 1. predicate device, Internal Hydrating Gel (K141718) is provided in a laminate tube (28 g) with a screw off cap of similar construction.
1. The subject device does not utilize any applicators/syringes. The previous predicate

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device Internal Hydrating Gel (K141718) included 8 applicators/syringes for internal application.

The different technological characteristics described above do not raise different types of safety and effectiveness questions, as they are commonly encountered in 510(k) reviews for personal lubricants. These differences in packaging can be addressed through shelf-life testing.

Performance Testing:

Shelf Life	Vaginal Moisturizing Gel has a shelf life of 36 months for thelarger, 50 gram tube and a shelf life of 18 months for the smaller,5 gram tube. The results of accelerated aging and real time studiesdemonstrate that the subject device in the new packaging meetsits specifications over the duration of the proposed shelf life.
Biocompatibility	Biocompatibility of the proposed device, External MoisturizingGel is identical to that of the predicate devices, Internal HydratingGel (K141718) and Vaginal Moisturizing Gel (K150615). Theformulation of the subject device remains unchanged from that ofthe predicate devices.
Performance TestingNon-Clinical	Performance of the proposed device is identical to the predicatedevices, Internal Hydrating Gel (K141718) and VaginalMoisturizing Gel (K150615).

Conclusion:

The proposed device, Vaginal Moisturizing Gel, is substantially equivalent to the predicate devices.

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.