Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.

Therapeutic

No.
The device is a personal lubricant intended to moisturize and lubricate for enhancing ease and comfort of intimate sexual activity, which is not considered a therapeutic function.

Diagnostic

No

The device is a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity; it does not diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "non-sterile, water based, colorless, transparent viscous gel" and describes its physical properties and packaging, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
Device Description: The description details a gel for external/internal application, focusing on physical properties like viscosity, pH, and compatibility with condoms. It does not mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition.
Regulatory Classification (Implied): The mention of "Over-The-Counter Use (21 CFR 801 Subpart C)" suggests a classification related to general wellness or personal care products, not IVDs which fall under different regulatory categories.

In summary, the device's purpose and description align with a personal lubricant, not a diagnostic tool that analyzes samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NUC

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penile and/or vaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Shelf Life: Vaginal Moisturizing Gel has a shelf life of 36 months for the larger, 50 gram tube and a shelf life of 18 months for the smaller, 5 gram tube. The results of accelerated aging and real time studies demonstrate that the subject device in the new packaging meets its specifications over the duration of the proposed shelf life.
Biocompatibility: Biocompatibility of the proposed device, External Moisturizing Gel is identical to that of the predicate devices, Internal Hydrating Gel (K141718) and Vaginal Moisturizing Gel (K150615). The formulation of the subject device remains unchanged from that of the predicate devices.
Performance Testing Non-Clinical: Performance of the proposed device is identical to the predicate devices, Internal Hydrating Gel (K141718) and Vaginal Moisturizing Gel (K150615).

Key Metrics

Not Found

Predicate Device(s)

K141718, K150615

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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)

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.

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 Incorporated
1101 Westchester Avenue
White Plains, NY 10604
Phone: 800-873-7400
Electronic: www.combe.com/contact | Device & Predicate
Device(s):
General Device
Characteristics | K171855 | K150615 | K141718 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Richard S. Grabarz, M.S., RAC
Sr. Manager Regulatory Affairs
Email: rgrabarz@combe.com
Phone: (914) 461-4467
Fax: (914) 697-7717 | Sponsor | Combe | Combe | Combe |
| Date Prepared: | July 20, 2017 | Indication for Use | 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. Not
compatible with
polyurethane
condoms. | 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. | 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
polyisoprene
condoms only. |
| Device Proprietary Names: | Vaginal Moisturizing Gel | Formulation | Same (see Device
Description) | Identical | Identical |
| Device Common Name: | Personal Lubricant | Condom Compatibility | Natural rubber latex
and polyisoprene
condoms | Natural rubber
latex and
polyisoprene
condoms | Polyisoprene
condoms only |
| Classification: | 21 CFR 884.5300 (Condom) | Base Type | Water | Water | Water |
| Regulatory Class: | II | Packaging | Laminate tube | Single use pre-
filled applicator
with twist off cap | Laminate tube
with screw-on
plastic syringe |
| Product Code: | NUC (lubricant, personal) | Amount of lubricant in
package (g) | 5 and 50 | 5.9 | 28 |
| Predicate Device: | Internal Hydrating Gel (K141718) and Vaginal
Moisturizing Gel (K150615) | | | | |

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

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 ●

4

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:

5

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