Gynomunal

K143349 · Polichem S.A · NUC · Sep 16, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143349
• Device Name: Gynomunal
• Applicant: Polichem S.A
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Gynomunal 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 with polyisoprene condoms, but not with polyurethane condoms.

Device Story

Gynomunal is a water-based personal lubricant gel; applied topically to penis or vagina to moisturize and supplement natural lubrication; enhances comfort during sexual activity. Used by consumers in home settings. Product is non-sterile; compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Benefits include improved comfort during sexual intercourse.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (vaginal irritation and sensitization), and ISO 10993-11 (acute systemic toxicity). Condom compatibility testing performed per ASTM D7661-10. Shelf-life stability confirmed through real-time and accelerated testing.

Technological Characteristics

Water-based, ivory to yellow personal lubricant gel. pH 5.5-6.5; viscosity 45,000-65,000 mPa*s; osmolality 2,000-3,000 mOsmol/Kg. Antimicrobial effectiveness per USP <51>; microbiological quality per USP <61>, <62>, <1111>. Non-sterile. 36-month shelf life.

Indications for Use

Indicated for individuals requiring personal lubrication to moisturize and supplement natural lubrication during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Me Again Long Lasting Vaginal Moisturizer (K112217)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a stylized eagle or bird-like figure, composed of three overlapping profiles facing to the right. The seal is black and white.

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

September 16, 2015

Polichem S.A. % Barry E Sands President ROMIS. Inc. 29 Water Street, Suite 305 Newburyport, MA 01950

Re: K143349

Trade/Device Name: Gynomunal Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: August 18, 2015 Received: August 21, 2015

Dear Barry Sands,

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 device

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

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -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

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

# Indications for Use

510(k) Number (if known) K143349

Device Name

Gynomunal Vaginal Gel

#### Indications for Use (Describe)

Gynomunal 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 with polyisoprene condoms, but not with polyurethane condoms.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

#### 510(k) SUMMARY

#### Polichem, S.A. 's Gynomunal

| Sponsor: | |
|----------------------|------------------------------------------------------------------------------|
| Manufacturer: | Polichem, S.A.<br>Via<br>Senago 42D<br>6912 – Lugano-Pazzallo<br>Switzerland |
| Official Contact: | Barry E. Sands |
| Phone: | 978-358-7307 |
| Fax: | 978-378-7384 |
| Date Prepared: | September 8, 2015 |
| Device Name: | Gynomunal |
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR 884.5300) |
| Product Code: | NUC |

#### Indications for Use

Predicate Device:

Gynomunal 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 with polyisoprene condoms, but not with polyurethane condoms.

Me Again Long Lasting Vaginal Moisturizer (K112217)

#### Technological Characteristics

Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months.

Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP <51>), and microbiological quality (Compliance with USP <61>, <62>, and <1111>).

| Color | Homogeneous, Translucent Gel<br>(Ivory, to slight yellow) |
|-------|-----------------------------------------------------------|
|-------|-----------------------------------------------------------|

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

| Odor | Characteristic |
|-----------------------------------|-------------------------------------------|
| pH | 5.5-6.5 |
| Viscosity | 45,000-65,000 mPa*s |
| Osmolality | 2,000 -3,000 mOsmol/Kg |
| Antimicrobial<br>Effectiveness | Complies to USP <51> |
| Total Aerobic<br>Microbial Counts | <100 cfu/g |
| Total Yeast and Mold<br>counts | <10 cfu/g |
| Microbial Absence | P. aeruginosa<br>S. aureus<br>C. albicans |

#### Performance Data

Gynomunal was demonstrated to be biocompatible utilizing the following tests:

- ISO 10993-5:2009—Cytotoxicity
- ISO 10993-10:2010—Vaginal Irritation
- ISO 10993-10:2010—Guinea Pig Maximization Sensitization
- ISO 10993-11:2006—Acute Systemic Toxicity

Gynomunal was demonstrated to maintain its specifications throughout its 36 month shelf-life through real time and accelerated testing.

To substantiate the revised claim of condom compatibility Polichem SA commissioned an independent laboratory to conduct condom compatibility studies with Gynomunal according to ASTM D7661 – 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results were reviewed within the context and requirements of ISO 4074 - Natural Latex Rubber Condoms - Requirements And Test Methods. Laboratory testing concluded that Gynomunal is compatible with natural rubber latex and polyisoprene condoms.

### Substantial Equivalence

Gynomunal is as safe and effective as the Me Again Long Lasting Vaginal Moisturizer. Gynomunal has the same intended use and principle of operation, and similar indications and technological characteristics as the predicate device. The minor technological differences between the Gynomunal and the predicate device raise no new types of questions of safety or effectiveness. Performance data provided in this premarket notification demonstrate that the Gynomunal is as safe and effective as Me Again Long Lasting Vaginal Moisturizer, and that

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

Gynomunal is compatible with natural rubber latex and polyisoprene condoms. Thus, Gynomunal is substantially equivalent to the predicate.