ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER

K112217 · Polichem S.A · NUC · Oct 16, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112217
• Device Name: ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
• Applicant: Polichem S.A
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Oct 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

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

Device Story

Non-sterile, water-based personal lubricant; delivered in single-use, pre-filled vaginal applicators. Used daily to supplement natural lubrication; enhances comfort during intimate sexual activity. Applied by user; OTC availability. Formulation contains ingredients common to cleared personal lubricants. Not compatible with latex, polyisoprene, or polyurethane condoms.

Clinical Evidence

No clinical data. Bench testing included biocompatibility (cytotoxicity per EN ISO 10993-5, delayed hypersensitivity per ISO 10993-10:2010, acute vaginal irritation, acute systemic toxicity) and condom compatibility testing per ASTM D7661-10.

Technological Characteristics

Water-based, non-greasy, non-sterile personal lubricant. Delivered via single-use, pre-filled vaginal applicators. Shelf life of 24 months. Biocompatibility testing performed per ISO 10993 standards. Condom compatibility tested per ASTM D7661-10.

Indications for Use

Indicated for individuals requiring vaginal or penile lubrication to enhance comfort during intimate sexual activity and to supplement natural body lubrication. Not compatible with natural rubber latex, polyisoprene, or 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

• Replens Long-Lasting Vaginal Moisturizer (K101241)
• CVS Personal Lubricant & Moisturizer (K062682)

Submission Summary (Full Text)

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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 [e-mail] [phone]

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

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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:

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.

#### 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.

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## 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

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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 [phone] or [phone] 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

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K112217 Indications for Use Form

# Indications for Use

## 510(k) Number: K112217

Device Name: Me Again® Long Lasting Vaginal Moisturizer

Indications for Use:

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.

| 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

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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:

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.

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