REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035

K101098 · Lil Drug Store Products, Inc. · NUC · Aug 17, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K101098
• Device Name: REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
• Applicant: Lil Drug Store Products, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Replens is a personal lubricant for 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 condoms and synthetic (polyurethane and polyisoprene) condoms.

Device Story

Replens is a non-sterile, water-based, white to off-white vaginal gel. It is supplied in a 35g tube with a reusable applicator to facilitate application and reduce mess. The device is intended for ongoing use as a long-lasting moisturizer for vaginal dryness, not exclusively for intimate sexual activity. It functions by providing moisture and lubrication to the vaginal mucosa. The device is for over-the-counter use. It is compatible with natural rubber latex and synthetic (polyurethane and polyisoprene) condoms. The gel is formulated with ingredients generally recognized as safe (GRAS) or meeting USP/NF standards.

Clinical Evidence

Evidence includes multiple clinical studies (1991-1994) involving 25-89 patients per study, evaluating vaginal pH, vaginal mucosa, symptom relief, and dryness index. Studies utilized various regimens (daily or 3x weekly). Results consistently indicated the product is safe and well-tolerated. Additional bench testing includes biocompatibility (cytotoxicity, irritation, systemic toxicity, hypersensitivity), USP <51> antimicrobial effectiveness, and condom compatibility.

Technological Characteristics

Water-based vaginal gel; non-sterile; non-irritating, non-greasy, non-staining. Ingredients meet USP/NF standards or are GRAS. Delivered via tube with reusable applicator. Shelf life of 3 years. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Indications for Use

Indicated for individuals requiring vaginal moisturization and lubrication to supplement natural lubrication and enhance comfort during intimate sexual activity. Compatible with natural rubber latex, polyurethane, and polyisoprene 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

• CVS Personal Lubricant & Moisturizer (K062682)

Submission Summary (Full Text)

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## K101098

# Replens Vaginal Moisturizer (35g Tube)

Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 1 of 4

# 510(k) Summary

#### Submitter:

AUG 1 7 2010

Lil' Drug Store Products, Inc. 1201 Continental Place NE Cedar Rapids, IA 52402

#### Contact Person:

Tricia Miller Director of Regulatory Telephone: [phone] Facsimile: 319-393-3494 Email: [e-mail]

#### Date:

August 13, 2010

#### Proprietary Name:

Replens Long-Lasting Vaginal Moisturizer (in 35g Tube with Reusable Applicator)

#### Common name:

Personal Lubricant

#### Classification name:

21 C.F.R. 884.5300 Lubricant, Patient, Vaginal, Latex Compatible Product Code: NUC Class: 2 Obstetrics/Gynecology Review Panel:

#### Predicate Devices:

CVS Personal Lubricant & Moisturizer Device Name: 510(k) Number: K062682 Product Code: NUC, MMS

#### Intended Use:

Replens is a personal lubricant for 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

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Idnr; 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 2 of 4

with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.

#### Description of Device

Replens Vaqinal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in a tube with a reusable applicator as a long-lasting moisturizer for vaginal dryness. The use of the reusable applicator provides less mess in application. Replens Vaginal Moisturizer is intended for ongoing use, not exclusively for use during intimate sexual activity.

Replens Vaginal Moisturizer contains ingredients commonly used in other products for vaginal use sold as medical devices and cosmetics. All ingredients are either NF, USP, or are considered "generally recognized as safe for their intended use". The quantitative formulation is considered confidential commercial information.

#### Technological Characteristics of the Device

Replens Vaginal Moisturizer is substantially equivalent to the identified previously cleared vaqinal lubricant predicate with respect to its design and materials, principle of operation, function, formulation, and intended use. It is also substantially equivalent to other water-based vaginal lubricants and personal lubricants being commercially marketed in the U.S.

#### Summary of Performance Data

Biocompatibility Testing: The following biocompatibility testing has been performed on Replens Long-Lasting Vaginal Moisturizer:

- Cytotoxicity .
- Acute Vaqinal Irritation .
- Subacute Vaqinal Irritation .
- Subacute Vaginal Irritation with Histological Examination .
- Acute Systemic Toxicity .
- Hypersensitivity .
- Acute Oral Toxicity .
- Acute Dermal Toxicity .
- Dermal Irritation .
- Eye Irritation. .

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Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 3 of 4

Clinical Studies: The following clinical studies have been performed on Replens Long-Lasting Vaginal Moisturizer:

- Bachmann GA, Notelovitz M, Gonzalez SJ, Thompson C, Morecraft BA. . (1991) Vaginal Dryness in Menopausal Women: Clinical Characteristics and Nonhormonal Treatment. Clinical Practice in Sexuality, 7(9): 1-8.
- Bachmann GA, Notelovitz M, Kelly SJ, Owens A, Thompson C. (1992) ● Long Term Nonhormonal Treatment of Vaginal Dryness. Clinical Practice in Sexuality, 8(8/9): 3-8.
- Zinny MA, Lee S. (1991) Double-Blind Study of the Comparative . Effects of Two Gels on Vaginal pH in Postmenopausal Women. Today's Therapeutic Trends, 8(4): 65-72.
- Young R, Goldzieher J, Kaufman R. (1991) A Study of the Effects of . Col-1003 In Postmenopausal Women. Unpublished.
- Nakamura R. (1991) Evaluation of Col-1003 in the treatment of . vaginal dryness in postmenopausal women. Unpublished.
- Whitehead M. (1991) A Randomised Double Blind Evaluation of Col-. 1003, a bioadhesive polymer system vaginal moisturizing gel and, KY
- Brand Lubricating Jelly in the treatment of vaginal dryness in postmenopausal women receiving concomitant oral hormone replacement therapy. Unpublished
- Nachtigall LE. (1994) Comparative study: Replens versus local . estrogen in menopausal women. Fertility and Sterility, 61(1): 178-180.
- Gelfand MM, Wendman E. (1994) Treating Vaginal Dryness in Breast . Cancer Patients: Results of Applying a Polycarbophil Moisturizing Gel. ]. Women's Health, 3(6): 427-433.

The format of the studies listed above is summarized in the table below:

| Citation | No.<br>Patients<br>Enrolled<br>(Replens) | Study<br>Design* | Dosage Regimen | Duration |
|----------------|------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------|-----------|
| Bachmann et al | 89 | D-B, X-over | 2.5 g per day | 5 days |
| Bachmann et al | 54 | Open | 2.5 g, 3 x weekly | 12 months |
| Zinny and Lee | 26 | D-B, parallel | 2.5 g alternate nights | 4 weeks |
| Young et al | 30 | Open | 2.5 g, 3 x weekly, plus<br>option of additional<br>application prior to<br>intercourse. | 12 months |
| Nakamura | 10 | Open, X-over<br>between<br>treatment<br>durations | 2.5 g daily | 1-5 days |

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Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 4 of 4

| Citation | No.<br>Patients<br>Enrolled<br>(Replens) | Study<br>Design* | Dosage Regimen | Duration |
|------------------------|------------------------------------------|------------------|-----------------------------------------------------------------------------------------|----------|
| Whitehead | 32 | D-B, X-over | 2.5 g, 3 x weekly plus<br>option of additional<br>application prior to<br>intercourse. | 8 weeks |
| Nachtigall | 15 | Open, parallel | 2.5 g, 3 x weekly | 3 months |
| Gelfand and<br>Wendman | 25 | Open | 2.5 g, 3 x weekly, plus<br>option of additional<br>application prior to<br>intercourse. | 3 months |

* D-B = double-blind; X-over = cross-over design

The parameters employed in the studies included the influence of Replens on vaginal pH and the vaginal mucosa, the relief of the patient's symptoms, the vaginal dryness index, determination of vaginal pH at varying time intervals after single or multiple applications of the gel, PAP smears and the completion of diary cards by the patient. All of the studies concluded that Replens was safe and well-tolerated.

Stability Data: Real-time stability data confirms a shelf life of three (3) vears for Replens Long-Lasting Vaqinal Moisturizer.

Preservative Effectiveness: Replens Long-Lasting Vaginal Moisturizer has successfully passed the requirements of the USP <51> Antimicrobial Effectiveness Test.

Condom Compatibility Testing: Condom compatibility testing confirms that Replens Long-Lasting Vaginal Moisturizer does not materially affect the strength or integrity of natural rubber latex or synthetic condoms (polyurethane and polyisoprene).

#### Conclusion

Based on the information presented in the 510(k) notice, it is concluded that Replens Long-Lasting Vaginal Moisturizer (in 35g Tube with Reusable Applicator) for OTC use is safe and effective for its proposed indications and is substantially equivalent in intended use, formulation, safety, and technological characteristics to the identified predicate device and other similar water-based personal lubricants.

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

Lil Drug Store Products, Inc. c/o Mr. Mark A. Job Responsible Third Party Regulatory Technology Services, Inc. 1394 25th Street, NW BUFFALO MN 55313

AUG 1 7 2010

·Re: K101098

Trade/Device Name: Replens Long-Lasting Vaginal Moisturizer (in 35 Tube with Reusable Applicator) Regulation Number: 21 CFR §884.5300 Regulation Name: Condom

Regulatory Class: II Product Code: NUC

Dated: July 30, 2010 Received: August 2, 2010

Dear Mr. Job:

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 of medical device-related

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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,

Duker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Idnr: 1.0 Indications Statement Version: 2.1 Date: May 12, 2010 Page 1 of 1

### STATEMENT OF INDICATIONS FOR USE

K101098 510(k) Number:

Device Name: Replens Long-Lasting Vaginal Moisturizer (in 35g Tube with Reusable Applicator)

- Indications for Use: Replens is a personal lubricant for 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 condoms and synthetic (polyurethane and polyisoprene) condoms.
Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shus L. Nolan.

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number