(105 days)
Not Found
No
The document describes a vaginal moisturizer and lubricant and does not mention any AI or ML components. The performance studies are related to biocompatibility, clinical efficacy for moisturizing, and compatibility with condoms, not AI/ML performance metrics.
No.
The product is a personal lubricant/moisturizer for comfort and ease of sexual activity, not for treating or preventing disease.
No
Explanation: The device is described as a personal lubricant and moisturizer for vaginal application, intended to enhance comfort and supplement natural lubrication, not to diagnose any condition.
No
The device description clearly states it is a "non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in single-use, pre-filled applicators," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for moisturizing and lubricating the vagina to enhance comfort during sexual activity and supplement natural lubrication. This is a physical effect, not a diagnostic test performed on a sample from the body.
- Device Description: The device is a gel applied topically to the vaginal area. It does not involve analyzing a biological sample (like blood, urine, or tissue) to diagnose a condition or provide information about a physiological state.
- Performance Studies: The studies described focus on biocompatibility, clinical effectiveness in relieving dryness symptoms, impact on vaginal pH and mucosa, and compatibility with condoms. These are all related to the physical effects and safety of the product when applied topically. There are no studies related to analyzing biological samples for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Replens Vaginal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in single-use, pre-filled applicators as a long-lasting moisturizer for vaginal dryness. The use of prefilled applicators 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 proprietary and considered confidential commercial information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
- 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.
Clinical Studies:
- 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.
- No. Patients Enrolled (Replens): 89
- Study Design: D-B, X-over
- Dosage Regimen: 2.5 g per day
- Duration: 5 days
- 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.
- No. Patients Enrolled (Replens): 54
- Study Design: Open
- Dosage Regimen: 2.5 g, 3 x weekly
- Duration: 12 months
- 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.
- No. Patients Enrolled (Replens): 26
- Study Design: D-B, parallel
- Dosage Regimen: 2.5 g alternate nights
- Duration: 4 weeks
- Younq R, Goldzieher J, Kaufman R. (1991) A Study of the Effects of . Col-1003 In Postmenopausal Women. Unpublished.
- No. Patients Enrolled (Replens): 30
- Study Design: Open
- Dosage Regimen: 2.5 g, 3 x weekly, plus option of additional application prior to intercourse.
- Duration: 12 months
- Nakamura R. (1991) Evaluation of Col-1003 in the treatment of . vaginal dryness in postmenopausal women. Unpublished.
- No. Patients Enrolled (Replens): 10
- Study Design: Open, X-over between treatment durations
- Dosage Regimen: 2.5 g daily
- Duration: 1-5 days
- 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
- No. Patients Enrolled (Replens): 32
- Study Design: D-B, X-over
- Dosage Regimen: 2.5 g, 3 x weekly plus option of additional application prior to intercourse.
- Duration: 8 weeks
- Nachtigall LE. (1994) Comparative study: Replens versus local . estrogen in menopausal women. Fertility and Sterility, 61(1): 178-180.
- No. Patients Enrolled (Replens): 15
- Study Design: Open, parallel
- Dosage Regimen: 2.5 g, 3 x weekly
- Duration: 3 months
- Gelfand MM, Wendman E. (1994) Treating Vaginal Dryness in Breast . Cancer Patients: Results of Applying a Polycarbophil Moisturizing Gel. J. Women's Health, 3(6): 427-433.
- No. Patients Enrolled (Replens): 25
- Study Design: Open
- Dosage Regimen: 2.5 g, 3 x weekly, plus option of additional application prior to intercourse.
- Duration: 3 months
Key Results: 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: Stability data confirms a shelf life of one (1) year for Replens Long-Lasting Vaginal Moisturizer.
Preservative Effectiveness: Replens Long-Lasting Vaginal Moisturizer has successfully passed the requirements of the USP Antimicrobial Effectiveness Test.
Dosing Consistency Study: Dosing consistency studies confirm the prefilled applicator delivers the required amount of gel.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KIGIZHI
Replens Vaginal Moisturizer (Applicators)
Image /page/0/Picture/2 description: The image shows a logo for "Lil' Drug Store Products". The words "Lil'" are in a cursive font above the word "DRUG" which is in a bold, sans-serif font. Below that, the word "STORE" is in a smaller, sans-serif font. The word "PRODUCTS" is at the very bottom of the logo in a sans-serif font.
Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 1 of 4
510(k) Summary
AUG 1 7 2010
Submitter:
Lil' Drug Store Products, Inc. 1201 Continental Place NE Cedar Rapids, IA 52402
Contact Person:
Tricia Miller Director of Regulatory Telephone: 319-294-3745 Facsimile: 319-393-3494 Email: tmiller@lildrugstore.com
Date:
August 13, 2010
Proprietary Name:
Replens Long-Lasting Vaginal Moisturizer (in pre-filled applicators)
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 Device:
CVS Personal Lubricant & Moisturizer Device Name: 510(k) Number: K062682 NUC, MMS Product Code:
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
1
Image /page/1/Picture/1 description: The image shows a logo with the words "Lil' DRUG STORE PRODUCTS" stacked on top of each other. "Lil'" is in a cursive font, while "DRUG" and "STORE" are in a bold, sans-serif font. "PRODUCTS" is in a smaller, sans-serif font at the bottom. There are horizontal lines above and below the text.
Replens Vaginal Moisturizer (Applicators) 5
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 Vaginal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in single-use, pre-filled applicators as a long-lasting moisturizer for vaginal dryness. The use of prefilled applicators 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 proprietary and considered confidential commercial information.
Technological Characteristics of the Device
Replens Vaginal Moisturizer is substantially equivalent to the identified previously cleared vaginal 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 .
- . Eve Irritation.
2
Replens Vaginal Moisturizer (Applicators) 5
Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 4 of 4
| Citation | No.
Patients
Enrolled
(Replens) | Study
Design* | Dosage Regimen | Duration |
|------------------------|------------------------------------------|------------------|-----------------------------------------------------------------------------------------|----------|
| Whitehead | 32 | D-B, X-over | 2.5 g, 3 x weekly plus
option of additional
application prior to
intercourse. | 8 weeks |
| Nachtigall | 15 | Open, parallel | 2.5 g, 3 x weekly | 3 months |
| Gelfand and
Wendman | 25 | Open | 2.5 g, 3 x weekly, plus
option of additional
application prior to
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: Stability data confirms a shelf life of one (1) year for Replens Long-Lasting Vaginal Moisturizer.
Preservative Effectiveness: Replens Long-Lasting Vaginal Moisturizer has successfully passed the requirements of the USP Antimicrobial Effectiveness Test.
Dosing Consistency Study: Dosing consistency studies confirm the prefilled applicator delivers the required amount of gel.
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 pre-filled applicators) 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 waterbased personal lubricants.
3
Replens Vaginal Moisturizer (Applicators) 510k
Image /page/3/Picture/2 description: The image shows a logo for "Lil' Drug Store Products". The words "Lil'" are in a cursive font at the top of the logo. Below that, the word "DRUG" is in a bold, sans-serif font. The word "STORE" is below that, in a smaller, sans-serif font. The word "PRODUCTS" is at the bottom of the logo, in a smaller, sans-serif font.
Idnr: 2.0 510k Summary Version: 2.2 Date: August 13, 2010 Page 3 of 4
Page 414
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.
- Younq 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. J. Women's Health, 3(6): 427-433.
The format of the studies listed above is summarized in the table below:
| Citation | No.
Patients
Enrolled
(Replens) | Study
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
option of additional
application prior to
intercourse. | 12 months |
| Nakamura | 10 | Open, X-over
between
treatment
durations | 2.5 g daily | 1-5 days |
4
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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: K101241
· Trade/Device Name: Replens Long-Lasting Vaginal Moisturizer Gel (in pre-filled applicators)
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
5
Page 2
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Huker Lemur us
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
6
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Replens Vaginal Moisturizer (Applicators) 5
Idnr: 1.0 Indications Statement Version: 2.1 Date: May 25, 2010 Page 1 of 1
STATEMENT OF INDICATIONS FOR USE
510(k) Number: KIO1241
Device Name: Replens Long-Lasting Vaginal Moisturizer (in prefilled applicators)
- 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)
Shay L. Wa
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number