(164 days)
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a vaginal moisturizer, with no mention of AI or ML technologies.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to treat or cure a medical condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is a personal lubricant intended to moisturize and lubricate for comfort and to supplement natural lubrication. It does not mention any diagnostic purpose.
No
The device description clearly states it is a vaginal gel packaged with a reusable applicator, indicating it is a physical product and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a personal lubricant for vaginal application to moisturize and lubricate for comfort during intimate sexual activity and to supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details a gel and applicator for physical application, not for testing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a person's health status, disease, or condition.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant.
The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.
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
Over-The-Counter Use
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
Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009. The results demonstrated that Replens Long-Lasting Moisturizer is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life: The subject device has a shelf-life of 22-months. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf-life.
Condom Compatibility: Replens Long-Lasting Vaginal Moisturizer was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. It was determined not to be compatible with polyurethane condoms.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below the previous line.
August 2, 2021
Church & Dwight Co., Inc. Supreet Sahota-Bhatti Sr. Manager, Regulatory Affairs 500 Charles Ewing Boulevard Ewing, NJ 08628
Re: K203818
Trade/Device Name: Replens Long-Lasting Vaginal Moisturizer Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 11, 2021
Dear Supreet Sahota-Bhatti:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 11, 2021. Specifically, FDA is updating this SE Letter (typo in the device specifications in the 510(k) summary) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica Garcia, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-2791, monica.garcia(@fda.hhs.gov.
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
June 11, 2021
Church & Dwight Co., Inc. Supreet Sahota-Bhatti Senior Manager, Regulatory Affairs 500 Charles Ewing Boulevard Ewing, NJ 08628
Re: K203818
Trade/Device Name: Replens Long-Lasting Vaginal Moisturizer Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 11, 2021 Received: May 12, 2021
Dear Supreet Sahota-Bhatti:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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.
2
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203818
Device Name Replens Long-Lasting Vaginal Moisturizer
Indications for Use (Describe)
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
| Research Use Only | |
|---|---|
| IVD |
| | 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 - K203818
1. Submitter Information
| Applicant: | Church & Dwight Co., Inc. |
|---|---|
| Address: | 500 Charles Ewing Boulevard Ewing, NJ 08628 |
2. Correspondent Information
| Contact: | Supreet Sahota-Bhatti
Sr. Manager, Regulatory Affairs |
|----------|----------------------------------------------------------|
| Address: | 469 North Harrison Street
Princeton, NJ 08543 |
| Phone: | (609) 806-7893 |
| Email: | supreet.sahota-bhatti@churchdwight.com |
3. Date prepared: June 9, 2021
4. Device Information
| Device Name: | Replens Long-Lasting Vaginal Moisturizer |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Replens Long-Lasting Vaginal Moisturizer |
|---|---|
| 510(k) Number: | K101098 |
| Manufacturer: | Church & Dwight Co., Inc. |
| Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
6. Device Description
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant.
The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.
Table 1: Device Specifications for Replens Long Lasting Vaginal Moisturizer
5
| Property | Specification |
|---|---|
| Appearance | White to off-white smooth homogenous gel |
| Odor | Odorless |
| Viscosity | 30,000 - 130,000 cPs |
| pH | 2.5 - 3.5 |
| Osmolality | 1200 - 2000 mOsm/Kg |
| Total Aerobic Microbial Count (TAMC per | |
| USP and ) | and ) |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Candida albicans | Absent/g |
| Escherichia coli | Absent/g |
| Salmonella sp. | Absent/g |
| Antimicrobial Effectiveness Testing per USP |
| Specification |
| Escherichia coli, Pseudomonas aeruginosa,
Staphylococcus aureus | Not less than 2.0 log reduction from the initial
count at 14 days, and no increase from the 14
day count at 28 days. |
| Candida albicans, Aspergillus brasiliensis | No increase from initial calculated count at 14
and 28 days |
7. Indications for Use
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject and Predicate Devices
| | Replens Long-Lasting
Vaginal Moisturizer
K203818
Subject Device | Replens Long-Lasting
Vaginal Moisturizer
K101098
Predicate Device | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal | Lubricant, Personal | Same |
| Product Code | NUC | NUC | Same |
| Indications for Use | Replens Long-Lasting Vaginal
Moisturizer is a personal lubricant
for vaginal application, intended to
moisturize and lubricate, to
enhance the ease and comfort of
intimate sexual activity and to | Replens Long-Lasting Vaginal
Moisturizer is a personal
lubricant for vaginal
application, intended to
moisturize and lubricate, to
enhance the ease and comfort | Same: The indications have
a minor difference in
wording; however, the
intended uses of both devices
are the same |
| | | | |
| | supplement the body's natural
lubrication. | of intimate sexual activity and
to supplement the body's
natural lubrication. | |
| | This product is compatible with
natural rubber latex and | This product is compatible
with natural rubber latex and | |
| | polyisoprene condoms. This | synthetic (polyurethane and | |
| | product is not compatible with | polyisoprene) condoms. | |
| | polyurethane condoms. | | |
| Form | White to off-white smooth
homogenous gel | White to off-white smooth
homogenous gel | Same |
| Water soluble | Yes | Yes | Same |
| Water-Based | Yes | Yes | Same |
| Primary ingredients | Water, Glycerin, Mineral Oil,
Polycarbophil, Carbomer
Homopolymer Type B,
Hydrogenated Palm Oil Glyceride,
Sorbic Acid, Benzyl Alcohol,
Ethylhexylglycerin, tocopherol,
and Sodium Hydroxide | Water, Glycerin, Mineral Oil,
Polycarbophil, Carbomer
Homopolymer Type B,
Hydrogenated Palm Oil
Glyceride, Sorbic Acid,
Methylparaben, Sodium
Hydroxide | Different: The formulation
of the subject device is
slightly different than the
predicate device.
Differences in personal
lubricant formulation do not
raise different questions of
safety and effectiveness
(S&E). |
| Over the counter use | Yes | Yes | Same |
| Sterile | No | No | Same |
| pH | 2.5 - 3.5 | 2.5 - 3.5 | Same |
| Osmolality | 1200 - 2000 mOsm/Kg | N/A | Different: The osmolality o
the predicate device is not
currently tested for release.
Differences in personal
lubricant osmolality do not
raise different questions of
S&E. |
| Condom Compatibility | Compatible with natural rubber
latex and polyisoprene | Compatible with natural
rubber latex, polyisoprene,
and polyurethane | Different: The subject
device is not compatible wit
polyurethane condoms.
Differences in personal
lubricant compatibility do
not raise different questions
of S&E. |
| Biocompatibility Tested | Yes | Yes | Same |
| Antimicrobial
Effectiveness Tested | Yes | Yes | Same |
| Microbial Limits | Total mold/yeast count