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.

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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the Replens Long-Lasting Vaginal Moisturizer. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) are not applicable to this type of regulatory submission. The goal here is to show that the new device is as safe and effective as the predicate device, primarily through non-clinical performance testing and comparison of technological characteristics.

However, I can extract information related to what is presented as "acceptance criteria" in the context of this submission, which are primarily product specifications and performance testing results.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents product specifications as the "acceptance criteria" for the device itself, rather than acceptance criteria for a diagnostic algorithm's performance. The "reported device performance" is essentially that the device meets these specifications.

Property	Acceptance Criteria (Specification)	Reported Device Performance (Implied by "demonstrated that the device can maintain its specifications")
Appearance	White to off-white smooth homogenous gel	Met
Odor	Odorless	Met
Viscosity	30,000 - 130,000 cPs	Met
pH	2.5 - 3.5	Met
Osmolality	1200 - 2000 mOsm/Kg	Met
Total Aerobic Microbial Count (TAMC)	<100 cfu/g	Met
Total Yeast and Mold Count (TYMC)	<10 cfu/g	Met
Pseudomonas aeruginosa	Absent/g	Met
Staphylococcus aureus	Absent/g	Met
Candida albicans	Absent/g	Met
Escherichia coli	Absent/g	Met
Salmonella sp.	Absent/g	Met
Antimicrobial Effectiveness (E. coli, P. aeruginosa, S. aureus)	Not less than 2.0 log reduction from initial count at 14 days, and no increase from 14-day count at 28 days.	Met
Antimicrobial Effectiveness (C. albicans, Aspergillus brasiliensis)	No increase from initial calculated count at 14 and 28 days.	Met
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic.	Met
Shelf-Life (duration)	22 months	Met (device maintains specifications over this duration)
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.	Met

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the traditional sense of a "test set" for an AI or diagnostic algorithm. The testing described is primarily laboratory-based (e.g., chemical properties, microbial testing, biocompatibility).
Data Provenance: Not explicitly stated regarding country of origin for the non-clinical tests. The tests themselves are laboratory tests following ISO and USP standards. All testing appears to be "prospective" in the sense that it was conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This submission is for a personal lubricant, not a diagnostic device requiring expert interpretation of images or other clinical data to establish ground truth. Ground truth for the reported properties (e.g., pH, viscosity, microbial counts) is established by analytical methods and laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in the type of laboratory testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/diagnostic device that would require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a personal lubricant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the "acceptance criteria" presented (device specifications) is derived from:

Analytical Chemistry and Physical Property Measurements: e.g., pH meters, viscometers, osmolality measurements.
Microbiological Testing: e.g., plate counts for microbial limits, specific assays for pathogen absence and antimicrobial effectiveness.
Biocompatibility Testing Standards: Following ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity).
Condom Compatibility Standards: Following ASTM D7661-10.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

In summary: The provided document is a 510(k) premarket notification for a medical device (a personal lubricant). Its purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance data (product specifications, biocompatibility, shelf-life, condom compatibility). It does not involve a clinical study with human subjects, diagnostic performance metrics, or AI algorithms, which are often associated with the detailed "acceptance criteria" and "study" descriptions requested in the prompt.

Summary

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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

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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.

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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

Enclosure

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Indications for Use

510(k) Number (if known) K203818

Device Name Replens Long-Lasting Vaginal Moisturizer

Indications for Use (Describe)

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-BhattiSr. Manager, Regulatory Affairs
Address:	469 North Harrison StreetPrinceton, 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

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

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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 perUSP <61> and <1111>)	<100 cfu/g
Total Yeast and Mold Count (TYMC per USP<61> and <1111>)	<10 cfu/g
Absence of Pathogens per USP <62>	Specification
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<51>	Specification
Escherichia coli, Pseudomonas aeruginosa,Staphylococcus aureus	Not less than 2.0 log reduction from the initialcount at 14 days, and no increase from the 14day count at 28 days.
Candida albicans, Aspergillus brasiliensis	No increase from initial calculated count at 14and 28 days

7. Indications for Use

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-LastingVaginal MoisturizerK203818Subject Device	Replens Long-LastingVaginal MoisturizerK101098Predicate Device	Comparison
Device ClassificationName	Lubricant, Personal	Lubricant, Personal	Same
Product Code	NUC	NUC	Same
Indications for Use	Replens Long-Lasting VaginalMoisturizer is a personal lubricantfor vaginal application, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity and to	Replens Long-Lasting VaginalMoisturizer is a personallubricant for vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort	Same: The indications havea minor difference inwording; however, theintended uses of both devicesare the same

	supplement the body's naturallubrication.	of intimate sexual activity andto supplement the body'snatural lubrication.
	This product is compatible withnatural rubber latex and	This product is compatiblewith natural rubber latex and
	polyisoprene condoms. This	synthetic (polyurethane and
	product is not compatible with	polyisoprene) condoms.
	polyurethane condoms.
Form	White to off-white smoothhomogenous gel	White to off-white smoothhomogenous gel	Same
Water soluble	Yes	Yes	Same
Water-Based	Yes	Yes	Same
Primary ingredients	Water, Glycerin, Mineral Oil,Polycarbophil, CarbomerHomopolymer Type B,Hydrogenated Palm Oil Glyceride,Sorbic Acid, Benzyl Alcohol,Ethylhexylglycerin, tocopherol,and Sodium Hydroxide	Water, Glycerin, Mineral Oil,Polycarbophil, CarbomerHomopolymer Type B,Hydrogenated Palm OilGlyceride, Sorbic Acid,Methylparaben, SodiumHydroxide	Different: The formulationof the subject device isslightly different than thepredicate device.Differences in personallubricant formulation do notraise different questions ofsafety 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 othe predicate device is notcurrently tested for release.Differences in personallubricant osmolality do notraise different questions ofS&E.
Condom Compatibility	Compatible with natural rubberlatex and polyisoprene	Compatible with naturalrubber latex, polyisoprene,and polyurethane	Different: The subjectdevice is not compatible witpolyurethane condoms.Differences in personallubricant compatibility donot raise different questionsof S&E.
Biocompatibility Tested	Yes	Yes	Same
AntimicrobialEffectiveness Tested	Yes	Yes	Same
Microbial Limits	Total mold/yeast count < 10 cfu/g	Total mold/yeast count <10cfu/g	Same
	Total aerobic microbial
	count < 100 cfu/g	Total aerobic microbial
	Absence of pathogenic	count <100 cfu/g
	organisms (Candida	Absence of pathogenic
	albicans, Pseudomonas	organisms (Candida
	aeruginosa, Staphylococcusaureus, Escherichia coli,	albicans, Pseudomonasaeruginosa, Staphylococcus
	Salmonella)	aureus
Packaging	35g Aluminum Tube (14applications)Reusable, two-piece, bluetranslucent, plastic (polyethylene)applicator.	35g Aluminum Tube (14applications)Reusable, two-piece, bluetranslucent, plastic(polyethylene) applicator.	Same
Shelf life	22 months	36 months	Different: The subjectdevice has a shorter shelf-lifethan the predicate device.Differences in shelf-life donot raise different questionsof S&E.

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The subject and predicate devices have different technological characteristics including differences in formulation, shelf life, and device specifications, as shown in the table above. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

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 as follows:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010)
. Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that Replens Long-Lasting Moisturizer is non-cytotoxic, nonirritating, 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.

10. Conclusion

The results of the performance testing described above demonstrate that Replens Long-Lasting Vaginal Moisturizer is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.