Replens Long-Lasting Vaginal Moisturizer

K203818 · Church & Dwight Co., Inc. · NUC · Jun 11, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K203818
• Device Name: Replens Long-Lasting Vaginal Moisturizer
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended 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.

Device Story

Replens Long-Lasting Vaginal Moisturizer is a non-sterile, water-based vaginal gel; supplied in 35g aluminum tube with reusable polyethylene applicator. Intended for OTC use to provide lubrication during intimate sexual activity. Device functions by physical application of gel to vaginal tissue to supplement natural moisture. User self-administers via applicator. Output is physical lubrication; aids in comfort during sexual activity. Benefits include reduced friction and enhanced comfort. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), shelf-life stability, and condom compatibility (ASTM D7661-10).

Technological Characteristics

Water-based gel; ingredients: Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, Sodium Hydroxide. pH 2.5-3.5; osmolality 1200-2000 mOsm/Kg. Viscosity 30,000-130,000 cPs. Non-sterile. Packaging: 35g aluminum tube with reusable polyethylene applicator. No software or electronic components.

Indications for Use

Indicated for vaginal application as a personal lubricant to moisturize, lubricate, and enhance comfort during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with 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 (K101098)

Submission Summary (Full Text)

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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, [phone], 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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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 ([e-mail]) or phone [phone] 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

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#### 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<br>Sr. Manager, Regulatory Affairs |
|----------|----------------------------------------------------------|
| Address: | 469 North Harrison Street<br>Princeton, NJ 08543 |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 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

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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 per<br>USP <61> and <1111>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC per USP<br><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<br><51> | Specification |
| Escherichia coli, Pseudomonas aeruginosa,<br>Staphylococcus aureus | Not less than 2.0 log reduction from the initial<br>count at 14 days, and no increase from the 14<br>day count at 28 days. |
| Candida albicans, Aspergillus brasiliensis | No increase from initial calculated count at 14<br>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<br>Vaginal Moisturizer<br>K203818<br>Subject Device | Replens Long-Lasting<br>Vaginal Moisturizer<br>K101098<br>Predicate Device | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification<br>Name | Lubricant, Personal | Lubricant, Personal | Same |
| Product Code | NUC | NUC | Same |
| Indications for Use | Replens Long-Lasting Vaginal<br>Moisturizer is a personal lubricant<br>for vaginal application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and to | Replens Long-Lasting Vaginal<br>Moisturizer is a personal<br>lubricant for vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort | Same: The indications have<br>a minor difference in<br>wording; however, the<br>intended uses of both devices<br>are the same |
| | | | |
| | supplement the body's natural<br>lubrication. | of intimate sexual activity and<br>to supplement the body's<br>natural lubrication. | |
| | This product is compatible with<br>natural rubber latex and | This product is compatible<br>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<br>homogenous gel | White to off-white smooth<br>homogenous gel | Same |
| Water soluble | Yes | Yes | Same |
| Water-Based | Yes | Yes | Same |
| Primary ingredients | Water, Glycerin, Mineral Oil,<br>Polycarbophil, Carbomer<br>Homopolymer Type B,<br>Hydrogenated Palm Oil Glyceride,<br>Sorbic Acid, Benzyl Alcohol,<br>Ethylhexylglycerin, tocopherol,<br>and Sodium Hydroxide | Water, Glycerin, Mineral Oil,<br>Polycarbophil, Carbomer<br>Homopolymer Type B,<br>Hydrogenated Palm Oil<br>Glyceride, Sorbic Acid,<br>Methylparaben, Sodium<br>Hydroxide | Different: The formulation<br>of the subject device is<br>slightly different than the<br>predicate device.<br>Differences in personal<br>lubricant formulation do not<br>raise different questions of<br>safety and effectiveness<br>(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<br>the predicate device is not<br>currently tested for release.<br>Differences in personal<br>lubricant osmolality do not<br>raise different questions of<br>S&E. |
| Condom Compatibility | Compatible with natural rubber<br>latex and polyisoprene | Compatible with natural<br>rubber latex, polyisoprene,<br>and polyurethane | Different: The subject<br>device is not compatible wit<br>polyurethane condoms.<br>Differences in personal<br>lubricant compatibility do<br>not raise different questions<br>of S&E. |
| Biocompatibility Tested | Yes | Yes | Same |
| Antimicrobial<br>Effectiveness Tested | Yes | Yes | Same |
| Microbial Limits | Total mold/yeast count < 10 cfu/g | Total mold/yeast count <10<br>cfu/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, Staphylococcus<br>aureus, Escherichia coli, | albicans, Pseudomonas<br>aeruginosa, Staphylococcus | |
| | Salmonella) | aureus | |
| Packaging | 35g Aluminum Tube (14<br>applications)<br>Reusable, two-piece, blue<br>translucent, plastic (polyethylene)<br>applicator. | 35g Aluminum Tube (14<br>applications)<br>Reusable, two-piece, blue<br>translucent, plastic<br>(polyethylene) applicator. | Same |
| Shelf life | 22 months | 36 months | Different: The subject<br>device has a shorter shelf-life<br>than the predicate device.<br>Differences in shelf-life do<br>not raise different questions<br>of 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.