LUVENA VAGINAL MOISTURIZER & LUBRICANT

K162235 · Laclede, Inc. · NUC · Mar 24, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162235
• Device Name: LUVENA VAGINAL MOISTURIZER & LUBRICANT
• Applicant: Laclede, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Luvena Vaginal Moisturizer and Lubricant 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 and polyisoprene condoms, but is not compatible with polyurethane condoms.

Device Story

Luvena Vaginal Moisturizer and Lubricant is a non-sterile, aqueous-based, cranberry-flavored gel; supplied in single-use EVA/PE copolymer plastic applicator tubes. Intended for personal vaginal use to provide moisture and lubrication during intimate sexual activity. Device is OTC; user-applied. Formulation provides physical lubrication; does not contain contraceptives or spermicides. Compatibility with natural rubber latex and polyisoprene condoms confirmed via ASTM D7661-10; incompatible with polyurethane condoms. Healthcare providers use the product to assist patients experiencing vaginal dryness; output is the physical application of the gel to the vaginal area to reduce friction and improve comfort.

Clinical Evidence

Bench testing only. Biocompatibility established per ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity). Physical testing included antimicrobial preservative effectiveness (USP <51>), condom compatibility (ASTM D7661-10), and shelf-life stability (ICH-Q1A/Q1E). Microbiological testing performed per USP <61>, <62>, and <1111>.

Technological Characteristics

Aqueous-based gel; pH 3.8-4.8. Materials: EVA/PE copolymer applicator. Standards: ASTM D7661-10 (condom compatibility), USP <61>/<62>/<1111> (microbial limits), USP <51> (preservative effectiveness), ISO 10993 (biocompatibility), ICH-Q1A/Q1E (stability). Non-sterile. Standalone device.

Indications for Use

Indicated for vaginal application in individuals requiring moisturization and lubrication to enhance comfort during intimate sexual activity and supplement 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

• Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant (K150841)

Submission Summary (Full Text)

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

March 24, 2017

Laclede, Inc. Michael Pellico President 2103 E. University Dr. Rancho Dominguez, CA 90220

Re: K162235

> Trade/Device Name: Luvena Vaginal Moisturizer and Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 21, 2017 Received: February 24, 2017

Dear Michael Pellico:

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.

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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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K162235

Device Name

Luyena Vaginal Moisturizer and Lubricant

Indications for Use (Describe)

Luyena Vaginal Moisturizer and Lubricant 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 and polyisoprene condoms, but is not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

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# 510 (k) Summary

| Submission By: | Laclede, Inc. |
|----------------|--------------------------------------------------------|
| Address: | 2103 E. University Drive<br>Rancho Dominguez, Ca 90220 |
| Telephone: | 310-605-4280 |
| Facsimile: | 310-605-4288 |
| Contact Name: | Michael A. Pellico, President |
| Email: | [e-mail] |

Date 510(k) Summary Prepared: March 23, 2017

| Trade Name: | Luvena Vaginal Moisturizer & Lubricant |
|----------------------|----------------------------------------|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 C.F.R. 884.5300) |
| Classification: | Class II |
| Product Code: | NUC (lubricant, personal) |

## Primary Predicate Device:

Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant: K150841, Laclede, Inc. This predicate device has not been subject to any design related recall.

## Device Description:

Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity.

This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.

## Device Specifications:

The device specifications for the Luvena Vaginal Moisturizer and Lubricant include appearance, odor, pH, viscosity, osmolality, Total Aerobic Microbial Count ((TAMC) (USP<61> and <1111>)), Total Yeast and Mold Count ((TYMC) (USP<61> and <1111>)), and absence of pathogenic organisms ((Pseudomonus aeruginosa, Staphylococcus aureus, Candida albicans (USP<62>)). These specifications were evaluated during the length of the proposed shelf life.

## Intended Use:

Luvena Vaginal Moisturizer and Lubricant 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

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natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.

# Substantial Equivalence:

Luvena Vaginal Moisturizer & Lubricant have the same intended use as the predicate device. However, the subject moisturizer & lubricants and the predicate device have different technological characteristics – namely differences in viscosity, formulation and package type. These differences do not raise different questions of safety & effectiveness.

| Features | Luvena Vaginal<br>Moisturizer &<br>Lubricant | Luvena Enhanced Personal<br>Moisturizer and<br>Luvena Enhanced Personal<br>Lubricant<br>K150841 | Differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Water Based | Yes | Yes | Same, The subject and<br>predicate device are water<br>based |
| Water Soluble | Yes | Yes | Same, The subject and<br>predicate device are soluble in<br>water |
| Non Sterile | Yes | Yes | Same, The subject and<br>predicate device are non-sterile. |
| Flavoring | Cranberry | Cranberry | Same, The subject and<br>predicate device have same<br>flavoring. |
| Container Type | Single use Applicator | Bottle with pump | The subject and predicate<br>device are different size and<br>shape for OTC packaging, but<br>these differences have no<br>impact on the safety or efficacy<br>of the personal lubricant. |
| Condom<br>compatibility | Yes<br>ASTM D7661-10<br>Compatible with<br>natural rubber latex<br>and polyisoprene<br>condoms, and not<br>compatible with<br>polyurethane<br>condoms. | Yes<br>ASTM D7661-10<br>Compatible with natural<br>rubber latex and<br>polyisoprene condoms, and<br>not compatible with<br>polyurethane condoms. | Same, The subject and<br>predicate device have been<br>tested for condom compatibility<br>in accordance with ASTM<br>D7661-10. |
| pH | Yes<br>3.8 - 4.8 | Yes<br>3.8 - 4.8 | Same, The subject and predicate<br>device have same pH range. |
| Microbiological<br>Examination of<br>Non-sterile<br>Products Testing | USP <61>/<62> | USP <61>/<62> | Same, The subject and predicate<br>device have been tested for<br>Microbial Limit test in<br>accordance with USP <61> and<br><62> and have same<br>specifications as recommended<br>in USP<1111> for vaginal use |
| | | products. | |
| Body Location<br>Target area | Vaginal application | Penile and/or<br>Vaginal application | Same, Subject and predicate device are for Vaginal application. |
| Intended Use | Moisturize & Lubricate during sexual activity | Moisturize & Lubricate during sexual activity | Same, Subject and predicate device have same intended use. |

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# Biocompatibilitv:

Biocompatibility of the final formulation of Luvena Vaginal Moisturizer & Lubricant was established through testing generally following ISO 10993, and includes cytotoxicity, sensitization, irritation, and acute systemic toxicity testing. The results demonstrate that the subject lubricant is biocompatible.

- · Acute Systemic Toxicity: ISO 10993-11:2006
- · Cytotoxicity: ISO 10993-5:2009
- · Vaginal Irritation Testing: ISO 10993-10:2010
- · Sensitization Testing Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010.

# Physical & Other Testing:

The physical and other testing performed on Luvena Vaginal Moisturizer & Lubricant included an Antimicrobial Preservative Effectiveness Validation testing under USP < 5 > Category 2. Lubricant- Condom Compatibility testing per ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms and Shelf life testing. Luvena Vaginal Moisturizer and Lubricant passed the Antimicrobial Effectiveness test and were found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. The results of accelerated time testing and real time testing according to ICH-Q1A (Stability testing of new drug substances and products) and ICH-Q1E (Evaluation of stability data) support the proposed shelf life for the subject lubricant.

# Conclusion:

The subject and predicate device have the same intended use and the different technological characteristics do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.