Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant

K150841 · Laclede, Inc. · NUC · Dec 29, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150841
• Device Name: Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
• Applicant: Laclede, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant is a personal lubricant, for penile and/or 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 Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant are non-sterile, aqueous, translucent, non-greasy liquids packaged in plastic bottles. Intended for OTC use, the lubricant is applied topically to penile and/or vaginal surfaces to supplement natural lubrication and enhance comfort during sexual activity. The device functions as a physical lubricant; it is not a contraceptive or spermicide. Healthcare providers do not operate the device; it is for patient self-use. The product benefits patients by reducing friction during intercourse. Compatibility with condom materials is verified via ASTM D7661 testing.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, acute systemic toxicity), antimicrobial preservative effectiveness (USP <51>), and condom compatibility (ASTM D7661). Results confirm biocompatibility and compatibility with natural rubber latex and polyisoprene condoms.

Technological Characteristics

Aqueous-based personal lubricant. Specifications include color, odor, pH, viscosity, osmolality, and microbial limits (TAMC/TYMC). Biocompatibility per ISO 10993-1. Condom compatibility tested per ASTM D7661. Non-sterile.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal application 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

• Aqua Lube Personal Lubricant (K110325)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.

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

December 29, 2015

Laclede, Inc. % Seth Mailhot Attorney Michael Best & Friedrich LLP 601 Pennsylvania Ave. NW. Suite 700 Washington, DC 20004

Re: K150841

> Trade/Device Name: Luvena Enhanced Personal Moisturizer Luvena Enhanced Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 30, 2015 Received: November 30, 2015

Dear Seth Mailhot.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 yours.

# Glenn B. Bell -S

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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## Indications for Use

510(k) Number (if known) K150841

Device Name Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant

## Indications for Use (Describe)

Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant is a personal lubricant, for penile and/or 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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# 510(k) Summary K150841

| Submitted by: | Laclede, Inc. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2103 E. University Drive<br>Rancho Dominguez, CA 90220 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Name: | Michael A. Pellico, President |
| E-mail: | [e-mail] |
| Date Submitted: | November 10, 2015 |
| Trade Name: | Luvena Enhanced Personal Moisturizer and<br>Luvena Enhanced Personal Lubricant |
| Classification Name: | Condom |
| Common Name: | Personal Lubricant |
| Product Code /<br>Regulation: | NUC (21 C.F.R. 884.5300) |
| Predicate Device: | Aqua Lube Personal Lubricant: K110325, Mayer Laboratories, Inc. |
| Description: | Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican<br>are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a<br>personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Persona<br>Lubricant are packed in a plastic bottle.<br><br>These devices are neither contraceptives nor spermicidals, nor do they contain any<br>such component. They are compatible with latex and polyisoprene condoms and not<br>compatible with polyurethane condoms as demonstrated in condom compatibility<br>testing conducted according to the standards defined by ASTM D7661. |
| Product Specifications: | The product specifications for the Luvena Enhanced Personal<br>Moisturizer and Luvena Enhanced Personal Lubricant include<br>color/appearance, odor, pH, viscosity, osmolality, Total Aerobic<br>Microbial Count (TAMC), Total Yeast and Mold Count (TYMC),<br>absence of pathogenic organisms, and antimicrobial effectiveness. |
| Intended Use: | Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican<br>is a personal lubricant, for penile and/or vaginal application, intended to moisturize<br>and lubricate, to enhance the ease and comfort of intimate sexual activity and<br>supplement the body's natural lubrication. This product is compatible with natural<br>rubber latex and polyisoprene condoms, but is not compatible with polyurethane<br>condoms. |
| Biocompatibility: | Biocompatibility of the final formulation of Luvena Enhanced Personal<br>Moisturizer and Luvena Enhanced Personal Lubricant were established<br>through testing generally following ISO 10993-1, and includes cytotoxicity,<br>sensitization, irritation, and acute systemic toxicity testing. The results<br>demonstrate that the subject lubricants are biocompatible. |
| Physical<br>& Other<br>Testing: | The physical and other testing performed on Luvena Enhanced Personal<br>Moisturizer and Luvena Enhanced Personal Lubricant included an Antimicrobial<br>Preservative Effectiveness Validation testing under USP <51>, Lubricant-<br>Condom Compatibility testing per ASTM D7661, and shelf life testing. Luvena<br>Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passed<br>the Antimicrobial Effectiveness test and were found to be compatible with natural<br>rubber latex and polyisoprene condoms, but not compatible with polyurethane<br>condoms. The results of real time testing support the proposed shelf life for the<br>subject lubricants. |
| Conclusion: | The subject lubricants are substantially equivalent to the proposed predicate device. |

#### Substantial

- Equivalence: Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant have the same intended use as the predicate device. However, the subject lubricants and the predicate device have different technological characteristics – namely differences in
formulation and specifications. The differences in technological characteristics do not raise different questions of safety and effectiveness.

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