WET PLATINUM PERSONAL LUBRICANT

K130012 · Trigg Laboratories, Inc. · NUC · Aug 22, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130012
• Device Name: WET PLATINUM PERSONAL LUBRICANT
• Applicant: Trigg Laboratories, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Trigg Laboratories Wet Platinum Premium 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, polyisoprene, and polyurethane condoms.

Device Story

Wet Platinum Premium Lubricant is a non-sterile, silicone-based, anhydrous personal lubricant; formulated as a clear, odorless, non-greasy gel. Intended for over-the-counter use by consumers for penile and/or vaginal application to supplement natural lubrication and enhance comfort during sexual activity. Product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Device does not contain contraceptives or spermicides.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing: biocompatibility (cytotoxicity, sensitization, vaginal irritation/systemic toxicity per ISO 10993-1) and condom compatibility (ASTM D7661-10) with natural rubber latex, polyisoprene, and polyurethane condoms. Shelf-life established via accelerated aging.

Technological Characteristics

Silicone-based anhydrous gel. Biocompatibility per ISO 10993-1. Condom compatibility per ASTM D7661-10. Specifications include viscosity, specific gravity, and microbial limits (total aerobic, yeast, mold, and absence of pathogens). Non-sterile.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during sexual activity. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Not a contraceptive or spermicide.

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

• One Silicone Personal Lubricant (K110690)
• K-Y® Brand Intrigue (K062796)

Submission Summary (Full Text)

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## 510(k) Summary K130012

| <br>TRIGG LABORATORIES,<br>INC.<br>28650 Braxton Ave.<br>Valencia, CA. 91355-4163<br>USA:[phone]<br>FAX:[phone] | Submitted by: | Trigg Laboratories Inc.<br>28650 Braxton Avenue<br>Valencia CA 91355 |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ernie Johnson<br>Vice President, Operations<br>Tel.: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date Prepared: | August 19, 2013 |
| | Propriety Name: | Wet Platinum Premium Lubricant® |
| | Proposed Trade Name: | Wet Platinum Premium Lubricant® |
| | Common Name: | Personal Lubricant |
| | Classification Name: | Condom<br>21 CFR §884.5300 Class II<br>NUC |
| | Predicate Devices: | One Silicone Personal Lubricant<br>ONE<br>510(k) No.: K110690 |
| | | and |
| | | K-Y® Brand Intrigue<br>Personal Products Co.<br>510(k) No.: K062796. |
| | Device Description: | The Wet Platinum Premium Lubricant® is a non-sterile, silicone<br>based personal lubricant, an over-the-counter personal lubricant,<br>formulated to be clear, non-irritating, non-greasy natural and<br>odorless. It is a Silicone soluble, gel-like liquid for use as a persona<br>lubricant. The Wet Platinum Premium Lubricant® contains a blend<br>of silicone fluid ingredients similar to ingredients found in the<br>predicate device. |
| | | The specifications for Wet Platinum include appearance, odor,<br>viscosity, specific gravity, total aerobic microbial count, total yeast<br>and mold count, absence of pathogenic organisms (Pseudomonas<br>aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia<br>coli, Salmonella, and Clostrida), and antimicrobial effectiveness.<br>Osmolality and pH are not applicable specifications because the<br>subject lubricant is anhydrous. |
| | Intended Use: | Wet Platinum Premium Lubricant Personal Lubricant is non-<br>sterile, an over-the-counter personal lubricant. |

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## 510(k) Summary K130012

Image /page/1/Picture/1 description: The image is a black and white logo. The logo is a black circle with a white shape in the center. The white shape is an irregular shape with a rounded bottom. The letters TM are in the bottom right corner of the logo.

TRIGG LABORATORIES, INC. 28650 Braxton Ave. Valencia, CA. 91355-4163

Technological

USA:(800) 248•4811 FAX:[phone]

The Trigg Laboratories Wet Platinum Premium Lubricant® is a Indications For Use: 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, polvisoprene, and polyurethane condoms.

> The Wet Platinum Premium Lubricant® and the predicate devices have the same Indications for Use Statement.

The Wet Platinum Premium Lubricant® consists mainly of silicone based personal lubricants, contains a blend of silicone fluid Characteristics: ingredients similar to other lubricants currently on the U.S. markets and substantially equivalent to the predicate devices.

> Wet Platinum Premium Lubricant® formula is neither a contraceptive nor a spermicide.

BIOCOMPATIBILITY: Biocompatibility testing was performed in accordance with ISO 10993-1 and other standards.

| Test Performed | Results |
|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity (MEM Elution Test) | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION<br>SENSITIZATION TEST- (Method for<br>Liquid Test Articles) | Product does not elicit a sensitization response |
| Vaginal Irritation and Systemic<br>Toxicity Following Once Daily<br>Application for Ten Consecutive<br>Days | Product produced no macroscopic or<br>microscopic evidence of acute systemic toxicity<br>and it is considered a non-irritant. |

Compatibility Testing was performed in accordance with ASTM Condom D7661-10 {Air Burst and Tensile); 'Standard Test Method for Compatibility: Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms.

> The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and Polyisoprene materials.

- Shelf Life Testing: The Wet Platinum Premium Lubricant® has a one-year shelf life based on the results of an accelerated aging study.
- Real-time aging studies continue to extend period to 3 years.
- Conclusion: The performance data demonstrate that the Wet Platinum Premium Lubricant® is substantially equivalent to its proposed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

### Public Health Service

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

August 22, 2013

Trigg Laboratories, Inc. % Ernie Johnson Vice President, Operations 28650 Braxton Avenue Valencia, CA 91355

Re: K130012

> Trade/Device Name: Wet Platinum Premium Lubricant® Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 12, 2013 Received: July 23, 2013

Dear Ernie Johnson:

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

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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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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

K130012 510(k) Number:

Device Name: Wet Platinum Premium Lubricant®

## Indications for Use:

"The Trigg Laboratories Wet Platinum Premium 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, polyisoprene, and polyurethane condoms."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Reproductive. Gastro-Renal, and Urological Devices 510(k) Number KI30012