Wet Original Personal Lubricant

K160211 · Trigg Laboratories D/B/A Wet International · NUC · Apr 27, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160211
• Device Name: Wet Original Personal Lubricant
• Applicant: Trigg Laboratories D/B/A Wet International
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Trigg Laboratories WET ORIGINAL® 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, polyisoprene, and polyurethane condoms.

Device Story

Wet Original is a water-based, non-sterile, over-the-counter personal lubricant. It is formulated as a clear, non-greasy, odorless aqueous gel. The device is intended for topical application to penile and/or vaginal tissues to supplement natural lubrication and enhance comfort during sexual activity. It is packaged in a low-density polyethylene (LDPE) tube. The lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. It is not a contraceptive or spermicide. The device is intended for patient self-use in a home setting.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and vaginal irritation), and ISO 10993-11 (systemic toxicity). Condom compatibility testing performed per ASTM D7661-10 on natural rubber latex, polyisoprene, and polyurethane condoms. Microbial quality verified via USP testing for aerobic microbial counts, yeast/mold counts, and antimicrobial effectiveness. Real-time aging study supports a two-year shelf life.

Technological Characteristics

Water-based lubricant containing glycerin, water, pentylene glycol, potassium sorbate, and sodium carboxymethylcellulose. Packaged in LDPE tube with disk top cap. Non-sterile. Evaluated for pH, viscosity, specific gravity, and osmolality. Compliant with ISO 10993 and ASTM D7661-10 standards.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. No specific age or gender restrictions stated.

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

• JO H20 Water Based Personal Lubricant (K150480)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures facing right.

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

April 27, 2016

Trigg Laboratories D/B/A Wet International Erica Loring Vice President, Regulatory Affairs and Quality Assurance 28650 Braxton Avenue Valencia, CA 91355

Re: K160211 Trade/Device Name: Wet Original® Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 25, 2016 Received: January 28, 2016

Dear Erica Loring,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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) K160211

Device Name WET ORIGINAL® Personal Lubricant

#### Indications for Use (Describe)

The Trigg Laboratories WET ORIGINAL® 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, polyisoprene, and polyurethane condoms.

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

| | 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

# Submitter Information:

| Date Prepared: | April 27, 2016 |
|----------------------------|----------------------------------------------------------------------------|
| Company Name: | Trigg Laboratories Inc. |
| Company Address: | 28650 Braxton Avenue<br>Valencia CA 91355 |
| Company Phone: | 1 [phone] |
| Company Facsimile: | 1 [phone] |
| Contact Person: | Erica Loring; Vice President, Regulatory & Quality<br>[e-mail] |
| Device Trade Name: | WET ORIGINAL® Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name(s): | Condom |
| Classification Regulation: | 21 CFR §884.5300, Class II |
| Device Product Code: | NUC |
| Advisory Panel: | Obstetrics and Gynecology |

#### Predicate device:

K150480 JO H20 Water Based Personal Lubricant UNITED CONSORTIUM INC. 29000 Hancock Pkwy Valencia, CA 91355

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## Indications for Use:

The Trigg Laboratories WET ORIGINAL" Personal Lubricant is 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 Description:

The WET ORIGINAL® Personal Lubricant is a non-sterile device. It is a water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, gel-like, liquid and odorless, aqueous-based. The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.

The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing.

The device formula is neither a contraceptive nor a spermicide.

#### Ingredients of the device:

| Ingredient | Function |
|-------------------------------|--------------|
| Glycerin | Humectant |
| Water (Aqua) | Solvent |
| Pentylene Glycol | Preservative |
| Potassium Sorbate | Preservative |
| Sodium Carboxymethylcellulose | Thickener |

## Technological Characteristics:

The technology involved in this product (WET ORIGINAL® Personal Lubricant) has no exceptional technological characteristics. The WET ORIGINAL® contains similar ingredients to other lubricants currently on the U.S. market.

This product is designed and packaged in a convenient low density polyethylene (LDPE) tube with a disk top cap, and peel seal.

Bench testing indicated that the lubricant has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. USP testing for Total Aerobic Microbial Counts, Total Yeast and mold Counts; absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality.

## Summary of Performance Data:

Biocompatibility studies and condom compatibility were conducted on the WET ORIGINAL® by an outside laboratory, in compliance with Good Laboratory Practices (GLPs). The subject device was evaluated for Biocompatibility according to the following FDA recognized ISO 10993 standards:

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- Cytotoxicity per ISO 10993-5:2009 .
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010
- Vaginal Irritation per ISO 10993-10:2010
- . Systemic Toxicity per to ISO 10993-11:2006 (2010)

The results of testing demonstrated that this formula meets acceptance requirements for all tests.

Bench testing indicated that the WET ORIGINAL® Personal Lubricant meets its specifications (i.e. pH, viscosity, specific gravity, osmolality, color and odor) for substantial equivalence to the predicate. USP testing for total aerobic microbial count, total yeast and mold counts; absence of pathogenic organisms, and antimicrobial effectiveness indicated microbial quality.

## Condom Compatibility:

Compatibility Testing was performed in accordance with ASTM D7661-10 (Air Burst and Tensile); 'Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms.

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

# Shelf Life Testing:

The WET ORIGINAL® Personal Lubricant has a two-year shelf life based on the results of a real-time aging study.

#### Conclusion:

The WET ORIGINAL® Personal Lubricant is substantially equivalent to its proposed predicate device.