(90 days)
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.
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.
This document is a 510(k) summary for a personal lubricant and as such, it does not describe a study that uses AI or involves human readers as typically seen in image or data analysis medical devices. Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and MRMC studies is not applicable in the context of this document.
However, I can extract the relevant performance data and acceptance criteria for the physical and biological properties of the personal lubricant as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5:2009) | Meets acceptance requirements | Meets acceptance requirements |
| Guinea Pig Maximization Sensitization (ISO 10993-10:2010) | Meets acceptance requirements | Meets acceptance requirements |
| Vaginal Irritation (ISO 10993-10:2010) | Meets acceptance requirements | Meets acceptance requirements |
| Systemic Toxicity (ISO 10993-11:2006 (2010)) | Meets acceptance requirements | Meets acceptance requirements |
| Bench Testing (Specifications) | Comparable to predicate device | Meets specifications for pH, viscosity, specific gravity, osmolality, color, and odor |
| Microbial Quality | USP standards (total aerobic microbial count, total yeast and mold counts; absence of pathogenic organisms) | Meets USP standards; indicated antimicrobial effectiveness |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (ASTM D7661-10) | Compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials |
| Shelf Life | 2-year shelf life | 2-year shelf life achieved based on real-time aging study |
Study Proving Device Meets Acceptance Criteria:
The studies conducted for the personal lubricant are primarily laboratory-based evaluations of its physical, chemical, and biological properties, not a clinical study involving human patients in the usual sense for diagnostic or therapeutic devices.
2. Sample Sizes and Data Provenance:
- Test Set (Samples/Units): The document does not specify the exact number of lubricant samples or units used for each test. However, it indicates that biocompatibility studies and condom compatibility testing were performed on the "WET ORIGINAL®" device.
- Data Provenance: The tests were conducted by an "outside laboratory," in compliance with Good Laboratory Practices (GLPs), which would suggest prospective testing specifically for this submission. The country of origin of the data is not explicitly stated.
3. Number of Experts and Qualifications:
- Not applicable as this is not an interpretive diagnostic device requiring expert opinion for ground truth. The "experts" involved would be the laboratory personnel qualified to perform the ISO and ASTM standard tests mentioned.
4. Adjudication Method:
- Not applicable as this is not an interpretive diagnostic device. Test results are based on quantitative measurements and defined standard protocols (e.g., ISO, ASTM, USP).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not a device that involves human readers interpreting data or images.
6. Standalone Performance Study:
- Yes, the performance data presented (biocompatibility, bench testing, microbial quality, condom compatibility, shelf life) can be considered "standalone" performance for the lubricant itself, without human intervention in the usage/interpretation loop. The device's properties were tested objectively against established standards.
7. Type of Ground Truth Used:
- The ground truth is based on established international standards and regulations for medical device safety and performance criteria, specifically:
- ISO 10993 series for biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity).
- ASTM D7661-10 for condom compatibility.
- USP (United States Pharmacopeia) standards for microbial quality.
- Internal specifications for physical properties (pH, viscosity, specific gravity, osmolality, color, odor) designed to demonstrate substantial equivalence to the predicate.
8. Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 AvenueValencia CA 91355 |
| Company Phone: | 1 (800) 248-4811 |
| Company Facsimile: | 1 (661) 775-3143 |
| Contact Person: | Erica Loring; Vice President, Regulatory & QualityEricaL@trigglabs.com |
| 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.
§ 884.5300 Condom.
(a)
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.(b)
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.