(90 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and compatibility of a personal lubricant, with no mention of AI or ML.
No.
The intended use of the device is for lubrication and moisture to enhance sexual activity, not to treat or cure a disease or condition.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical, water-based personal lubricant, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity. This is a topical application for physical comfort and lubrication, not for diagnosing a condition or examining specimens from the human body.
- Device Description: The description focuses on the physical properties of the lubricant (water-based, non-irritating, etc.) and its compatibility with condoms. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The information provided describes a Class II medical device (personal lubricant) intended for direct application to the body for a physical purpose. IVDs are a distinct category of medical devices used for testing biological samples outside of the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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:
- Glycerin: Humectant
- Water (Aqua): Solvent
- Pentylene Glycol: Preservative
- Potassium Sorbate: Preservative
- Sodium Carboxymethylcellulose: Thickener
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
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.
The WET ORIGINAL® Personal Lubricant has a two-year shelf life based on the results of a real-time aging study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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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3
510(k) SUMMARY
Submitter Information:
| Date Prepared: | April 27, 2016 |
|---|---|
| Company Name: | Trigg Laboratories Inc. |
| Company Address: | 28650 Braxton Avenue |
| Valencia CA 91355 | |
| Company Phone: | 1 (800) 248-4811 |
| Company Facsimile: | 1 (661) 775-3143 |
| Contact Person: | Erica Loring; Vice President, Regulatory & Quality |
| EricaL@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
4
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:
5
- 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.