(129 days)
Not Found
No
The device is a personal lubricant and the summary contains no mention of AI or ML technology.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a personal lubricant intended to moisturize and aid in sexual activity, not treat a medical condition.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its composition, packaging, and physical properties, and the performance studies focus on biocompatibility and condom compatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "personal lubricant for penile, anal 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 describes a product applied to the body for physical lubrication, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "water and silicone blend personal lubricant" for "lubrication during intimate sexual activity." This aligns with the intended use and does not suggest any diagnostic function.
- No mention of diagnostic testing: The document does not mention any form of testing on biological samples (blood, urine, tissue, etc.) to detect or measure substances or characteristics related to a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf-life, which are relevant to a personal lubricant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This personal lubricant does not fit that definition.
N/A
Intended Use / Indications for Use
The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 were performed in accordance with the 2016 FDA quidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- · Cytotoxicity (ISO Agarose Overlay Method, ISO 10993-5:2009)
- · Sensitization (ISO Guinea Pig Maximization. ISO 10993-10:2010)
- · Vaqinal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- · Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006)
The results of testing demonstrated the subject lubricant is biocompatible.
Condom Compatibility: Testing was performed according to ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results of testing demonstrated that this device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Shelf-Life Testing: Wet Water Based Personal Lubricant has an 18 month shelf-life based on the results of accelerated and real-time aging studies. The parameters identified in the Device Description section of this summary were assessed and devices shown to meet specifications at all time points.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".
October 11, 2019
Trigg Laboratories, Inc. D/B/A Wet International Louie Goryoka Senior EVP, Operations and QA/RA 4220 W Windmill Lane, Suite 140 Las Vegas, NV 89139
Re: K191480
Trade/Device Name: Wet® Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 6, 2019 Received: September 11, 2019
Dear Louie Goryoka:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica Garcia Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191480
Device Name
Wet® Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Indications for Use (Describe)
The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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. This product 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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3
510(K) SUMMARY
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-
| Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-
| Based Hybrid) | |
|---|---|
| Company Name: | TRIGG LABORATORIES, INC, DOING BUSINESS AS (DBA) WET |
| INTERNATIONAL | |
| Company Address: | 4220 W WINDMILL LANE, SUITE 140 |
| LAS VEGAS, NV 89139 | |
| Contact Number: | Phone: (818) 585-7488 |
| Email: mdci@m-dci.us | |
| Contact Person: | Louie Goryoka |
| Trigg Laboratories, Inc., DBA Wet International | |
| 4220 W WINDMILL LANE, SUITE 140 | |
| Las Vegas, NV 89139 | |
| Summary Preparation Date: | October 11, 2019 |
| Device Trade Name: | Wet® Water Based Personal Lubricant (additionally, |
| branded as WET Platinum Houston, Elite Water-Based | |
| Hybrid) | |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
| Predicate Devices: | JO Classic Hybrid Personal Lubricant |
| 510(k) Number: | K181408 |
| Manufacturer: | United Consortium |
| Product Code: | NUC |
| Device Class: | Class II |
The predicate device has not been subject to a design-related recall.
Device Description
The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
| Property | Specification |
|---|---|
| Appearance | Particle-Free / Slightly cloudy |
| Color | Slightly cloudy (Hazy) |
| Odor | Odorless (Characteristic) |
| Viscosity@25°C Spindle LV#3@10rpm (cps) | 5,000 cps – 13,000 cps |
| Specific Gravity @25°C | 1.01 -1.05 |
| pH | 6.0-7.5 |
| Osmolality | 3,691-6,140 mOsm/kg |
Device specifications are listed in the table below:
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510(K) SUMMARY
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-
| Based Hybrid) | |
|---|---|
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per | |
| USP and | and |
| Enrichment (Pathogens) | Absent |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| E. Coli | Absent |
| Salmonella/Shigella | Absent |
| Candida albicans | Absent |
Indications for Use
The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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. This product is not compatible with polyurethane condoms.
Predicate Device Comparison
The table below compares the intended use and technological characteristics of the subject and predicate devices:
| | Wet Water Based Personal
Lubricant
K191480
Subject Device | JO Classic Hybrid Personal
Lubricant
K181408
Predicate Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Wet Water Based Personal
Lubricant (additionally, branded as
WET Platinum Houston, Elite
Water-Based Hybrid) is a personal
lubricant for penile, anal 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.
This product is not compatible with
polyurethane condoms. | JO Classic Hybrid Personal
Lubricant is a personal
lubricant for penile, anal and/or
vaginal application, intended to
lubricate and moisturize, 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. This product is not
compatible with polyurethane
condoms. |
| Appearance | Slightly cloudy | Off-white, opaque thick liquid |
| Ingredients | Propylene Glycol, Water,
Dimethicone, Cyclopentasiloxane,
PEG/PPG 18/18 Dimethicone,
Caprylhydroxamic Acid, 1,2-
Hexanediol, Propanediol, Sodium
Polyacrylate, Trideceth-6. | Propylene Glycol, Water,
Phenoxyethanol, Dimethicone,
Cellulose Gum,
Cyclopentasiloxane, Sodium
Polyacrylate, Trideceth-6,
PEG/PPG-18/18 Dimethicone |
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510(K) SUMMARY
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hvhrid)
| | Hydroxyethylcellulose, Sodium
Acetate, Cellulose | Based Hybrid) |
|----------------------------|-----------------------------------------------------|------------------------------------------|
| Over the
Counter Use | Yes | Yes |
| Sterile | No | No |
| Condom
Compatibility | Natural Rubber Latex and
Polyisoprene | Natural Rubber Latex and
Polyisoprene |
| Biocompatibility
Tested | Yes | Yes |
| Antimicrobial
Tested | Yes | Yes |
| Shelf-Life | 1.5 Years (18 months) | 3 Years (36 months) |
The subject and predicate device have the same indications for use; therefore, they have the same intended use. The technological characteristic differences noted above (e.g., formulation, shelf-life, etc.) between the subject and predicate device do not raise different questions of safety or effictiveness.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies were performed in accordance with the 2016 FDA quidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- · Cytotoxicity (ISO Agarose Overlay Method, ISO 10993-5:2009)
- · Sensitization (ISO Guinea Pig Maximization. ISO 10993-10:2010)
- · Vaqinal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- · Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006)
The results of testing demonstrated the subject lubricant is biocompatible.
Condom Compatibility
Testing was performed according to ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results of testing demonstrated that this device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Shelf-Life Testing
Wet Water Based Personal Lubricant has an 18 month shelf-life based on the results of accelerated and real-time aging studies. The parameters identified in the Device Description section of this summary were assessed and devices shown to meet specifications at all time points.
Conclusion
The results of the performance testing described above demonstrate that the Wet Water Based Personal Lubricant product is as safe and effective for its intended use as the predicate device and supports a determination of substantial equivalence.