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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the "Wet® Water Based Personal Lubricant" device, including its compatibility with condoms and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Particle-Free / Slightly cloudy	Slightly cloudy (Hazy)
Color	Slightly cloudy (Hazy)	Slightly cloudy (Hazy)
Odor	Odorless (Characteristic)	Odorless (Characteristic)
Viscosity@25°C Spindle LV#3@10rpm (cps)	5,000 cps – 13,000 cps	Met specification (actual value not provided)
Specific Gravity @25°C	1.01 -1.05	Met specification (actual value not provided)
pH	6.0-7.5	Met specification (actual value not provided)
Osmolality	3,691-6,140 mOsm/kg	Met specification (actual value not provided)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Meets USP <51> acceptance criteria for Category 2 products
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g
Absence of Pathogens per USP <62>	Absent (Enrichment, P. aeruginosa, S. aureus, E. Coli, Salmonella/Shigella, C. albicans)	Absent (Enrichment, P. aeruginosa, S. aureus, E. Coli, Salmonella/Shigella, C. albicans)
Biocompatibility	Met ISO 10993 requirements	Demonstrated biocompatible
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms
Shelf-Life	At least 1.5 Years (18 months)	1.5 Years (18 months)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each specific test. The document mentions "results of testing" and "results of accelerated and real-time aging studies" without providing specific numbers of samples tested.
Data Provenance: The data is generated from performance testing conducted by the manufacturer, Trigg Laboratories, Inc., as part of their 510(k) submission to the FDA. The provenance of external data used for comparison (e.g., predicate device data) is not detailed beyond referencing the predicate K number. The studies appear to be prospective for the subject device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests performed are laboratory-based and generally do not involve human "experts" establishing a ground truth in the way a clinical study would. The acceptance criteria are based on established scientific and regulatory standards (e.g., USP, ISO, ASTM).

4. Adjudication method for the test set:

This information is not applicable as the tests are for physical, chemical, and microbiological properties, as well as biocompatibility, which are objectively measured against predefined standards rather than adjudicated by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a personal lubricant, not an AI-powered diagnostic or imaging device, and therefore does not involve human readers or AI assistance in its use or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical product (lubricant), not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on:

Pre-defined chemical and physical specifications: For properties like appearance, color, odor, viscosity, specific gravity, pH, and osmolality.
Established microbiological standards: USP <51>, <61>, <62>, and <1111> for antimicrobial effectiveness and microbial counts.
International Biocompatibility Standards: ISO 10993-1, 10993-5, 10993-10, 10993-11.
Condom Compatibility Standards: ASTM D7661-10.
Accelerated and Real-time Aging Studies: To determine shelf-life.

These are objective standards and laboratory test results, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

This is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The device formulation and manufacturing process would be developed and refined through R&D, but this is not analogous to a training set for an algorithm.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as point 8.

Summary

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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

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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

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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)

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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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) WETINTERNATIONAL
Company Address:	4220 W WINDMILL LANE, SUITE 140LAS VEGAS, NV 89139
Contact Number:	Phone: (818) 585-7488Email: mdci@m-dci.us
Contact Person:	Louie GoryokaTrigg Laboratories, Inc., DBA Wet International4220 W WINDMILL LANE, SUITE 140Las 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-BasedHybrid)
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

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 <51>	Meets USP <51> acceptance criteria for Category 2 products
Total aerobic microbial count (TAMC) perUSP <61> and <1111>	<10 cfu/g
Total yeast and mold count (TYMC) perUSP <61> and <1111>	<10 cfu/g
Absence of Pathogens per USP <62>
Enrichment (Pathogens)	Absent
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
E. Coli	Absent
Salmonella/Shigella	Absent
Candida albicans	Absent

Indications for Use

Predicate Device Comparison

The table below compares the intended use and technological characteristics of the subject and predicate devices:

	Wet Water Based PersonalLubricantK191480Subject Device	JO Classic Hybrid PersonalLubricantK181408Predicate Device
Indications forUse	The Wet Water Based PersonalLubricant (additionally, branded asWET Platinum Houston, EliteWater-Based Hybrid) is a personallubricant for penile, anal and/orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatible withpolyurethane condoms.	JO Classic Hybrid PersonalLubricant is a personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
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, SodiumPolyacrylate, Trideceth-6.	Propylene Glycol, Water,Phenoxyethanol, Dimethicone,Cellulose Gum,Cyclopentasiloxane, SodiumPolyacrylate, 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, SodiumAcetate, Cellulose	Based Hybrid)
Over theCounter Use	Yes	Yes
Sterile	No	No
CondomCompatibility	Natural Rubber Latex andPolyisoprene	Natural Rubber Latex andPolyisoprene
BiocompatibilityTested	Yes	Yes
AntimicrobialTested	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.

Regulation Number and Section

§ 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.