The Wet Organics 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. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.

The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.

The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.

AI/ML Overview

This document describes the 510(k) summary for the Wet Organics Personal Lubricant and contains information about its acceptance criteria and the studies performed.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear to slightly cloudy, semi-viscous, particle-free liquid	Clear to slightly cloudy, semi-viscous, particle-free liquid (Implied by meeting spec.)
Color	brown	brown (Implied by meeting spec.)
Odor	Odorless (Characteristic)	Odorless (Implied by meeting spec.)
Viscosity@25°C Spindle LV#3hu@10rpm (cps)	1,000 cps – 2,300 cps	Within 1,000-2,300 cps range (Implied by meeting spec.)
Specific Gravity@25°C	0.95 - 1.05	Within 0.95-1.05 range (Implied by meeting spec.)
pH	4.0 to 5.0	Within 4.0-5.0 range (Implied by meeting spec.)
Osmolality	<1,800 mOSm	<1,800 mOSm (Implied by meeting spec.)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Met USP <51> acceptance criteria (Implied by meeting spec.)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g (Implied by meeting spec.)
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	<10 cfu/g (Implied by meeting spec.)
Absence of Pathogens per USP <62>	Absent	Absent (Implied by meeting spec.)
Pseudomonas aeruginosa	Absent	Absent
Staphylococcus aureus	Absent	Absent
E. Coli	Absent	Absent
Salmonella	Absent	Absent
Candida albicans	Absent	Absent
Biocompatibility (Cytotoxicity)	Not cytotoxic	Not cytotoxic
Biocompatibility (Sensitization)	Not sensitizing	Not sensitizing
Biocompatibility (Vaginal Irritation)	Not irritating	Not irritating
Biocompatibility (Acute Systemic Toxicity)	Not acutely systemically toxic	Not acutely systemically toxic
Condom compatibility (Natural rubber latex)	Compatible	Compatible
Condom compatibility (Polyisoprene)	Compatible	Compatible
Condom compatibility (Polyurethane)	Not compatible (Stated in Indications for Use)	Not compatible
Shelf Life	12 months	12 months (Met device specifications after this period)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each test (biocompatibility, condom compatibility, shelf-life). It states "three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms" for condom compatibility. The provenance of the data (country of origin, retrospective/prospective) is not explicitly mentioned. However, given that these are standard laboratory tests for medical device submission to the FDA, they are generally conducted in a controlled, prospective manner following established protocols and standards (e.g., ISO, ASTM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the submitted document. The document describes laboratory performance tests for a personal lubricant, not a diagnostic device requiring expert interpretation of results to establish a "ground truth." The ground truth for these tests is based on the results of the standardized assays and measurements themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers provide interpretations (e.g., medical imaging) and disagreements need to be resolved. The tests described are laboratory-based with objective measurements.

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 as the document is for a personal lubricant and doesn't involve AI or human readers for diagnostic interpretation.

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

This is not applicable. The device is a personal lubricant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests in this document is based on:

Quantitative measurements and chemical analyses: For properties like viscosity, pH, specific gravity, osmolality, and microbial counts.
Established biological assays: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
Standardized physical test methods: For condom compatibility (ASTM D7661-10).
Real-time stability testing: For shelf-life, where samples are tested against specifications over time.

These are objective, laboratory-derived results against predefined specifications and standards.

8. The sample size for the training set

This is not applicable. The device is a manufacturing product (personal lubricant), not an AI/ML model that requires a training set.

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

This is not applicable, as there is no training set for this device.

Summary

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November 21, 2018

Trigg Laboratories DBA Wet International % Louie Goryoka Regulatory & Quality Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K182027

Trade/Device Name: Wet Organics Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2018 Received: October 25, 2018

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 mav, 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 avare 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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -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) K182027

Device Name Wet Organics Personal Lubricant

Indications for Use (Describe)

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 K182027 Wet Organics Personal Lubricant

Company Name:	Trigg Laboratories DBA Wet International
Company Address:	4220 W Windmill Lane, Suite 140Las Vegas, NV 89139
Contact Number:	Phone: (702) 957-4400Email: mdci@m-dci.us
Contact Person:	Louie Goryoka – Regulatory & Quality ConsultantMed-Device Consulting, Inc.Phone: (818) 735-0488Email: mdci@m-dci.us
Summary Preparation Date:	November 21, 2018
Device Trade Name:	Wet Organics Personal Lubricant
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR §884.5300
Product Code:	NUC (lubricant, personal)
Device Class:	Class II
Predicate Devices:	Aloe Cadabra Personal Lubricant
510(k) Number:	K124044
Manufacturer:	Seven Oaks Ranch, Inc.
Product Code:	NUC

The predicate device has not been subject to a design-related recall.

Device Description

The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.

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510(K) SUMMARY K182027 Wet Organics Personal Lubricant

The device specifications are listed in the table below:

Property	Specification
Appearance	Clear to slightly cloudy, semi-viscous, particle-free liquid
Color	brown
Odor	Odorless (Characteristic)
Viscosity@25°C Spindle LV#3hu@10rpm (cps)	1,000 cps – 2,300 cps
Specific Gravity@25°C	0.95 - 1.05
pH	4.0 to 5.0
Osmolality	<1,800 mOSm
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<10 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g
Absence of Pathogens per USP <62>
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
E. Coli	Absent
Salmonella	Absent
Candida albicans	Absent

Indications for Use

The Wet Organics 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. The product is compatible with natural rubber latex and Polyisoprene condoms. This product is not compatible with Polyurethane condoms.

Predicate Device Comparison

The table below lists the comparative intended use and technological characteristics of the subject and predicate device.

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510(K) SUMMARY K182027 Wet Organics Personal Lubricant

Table 2: Comparator Table for Subject Device –Wet Organics Personal Lubricant and Predicate Device Aloe Cadabra Personal Lubricant.

Characteristic/Feature	Wet Organics Personal Lubricant	Aloe Cadabra Personal Lubricant(k) number K124044
Indications for Use	Personal lubricant, for penile and/orvaginal application, intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication.The product is compatible withnatural rubber latex andpolyisoprene condoms.This product is not compatible withpolyurethane condoms	Personal lubricant, for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms.
Primary Ingredients	Purified WaterOrganic aloe barbadensis leaf juiceZemea Select PropanediolVegeluron GelCellosize QP-30000-HXanthan GumSodium HyaluronateMicrocare SBCitric AcidCo Extract Blend	Organic aloe veraXanthan GumCitric AcidPotassium SorbateSodium Benzoate
Over-the-Counter Use	Yes	Yes
Condom compatibility	Natural rubber latex andpolyisoprene	Natural rubber latex andpolyisoprene
Sterile	No	No
Shelf life	12 months	3 years

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The subject and predicate device have the same intended use - for penile 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.

The Wet Organics Personal Lubricant contains similar ingredients to other cleared lubricants, including the predicate device. However, the subject and predicate device have slightly different formulations, different specifications and different shelf life. These differences do not raise different types of safety and effectiveness questions.

Summary of Performance Data:

Biocompatibility

Biocompatibility studies were performed in accordance with the 2016 FDA guidance 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 per ISO 10993-5:2009
Sensitization per ISO 10993-10:2010
Vaginal Irritation per ISO 10993-10:2010
Acute Systemic Toxicity per ISO 10993-11:2006

The results of testing demonstrated the subject device is not cytotoxic, not sensitizing, not irritating and is not acutely systemically toxic.

Condom Compatibility

Condom compatibility testing was performed per ASTM D7661-10 "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 Wet Organics Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. The results also demonstrated that the product is not compatible with polyurethane condoms.

Shelf Life Testing

The results of real time studies demonstrated that the Wet Organics Personal Lubricant is shown to have a 12 months shelf-life and met the device specifications as listed in Table 1 of this 510(k) Summary.

Conclusion

The Wet Organics Personal Lubricant has the same intended use as the predicate device. In addition, the Wet Organics Personal Lubricant has similar technological characteristics as compared to the predicate device. Differences in technological characteristics between the subject and predicate device did not raise different questions of safety and effectiveness. Performance testing conducted on the Wet Organics Personal Lubricant demonstrated that it was as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate.

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.