Wet Essential95 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

The Wet Essential95 Personal Lubricant is a non-sterile, water-based personal lubricant 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. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Wet Essential95 Personal Lubricant). It does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria for an AI model, data sets, expert involvement, and statistical studies like MRMC, is not applicable to this document.

However, I can extract information related to the device's performance testing and criteria for its intended use as a personal lubricant.

Here's the information that can be extracted or derived from the document:

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

The document provides specifications that essentially serve as acceptance criteria for the physical and chemical properties of the lubricant, as well as biological and compatibility performance.

Property	Specification (Acceptance Criteria)	Reported Device Performance (Implied "Meets Specification")
Appearance	Semi-opaque, particle-free, liquid gel	Met
Color	Light tan to brown	Met
Odor	Vanilla	Met
Viscosity@25°C Spindle LV#3 @20rpm (cps)	400 cps - 3,200 cps	Met
Specific Gravity@25°C per USP <841>	0.99 – 1.04	Met
pH per USP <791>	4.5 - 5.5	Met
Osmolality per USP <785>	150-300 mOsm/kg, 1:10 dilution	Met
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Demonstrated to meet USP <51> acceptance criteria (implies effective against microbial growth)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	<100 cfu/g	Met (<100 cfu/g)
Total yeast and mold count (TYMC) per USP <61> and <1111>	<10 cfu/g	Met (<10 cfu/g)
Absence of Pathogens per USP <62>	Absent	Absent (Met)
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic	Confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible (per ASTM D7661-10(R) 2017)
Condom Compatibility (Polyisoprene)	Compatible	Compatible (per ASTM D7661-10(R) 2017)
Condom Compatibility (Polyurethane)	Not compatible	Not compatible (per ASTM D7661-10(R) 2017)
Shelf-Life	8.5 months (maintains specifications)	Demonstrated to maintain specifications over 8.5 months (accelerated testing results)

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

Sample Size: The document does not specify exact sample sizes for each test conducted. It states that "testing was conducted" and "results from accelerated testing demonstrated," implying that sufficient samples were used to meet the requirements of the listed standards (e.g., ISO 10993-11, ISO 10993-5, ISO 10993-10, ASTM D7661-10(R) 2017, USP <51>, <61>, <62>, <791>, <785>, <841>). These standards typically have their own minimum sample size requirements for valid results.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted in accordance with international standards (ISO, ASTM, USP) and FDA guidance, suggesting a robust and controlled testing environment. The data would be considered prospective, as it was generated specifically for this premarket notification.

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

This concept is not applicable to this type of device and testing. Ground truth in this context refers to the defined specifications and performance standards established by recognized testing methods (e.g., USP monographs, ISO standards, ASTM standards). The "experts" would be the scientists and technicians performing the lab tests according to these established protocols, and their qualifications would be adherence to Good Laboratory Practices (GLP) and expertise in the specific analytical or biological testing methods. No human interpretation of images or clinical data for "ground truth" establishment in the AI/ML sense is mentioned or relevant here.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret data, and discrepancies need to be resolved. This document reports on laboratory and bench testing against defined physical, chemical, and biological specifications, which do not involve such adjudication.

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:

Not applicable. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or relevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for this device's performance validation is the adherence to established physical, chemical, and biological standards and specifications. For instance:

USP (United States Pharmacopeia) Monographs: for pH, viscosity, osmolality, microbial counts, and antimicrobial effectiveness.
ISO (International Organization for Standardization) Standards: for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
ASTM (American Society for Testing and Materials) Standards: for condom compatibility.
Developer-defined specifications: for appearance, color, odor, specific gravity, which are then verified through standard analytical methods.

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/ML model that requires a training set. The "formulation" or "design" process leads to the product, which is then validated. There isn't a "training set" in the computational sense.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 7, 2022

Trigg Laboratories, Inc. Marla Bolden Regulatory/Ouality Control Manager 4220 W. Windmill Lane. Suite 140 Las Vegas, NV 89139

Re: K220534

Trade/Device Name: Wet Essential95 Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 7, 2022 Received: June 7, 2022

Dear Marla Bolden:

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.

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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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 D. Garcia, Ph.D. 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) K220534

Device Name Wet Essential95 Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☐ Transaction involving USDA-funded Child Nutrition Programs	☑ Direct Farm to Consumer sales
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| | 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 K220534 Wet Essential95 Personal Lubricant

1. Submitter Information

Company Name:	Trigg Laboratories, Inc.
Company Address:	4220 W Windmill Lane, Suite 140Las Vegas, NV 89139
Company Phone:	(702) 957-4400
Contact Person:	Marla BoldenRegulatory and Quality Control ManagerTrigg Laboratories, Inc.Email: marlab@trigglabs.com

July 1, 2022 Date Prepared:

2. Subject Device

Device Trade Name:	Wet Essential95 Personal Lubricant
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Device Class:	Class II
Product Code:	NUC (lubricant, personal)

1. Predicate Device

Device Name	Aloe Cadabra Personal Lubricant and Aloe Cadabra
	Flavored/Scented Lubricants
510(k) number	K124044
Manufacturer	Seven Oaks Ranch, Inc.

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

4. Device Description

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The specifications for Wet Essential95 Personal Lubricant are described in Table 1.

Property	Specification
Appearance	Semi-opaque, particle-free, liquid gel
Color	Light tan to brown
Odor	Vanilla
Viscosity@25°C Spindle LV#3 @20rpm (cps)	400 cps - 3,200 cps
Specific Gravity@25°C per USP <841>	0.99 – 1.04
pH per USP <791>	4.5 - 5.5
Osmolality per USP <785>	150-300 mOsm/kg, 1:10 dilution
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria forCategory 2 products
Total aerobic microbial count (TAMC) per USP <61>and <1111>	<100 cfu/g
Total yeast and mold count (TYMC) per USP <61>and <1111>	<10 cfu/g
Absence of Pathogens per USP <62>	Absent

	Table 1: Device Specifications for the Wet Essential95 Personal Lubricant

5. Indication for Use Statement

Wet Essential95 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

6. Comparison of Intended Use and Technological Characteristics

The following table compares the intended use and technological characteristics of the subject and predicate device:

of the Subject and Predicate Device
	K220534Subject Device	K124044Predicate Device	Comparison
Device Name	Wet Essential95Personal Lubricant	Aloe Cadabra Lubricant,Aloe CadabraFlavored/scented Lubricants
Indications forUse	Wet Essential95 PersonalLubricant is a personallubricant, for penile and/orvaginal application, intendedto moisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubber	Aloe Cadabra® Lubricantand Aloe Cadabra®Flavored/ScentedLubricants are personallubricants, for penileand/or vaginalapplication, intended tomoisturize and lubricate,to enhance the ease andcomfort of intimate sexual	The indications foruse for the subjectand predicatedevice are thesame. Therefore,the subject andpredicate devicehave the sameintended use.

	latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	activity and supplementthe body's naturallubrication. This product iscompatible with naturalrubber latex andpolyisoprene condoms.This product is notcompatible withpolyurethane condoms.
Rx/OTC	OTC	OTC	Same
Base Type	Water	Water	Same
Sterile	No	No	Same
PrimaryIngredients	Aloe Barbadensis LeafJuice; Chamomilla Recuitita(Matricaria) Extract;Chamomilla Recuitita(Chamomile) FlowerExtract; CyamopsisTetragonoloba (Guar) Gum;Xanthan Gum; VanillaFlavor; Potassium Sorbate;Sodium Benzoate; SteviaRebaudiana Extract; CitricAcid	95% organic aloeAdditional formulationinformation is not publiclyavailable	Different: Thesubject andpredicate devicehave differences informulation. Thesedifferences do notraise differentquestions of safetyand effectiveness(S&E).
pH	4.5-5.5	Not publicly available	Different: Thesubject andpredicate devicesmay differ in pHspecification.Differences in pHspecification do notraise differentquestions S&E.
Osmolality	150-300 mOsm/kg, 1:10dilution	Not publicly available	Different: Thesubject andpredicate devicesmay differ inosmolalityspecification.Differences inosmolalityspecification do notraise differentquestions of S&E.
Viscosity	400-3,200 cps	Not publicly available	Different: Thesubject andpredicate devicesmay differ in

			viscosityspecification.Differences inviscosityspecification do notraise differentquestions of S&E.
BiocompatibilityTested	Yes	Yes	Same
Microbial LimitsTested (per USP<61>)	Yes	Yes	Same
AntimicrobialEffectiveness(per USP<51>)	Yes	Not tested	Different: Thesubject deviceunderwentantimicrobialeffectiveness testingConducting thistesting to ensurethat the device willnot support orenhance the growthof microorganismsdoes not raisedifferent questionsof S&E.
Absence ofPathogenicOrganismsper USP <62>	Yes	Yes	Same
CondomCompatibility	Compatible with naturalrubber latex and polyisoprenecondoms. Not compatiblewith polyurethane condoms.	Compatible with naturalrubber latex andpolyisoprene condoms.Not compatible withpolyurethane condoms.	Same
Shelf-Life	8.5 Months	2 years	Different: Thesubject andpredicate devicehave different shelf-life durations. Thesedifferences do notraise differentquestions of S&E.

Table 2: Intended Use and Technological Characteristics Comparison

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The subject and predicate devices have the same indications for use and the same intended use (i.e., to provide lubrication during intimate sexual activity). The subject and predicate devices have different technological characteristics, including different formulations, device specifications, and shelf-life. The different technological characteristics identified do not raise different questions of safety and effectiveness.

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7. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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." The following testing was conducted:

Acute Systemic Toxicity (ISO 10993-11:2017)
Cytotoxicity (Direct Contact, ISO 10993-5:2009) ●
. Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
Irritation (Vaginal Irritation, ISO 10993-10:2010) ●

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

Condom Compatibility

The compatibility of Wet Essential95 Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Wet Essential95 Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Wet Essential95 Personal Lubricant not to be compatible with polyurethane condoms.

Shelf-Life

The subject device has a shelf-life of 8.5 months. Results from accelerated testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

8. Conclusion

The results of the testing described above demonstrate that Wet Essential95 Personal Lubricant is as safe and effective 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.