(92 days)
Wet Flavored Personal Lubricants are personal lubricants 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. The product is not compatible with polyurethane condoms.
The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow. The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.
The provided document describes the FDA's 510(k) clearance for "Wet Flavored Personal Lubricants," establishing its substantial equivalence to a predicate device. The document does not contain details about a study that adheres to the format of acceptance criteria, test set, ground truth, and human reader performance typically associated with AI/ML diagnostic tools. Instead, it presents performance data for the lubricant itself, focusing on biocompatibility, shelf-life, and condom compatibility.
Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" and "study" to fit the context of this device's clearance:
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Particle free | Particle free |
| Color | Colorless to Slight Yellow | Colorless to Slight Yellow |
| Odor | Sweet/Characteristic | Sweet/Characteristic |
| Viscosity (cps) | 200-700 cps | 200-700 cps (Meets specification) |
| Specific Gravity | 1.05 - 1.15 | 1.05 - 1.15 (Meets specification) |
| pH | 5.5-6.8 | 5.5-6.8 (Meets specification) |
| Osmolality | 400-800 mOsm/kg | 400-800 mOsm/kg (Meets specification) |
| 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 |
| Presence of Pathogens per USP <62>: | Absent | Absent |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida Albicans | Absent | Absent |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic |
| Shelf-Life | 2 years | Shown to have a 2-year shelf-life (accelerated aging confirmed; real-time ongoing) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms |
2. Sample sized used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for an AI/ML device, nor does it provide data provenance in terms of country of origin or retrospective/prospective nature. Instead, the "test set" would be the samples of the lubricant itself that were subjected to various physical, chemical, and biological tests. The specific quantities of lubricant used for each test are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device clearance. "Ground truth" for a personal lubricant is established through objective laboratory testing against recognized standards (e.g., USP monographs, ASTM standards, ISO standards for biocompatibility), not by expert consensus in the way a diagnostic AI/ML algorithm's performance is often evaluated. The experts involved would be laboratory technicians and scientists performing the tests, but their number and specific qualifications are not detailed here.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for subjective assessments in AI/ML performance evaluation where a consensus among human experts is needed. For the lubricant, the results are objective measurements or categorical determinations (e.g., "absent," "meets criteria").
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 is not an AI/ML device. There are no human readers or AI assistance involved in evaluating the lubricant's performance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm. The performance evaluation is inherently "standalone" in the sense that the device's properties are measured directly without human interpretation influencing the measurement outcome (though humans operate the testing equipment).
7. The type of ground truth used
The ground truth for this device is based on:
- Objective laboratory measurements and chemical/physical properties: For appearance, color, odor, viscosity, specific gravity, pH, and osmolality.
- Established microbiological standards: USP <51>, <61>, <62>, <1111> for antimicrobial effectiveness and microbial counts/absence of pathogens.
- International biological evaluation standards: ISO 10993 series for biocompatibility.
- ASTM standards: For condom compatibility (ASTM D7661-18, ASTM D3492-16).
These standards and measurements define the "ground truth" for whether the product meets its specifications and safety requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 23, 2022
Trigg Laboratories, Inc. Marla Bolden Regulatory/Ouality Control Manager 4220 West Windmill Lane. Suite 140 Las Vegas, NV 89139
Re: K221829
Trade/Device Name: Wet Flavored Personal Lubricants Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 24, 2022 Received: June 27, 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,
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) K221829
Device Name Wet Flavored Personal Lubricants
Indications for Use (Describe)
Wet Flavored Personal Lubricants are personal lubricants 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. The product is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
区 | Over-The-Counter Use (21 CFR 801 Subpart C)
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K221829 Page 1 of 4
Wet Flavored Personal Lubricants 510(k) Summary - K22189
| 510(k) Owner: | TRIGG LABORATORIES, INC. |
|---|---|
| Street Address: | 4220 W WINDMILL LANE, SUITE 140LAS VEGAS, NV 89139 |
| Establishment Registration Number: | 3003963141 |
| Contact Person: | Marla BoldenRegulatory and Quality Control Manager |
| Contact Number: | Phone: (702) 957-4421 |
| Summary Preparation Date: | August 23, 2022 |
| Device Trade Name: | Wet Flavored Personal Lubricants |
| Device Versions: | Wet Sultry Strawberry Flavored Personal LubricantWet Juicy Watermelon Flavored Personal LubricantWet Tropical Explosion Flavored Personal LubricantWet Popp'n Cherry Flavored Personal LubricantWet Desserts Frosted Cupcake Flavored Personal LubricantWet Desserts Whipped Cream Flavored Personal Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR §884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
| Predicate Device: | Product Name: JO Gelato Flavored Personal Lubricant510(k) Number: K172447Manufacturer: United Consortium |
The predicate device has not been subject to a design-related recall.
Device Description:
The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow.
The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.
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The device specifications are listed in Table 1 below:
| Property | Specification |
|---|---|
| Appearance | Particle free |
| Color | Colorless to Slight Yellow |
| Odor | Sweet/Characteristic |
| Viscosity (cps) | 200- 700 cps |
| Specific Gravity | 1.05 - 1.15 |
| pH | 5.5-6.8 |
| Osmolality | 400-800 mOsm/kg |
| Antimicrobial effectiveness perUSP <51> | Meets USP <51> acceptancecriteria 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 |
| Presence of Pathogens per USP<62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella | Absent |
| Escherichia coli | Absent |
| Candida Albicans | Absent |
Table 1: Device Specifications for Subject Device - Wet Flavored Personal Lubricants
Indications for Use:
Wet Flavored Personal Lubricants are personal lubricants 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. The product is not compatible with polyurethane condoms.
Substantial Equivalence Discussion:
The table below lists the comparative intended use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject Device - Wet Flavored Personal Lubricants and Predicate Device JO Gelato Flavored Personal Lubricants
| Characteristic/Feature | Wet Flavored Personal Lubricants | JO Gelato Flavored PersonalLubricants (K172447) |
|---|---|---|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Intended Use | Wet Flavored Personal Lubricants arepersonal lubricants for penile and/orvaginal application, intended tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. The product iscompatible with natural rubber latex andpolyisoprene condoms. The product is | JO Gelato Flavored Personal Lubricantsare water-based personal lubricantsfor penile and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplementthe body's natural lubrication. Thisproduct is compatible with natural |
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| not compatible with polyurethanecondoms. | rubber latex, polyurethane andpolyisoprene condoms. | |
|---|---|---|
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water/Eau, Glycerin, Pentylene Glycol,Flavor/Aroma, Cellulose Gum, PotassiumSorbate, Sucralose | Water (Aqua), Glycerin, PotassiumSorbate, Hydroxyethylcellulose,Flavor(Aroma), Sodium Chloride,Sucralose, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex and Polyisoprene | Natural Rubber Latex, Polyisoprene,Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 years | 2 years |
| Appearance | Particle free | Clear, semi-viscous liquid |
| Color | Colorless to Slight Yellow | Color |
| Odor | Sweet/Characteristic | Sweet/Characteristic |
| Viscosity (cps) | 200- 700 cps | 2000 - 3700 cps |
| Specific Gravity | 1.05 - 1.15 | 0.900 - 1.050 |
| pH | 5.5-6.8 | 5.0 - 6.0 |
| Osmolality | 400-800 mOsm/kg | 1350 – 1550 mOsm/kg |
| Antimicrobial effectivenessper USP <51> | Meets USP <51> acceptance criteria forCategory 2 products | Meets USP <51> acceptance criteria forCategory 2 products |
| Total aerobic microbial count(TAMC) per USP <61> and<111> | <10 cfu/g | <10 cfu/g |
| Total yeast and mold count(TYMC) per USP <61> and<1111> | <10 cfu/g | <10 cfu/g |
| Presence of Pathogens perUSP <62> | Absent | Absent |
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 subject and predicate device have different technological characteristics, including different formulation, viscosity, specific gravity, pH and osmolality. The different specifications of the subject device do not raise different types of safety and effectiveness questions. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.
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Summary of Performance Data:
Biocompatibility:
Biocompatibility testing was performed in accordance with 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 10993-1:2018 as follows:
- Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2017)
- Cytotoxicity (ISO Direct Contact, ISO 10993-5:2009)
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
- Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010/10993-23:2021)
The results of testing demonstrated that the subject device is non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
Shelf-Life:
The Wet Flavored Personal Lubricant is shown to have a two-year shelf life per ICH Guideline "EVALUATION FOR STABILITY DATA Q1E" 2003, for Accelerated Aging. Testing on samples with accelerated aging showed that the subject device specifications at baseline and at the end of the proposed shelf life. In addition, a real-time aging study is being conducted to confirm results of the accelerated aging study through the proposed two-year shelf life of the product.
Condom Compatibility:
Compatibility Testing was performed per ASTM D7661-18 (Air Burst and Tensile); "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and ASTM D3492-16: "Standard Specification for Rubber Contraceptives (Male Condoms)." The results show that Wet Flavored Personal Lubricants are compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the Wet Flavored Personal Lubricants are as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.