(92 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technologies.
No
The product is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose, treat, or prevent a disease or condition.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a medical condition.
No
The device is a personal lubricant, which is a physical substance applied to the body. The description focuses on its chemical composition, physical properties, and compatibility with condoms, indicating it is a hardware/substance-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 describes a topical application for physical comfort and enhancement of sexual activity.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description reinforces the topical nature of the product as a "personal lubricant."
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information about a person's health status.
The device is clearly intended for external, topical use to facilitate sexual activity, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
1
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
2
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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3
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 140 |
| LAS VEGAS, NV 89139 | |
| Establishment Registration Number: | 3003963141 |
| Contact Person: | Marla Bolden |
| Regulatory 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 Lubricant |
| Wet Juicy Watermelon Flavored Personal Lubricant | |
| Wet Tropical Explosion Flavored Personal Lubricant | |
| Wet Popp'n Cherry Flavored Personal Lubricant | |
| Wet Desserts Frosted Cupcake Flavored Personal Lubricant | |
| Wet 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 Lubricant |
| 510(k) Number: K172447 | |
| Manufacturer: 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.
4
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 per | |
| USP | Meets USP acceptance |
| criteria for Category 2 products | |
| Total aerobic microbial count | |
| (TAMC) per USP and | and |
| 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 Personal
Lubricants (K172447) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Intended 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 | JO Gelato Flavored Personal Lubricants
are water-based personal lubricants
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
product is compatible with natural |
5
| | not compatible with polyurethane
condoms. | rubber latex, polyurethane and
polyisoprene condoms. |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water/Eau, Glycerin, Pentylene Glycol,
Flavor/Aroma, Cellulose Gum, Potassium
Sorbate, Sucralose | Water (Aqua), Glycerin, Potassium
Sorbate, 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 effectiveness
per USP | Meets USP acceptance criteria for
Category 2 products | Meets USP acceptance criteria for
Category 2 products |
| Total aerobic microbial count
(TAMC) per USP and
| and
| | 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.
6
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.