(188 days)
Not Found
No
The device description and performance studies focus on the chemical formulation, biocompatibility, and condom compatibility of a personal lubricant. There is no mention of AI or ML technology.
No
The device is described as a personal lubricant intended to moisturize and lubricate for enhancing ease and comfort during intimate sexual activity, supplementing natural lubrication. Its primary function is to facilitate sexual activity and improve comfort, not to treat or prevent a disease or condition, which is the defining characteristic of a therapeutic device.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states it is a water-based, non-sterile personal lubricant with a detailed chemical formulation and packaging description, indicating it is a physical product, 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 clearly stated as a "personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication." This describes a device used on the body for physical lubrication, not a device used to test samples from the body to diagnose or monitor a medical condition.
- Device Description: The description details the physical form (water-based lubricant), ingredients, and packaging. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on shelf life, biocompatibility (how the device interacts with the body), and condom compatibility. These are relevant to a topical lubricant, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Trophikos Vaginal Moisturizer is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Trophikos Vaginal Moisturizer is a water-based, non-sterile personal lubricant, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerin, Simmondsia Chinensis (Jojoba) seed oil, cetyl alcohol, dimethicone, tetrahexyldecyl ascorbate, Leuconostoc/radish root ferment filtrate, sodium hyaluronate, palmitoyl tripeptide-5, acetyl tetrapeptide-2, hydrogenated lecithin, ubiquinone, tocopheryl acetate, caprylyl glycol, tocopherol, citric acid, potassium sorbate, squalane, glyceryl stearate, polyacrylate crosspolymer-6, and tbutyl alcohol. Trophikos Vaginal Moisturizer is packaged in 30 mL airless bottles made of styrene-acrylonitrile, with a piston made of polyethylene, and an aluminum base. Trophikos Vaginal Moisturizer is a personal lubricant with over-the-counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Shelf Life: All device parameters listed in Table 1 were tested and met the specifications across the shelf life duration.
Biocompatibility: The biocompatibility evaluations were conducted 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". The following biocompatibility testing was conducted:
- Cytotoxicity (ISO 10993-5:2009)
- Guinea Pig Maximization Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The above biocompatibility testing was performed, and the results provided are adequate to support the conclusion that the subject device is biocompatible.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". The results of the testing indicate that the subject device is compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 14, 2021
Trophikos, LLC % Paul E. Dryden President Trophikos, LLC c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K201922
Trade/Device Name: Trophikos Vaginal Moisturizer Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 11, 2020 Received: December 15, 2020
Dear Paul E. Dryden:
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.
1
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 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 (OS) 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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201922
Device Name Trophikos Vaginal Moisturizer
Indications for Use (Describe)
Trophikos Vaginal Moisturizer is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
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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3
510(k) Summary
| Date Prepared: | January 12, 2021 |
|---|---|
| Submission Sponsor: | Trophikos, LLC |
| 1212 Collier Rd NW | |
| Atlanta, GA 30318 | |
| Telephone - (877) 421-7160 | |
| Terri Jackson Wade - CEO | |
| Submission Correspondent: | Paul Dryden |
| Trophikos, LLC c/o ProMedic, LLC | |
| 131 Bay Point Dr. NE, St. Petersburg, FL 33704 | |
| USA | |
| (239) 306-6061 | |
| paul.dryden@promedic.cc | |
| Trade Name: | Trophikos Vaginal Moisturizer |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | II |
| Predicate Device: | Satisfaite |
| Manufacturer: | FemmePharma Consumer Healthcare, LLC |
| 510(k) Number: | K190752 |
The predicate device has not been subject to a design-related recall.
Device Description:
Trophikos Vaginal Moisturizer is a water-based, non-sterile personal lubricant, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerin, Simmondsia Chinensis (Jojoba) seed oil, cetyl alcohol, dimethicone, tetrahexyldecyl ascorbate, Leuconostoc/radish root ferment filtrate, sodium hyaluronate, palmitoyl tripeptide-5, acetyl tetrapeptide-2, hydrogenated lecithin, ubiquinone, tocopheryl acetate, caprylyl glycol, tocopherol, citric acid, potassium sorbate, squalane, glyceryl stearate, polyacrylate crosspolymer-6, and tbutyl alcohol. Trophikos Vaginal Moisturizer is packaged in 30 mL airless bottles made of styrene-acrylonitrile, with a piston made of polyethylene, and an aluminum base. Trophikos Vaginal Moisturizer is a personal lubricant with over-the-counter (OTC) use.
The device specifications are listed in Table 1 below:
4
| Parameter | Specifications | |
|---|---|---|
| Appearance | Gel Cream | |
| Odor | Characteristic | |
| Color | Off-White | |
| pH per USP | 3.8 – 4.6 | |
| Viscosity per USP | 25,000 - 75,000 cP | |
| Osmolality per USP | 750 – 840 mOsm/kg | |
| Total Yeast and Mold Count (TYMC) per | ||
| USP and | ≤ 10 cfu/g | |
| Total Aerobic Microbial Count (TAMC) | ||
| per USP and | ≤ 100 cfu/g | |
| Absence of Pathogenic Organism per USP | E. coli | Absent |
| Salmonella | Absent | |
| C.albicans | Absent | |
| S. aureus | Absent | |
| P. aeruginosa | Absent | |
| Antimicrobial Effectiveness per USP | Bacteria: No less than 2.0 log reduction at | |
| 14 days and no increase from 14-day | ||
| count at the 28-day count | ||
| Yeast/Mold: No increase from the initial | ||
| calculated count at 14 and 28 days |
Table 1: Specifications for Trophikos Vaginal Moisturizer (Subject Device)
Indications for Use:
Trophikos Vaginal Moisturizer is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Summary of Technological Characteristics of Subject Device in Comparison to Predicate:
Comparison of the technological features of the subject and predicate devices is provided in Table 2 below:
| | K190752
Predicate Device | K201922
Subject Device |
|-------------|-----------------------------|----------------------------------|
| Device Name | Satisfaite | Trophikos Vaginal
Moisturizer |
| Table 2: Technological Characteristics of Subject Device Compared to Predicate Device | ||
|---|---|---|
| Indication for | ||
| Use | Satisfaite™ is a personal | |
| lubricant, for vaginal application, | ||
| intended to moisturize and | ||
| lubricate, to supplement the | ||
| body's natural lubrication, and to | ||
| enhance the ease and comfort of | ||
| intimate sexual activity. This | ||
| product is compatible with | ||
| natural rubber latex, and | ||
| polyisoprene condoms; and is not | ||
| compatible with polyurethane | ||
| condoms. | Trophikos Vaginal Moisturizer is | |
| a personal lubricant, for vaginal | ||
| application, intended to moisturize | ||
| and lubricate, to enhance the ease | ||
| and comfort of intimate sexual | ||
| activity and to supplement the | ||
| body's natural lubrication. This | ||
| product is compatible with natural | ||
| rubber latex and polyisoprene | ||
| condoms and is not compatible | ||
| with polyurethane condoms. | ||
| Water-based | Yes | Yes |
| Primary | ||
| Ingredients | Purified water, glycerin, | |
| propylene glycol, | ||
| hydroxyethylcellulose, sodium | ||
| hyaluronate, hydrochloric acid, | ||
| methylparaben, vitamin E | Water (aqua), glycerin, | |
| Simmondsia Chinensis (Jojoba) | ||
| seed oil, cetyl alcohol, | ||
| dimethicone, tetrahexyldecyl | ||
| ascorbate, sodium hyaluronate, | ||
| palmitoyl tripeptide-5, acetyl | ||
| tetrapeptide-2, hydrogenated | ||
| lecithin, ubiquinone, tocopheryl | ||
| acetate, caprylyl glycol, | ||
| tocopherol, citric acid, | ||
| potassium sorbate, squalane, | ||
| glyceryl stearate, | ||
| Leuconostoc/radish root ferment | ||
| filtrate, polyacrylate | ||
| crosspolymer-6, t-butyl alcohol | ||
| 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. | ||
| Sterile | No | No |
| Antimicrobial | ||
| Tested | Yes | Yes |
| Biocompatibility | ||
| Tested | Yes | Yes |
| OTC use | Yes | Yes |
5
The subject and predicate device have different technological characteristics including their formulation. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
6
Summary of Performance Testing:
Shelf Life: All device parameters listed in Table 1 were tested and met the specifications across the shelf life duration.
Biocompatibility: The biocompatibility evaluations were conducted 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". The following biocompatibility testing was conducted:
- Cytotoxicity (ISO 10993-5:2009)
- Guinea Pig Maximization Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The above biocompatibility testing was performed, and the results provided are adequate to support the conclusion that the subject device is biocompatible.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". The results of the testing indicate that the subject device is compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms.
Substantial Equivalence Conclusion: The results of the performance testing described above demonstrate that Trophikos Vaginal Moisturizer is as safe and effective as the predicate device and supports a determination of substantial equivalence.