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.

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.

AI/ML Overview

The provided text describes the Trophikos Vaginal Moisturizer, which is a personal lubricant. The information focuses on its performance testing and how it demonstrates substantial equivalence to a predicate device, rather than a study proving it meets acceptance criteria for an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML studies is not applicable.

Here's an analysis of the available information:

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

The acceptance criteria are referred to as "Specifications" in the document (Table 1). The reported device performance is that these specifications were "met" across the shelf life duration.

Parameter	Specifications (Acceptance Criteria)	Reported Device Performance
Appearance	Gel Cream	Met (implied, as all parameters met specifications)
Odor	Characteristic	Met (implied, as all parameters met specifications)
Color	Off-White	Met (implied, as all parameters met specifications)
pH per USP<912>	3.8 – 4.6	Met (implied, as all parameters met specifications)
Viscosity per USP <912>	25,000 - 75,000 cP	Met (implied, as all parameters met specifications)
Osmolality per USP <785>	750 – 840 mOsm/kg	Met (implied, as all parameters met specifications)
Total Yeast and Mold Count (TYMC) per USP <61> and <1111>	≤ 10 cfu/g	Met (implied, as all parameters met specifications)
Total Aerobic Microbial Count (TAMC) per USP <61> and <1111>	≤ 100 cfu/g	Met (implied, as all parameters met specifications)
Absence of Pathogenic Organism per USP<62>	E. coli, Salmonella, C.albicans, S. aureus, P. aeruginosa (all Absent)	Met (implied, as all parameters met specifications)
Antimicrobial Effectiveness per USP<51> (Bacteria)	No less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count	Met (implied, as all parameters met specifications)
Antimicrobial Effectiveness per USP<51> (Yeast/Mold)	No increase from the initial calculated count at 14 and 28 days	Met (implied, as all parameters met specifications)

Additionally, specific performance tests were conducted:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Evaluation in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, including specific tests for Cytotoxicity (ISO 10993-5), Guinea Pig Maximization Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The results must be adequate to support the conclusion that the device is biocompatible.	Performed, and "the results provided are adequate to support the conclusion that the subject device is biocompatible."
Condom Compatibility	Evaluation in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". Determine compatibility with natural rubber latex, polyisoprene, and polyurethane 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."
Shelf Life	All device parameters listed in Table 1 (Appearance, Odor, Color, pH, Viscosity, Osmolality, Microbial Counts, Antimicrobial Effectiveness) must meet their respective specifications across the shelf life duration.	"All device parameters listed in Table 1 were tested and met the specifications across the shelf life duration."

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

This document pertains to a medical device (vaginal moisturizer), not an AI/ML software. Therefore, the concept of a "test set" for an algorithm is not applicable. The performance testing involves laboratory tests on the product itself (e.g., chemical properties, microbial counts, biocompatibility with tissue models/animals, and compatibility with condoms). The document does not specify the sample sizes for these tests or the data provenance in terms of country of origin, nor is it relevant given the nature of the device.

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)

Not applicable, as this is not an AI/ML device relying on expert-established ground truth.

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

Not applicable, as this is not an AI/ML device requiring adjudication of results from a test set.

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. The device is a physical product (vaginal moisturizer), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm.

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

For the physical and chemical properties and microbial tests, the "ground truth" is defined by established laboratory testing standards (e.g., USP, ASTM) and the specified ranges or thresholds. For biocompatibility, the ground truth is determined by the results of the ISO 10993 series tests. For condom compatibility, the ground truth is determined by the results of the ASTM D7661-10 test. There isn't an "expert consensus" or "pathology" type of ground truth in the context of this product's evaluation.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

In summary, the provided document is a 510(k) clearance letter for a physical medical device (vaginal moisturizer) and details its physical, chemical, and biological performance characteristics against established standards, rather than the performance of an AI/ML algorithm.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K201922

Device Name Trophikos Vaginal Moisturizer

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

Date Prepared:	January 12, 2021
Submission Sponsor:	Trophikos, LLC1212 Collier Rd NWAtlanta, GA 30318Telephone - (877) 421-7160Terri Jackson Wade - CEO
Submission Correspondent:	Paul DrydenTrophikos, LLC c/o ProMedic, LLC131 Bay Point Dr. NE, St. Petersburg, FL 33704USA(239) 306-6061paul.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:

The device specifications are listed in Table 1 below:

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Parameter	Specifications
Appearance	Gel Cream
Odor	Characteristic
Color	Off-White
pH per USP<912>	3.8 – 4.6
Viscosity per USP <912>	25,000 - 75,000 cP
Osmolality per USP <785>	750 – 840 mOsm/kg
Total Yeast and Mold Count (TYMC) perUSP <61> and <1111>	≤ 10 cfu/g
Total Aerobic Microbial Count (TAMC)per USP <61> and <1111>	≤ 100 cfu/g
Absence of Pathogenic Organism per USP<62>	E. coli	Absent
	Salmonella	Absent
	C.albicans	Absent
	S. aureus	Absent
	P. aeruginosa	Absent
Antimicrobial Effectiveness per USP<51>	Bacteria: No less than 2.0 log reduction at14 days and no increase from 14-daycount at the 28-day count
	Yeast/Mold: No increase from the initialcalculated count at 14 and 28 days

Table 1: Specifications for Trophikos Vaginal Moisturizer (Subject Device)

Indications for Use:

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:

	K190752Predicate Device	K201922Subject Device
Device Name	Satisfaite	Trophikos VaginalMoisturizer

Table 2: Technological Characteristics of Subject Device Compared to Predicate Device

Indication forUse	Satisfaite™ is a personallubricant, for vaginal application,intended to moisturize andlubricate, to supplement thebody's natural lubrication, and toenhance the ease and comfort ofintimate sexual activity. Thisproduct is compatible withnatural rubber latex, andpolyisoprene condoms; and is notcompatible with polyurethanecondoms.	Trophikos Vaginal Moisturizer isa personal lubricant, for vaginalapplication, intended to moisturizeand lubricate, to enhance the easeand comfort of intimate sexualactivity and to supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms and is not compatiblewith polyurethane condoms.
Water-based	Yes	Yes
PrimaryIngredients	Purified water, glycerin,propylene glycol,hydroxyethylcellulose, sodiumhyaluronate, hydrochloric acid,methylparaben, vitamin E	Water (aqua), glycerin,Simmondsia Chinensis (Jojoba)seed oil, cetyl alcohol,dimethicone, tetrahexyldecylascorbate, sodium hyaluronate,palmitoyl tripeptide-5, acetyltetrapeptide-2, hydrogenatedlecithin, ubiquinone, tocopherylacetate, caprylyl glycol,tocopherol, citric acid,potassium sorbate, squalane,glyceryl stearate,Leuconostoc/radish root fermentfiltrate, polyacrylatecrosspolymer-6, t-butyl alcohol
CondomCompatibility	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible withpolyurethane condoms.	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible withpolyurethane condoms.
Sterile	No	No
AntimicrobialTested	Yes	Yes
BiocompatibilityTested	Yes	Yes
OTC use	Yes	Yes

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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.

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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.

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.