Gynatrof 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.

Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.

Device Description

Gynatrof® is a personal lubricant intended to moisturize, lubricate, and enhance the ease and comfort of intimate sexual activity as well as supplement the body's natural lubrication. The product is supplied with a reusable, non-sterile, single-patient use applicator. Gynatrot® is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The product is intended for over-the-counter use.

The device formulation consists of Aqua/Water, Hydroxyethylcellulose, Lactic Acid, Polysorbate 20, Potassium Sorbate, Sodium Hyaluronate, Sodium Levulinate, Tocopherol. Gynatrof® is supplied in a 50 mL white tube; each tube contains sufficient product for 20 applications using the reusable applicator.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the medical device Gynatrof®. It focuses on demonstrating substantial equivalence to a predicate device, not on evaluating the device's performance against specific acceptance criteria in a clinical study involving human patients or complex AI algorithms.

Therefore, many of the requested elements are not applicable to this submission. The information provided is primarily related to the device specifications and non-clinical performance data which are used to show that the device is as safe and effective as a legally marketed predicate device.

Here's a breakdown of the applicable and non-applicable requested information:

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

The document provides "Device Specifications" which can be considered acceptance criteria for the physical and chemical properties of the lubricant. It then states that a shelf-life study evaluated these specifications, and the results demonstrated the device's stability over 12 months.

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Implied from "The shelf-life study evaluated all device specifications listed in Table 1")
Appearance	Off white to pale yellow gel	Met specifications after real-time aging for 12 months.
Odor	Characteristic	Met specifications after real-time aging for 12 months.
pH (25°C)	5.00 ± 0.50	Met specifications after real-time aging for 12 months.
Viscosity	67,500 - 100,000 cps (T4- 3rpm)	Met specifications after real-time aging for 12 months.
Osmolality	120 - 250 mOsm/kg	Met specifications after real-time aging for 12 months.
Specific Gravity (25°C)	0.9000 - 1.1000	Met specifications after real-time aging for 12 months.
Antimicrobial Effectiveness	Bacteria - Not less than 2.0 logreduction from the initial count at14 days, and no increase from the14 days' count at 28 days.Yeast and Molds - No increasefrom the initial calculated count at14 and 28 days. No increase isdefined as not more than 0.5 logunit higher than the previousvalue measured.	Met specifications (implied, as this testing was conducted).
Total Microbial Count	< 100 CFU/g	Met specifications (implied, as this testing was conducted).
Fungal/Yeast/Mold Limits	< 10 CFU/g	Met specifications (implied, as this testing was conducted).
Absence of Pathogenic Organisms	Absent (PseudomonasAeruginosa, StaphylococcusAureus, E. Coli, Salmonella, C.Albicans)	Met specifications (implied, as this testing was conducted).
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.	Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (as per ASTM D7661-18)	Demonstrated to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms (as per ASTM D7661-18).
Shelf Life	Stable for at least 12 months, meeting all device specifications.	The device has a shelf-life of 12-months based on the results of a real-time aging study, evaluating all device specifications.

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

This information is not explicitly detailed in the provided text. The studies mentioned are non-clinical (biocompatibility, condom compatibility, shelf-life). These types of studies typically involve laboratory samples of the product itself and possibly in vitro or animal models for biocompatibility, rather than human test sets or patient data.

Sample Size: Not specified for each test, but standard for laboratory testing of a manufactured product. For example, condom compatibility testing would likely involve a specific number of condoms and lubricant samples as per the ASTM standard.
Data Provenance: Not specified, but generally from the manufacturer's testing facilities or contract research organizations (CROs) that perform these standardized tests. These are prospective tests conducted specifically for this submission.

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. This device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for the device specifications comes from standardized test methods (e.g., USP <791> for pH) and the results derived from those methods. Biocompatibility and condom compatibility also rely on standardized methodologies and measurable outcomes, not expert consensus interpretation in a clinical context.

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

Not applicable. As this is not a clinical study involving human interpretation of medical data, there is no need for adjudication methods typical of multi-reader studies.

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-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance is established by reference to:

Standardized Test Methods: e.g., USP <791> for pH, USP <912> for viscosity, USP <51> for Antimicrobial Effectiveness, USP <61> for Total Microbial Count, USP <62> for Absence of Pathogenic Organisms.
International Standards for Biocompatibility: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Vaginal Irritation), ISO 10993-11 (Acute Systemic Toxicity).
ASTM Standard for Condom Compatibility: ASTM D7661-18.
The "ground truth" for these tests is therefore the objective, measurable outcome of these standardized scientific and engineering tests, not subjective expert consensus or clinical outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The product formulation is developed through research and development, and then tested for specifications.

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

Not applicable. There is no "training set" in the context of an AI algorithm. The product formulation and manufacturing process are developed to meet the desired specifications and performance characteristics, which are then verified through the non-clinical testing described.

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 1, 2024

Tyros Biopharma Inc. % Roshana Ahmed President Ouaras. LLC 2101 Camino Rey Fullerton, California 92833

Re: K232040

Trade/Device Name: Gynatrof® Regulation Number: 21 CFR 884.5300 Regulation Name: Lubricant, Personal Regulatory Class: II Product Code: NUC Dated: February 2, 2024 Received: February 2, 2024

Dear Roshana Ahmed:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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 -S

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

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Indications for Use

510(k) Number (if known) K232040

Device Name

Gynatrof®

Indications for Use (Describe)

Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K232040

I. Submitter

Tyros Biopharma Inc. 4702 Louis-B.-Mayer Suite 305 Laval, QC H7P 0L9 Canada

Contact Person: Anthony Gouvoussis, CEO Phone: 514-447-1485 Date Prepared: February 29, 2024

II. Subject Device Information

Device Proprietary Name:	Gynatrof®
Common or Usual Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Product Code:	NUC (Lubricant, Personal)
Device Classification	Class II

III. Predicate Device Information

Device Proprietary Name:	Gynomunal
510(k) number	K143349
Manufacturer	Polichem SA
Regulation Number:	21 CFR 884.5300
Product Code:	NUC (Lubricant, Personal)
Device Classification	Class II

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

IV. Device Description

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The device specifications are listed in the table below:

Parameter	Test Method	Specification
Appearance	Visualinspection	Off white to pale yellow gel
Odor	Olfactory	Characteristic
pH (25°C)	USP <791>	5.00 ± 0.50
Viscosity	USP <912>	67,500 - 100,000 cps (T4- 3rpm)
Osmolality	USP <785>	120 - 250 mOsm/kg
Specific Gravity (25°C)	USP <841>	0.9000 - 1.1000
Antimicrobial Effectiveness	USP <51>	Bacteria - Not less than 2.0 logreduction from the initial count at14 days, and no increase from the14 days' count at 28 days.Yeast and Molds - No increasefrom the initial calculated count at14 and 28 days. No increase isdefined as not more than 0.5 logunit higher than the previousvalue measured.
Total Microbial Count	USP <61>	< 100 CFU/g
Fungal/Yeast/Mold Limits	USP <61>	< 10 CFU/g
Absence of Pathogenic Organisms	USP <62>	Absent (PseudomonasAeruginosa, StaphylococcusAureus, E. Coli, Salmonella, C.Albicans)

Table 1 - Device Specifications

V. Indications for Use

Gynatrof® 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.

Gynatrof® is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.

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VI. Comparison of Intended Use and Technological Characteristics with the Predicate Device

Table 2 : Technological Comparison between Subject Device - Gynatrof and Predicate device-Gynomunal
Feature	Gynatrof (Subject device)	Gynomunal (Predicate Device)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	Gynatrof is a personal lubricant, forvaginal and/or penile application,intended to moisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. Gynatrof is compatiblewith natural rubber latex, polyisoprenecondoms, and polyurethane condoms.	Gynomunal is a personal lubricant, forpenile and/or vaginal application,intended to moisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity and supplementthe body'snatural lubrication. This product iscompatible with natural rubber latexcondoms
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Aqua/Water, Hydroxyethyl cellulose,Lactic Acid, Polysorbate 20, PotassiumSorbate, Sodium Hyaluronate, SodiumLevulinate, Tocopherol.	Purified water, propylene glycol,denatured ethanol, hop extract(Humulus lupulus), soy lecithin(E322), carbomer, methyl-4-hydroxybenzoate (E219),cholesterol, imidazolidinylurea,sodium edetate, hyaluronic acid,propyl-4-hydroxybenzoate(E217), tocopherol acetate(vitamin E)
pH	4.50 to 5.50	5.5 to 6.5
Osmolality	120 - 250 mOsm/kg	2,000 - 3,000 mOsmol/Kg
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex, Polyisoprene,Polyurethane	Natural Rubber Latex
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested (USP<51>, USP <61>, USP<62>)	Yes	Yes
Shelf life	12 months	36 months

The subject and predicate device have similar indications for use statements and have the same intended use (i.e., provides lubrication during intimate sexual activity).

The subject and predicate devices are both water-based, non-sterile lubricants with differences in technological characteristics, including different formulations and device specifications. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

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VII. Summary of Non-Clinical Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility: Biocompatibility studies were performed in accordance with the 2020 FDA guidance 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:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, nonirritating, and non-systemically toxic.

Condom Compatibility: The compatibility of the subject devices with natural rubber latex. polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of testing demonstrated that the subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Shelf Life: The subject device has a shelf-life of 12-months based on the results of a real-time aging study. The shelf-life study evaluated all device specifications listed in Table 1.

VIII. Conclusion

The results of the performance testing described above demonstrate that Gynatrof® 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.