(235 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and chemical properties, biocompatibility, and condom compatibility. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The product is a personal lubricant intended to moisturize and lubricate for ease and comfort during sexual activity, which is not considered a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section states that Gynatrof is a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity and supplement natural lubrication. It does not mention any diagnostic purpose.
No
The device is a personal lubricant supplied in a tube with a reusable applicator, which are physical components, 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 moisturizing and lubricating to enhance comfort during sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description reinforces its function as a lubricant and details its formulation and packaging. There is no mention of analyzing samples from the body to provide diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life, which are relevant for a personal lubricant, not an IVD.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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"
1
(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
2
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
3
Indications for Use
510(k) Number (if known) K232040
Device Name
Gynatrof®
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
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.
5
The device specifications are listed in the table below:
| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual | |
| inspection | Off white to pale yellow gel | |
| Odor | Olfactory | Characteristic |
| pH (25°C) | USP | 5.00 ± 0.50 |
| Viscosity | USP | 67,500 - 100,000 cps (T4- 3rpm) |
| Osmolality | USP | 120 - 250 mOsm/kg |
| Specific Gravity (25°C) | USP | 0.9000 - 1.1000 |
| Antimicrobial Effectiveness | USP | Bacteria - Not less than 2.0 log |
| reduction from the initial count at | ||
| 14 days, and no increase from the | ||
| 14 days' count at 28 days. | ||
| Yeast and Molds - No increase | ||
| from the initial calculated count at | ||
| 14 and 28 days. No increase is | ||
| defined as not more than 0.5 log | ||
| unit higher than the previous | ||
| value measured. | ||
| Total Microbial Count | USP | |
| Aeruginosa, Staphylococcus | ||
| Aureus, 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.
6
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, for | |||
| vaginal and/or penile 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. | Gynomunal 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. This product is | ||||
| compatible with natural rubber latex | ||||
| condoms | ||||
| Water soluble | Yes | Yes | ||
| Contains water | Yes | Yes | ||
| Primary ingredients | Aqua/Water, Hydroxyethyl cellulose, | |||
| Lactic Acid, Polysorbate 20, Potassium | ||||
| Sorbate, Sodium Hyaluronate, Sodium | ||||
| Levulinate, 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 | ||||
| , USP , USP | ||||
| ) | 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.
7
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.