HyaloGYN® is a personal lubricant for 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 polyisoprene condoms.

Device Description

HyaloGYN is a line extension to add a formulation of HyaloGYN not made with parabens. It is a nonsterile, colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process.

HyaloGYN is a non-hormonal vaginal moisturizer intended to hydrate the vaginal epithelium because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol combine with the hyaluronic acid derivative to enable HyaloGYN to achieve its thick, viscous gel form, and the mucoadhesive properties to allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating this tissue. It is provided in an aluminum tube and packaged together with single-use applicators in a cardboard box. HyaloGYN has a shelf life of 3 years.

AI/ML Overview

This document is a 510(k) summary for the HyaloGYN Vaginal Hydrating Gel, demonstrating its substantial equivalence to previously cleared devices. It describes the device, its intended use, and provides a summary of performance data including biocompatibility, bench testing, and a clinical study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device's main function (vaginal moisturizing and lubrication) in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the positive outcomes of the clinical study, demonstrating safety and effectiveness for its intended use.

However, where an explicit criterion is mentioned (condom compatibility), it is included. For other assessments, the "acceptance criteria" are interpreted as successful completion of the test/study without adverse findings, and "reported device performance" summarizes the key findings.

Acceptance Criteria (Implied/Explicit)	Reported Device Performance
Biocompatibility:
- In vitro Cytotoxicity Assay per ISO 10993-5	Confirmed safe.
- Sensitization (Guinea Pig Maximization Test) per ISO 10993-10	Confirmed safe.
- Vaginal Irritation Test per ISO 10993-10	Confirmed safe.
- Acute Systemic Toxicity Rat per ISO 10993-11	Confirmed safe.
Bench Performance:
- Condom compatibility per ASTM D7661-10	The subject device product is compatible with polyisoprene condoms.
- Appearance	Met product specifications at release.
- Odor	Met product specifications at release.
- Color	Met product specifications at release.
- Weight	Met product specifications at release.
- pH	Met product specifications at release.
- Hyaluronic acid content	Met product specifications at release.
- Total Aerobic Microbial Count	Met product specifications at release.
- Total combined yeasts/molds count	Met product specifications at release.
- Absence of common pathogens (Pseudomonas aeruginosa, Staphylococcus	Met product specifications at release.
aureus, Candida albicans)
- Viscosity	Met product specifications at release.
- Osmolality	Met product specifications at release.
Clinical Performance:
- Safety (absence of adverse events)	Safety considered excellent, demonstrated by absence of adverse events and investigator's overall tolerability score (98.7%). No alterations of the vaginal ecosystem.
- Effectiveness (moisturizing effects on vaginal mucosa)	The test material demonstrated moisturizing effects on the vaginal mucosa.
Stability Testing:
- Shelf life	HyaloGYN® has a 36-months shelf life based on the results of shelf life testing.

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

Sample size for the test set:
- Clinical Study: 80 women were enrolled.
- Biocompatibility and Bench Testing: Sample sizes are not explicitly stated for these tests, but they were conducted on the device material itself.
Data provenance:
- Clinical Study: Conducted in Italy, and was a prospective, open, uncontrolled pilot clinical study.
- Other tests (Biocompatibility, Bench, Stability): The specific origin of data for these tests is not explicitly stated beyond being conducted by Fidia.

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)

The document refers to "investigator's overall assessment of tolerability score (98.7%)" in the clinical study. It does not specify the number of investigators/experts or their specific qualifications (e.g., years of experience, specialty beyond being the study investigator) who established ground truth for the clinical performance points like tolerability and moisturizing effects.
For biocompatibility and bench testing, "experts" involved are implied to be personnel conducting the tests according to ISO/ASTM standards, but their specific number and qualifications are not detailed.

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

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. It was an "open, uncontrolled clinical study" where a single investigator's assessment contributed to the "tolerability score."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
This device is a vaginal hydrating gel, not an AI or diagnostic imaging device. Therefore, a study assessing human reader improvement with AI assistance is not applicable.

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

No, this is not an algorithm or AI device. Therefore, "standalone" algorithm performance is not applicable. The device itself (the gel) is the "standalone" product being tested.

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

Clinical Study: The ground truth for effectiveness (moisturizing effects) and safety (tolerability, absence of adverse events, no alterations of vaginal ecosystem) was established through clinical observation and assessment by the study investigator based on pre-defined clinical endpoints and patient feedback.
Biocompatibility Testing: Ground truth established by adherence to and results of standardized ISO test methods.
Bench Testing: Ground truth established by adherence to product specifications at release (e.g., pH, viscosity, microbial counts) and standardized ASTM test methods (condom compatibility).

8. The sample size for the training set

This device is a medical product (gel), not an AI algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable. Its formulation and design would be based on scientific principles and previous research/development, not algorithmic training data.

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

As stated above, this is not an AI algorithm, so there is no "training set" in the context of machine learning. The "ground truth" for the device's formulation and design would be based on chemical, biological, and pharmaceutical principles, historical data from similar products, and laboratory studies of its components.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2015

Fidia Farmaceutici Spa % Vivian Kelly US Agent/Regulatory Affairs Manager Fidia Pharma Usa Inc Morris Corporate Center 1, Building C, 300 Interpace Parkway Parsippany, New Jersey 07054

Re: K150883

Trade/Device Name: HyaloGYN Vaginal Hydrating Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: August 4. 2015 Received: August 4, 2015

Dear Vivian Kelly:

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. 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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150883

Device Name HyaloGYN® Vaginal Hydrating Gel

Indications for Use (Describe)

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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K150883

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Applicant:	Fidia Farmaceutici, S.p.A.Via Ponte della Fabbrica 3/A35031 Abano Terme (PD) - Italy
Contact Person:	Vivian Kelly, MS, RACRegulatory Affairs ManagerPhone: 973-577-6202Fidia Pharma USA Inc.Morris Corporate Center 1, Building C300 Interpace Parkway,Parsippany, New Jersey 07054
Date Prepared:	September 1, 2015

Device Information:

Proprietary Name:	HyaloGYN® Vaginal Hydrating Gel
Device Common Name	Vaginal Moisturizer
Device Classification Name:	Personal Lubricant
Regulation Number	21 CFR 884.5300
Regulation Name	Condom
Regulatory Class	II
Product Code	NUC (lubricant, personal)

Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed:

· HyaloGYN® Vaginal Hydrating Gel, Fidia Farmaceutici, S.p.A. K094039

Legally Marketed Reference Device Used to Support Substantial Equivalence:

· Replens Long-Lasting Vaginal Moisturizer, Lil' Drug Store Products, Inc. K101098
· Elegance Woman's Lubricant, Elegance K070587

Description of Device:

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Technological Characteristics of the Device:

The proposed device formula is proprietary and consists of safe, water-soluble ingredients similar to the identified predicate device. The comparison of key design features and the performance testing demonstrate that HyaloGYN is substantially equivalent to its predicate in regards its technological characteristics including intended use, indications for use, design, materials, operational principles and performance characteristics.

The device is designed to meet the following Product Specifications at release: Appearance, odor, color weight, pH, hyaluronic acid content, Total Aerobic Microbial Count, Total combined yeasts/molds count, absence of common pathogens (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans), viscosity, and osmolality.

Indications for Use:

Summary of Performance Data:

Biocompatibility Testing

The following biocompatibility studies were conducted and confirm it is safe for the proposed indication:

. In vitro Cytotoxicity Assay per ISO 10993-5
. Sensitization (Guinea Pig Maximization Test) per ISO 10993-10
. Vaginal Irritation Test per ISO 10993-10
. Acute Systemic Toxicity Rat per ISO 10993-11

Performance Testing - Bench

Condom compatibility testing was conducted per ASTM D7661-10. The results concluded that the subject device product is compatible with polyisoprene condoms.

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Performance Testing - Clinical

Fidia conducted the following study on the subject device and a summary is provided below:

·Tempera G. Evaluation of the Tolerability and Efficacy of Hyalgel Vaginal (HYALOgin™) for the Treatment of Vaginal Dryness and Irritation Final Clinical Report, September 22, 1998

A pilot, open, uncontrolled clinical study conducted in Italy to assess the safety and effectiveness of HyaloGYN. A total of 80 women were enrolled at a single site. They were instructed to use the test product every three days for 30 days. Follow-up visits were performed on Days 7 and 21, with the final visit taking place three days after the last application of test product. The results obtained in this study demonstrated that the test material had moisturizing effects on the vaginal mucosa. Safety was considered to be excellent as demonstrated by the absence of adverse events and the investigator's overall assessment of tolerability score (98.7%). There were no alterations of the vaginal ecosystem.

This study supports the substantial equivalence of the subject device to Replens, the reference device, cleared in K101098 as a personal lubricant/moisturizer and demonstrates the safe and effective use of HyaloGYN as a personal lubricant to successfully supplementing the body's natural lubrication.

Stability Testing

HyaloGYN® has a 36-months shelf life based on the results of shelf life testing.

Conclusion:

HyaloGYN® Hydrating Gel is substantially equivalent to the predicate HyaloGYN® Hydrating Gel and the reference predicate device, Replens Long-lasting Vaginal Moisturizer and Elegance Woman's Lubricant. The intended use and fundamental technology of the system remain unchanged. Furthermore, performance testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to other vaginal moisturizers. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy.

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.