Hyalo GYN® Vaginal Moisturizing Suppositories are personal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Hyalo GYN® Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Description

Hyalo GYN® Vaginal Moisturizing Suppositories are non-sterile, glyceride-based personal lubricants. The subject lubricant is intended to moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The Hyalo GYN® Vaginal Moisturizing Suppositories are provided in peel-to-open pre-cut strips, in an outer cardboard box with a package insert.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, Hyalo GYN® Vaginal Moisturizing Suppositories, and presents a 510(k) summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria in the way an AI algorithm might. Therefore, the information requested about acceptance criteria and a study to prove meeting those criteria, in the context of an AI device, is not fully applicable or directly available in this document.

However, I can extract the closest analogous information regarding the device's specifications and supporting performance data provided in the 510(k) summary. It details technical requirements and testing conducted to ensure safety and effectiveness, which are regulatory "acceptance criteria" for this type of product.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device like Hyalo GYN® Vaginal Moisturizing Suppositories, the "acceptance criteria" are the defined specifications that the product must meet. The "reported device performance" indicates that the device did meet these specifications during testing.

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	White to ivory white suppositories in suitable plastic pre-formed shells, tightly sealed & easy to open	Met specification (implied by 510(k) clearance and conclusion stating device is safe and effective)
Odor	Wax-like smell	Met specification (implied by 510(k) clearance and conclusion stating device is safe and effective)
Antimicrobial Effectiveness	Meets requirements per the standard. (USP <51>)	Met specification
Uniformity of dosage unit	Meets requirements for Content Uniformity (Ph. Eur. <2.9.40>, current ed.)	Met specification
Hyaff11p50 assay	0.18-0.22 % w/w	Met specification
Disintegration time	No more than (NMT) 60 minutes (Ph. Eur. <2.9.2>, current ed.)	Met specification
Osmolality	≤ 1200 mOsm/kg (Ph. Eur. <2.2.35>, current ed.)	Met specification
Consistency	0.1-5.0 mm	Met specification
Peroxide value (Ip)	≤ 10 mEqO2 / kg (Ph. Eur. <2.5.5>, current ed., method A)	Met specification
Microbiological quality (TAMC)	≤100 cfu/g (Ph. Eur. <2.6.12>, current ed., Ph. Eur. <2.6.13>, current ed.)	Met specification
Microbiological quality (TYMC)	≤10 cfu/g (Ph. Eur. <2.6.13>, current ed.)	Met specification
Microbiological quality (pathogens)	Pseudomonas aeruginosa: Absent; Staphylococcus aureus: Absent; Candida albicans: Absent	Met specification
Biocompatibility	Demonstrated to be biocompatible per ISO 10993-1, 10993-5, 10993-10, 10993-11. (Specific criteria for each test not detailed in summary but implied)	Demonstrated to be biocompatible (Results of testing "demonstrated that the subject lubricants are biocompatible.")
Condom Compatibility	Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (this is a stated characteristic, not a performance target to "meet" as much as a determination)	Demonstrated that the device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms based on ASTM D7661-10. This is reflected in labeling
Shelf-life	Maintain all specifications for 24 months	Met all specifications at baseline and following aging for 24-month shelf life.

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes for each of the performance (stability, biocompatibility, microbiology, etc.) or material compatibility tests. The tests refer to established standards (USP <51>, Ph. Eur., ASTM D7661-10, ISO 10993 standards). The data provenance is laboratory testing performed by the manufacturer, Fidia Farmaceutici S.p.A., to support device specifications and substantial equivalence. It is not patient or clinical data, thus concepts like country of origin for patient data or retrospective/prospective are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device and submission. This is not an AI/diagnostic device that requires expert ground truth for image or data interpretation. The "ground truth" for this device's performance is established by standardized laboratory test methods and their defined pass/fail criteria.

4. Adjudication method for the test set

This question is not applicable. There's no "adjudication" in the sense of reconciling multiple expert opinions for data labeling for an AI algorithm. The tests are scientific and follow established protocols with objective outcomes.

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

This question is not applicable. The device is a personal lubricant, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies are not relevant.

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

This question is not applicable. The device is a physical product, not an algorithm.

7. The type of ground truth used

For the laboratory performance tests and material compatibility, the "ground truth" is defined by the validated and established scientific methods and standards themselves (e.g., USP <51> for antimicrobial effectiveness, Ph. Eur. for disintegration time and osmolality, ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility). The criteria within these standards define what constitutes an acceptable result.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fidia Farmaceutici S.p.A. % Vivian Kelly, MS, RAC US Agent / Associate Director, Regulatory Affairs Fidia Pharma USA, Inc. 100 Campus Drive, Suite 105 Florham Park, NJ 07932

Re: K191052

Trade/Device Name: Hyalo GYN® Vaginal Moisturizing Suppositories Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 18, 2019 Received: April 19, 2019

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. 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.

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

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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-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 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,

Monica D. Garcia, Ph.D. Acting 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

Enclosure

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Indications for Use

510(k) Number (if known) K191052

Device Name

Hyalo GYN® Vaginal Moisturizing Suppositories

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)

_ | 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 - K191052

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, RACAssociate Director, Regulatory AffairsFidia Pharma USA Inc.100 Campus Drive, Suite 105Florham Park, NJ 07932Phone: 973-577-6202
Date Prepared:	January 8, 2020

Device Information:

Proprietary Name:	Hyalo GYN® Vaginal Moisturizing Suppositorie
Device Common Name	Personal Lubricant
Regulation Number	21 CFR 884.5300
Regulation Name	Condom
Regulatory Class	II
Product Code	NUC (lubricant, personal)

Predicate device:

Hyalo GYN® Vaginal Hydrating Gel, K150833

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

Description of Device:

The device specifications are listed in the table below:

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Parameter	Specification	Test Method
Appearance	White to ivory whitesuppositories in suitableplastic pre-formed shells,tightly sealed & easy toopen	Visual
Odor	Wax-like smell	Olfactory
Antimicrobial Effectiveness	Meets requirements per thestandard.	USP <51>
Uniformity of dosage unit	Meets requirements forContent Uniformity	Ph. Eur. <2.9.40>, current ed.
Hyaff11p50 assay	$0.18-0.22 % w/w$	HPLC internal method
Disintegration time	No more than (NMT) 60 minutes	Ph. Eur. <2.9.2>, current ed.
Osmolality	≤ 1200 mOsm/kg	Ph. Eur. <2.2.35>, current ed.
Consistency	$0.1-5.0$ mm	Internal method
Peroxide value (Ip)	≤ 10 mEqO2 / kg	Ph. Eur. <2.5.5>, current ed.,method A
Microbiological quality
- Total Microbial Count (TAMC)	≤100 cfu/g	Ph. Eur. <2.6.12>, current ed.Ph. Eur. <2.6.13>, current ed.
- Fungal/Yeast/Mold Limits (TYMC)	≤10 cfu/g	Ph. Eur. <2.6.13>, current ed.
- Pseudomonas aeruginosa	Absent
- Staphylococcus aureus	Absent
- Candida albicans	Absent

Indications for Use:

Hyalo GYN® Vaginal Moisturizing Suppositories are personal lubricants 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. Hyalo GYN® Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Predicate Device Comparison:

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	Subject Device	Predicate Device
	K191052	K150883
Indications for Use	Hyalo GYN®VaginalMoisturizing Suppositoriesare personal lubricants forvaginal application,intended to moisturize andlubricate, to enhance theease and comfort of intimatesexual activity andsupplement the body'snatural lubrication. HyaloGYN® Vaginal MoisturizingSuppositories are notcompatible with naturalrubber latex, polyurethaneand polyisoprene condoms.	Hyalo GYN® is apersonal lubricant forvaginal applicationintended to moisturizeand lubricate, toenhance the ease andcomfort of intimatesexual activity andsupplement thebody's naturallubrication. Thisproduct is compatiblewith polyisoprenecondoms.
Over the counter use	Yes	Yes
Sterile	No	No
Ingredients	Hyaluronic acid	Hyaluronic acid
	Glycerides of vegetableorigin	Propylene glycol
	Glycerides of vegetableorigin	Carbomer
	Methylpropanediol	Methylpropanediol
	Carprylyl glycol, 1-2hexanediol	Carprylyl glycol, 1-2hexanediol
	Lactic acid	Sodium hydroxide
	Purified water	Purified water

The subject and predicate device do not have identical indications for use statements; however, their intended uses are the same, i.e., lubrication during intimate sexual activity.

The subject device and predicate device have different technological characteristics, including their formulation and specifications. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

Summary of Performance Data:

Biocompatibility:

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Biocompatibility studies were performed 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" and ISO 10993- 1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009) ●
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2006) ●

The results of this testing demonstrated that the subject lubricants are biocompatible.

Condom Compatibility:

Condom Compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the subject device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Shelf-life Testing

Hyalo GYN® Vaginal Moisturizing Suppositories has a 24-month shelf life based on the results of real time shelf life testing. At baseline and following aging, the device met all specifications as listed in the device specifications table.

Conclusion:

The results of the performance testing described above demonstrate that the Hyalo GYN® Vaginal Moisturizing Suppositories 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.