HYALO GYN 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.

Device Description

HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process. HYALO GYN is intended for use as a personal lubricant. HYALO GYN is compatible with latex condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and a shelf life of 3 years.

HYALO GYN acts as a moisturizer and lubricant because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol, combined with the hyaluronic acid derivative, enable HYALO GYN to achieve its thick, viscous gel form, and the mucoadhesive properties of the product allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating and protecting this tissue.

AI/ML Overview

The provided document is a 510(k) summary for the device HYALO GYN®, a vaginal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.

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

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for all performance aspects. Instead, it describes studies and their outcomes to support safety and effectiveness. Based on the information provided, the following table summarizes the performance data and the implied criteria met:

Performance Aspect	Implied Acceptance Criteria (Based on Study Outcome)	Reported Device Performance
Biocompatibility
Cytotoxicity	Not cytotoxic	Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic.
Acute Intraperitoneal Toxicity	Lethal dose >10 ml/kg	An acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal dose is >10 ml/kg but <20 ml/kg.
Skin Sensitization	Lack of a sensitizing effect	A skin sensitization study provides evidence for the lack of a sensitizing effect.
Vaginal Tolerance	Minimal vaginal irritant	Vaginal tolerance testing demonstrated that HYALO GYN is a minimal vaginal irritant in the rabbit model.
Non-Clinical Performance
Condom Compatibility	No macroscopic signs, no statistically significant differences in tensile strength, elongation at break, and breaking force with various condom types.	Condom compatibility testing demonstrates that HYALO GYN is compatible with latex, polyurethane, and natural skin condoms. No macroscopic signs and no statistically significant differences were observed in tensile strength, elongation at break, and breaking force between treated and non-treated groups of condoms.
Shelf Life	36 months	Stability studies conducted in accordance with the ICH Q1A guidelines confirm a shelf-life of 36 months.
Clinical Performance
Moisturizing Effects	Demonstrated moisturizing effects on the vaginal mucosa.	The results obtained in this study demonstrated that the test material had moisturizing effects on the vaginal mucosa.
Safety/Tolerability	Absence of adverse events, excellent tolerability score, no alterations of vaginal ecosystem.	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. The conclusion also notes "the lack of adverse events reported over 8 years of postmarket experience with HYALO GYN outside of the U.S. demonstrate the safe and effective use of this device."

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

Clinical Study:
- Sample Size: 80 women.
- Data Provenance: Conducted in Italy; "pilot, open, uncontrolled clinical study" which typically implies prospective data collection for the duration of the study.
Biocompatibility Studies: Specific sample sizes are not provided for the individual in vitro and animal studies (cytotoxicity, acute intraperitoneal toxicity, skin sensitization, vaginal tolerance).
Non-Clinical Performance (Condom Compatibility, Stability): Specific sample sizes are not provided for the individual tests.

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)

For the clinical study, the document mentions "the investigator's overall assessment of tolerability score (98.7%)". The number and qualifications of the investigators (experts) are not specified.
For other performance assessments (biocompatibility, condom compatibility, stability), the "ground truth" or evaluators are implied by the nature of the tests (e.g., laboratory personnel for cytotoxicity, tensile strength measurements). Specific details on the number or qualifications of experts involved in establishing ground truth for these non-clinical tests are not provided.

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

For the clinical study, the document states it was an "open, uncontrolled clinical study." There is no mention of an adjudication method for the clinical outcomes or adverse events. The tolerability assessment was by "the investigator."
For non-clinical tests, adjudication methods are generally not applicable in the same way as for clinical studies involving subjective assessments.

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, an MRMC comparative effectiveness study was not done. This study is for a medical device that is a personal lubricant, not an AI-assisted diagnostic or imaging device, so such a study design is not applicable.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical product (a lubricant), not an algorithm or AI.

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

Clinical Study: The effectiveness (moisturizing effects, tolerability, absence of adverse events, no alterations of vaginal ecosystem) was assessed based on clinical observation and patient outcomes data, likely clinician assessment and patient-reported symptoms, though specific details of the assessment tools are not provided. The tolerability score was based on "the investigator's overall assessment."
Biocompatibility Studies: Ground truth was established through laboratory testing standards and measurements (e.g., cell viability for cytotoxicity, animal responses for toxicity and irritation).
Non-Clinical Performance (Condom Compatibility, Stability): Ground truth was established through standardized physical and chemical laboratory tests (e.g., tensile strength testing, stability protocols).

8. The sample size for the training set

For a device like HYALO GYN® (a lubricant), the concept of a "training set" as understood in machine learning or AI is not applicable. The device's performance is not based on a trained algorithm. Its formulation is developed through pharmaceutical research and manufacturing processes, and then tested for safety and efficacy.

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

As noted above, a "training set" is not applicable for this type of medical device. The "ground truth" for its development would involve established scientific principles, pharmaceutical formulation expertise, and pre-clinical testing to ensure its properties met the intended design specifications, but not in the context of an algorithm's training data.

Summary

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510(k) SUMMARY

510(k) Owner:	Fidia Farmaceutici, S.p.A.Via Ponte dell Fabbrica 3/A35031 Abano TermePADOVA, ITALY
Contact:	Dr. Giusi LoCastroRegulatory Affairs
Phone:	+39-049-8232906
Fax:	+39-049-8232398
	MAY - 7 2010
Date Summary Prepared:	May 4, 2010
Device:
Trade Name:	HYALO GYN®
Common/Classification Name:	Lubricant, Patient, Vaginal, LatexCompatibileProduct Code NUC
Classification:	21 C.F.R. § 884.5300
Predicate Device:	Glycerin & Paraben Free AstroglideBiofilm, Inc.K072647
Device Description:	HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gelthat contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid),propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate andpropyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). Thehyaluronic acid is manufactured using a bacterial fermentation process.HYALO GYN is intended for use as a personal lubricant. HYALO GYN iscompatible with latex condoms: lubricated/non-lubricated latex, lubricatedpolyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 anda shelf life of 3 years.HYALO GYN acts as a moisturizer and lubricant because of the stronghydrating properties of its hyaluronic acid derivative component. Thecarbomer and propylene glycol, combined with the hyaluronic acidderivative, enable HYALO GYN to achieve its thick, viscous gel form, andthe mucoadhesive properties of the product allow it to adhere to the vaginalmucosa, enhancing the residence time, thus hydrating and protecting thistissue.

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K094039Pg 2 of 2
Intended Use:	Hyalo Gyn is a personal lubricant, for penile and/or vaginal application,intended to moisturize and lubricate, to enhance the ease and comfort ofintimate sexual activity and supplement the body's natural lubrication. Thisproduct is compatible with condoms: lubricated/non-lubricated latex,lubricated polyurethane, lubricated natural skin.
TechnologicalCharacteristics:	HYALO GYN is substantially equivalent to the predicate device with regardto intended use and technological characteristics. Hydeal-D has been used inlegally marketed devices, and no new questions of safety or effectiveness arepresented. In addition, the other components (carbomer, propylene glycol,preservatives, and water) meet the specifications defined in the United StatesPharmacopoeia (USP) or National Formulary (NF), where applicable.
BiocompatibilityData	Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic. Anacute intraperitoneal toxicity study on HYALO GYN indicated that the lethaldose is >10 ml/kg but <20 ml/kg. A skin sensitization study providesevidence for the lack of a sensitizing effect. Vaginal tolerance testingdemonstrated that HYALO GYN is a minimal vaginal irritant in the rabbitmodel.
PerformanceData --Nonclinical	Condom compatibility testing demonstrates that HYALO GYN is compatiblewith latex, polyurethane, and natural skin condoms. No macroscopic signsand no statistically significant differences were observed in tensile strength,elongation at break, and breaking force between treated and non-treatedgroups of condoms. Stability studies conducted in accordance with the ICHQ1A guidelines confirm a shelf-life of 36 months.
PerformanceData -- Clinical	A pilot, open, uncontrolled clinical study was conducted in Italy to assess thesafety and effectiveness of HYALO GYN. A total of 80 women wereenrolled at a single site. They were instructed to use the test product everythree 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 testproduct. The results obtained in this study demonstrated that the test materialhad moisturizing effects on the vaginal mucosa. Safety was considered to beexcellent as demonstrated by the absence of adverse events and theinvestigator's overall assessment of tolerability score (98.7%). There were noalterations of the vaginal ecosystem.
Conclusions	Based on the biocompatibility testing, nonclinical performance testing, andthe clinical data provided in this 510(k), it is concluded that HYALO GYN issafe and effective as a vaginal lubricant and moisturizer, and at least as safeand effective as legally marketed vaginal lubricants. Further, the lack ofadverse events reported over 8 years of postmarket experience with HYALOGYN outside of the U.S. demonstrate the safe and effective use of this device.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

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

MAY - 7 2010

Fidia Farmaceutici S.p.A % Sharon A. Segal, Ph.D. Director of Regulatory Science Morgan, Lewis & Bockius, LLP 1111 Pennsylvania Avenue, N.W. WASHINGTON DC 20004

Re: K094039 Trade Name: HY ALO GYN® Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 7, 2010 Received: April 7, 2010

Dear Dr. Segal:

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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

・

lubricated latex, lubricated polyurethane, lubricated natural skin.

510(k) Number (if known):	K094039
Device Name:	HYALO GYN®
Indications for Use:	HYALO GYN 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 condoms: lubricated/non-

. .

· :

. .

Prescription Use Part 21 CFR 801 Subpart D)

: :

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

. . . . . .

・

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K094039

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.