(152 days)
No
The device description and performance studies focus on the chemical composition and hydrating properties of a gel, with no mention of AI or ML technology.
No
The intended use of HyaloGYN is as a personal lubricant for vaginal application to moisturize and lubricate, enhancing the ease and comfort of intimate sexual activity and supplementing natural lubrication, which describes a non-therapeutic function.
No
This device is described as a personal lubricant and vaginal moisturizer intended to enhance comfort and hydrate the vaginal epithelium. Its function is entirely therapeutic and supportive, not for identifying the presence or nature of a medical condition.
No
The device description clearly states it is a gel provided in an aluminum tube with applicators, indicating it is a physical product, 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 vaginal application to moisturize and lubricate, enhance comfort during sexual activity, and supplement natural lubrication. This is a topical application for a physical effect, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the composition and physical properties of a gel intended for direct application to the vaginal mucosa. It does not describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Anatomical Site: While the anatomical site is vaginal, the application is for lubrication and hydration, not for collecting or analyzing a sample from the vagina for diagnostic information.
- Performance Studies: The performance study described focuses on the moisturizing effects and safety of the gel when applied, not on the accuracy of a diagnostic test.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) to provide information for diagnosing, monitoring, or treating a disease or condition. HyaloGYN does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC (lubricant, personal)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Performance Testing - Clinical
Study Type: Pilot, open, uncontrolled clinical study
Sample Size: A total of 80 women were enrolled.
Data Source: Conducted in Italy at a single site.
Key Results: 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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
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
1
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)
Device Name HyaloGYN® Vaginal Hydrating Gel
Indications for Use (Describe)
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.
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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Image /page/3/Picture/1 description: The image contains the logo for Fidia Pharma USA Inc. The logo consists of a blue circular graphic on the left, which appears to be an abstract representation of a globe or a cell. To the right of the graphic, the word "fidia" is written in a bold, blue sans-serif font. Below "fidia", the text "Pharma USA Inc" is written in a smaller, lighter blue font.
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/A
35031 Abano Terme (PD) - Italy |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Kelly, MS, RAC
Regulatory Affairs Manager
Phone: 973-577-6202
Fidia Pharma USA Inc.
Morris Corporate Center 1, Building C
300 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:
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.
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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.
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:
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.
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.