(265 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a vaginal lubricant, with no mention of AI or ML.
No.
The intended use of the device is for moisturizing and lubricating to enhance comfort during sexual activity and supplement natural lubrication, which are not considered therapeutic actions.
No
The device is described as a personal lubricant intended to moisturize and lubricate, not to diagnose a condition. Its stated uses are for comfort and supplementation of natural lubrication.
No
The device description clearly states it is a physical product (suppositories) and describes its composition and packaging, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a physical effect on the body, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description confirms it's a "glyceride-based personal lubricant" for moisturizing and lubricating the vaginal epithelium. This aligns with its intended use as a personal care product, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening of 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 specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina / vaginal epithelium
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: 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. Testing included Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006). The results 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
2
Indications for Use
510(k) Number (if known) K191052
Device Name
Hyalo GYN® Vaginal Moisturizing Suppositories
Indications for Use (Describe)
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.
| 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)
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."
3
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/A
35031 Abano Terme (PD) – Italy |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Kelly, MS, RAC
Associate Director, Regulatory Affairs
Fidia Pharma USA Inc.
100 Campus Drive, Suite 105
Florham Park, NJ 07932
Phone: 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:
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.
The device specifications are listed in the table below:
4
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to ivory white | |
| suppositories in suitable | ||
| plastic pre-formed shells, | ||
| tightly sealed & easy to | ||
| open | Visual | |
| Odor | Wax-like smell | Olfactory |
| Antimicrobial Effectiveness | Meets requirements per the | |
| standard. | USP | |
| Uniformity of dosage unit | Meets requirements for | |
| Content Uniformity | Ph. Eur. , current ed. | |
| Hyaff11p50 assay | $0.18-0.22 % w/w$ | HPLC internal method |
| Disintegration time | No more than (NMT) 60 minutes | Ph. Eur. , current ed. |
| Osmolality | ≤ 1200 mOsm/kg | Ph. Eur. , current ed. |
| Consistency | $0.1-5.0$ mm | Internal method |
| Peroxide value (Ip) | ≤ 10 mEqO2 / kg | Ph. Eur. , current ed., |
| method A | ||
| Microbiological quality | ||
| - Total Microbial Count (TAMC) | ≤100 cfu/g | Ph. Eur. , current ed. |
| Ph. Eur. , current ed. | ||
| - Fungal/Yeast/Mold Limits (TYMC) | ≤10 cfu/g | Ph. Eur. , 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:
5
| Subject Device | Predicate Device | |
|---|---|---|
| K191052 | K150883 | |
| 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. | Hyalo GYN® 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. | ||
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Ingredients | Hyaluronic acid | Hyaluronic acid |
| Glycerides of vegetable | ||
| origin | Propylene glycol | |
| Glycerides of vegetable | ||
| origin | Carbomer | |
| Methylpropanediol | Methylpropanediol | |
| Carprylyl glycol, 1-2 | ||
| hexanediol | Carprylyl glycol, 1-2 | |
| hexanediol | ||
| 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:
6
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.