(128 days)
Not Found
No
The device description and intended use clearly define a personal lubricant with a chemical composition and mechanism of action based on hydration and lubrication. There is no mention of any computational or algorithmic components, let alone AI or ML. The performance study is a clinical trial evaluating the physical effects of the gel, not the performance of any AI/ML algorithm.
No.
The intended use of the device is to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication, which are not considered therapeutic effects.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, and not for diagnosing any medical condition.
No
The device description clearly states it is a gel containing various chemical components, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of HYALO GYN is clearly stated as 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 describes a product used externally or internally for physical lubrication and comfort during sexual activity.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description of HYALO GYN details its composition as a gel with moisturizing and lubricating properties. It does not mention any components or mechanisms for analyzing biological samples.
- Clinical Study: The clinical study described focuses on the moisturizing effects and safety of the product when applied to the vaginal mucosa, not on the analysis of biological samples for diagnostic purposes.
Therefore, based on the provided information, HYALO GYN functions as a personal lubricant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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-lubricated latex, lubricated polyurethane, lubricated natural skin.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal, penile
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A pilot, open, uncontrolled clinical study was conducted in Italy to assess the safety and effectiveness of HYALO GYN. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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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510(k) SUMMARY
| 510(k) Owner: | Fidia Farmaceutici, S.p.A.
Via Ponte dell Fabbrica 3/A
35031 Abano Terme
PADOVA, ITALY |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Giusi LoCastro
Regulatory 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, Latex
Compatibile
Product Code NUC |
| Classification: | 21 C.F.R. § 884.5300 |
| Predicate Device: | Glycerin & Paraben Free Astroglide
Biofilm, Inc.
K072647 |
| 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. |
1
| K094039
| Pg 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 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. | |
| Technological | |
| Characteristics: | HYALO GYN is substantially equivalent to the predicate device with regard |
| to intended use and technological characteristics. Hydeal-D has been used in | |
| legally marketed devices, and no new questions of safety or effectiveness are | |
| presented. In addition, the other components (carbomer, propylene glycol, | |
| preservatives, and water) meet the specifications defined in the United States | |
| Pharmacopoeia (USP) or National Formulary (NF), where applicable. | |
| Biocompatibility | |
| Data | Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic. An |
| acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal | |
| dose is >10 ml/kg but |