(296 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technologies.
No.
The device's intended use is to moisturize and lubricate to enhance comfort during sexual activity, not to treat or prevent a medical condition.
No
Gynomunal is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical, water-based personal lubricant with specific physical and chemical properties, not a software application.
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 moisturizing and lubricating during sexual activity. This is a topical application for physical comfort and ease, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description focuses on physical properties (color, odor, pH, viscosity, osmolality) and microbiological quality, which are relevant for a topical product, not for an IVD.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility and condom compatibility, which are relevant for a personal lubricant, not for an IVD.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Gynomunal does not fit this description.
N/A
Intended Use / Indications for Use
Gynomunal 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 natural rubber latex and with polyisoprene condoms, but not with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months.
Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP ), and microbiological quality (Compliance with USP , , and ).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or 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)
Gynomunal was demonstrated to be biocompatible utilizing the following tests:
- ISO 10993-5:2009—Cytotoxicity
- ISO 10993-10:2010—Vaginal Irritation
- ISO 10993-10:2010—Guinea Pig Maximization Sensitization
- ISO 10993-11:2006—Acute Systemic Toxicity
Gynomunal was demonstrated to maintain its specifications throughout its 36 month shelf-life through real time and accelerated testing.
To substantiate the revised claim of condom compatibility Polichem SA commissioned an independent laboratory to conduct condom compatibility studies with Gynomunal according to ASTM D7661 – 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results were reviewed within the context and requirements of ISO 4074 - Natural Latex Rubber Condoms - Requirements And Test Methods. Laboratory testing concluded that Gynomunal is compatible with natural rubber latex and polyisoprene condoms.
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.
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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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a stylized eagle or bird-like figure, composed of three overlapping profiles facing to the right. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Polichem S.A. % Barry E Sands President ROMIS. Inc. 29 Water Street, Suite 305 Newburyport, MA 01950
Re: K143349
Trade/Device Name: Gynomunal Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: August 18, 2015 Received: August 21, 2015
Dear Barry Sands,
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,
Herbert P. Lerner -S
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) K143349
Device Name
Gynomunal Vaginal Gel
Indications for Use (Describe)
Gynomunal 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 natural rubber latex and with polyisoprene condoms, but not with polyurethane 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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510(k) SUMMARY
Polichem, S.A. 's Gynomunal
| Sponsor: | |
|---|---|
| Manufacturer: | Polichem, S.A. |
| Via | |
| Senago 42D | |
| 6912 – Lugano-Pazzallo | |
| Switzerland | |
| Official Contact: | Barry E. Sands |
| Phone: | 978-358-7307 |
| Fax: | 978-378-7384 |
| Date Prepared: | September 8, 2015 |
| Device Name: | Gynomunal |
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR 884.5300) |
| Product Code: | NUC |
Indications for Use
Predicate Device:
Gynomunal 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 natural rubber latex and with polyisoprene condoms, but not with polyurethane condoms.
Me Again Long Lasting Vaginal Moisturizer (K112217)
Technological Characteristics
Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months.
Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP ), and microbiological quality (Compliance with USP , , and ).
| Color | Homogeneous, Translucent Gel
(Ivory, to slight yellow) |
| ------- | ----------------------------------------------------------- |
|---|
4
| Odor | Characteristic |
|---|---|
| pH | 5.5-6.5 |
| Viscosity | 45,000-65,000 mPa*s |
| Osmolality | 2,000 -3,000 mOsmol/Kg |
| Antimicrobial | |
| Effectiveness | Complies to USP |
| Total Aerobic | |
| Microbial Counts |