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.

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 <51>), and microbiological quality (Compliance with USP <61>, <62>, and <1111>).

AI/ML Overview

The provided document is a 510(k) summary for the Gynomunal Vaginal Gel, a personal lubricant. It details the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document lists several device specifications and performance criteria that Gynomunal must meet.

Acceptance Criteria	Reported Device Performance
Physical-Chemical Characteristics
Color	Homogeneous, Translucent Gel (Ivory, to slight yellow)
Odor	Characteristic
pH	5.5-6.5
Viscosity	45,000-65,000 mPa*s
Osmolality	2,000 -3,000 mOsmol/Kg
Antimicrobial Effectiveness
Antimicrobial Effectiveness	Complies to USP <51>
Microbiological Quality
Total Aerobic Microbial Counts	<100 cfu/g
Total Yeast and Mold counts	<10 cfu/g
Microbial Absence	P. aeruginosa, S. aureus, C. albicans
Biocompatibility
Cytotoxicity (ISO 10993-5:2009)	Demonstrated to be biocompatible
Vaginal Irritation (ISO 10993-10:2010)	Demonstrated to be biocompatible
Guinea Pig Maximization Sensitization (ISO 10993-10:2010)	Demonstrated to be biocompatible
Acute Systemic Toxicity (ISO 10993-11:2006)	Demonstrated to be biocompatible
Shelf-life
Maintain specifications for 36 months	Demonstrated to maintain specifications throughout its 36-month shelf-life
Condom Compatibility
Compatible with natural rubber latex condoms	Compatible (per ASTM D7661-10 and ISO 4074)
Compatible with polyisoprene condoms	Compatible (per ASTM D7661-10 and ISO 4074)
Compatible with polyurethane condoms	Not compatible (stated directly in "Indications for Use")

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

The document does not specify the exact sample sizes used for each test. For the condom compatibility study, it mentions that an "independent laboratory" was commissioned but does not provide details on the number of condoms or lubricant samples tested. The data provenance is implied to be from an independent laboratory, but the country of origin is not specified. The tests appear to be prospective laboratory studies conducted by the manufacturer or commissioned by them.

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)

The document does not mention the use of "experts" to establish ground truth in the context of human interpretation, as this is a personal lubricant and not an image-based diagnostic device. The ground truth for its performance is established through standardized laboratory tests (e.g., ISO, USP, ASTM standards) and objective measurements.

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

Not applicable. As described above, the acceptance criteria are based on objective, standardized laboratory measurements and not on human adjudication of subjective data.

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

Not applicable. Gynomunal is a personal lubricant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of AI assistance for human readers is not relevant.

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

Not applicable. Gynomunal is a physical product, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in that it performs its intended function independently of human interpretation of its output (beyond the user's experience).

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

The ground truth for Gynomunal's performance is based on objective, standardized laboratory measurements and scientific standards. This includes:

Physical-chemical assays: pH, viscosity, osmolality measurements.
Microbiological testing: Total aerobic microbial counts, yeast and mold counts, and specific pathogen absence, adhering to USP standards.
Biocompatibility testing: Following ISO 10993 standards for cytotoxicity, irritation, sensitization, and systemic toxicity.
Stability/Shelf-life testing: Real-time and accelerated testing to ensure specifications are maintained over time.
Condom compatibility testing: Adherence to ASTM D7661-10 and ISO 4074 standards for material integrity.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The development and formulation of the product would have involved various R&D experiments and testing, but these are not referred to as "training sets."

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

Not applicable, as there is no "training set" in the context of this device. The ground truth for product development and validation relies on established scientific principles, analytical chemistry, microbiology, and biocompatibility testing standards.

Summary

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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

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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)

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.ViaSenago 42D6912 – Lugano-PazzalloSwitzerland
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:

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 <51>), and microbiological quality (Compliance with USP <61>, <62>, and <1111>).

Color	Homogeneous, Translucent Gel(Ivory, to slight yellow)
-------	-----------------------------------------------------------

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Odor	Characteristic
pH	5.5-6.5
Viscosity	45,000-65,000 mPa*s
Osmolality	2,000 -3,000 mOsmol/Kg
AntimicrobialEffectiveness	Complies to USP <51>
Total AerobicMicrobial Counts	<100 cfu/g
Total Yeast and Moldcounts	<10 cfu/g
Microbial Absence	P. aeruginosaS. aureusC. albicans

Performance Data

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.

Substantial Equivalence

Gynomunal is as safe and effective as the Me Again Long Lasting Vaginal Moisturizer. Gynomunal has the same intended use and principle of operation, and similar indications and technological characteristics as the predicate device. The minor technological differences between the Gynomunal and the predicate device raise no new types of questions of safety or effectiveness. Performance data provided in this premarket notification demonstrate that the Gynomunal is as safe and effective as Me Again Long Lasting Vaginal Moisturizer, and that

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Gynomunal is compatible with natural rubber latex and polyisoprene condoms. Thus, Gynomunal is substantially equivalent to the predicate.

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.