LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Device Description

LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in single use pouches and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort.

The specifications for the LUBRIGYN CREAM include appearance, color, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called LUBRIGYN CREAM, a personal lubricant. It details the device's indications for use, description, and technological characteristics, and aims to prove substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Biocompatibility:
Cytotoxicity (according to ISO 10993-5)	Test performed. Results demonstrated the device can be considered biocompatible.
Sensitization (according to ISO 10993-10)	Test performed. Results demonstrated the device can be considered biocompatible.
Vaginal Irritation (according to ISO 10993-10)	Test performed. Results demonstrated the device can be considered biocompatible.
Acute Systemic Toxicity (according to ISO 10993-11)	Test performed. Results demonstrated the device can be considered biocompatible.
Stability:
Shelf life	36 months (confirmed by stability tests on expired product).
Microbiological Effectiveness:
Anti-microbial effectiveness (according to USP 51)	Microbiological challenge test performed on expired product. Confirmed anti-microbial effectiveness.
Condom Compatibility:
Compatibility with Natural Rubber Latex condoms (per ASTM D7661-10)	Not compatible (testing showed LUBRIGYN CREAM is not compatible).
Compatibility with Polyisoprene condoms (per ASTM D7661-10)	Not compatible (testing showed LUBRIGYN CREAM is not compatible).
Compatibility with Polyurethane condoms (per ASTM D7661-10)	Not compatible (testing showed LUBRIGYN CREAM is not compatible).
Device Specifications (Intrinsic to product):
Appearance	Specifications for appearance established.
Color	Specifications for color established.
Viscosity	Specifications for viscosity established.
Density	Specifications for density established.
Emulsion stability	Specifications for emulsion stability established.
Osmolality	Specifications for osmolality established.
Total microbial count	Specifications for total microbial count established.
Total yeast and mold count	Specifications for total yeast and mold count established.
Absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans)	Specifications for absence of pathogen organisms established (implicitly met through testing / QC).

Note: The document states that the "no-clinical performance testing conducted demonstrates that LUBRIGYN CREAM is substantially equivalent to the proposed predicate device." The acceptance criteria for the comparative effectiveness of the device itself are related to demonstrating similarity in performance to a predicate device, as this is a 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance testing (biocompatibility, stability, microbiological challenge, condom compatibility). It does not mention a clinical "test set" in the context of human subjects or a dataset for an AI algorithm.

Sample size for non-clinical testing: The specific sample sizes for each of the non-clinical tests (e.g., number of animals for toxicity, number of condoms for compatibility) are not provided in this summary.
Data provenance: The standard tests cited (ISO 10993 series, USP 51, ASTM D7661-10) are international standards for laboratory testing. The country of origin of the data is not explicitly stated beyond the submitter and consultant being based in Italy. This is prospective data generated specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The LUBRIGYN CREAM product is a personal lubricant, and the testing described is non-clinical laboratory testing, not a diagnostic device analyzed by human experts.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no "test set" in the context of human expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not a diagnostic device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is established by adherence to recognized international and national standards/test methods (ISO, USP, ASTM) that define acceptable performance characteristics for medical devices of this type. For example, for biocompatibility, the ground truth is "non-toxic," "non-sensitizing," etc., as determined by the specific criteria within the ISO standards. For condom compatibility, the ground truth is "compatible" or "not compatible" based on the measurements and criteria outlined in ASTM D7661-10.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI or machine learning component to this device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2014

Uniderm Farmaceutici S.R.L. % Guido Bonapace Consultant ISEMED S.R.L. Via A. Altobelli Bonetti 3/A 40026 Imola Bologna, Italy

Re: K132772

Trade/Device Name: Lubrigyn Cream Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 22, 2014 Received: July 25, 2014

Dear Guido Bonapace,

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.

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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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Benjamin R. Fisher -S

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):

K132772

Device Name:

LUBRIGYN CREAM

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary for LUBRIGYN CREAM

This 510(k) Summary is submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	UNIDERM FARMACEUTICI srl is located at:Via E. Ortolani, 21100125 – ROMAITALY
Contact Person:	Guido Bonapace (consultant)ISEMED srlVia A. Altobelli Bonetti 3/A40026 Imola (BO)ItalyMob.phone: +39-335-5378686Telephone: +39-0542-683803Fax: +39-0542-698456Email: gbonapace@isemed.eu
Summary Preparation Date:	July 22,2014
Names
Device Name:	LUBRIGYN CREAM
Regulation NumberRegulation NameCommon Name:Product Code:Classification:	884.5300CondomLubricant PersonalNUCII

3. Predicate Device

The LUBRIGYN CREAM is substantially equivalent to the following device:

Applicant	Device name	510(k)Number	Productcode
POLICHEM SA	me again(r) long lasting vaginalmoisturizer,vh essentials (r) long lasting vaginalmoisturizer	K112217	NUC

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LUBRIGYN CREAM and its predicate device are indicated for the same intended use and have equivalent technological characteristics.

4. Intended Use

5. Device Description

6. Technological Characteristics

The LUBRIGYN CREAM formula is proprietary. The product however consists of water based ingredients with an action comparable to other lubricants currently on the market. LUBRIGYN CREAM is substantially equivalent to the predicate device with respect to intended use and technological characteristics

7. Summary of Performance Data

Biocompatibility Testing: the following biocompatibility tests were performed on LUBRIGYN CREAM :

•Cytotoxicity according to ISO 10993-5
·Sensitization according to ISO 10993-10
·Vaginal irritation according to ISO 10993-10
•Acute systemic Toxicity according to ISO 10993-11

The results of biocompatibility test showed that LUBRIGYN CREAM can be considered biocompatible.

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UNIDERM FARMACEUTICI SRL 510(K) NOTIFICATION

Stability Testing: Stability tests performed on already expired product confirm a shelf life of 36 months for LUBRIGYN CREAM .

Microbiological Challenge Test: a microbiological challenge test according to USP 51 was performed on expired product to confirm anti-microbial effectiveness.

Condom compatibility testing: The compatibility of LUBRIGYN CREAM was evaluated with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10. The testing showed that the LUBRIGYN CREAM is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Conclusion drawn from testing performed:

The no-clinical performance testing conducted demonstrates that LUBRIGYN CREAM is substantially equivalent to the proposed predicate device.

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.