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 a 50 mail airless container 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, odor, pH, 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

The provided text describes the 510(k) premarket notification for "LUBRIGYN CREAM" in an airless container. The submission aims to demonstrate substantial equivalence to a predicate device, which is an earlier version of LUBRIGYN CREAM in single-use sachets (K132772).

Here's an analysis based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a typical statistical sense (e.g., minimum sensitivity, specificity) for a diagnostic or AI device. Instead, it focuses on demonstrating equivalence to a predicate device by comparing technological characteristics and conducting stability testing.

Acceptance Criteria (Implied by Equivalence to Predicate)	Reported Device Performance (LUBRIGYN CREAM - Airless Container)
Identical Formulation	Identical formulation
Identical Bulk Manufacturing Process	Identical bulk manufacturing process
Identical Product Release Specification	Identical product release specification (including appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count, and absence of pathogen organisms)
Shelf-life	36 months (confirmed by stability testing on not opened and opened containers)
Packaging Functionality	Airless container prevents air ingress when product is dispensed. Tamper evident seal in primary packaging and warning in secondary packaging.
Intended Use	Same intended use as predicate: 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.
Compatibility	Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (same as predicate).

2. Sample Size for Test Set and Data Provenance:

The document describes stability testing and comparison of characteristics, not a clinical "test set" in the context of evaluating a diagnostic or AI device.

Sample Size: Not explicitly stated as a number of subjects or cases. The "sample" for stability testing would refer to units of the LUBRIGYN CREAM product. It mentions "stability tests performed on already expired product," implying multiple units were tested over time.
Data Provenance: The study is focused on the product itself and its characteristics. The manufacturer is "UNIDERM FARMACEUTICI srl" located in Italy. The testing was conducted internally or by a contracted lab. This is product performance data, not patient-derived data from a specific country.
Retrospective/Prospective: Stability testing is inherently prospective, as it involves monitoring product characteristics over time.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a product performance study, not a study requiring expert clinical review to establish ground truth for a diagnostic or AI device. The "ground truth" here is the established specifications and verified shelf-life of the product.

4. Adjudication Method for Test Set:

Not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This submission is for a personal lubricant, not a diagnostic or AI device requiring an MRMC study. There's no AI component.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

Identical Formulation & Manufacturing Process: Verification of consistency with the predicate device.
Product Release Specifications: Defined by the manufacturer for parameters like pH, viscosity, microbial counts, etc. These are established laboratory standards.
Stability Test Results: Objective measurements over time showing the product maintains its specifications.

8. Sample Size for Training Set:

Not applicable. There is no "training set" as this is not an AI or machine learning device.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

February 19, 2015

Uniderm Farmaceutici Srl. % Maurizio Pantaleoni Consultant Isamed. Srl. Via A. Altobelli Bonetti 3/A 40026 Imola (BO) Italy

Re: K150147 Trade/Device Name: Lubrigyn Cream Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 15, 2015 Received: January 22, 2015

Dear Maurizio Pantaleoni,

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 mav 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150147

Device Name LUBRIGYN CREAM

Indications for Use (Describe)

This product is not compatible with natural rubber latex, polyisoprene and polyurethane condoms

Type of Use (Select one or both, as applicable)

] 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:

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"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."

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510(k) Summary for LUBRIGYN CREAM – Airless Container

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

General Information 1.

	Submitter:	UNIDERM FARMACEUTICI srl is located at:Via E. Ortolani, 21100125 – ROMAITALY
	Contact Person:	Maurizio Pantaleoni (consultant)ISEMED srlVia A. Altobelli Bonetti 3/A40026 Imola (BO)ItalyMob.phone: +39-348-4435155Telephone: +39-0542-683803Fax: +39-0542-698456Email: regulatory@isemed.eu
	Summary Preparation Date:	January 15, 2015
2.	Names
	Device Name:	LUBRIGYN CREAM
	Regulation Number	884.5300
	Regulation Name	Condom
	Common Name:	Lubricant Personal
	Product Code:	NUC
	Classification:	II

3. Predicate Device

The subject device Lubrigyn cream is substantially equivalent to the following predicate device:

Applicant	Device name	510(k)Number	Productcode
UNIDERMFARMACEUTICI	LUBRIGYN CREAM(single pocket-sized sachet)	K132772	NUC

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4. Intended Use

5. Device Description

The specifications for the LUBRIGYN CREAM include appearance, color, odor, pH, 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).

6. Comparison of technological characteristics with the predicate device

LUBRIGYN CREAM (Airless Container) and its predicate device are indicated for the same intended use and have equivalent technological characteristics:

•identical formulation
identical bulk manufacturing process
identical product release specification.

The differences between the two products are:

•LUBRIGYN CREAM ( Airless Container) is packaged in a multidose container (50 ml) instead of a 2 ml single pocket size sachet. The Airless container is a 50 ml polypropylene container that prevents air ingress when the product is dispensed through the pump.
•As a consequence of the point above, a new stability study was performed on LUBRIGYN CREAM (Airless container) in order to confirm shelf life (36 months). The study has been performed both on not opened and opened product.
•The labeling has been modified as indicated below:
- oModification of the quantity on secondary packaging, primary packaging and instruction for use (50 ml instead of 2 ml for 20 sachets)
- olntroduction of a "direction for use" about dosage on secondary packaging, primary packaging and instruction for use in order to inform the user about the number of "pushes" needed to obtain the same quantity of the single pocket-size sachet (2ml)

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olntroduction of a tamper evident seal in primary packaging and a tamper evident warning in secondary packaging.

7. Summary of Performance Data

Stability Testing: Stability tests performed on already expired product confirm a shelf life of 36 months for LUBRIGYN CREAM (Airless container). The tests have been performed both on not opened and opened (Half emptied) containers.

8. Conclusions

The performance data summarized above demonstrate that LUBRIGYN CREAM is substantially equivalent to the proposed predicate device (K132772).

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.