(28 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 is described as a personal lubricant intended to moisturize and lubricate for enhance comfort during sexual activity, and supplement natural lubrication. It does not treat or prevent a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states that LUBRIGYN CREAM is a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate activity and supplement natural lubrication. This description clearly indicates a therapeutic or supportive function, not a diagnostic one. There is no mention of identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is a cream, which is a physical substance, not software.
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 penile and/or vaginal application to moisturize and lubricate for intimate sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or examining specimens from the body.
- Device Description: The description focuses on the physical properties and microbial safety of the cream itself. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of a diagnostic purpose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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).
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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)
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
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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, 211
00125 – ROMA
ITALY |
|----|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Maurizio Pantaleoni (consultant)
ISEMED srl
Via A. Altobelli Bonetti 3/A
40026 Imola (BO)
Italy
Mob.phone: +39-348-4435155
Telephone: +39-0542-683803
Fax: +39-0542-698456
Email: 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 | Product
code |
|-------------------------|------------------------------------------------|------------------|-----------------|
| UNIDERM
FARMACEUTICI | LUBRIGYN CREAM
(single pocket-sized sachet) | K132772 | NUC |
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4. Intended Use
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.
5. 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).
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).