(351 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a personal lubricant, with no mention of AI or ML technologies.
No.
The intended use of the device is for moisturizing and lubricating to enhance comfort during intimate sexual activity and supplement natural lubrication, which are not therapeutic purposes.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate activity, not to diagnose a medical condition.
No
The device description clearly indicates it is a cream, which is a physical substance, not software. The performance studies also focus on the physical and biological properties of the cream.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 describes a product used topically for physical comfort and lubrication during sexual activity.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: LUBRIGYN CREAM does not perform any tests on bodily samples to diagnose or detect anything. Its function is purely physical lubrication and moisturizing.
The information provided about biocompatibility, stability, and microbiological testing are standard tests for medical devices applied to the body, but they do not indicate an IVD function. The predicate devices also confirm its classification as a personal lubricant, not an IVD.
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 (comma separated list FDA assigned to the subject device)
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 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).
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)
Biocompatibility Testing:
- 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
Results: The results of biocompatibility test showed that LUBRIGYN CREAM can be considered biocompatible.
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.
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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be connected, forming a single, unified shape.
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.
1
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
2
Indications for Use
510(k) Number (if known):
Device Name:
LUBRIGYN CREAM
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.
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)
3
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, 211
00125 – ROMA
ITALY |
|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Guido Bonapace (consultant)
ISEMED srl
Via A. Altobelli Bonetti 3/A
40026 Imola (BO)
Italy
Mob.phone: +39-335-5378686
Telephone: +39-0542-683803
Fax: +39-0542-698456
Email: gbonapace@isemed.eu |
| Summary Preparation Date: | July 22,2014 |
| Names | |
| Device Name: | LUBRIGYN CREAM |
| Regulation Number
Regulation Name
Common Name:
Product Code:
Classification: | 884.5300
Condom
Lubricant Personal
NUC
II |
3. Predicate Device
The LUBRIGYN CREAM is substantially equivalent to the following device:
| Applicant | Device name | 510(k)
Number | Product
code |
|-------------|-----------------------------------------------------------------------------------------------------------|------------------|-----------------|
| POLICHEM SA | me again(r) long lasting vaginal
moisturizer,
vh essentials (r) long lasting vaginal
moisturizer | K112217 | NUC |
4
LUBRIGYN CREAM and its predicate device are indicated for the same intended use and have equivalent technological characteristics.
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 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).
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.
5
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.