(274 days)
Not Found
No
The summary describes a personal lubricant and moisturizer with no mention of AI or ML technology in its intended use, device description, or performance studies.
No
The device is a personal lubricant intended to enhance comfort during sexual activity and supplement natural lubrication. It does not treat or prevent any specific condition, disease, or medical problem, which aligns with the definition of a personal lubricant rather than a therapeutic device.
No
The device is described as a personal lubricant and moisturizer for comfort and ease of intimate sexual activity, not for diagnosing any medical condition.
No
The device description clearly states it is a "non-sterile, translucent, non-greasy, aqueous thick liquid" packed in a "plastic bottle," indicating it is a physical product, 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 enhance comfort during sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a biological sample.
- Device Description: The description details a non-sterile, translucent liquid for topical use. It explicitly states it's not a contraceptive or spermicidal.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing any diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility, antimicrobial effectiveness, condom compatibility, and shelf life – all relevant to a personal lubricant, not an IVD.
IVD devices are designed to be used in vitro (outside the body) 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
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant 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 polyisoprene condoms, but is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Personal Lubricant are packed in a plastic bottle.
These devices are neither contraceptives nor spermicidals, nor do they contain any such component. They are compatible with latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to the standards defined by ASTM D7661.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Biocompatibility of the final formulation of Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant were established through testing generally following ISO 10993-1, and includes cytotoxicity, sensitization, irritation, and acute systemic toxicity testing. The results demonstrate that the subject lubricants are biocompatible.
Physical & Other Testing: The physical and other testing performed on Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant included an Antimicrobial Preservative Effectiveness Validation testing under USP , Lubricant-Condom Compatibility testing per ASTM D7661, and shelf life testing. Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passed the Antimicrobial Effectiveness test and were found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. The results of real time testing support the proposed shelf life for the subject lubricants.
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 seal of 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 design featuring three stylized 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
December 29, 2015
Laclede, Inc. % Seth Mailhot Attorney Michael Best & Friedrich LLP 601 Pennsylvania Ave. NW. Suite 700 Washington, DC 20004
Re: K150841
Trade/Device Name: Luvena Enhanced Personal Moisturizer Luvena Enhanced Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 30, 2015 Received: November 30, 2015
Dear Seth Mailhot.
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
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.
Glenn B. Bell -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) K150841
Device Name Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant
Indications for Use (Describe)
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant 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 polyisoprene condoms, but is not compatible with polyurethane condoms.
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 K150841
Submitted by: | Laclede, Inc. |
---|---|
Address: | 2103 E. University Drive |
Rancho Dominguez, CA 90220 | |
Telephone: | (310) 605-4280 |
Facsimile: | (310) 605-4288 |
Contact Name: | Michael A. Pellico, President |
E-mail: | mpellico@laclede.com |
Date Submitted: | November 10, 2015 |
Trade Name: | Luvena Enhanced Personal Moisturizer and |
Luvena Enhanced Personal Lubricant | |
Classification Name: | Condom |
Common Name: | Personal Lubricant |
Product Code / | |
Regulation: | NUC (21 C.F.R. 884.5300) |
Predicate Device: | Aqua Lube Personal Lubricant: K110325, Mayer Laboratories, Inc. |
Description: | Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican |
are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a | |
personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Persona | |
Lubricant are packed in a plastic bottle. |
These devices are neither contraceptives nor spermicidals, nor do they contain any
such component. They are compatible with latex and polyisoprene condoms and not
compatible with polyurethane condoms as demonstrated in condom compatibility
testing conducted according to the standards defined by ASTM D7661. |
| Product Specifications: | The product specifications for the Luvena Enhanced Personal
Moisturizer and Luvena Enhanced Personal Lubricant include
color/appearance, odor, pH, viscosity, osmolality, Total Aerobic
Microbial Count (TAMC), Total Yeast and Mold Count (TYMC),
absence of pathogenic organisms, and antimicrobial effectiveness. |
| Intended Use: | Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican
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 polyisoprene condoms, but is not compatible with polyurethane
condoms. |
| Biocompatibility: | Biocompatibility of the final formulation of Luvena Enhanced Personal
Moisturizer and Luvena Enhanced Personal Lubricant were established
through testing generally following ISO 10993-1, and includes cytotoxicity,
sensitization, irritation, and acute systemic toxicity testing. The results
demonstrate that the subject lubricants are biocompatible. |
| Physical
& Other
Testing: | The physical and other testing performed on Luvena Enhanced Personal
Moisturizer and Luvena Enhanced Personal Lubricant included an Antimicrobial
Preservative Effectiveness Validation testing under USP , Lubricant-
Condom Compatibility testing per ASTM D7661, and shelf life testing. Luvena
Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant passed
the Antimicrobial Effectiveness test and were found to be compatible with natural
rubber latex and polyisoprene condoms, but not compatible with polyurethane
condoms. The results of real time testing support the proposed shelf life for the
subject lubricants. |
| Conclusion: | The subject lubricants are substantially equivalent to the proposed predicate device. |
Substantial
- Equivalence: Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant have the same intended use as the predicate device. However, the subject lubricants and the predicate device have different technological characteristics – namely differences in
formulation and specifications. The differences in technological characteristics do not raise different questions of safety and effectiveness.
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