(189 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties and biocompatibility, with no mention of AI or ML.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose, cure, mitigate, treat, or prevent disease.
No
This product is a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity, not to diagnose a disease or condition.
No
The device description clearly states it is a "silicone-based personal lubricant" provided in a "plastic pump dispenser," 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 for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a topical application for physical comfort and enhancement, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description focuses on the physical properties of the lubricant (silicone-based, gel-like liquid, biocompatible, compatible with condoms) and its packaging. It does not describe a device that interacts with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The performance studies focus on biocompatibility, compatibility with condoms, physical properties, and shelf-life – all relevant to a personal lubricant, not an IVD.
In summary, the LifeStyles® Luxe™ Premium Personal Lubricant is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LifeStyles® Luxe™ Premium 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, polyurethane, and polyisoprene condoms.
Product codes
NUC
Device Description
LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
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
Bench testing indicated that the lubricant lasts longer than hydrous lubricants, without drying out or becoming sticky, and that it has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. Microbial limits testing was conducted per USP and USP indicated microbial quality. Realtime and accelerated aging tests indicate a 3 year shelf-life for the lubricant.
Key Metrics
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.
0
Traditional 510(k) Summary
510(k) SUMMARY
Applicant:
Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, AL 36303 USA Phone: (732) 345-2174 Fax: (732)603-7960
Contact Person:
January 19, 2013
Date Prepared:
510K:
LifeStyles® Luxe™ Premium Personal Lubricant Proprietary Name:
Personal Lubricant Common Name:
Classification Name: Lubricant, patient, vaginal, latex compatible (Class II, 21 CFR 884.5300, Product Code NUC)
Robert Mahler, Regulatory Affairs Director, Americas
Predicate Device: Vielle™ Lubricant (K051288)
Device Description:
LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
Indications for Use:
LifeStyles® Luxe™ Premium 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, polyurethane, and polyisoprene condoms.
Technological Characteristics:
LifeStyles® Luxe™ Premium Personal Lubricant contains a similar blend of silicone oils as the predicate device. Testing per ASTM D7661 indicated that the lubricant formulation is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility. Bench testing indicated that the lubricant lasts longer than hydrous lubricants, without drying out or becoming sticky, and that it has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. Microbial limits testing was conducted per USP and USP indicated microbial quality. Realtime and accelerated aging tests indicate a 3 year shelf-life for the lubricant.
Summary:
LifeStyles® Luxe™ Premium Personal Lubricant has the same intended use and basic technological characteristics as the predicate device. This lubricant is substantially equivalent to its proposed predicate device.
J
Rg.1c
FEB 1 9 2013
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2013
Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal Consultant DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401
Re: K122477
Trade/Device Name: LifeStyles® Luxe™ Premium Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 29, 2013 Received: February 4, 2013
Dear Ms. Di Gangi:
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.
2
Page 2 -- Ms. Donna Di Gangi
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/ucm1.15809.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/Resourcesfor You/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
3
Indications for Use
510(k) Number (if known): K122477
Device Name: LifeStyles® Luxe™ Premium Personal Lubricant
Indications for Use: LifeStyles® Luxe™ Premium 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, polyurethane, and polyisoprene condoms.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.02.19 18:17:55 -05'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122477 510(k) Number
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