(170 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.
A personal lubricant intended to moisturize and lubricate for sexual activity and supplement natural lubrication does not fall under the typical definition of a therapeutic device designed to treat or cure a medical condition.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing comfort during sexual activity, not for diagnosing any medical condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description explicitly mentions it is a "gel-like liquid" provided in a "plastic pump dispenser."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device's Intended Use: The intended use of LifeStyles® Warm Lovin'™ Personal Lubricant is clearly stated as a personal lubricant for penile and/or vaginal application to enhance the ease and comfort of intimate sexual activity. It is applied to the body, not used to test samples from the body.
- Device Description: The description reinforces its function as a lubricant applied externally.
- Lack of Diagnostic Information: The documentation does not mention any diagnostic purpose, testing of bodily samples, or providing information about a person's health status.
Therefore, based on the provided information, this device falls under the category of a personal lubricant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
LifeStyles® Warm Lovin'™ 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® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that 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
Non-Clinical Testing: Testing per ASTM D 7661 indicated that, like the predicate, the lubricant formulation is compatible with 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 is non-staining and that it has an appropriate viscosity, pH, specific gravity, appearance, color and odor for substantial equivalence to the predicate. USP testing for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality. Real-time 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
Ansell
Page 1 of 2 Traditional 510(k) Summary
510(k) SUMMARY
FEB 2 2 2013
| Applicant: | Ansell Healthcare Products, LLC |
|---|---|
| 1635 Industrial Road, | |
| Dothan, AL 36303 | |
| USA | |
| Phone: (334) 615-2563 | |
| Fax: (334) 615-2574 | |
| Contact Person: | Robert Mahler, Regulatory Affairs Director, Americas |
| Date Prepared: | February 8, 2013 |
| 510(k) Number: | K122720 |
| Proprietary Name: | LifeStyles® Warm Lovin'TM Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name: | Lubricant, patient, vaginal, latex compatible (Class II, 21 CFR |
| 884.5300, Product Code NUC) | |
| Predicate Device: | K Y ® Brand Warming Liquid Personal Lubricant (K021492) |
Device Description:
LifeStyles® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
Indications for Use:
LifeStyles® Warm Lovin'™ 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® Warm Lovin'™ Personal Lubricant contains a similar blend of ingredients as the predicate device that create a warming gel lubricant. Like the predicate, the lubricant formulation is compatible with condoms and biocompatible, and has appropriate characteristics (i.e. viscosity, pH, specific gravity, appearance, color , odor, microbial quality) for a personal lubricant.
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Image /page/1/Picture/0 description: The image shows the word "Ansell" in a bold, sans-serif font. The word is written in black and is underlined with a thin, slightly curved line. The font is simple and clear, making the word easily readable.
510(k) SUMMARY (Continued)
Non-Clinical Testing:
Testing per ASTM D 7661 indicated that, like the predicate, the lubricant formulation is compatible with 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 is non-staining and that it has an appropriate viscosity, pH, specific gravity, appearance, color and odor for substantial equivalence to the predicate. USP testing for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality. Real-time and accelerated aging tests indicate a 3-year shelf-life for the lubricant.
Summary:
LifeStyles® Warm Lovin™ Personal Lubricant has the same intended use and basic technological characteristics as the predicate device. This lubricant is as safe and effective as the predicate device.
END
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2013
Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal Consultant DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401
Re: K122720
Trade/Device Name: LifeStyles® Warm Lovin'™ Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 11, 2013 Received: February 12, 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.
3
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/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 yours,
HerbertPLerner-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
4
Traditional 510(k) Ansell Healthcare Products, LLC
Indications for Use
510(k) Number (if known):
Device Name: LifeStyles® Warm Lovin'TM Personal Lubricant
Indications for Use: LifeStyles® Warm Lovin'™ 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)
Herbert R. Deliner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122720 510(k) Number
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