(189 days)
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.
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.
The provided text describes a 510(k) submission for a personal lubricant, not an AI-powered medical device or diagnostic tool. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and sample sizes for training/test sets are not applicable to this document.
However, I can extract the acceptance criteria and the "device performance" as reported for this personal lubricant, even though they are for a different type of product than typically discussed in AI contexts.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Description of Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Compatibility with Condoms: Compatibility with natural rubber latex, polyurethane, and polyisoprene condoms. | Testing per ASTM D7661 indicated that the lubricant formulation is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
| Biocompatibility: Absence of cytotoxicity, vaginal irritation, sensitization, and systemic toxicity. | Testing in accordance with ISO 10993 indicated device biocompatibility for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity. |
| Lubrication Duration: Lasts longer than hydrous lubricants without drying out or becoming sticky. | Bench testing indicated that the lubricant lasts longer than hydrous lubricants, without drying out or becoming sticky. |
| Physical Properties: Appropriate viscosity, specific gravity, appearance, color, and odor for substantial equivalence to the predicate. | Bench testing indicated that it has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. |
| Microbial Quality: Meets microbial limits. | Microbial limits testing was conducted per USP <61> and USP <62> indicated microbial quality. |
| Shelf-Life: Minimum shelf-life of 3 years. | Realtime and accelerated aging tests indicate a 3 year shelf-life for the lubricant. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "sample size" in the context of a test set for an AI model. The testing described (ASTM D7661, ISO 10993, USP <61>/<62>, bench testing, aging tests) would have involved specific sample sizes of the lubricant and test materials (e.g., condom samples, biological samples for biocompatibility), but these quantities are not detailed in this summary.
- Data Provenance: Not applicable in the AI sense. The testing was conducted for regulatory purposes to demonstrate safety and effectiveness for a medical device (personal lubricant) in the USA (submission by Ansell Healthcare Products, LLC in Dothan, AL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical and chemical product, not one requiring expert human interpretation for "ground truth" as in medical imaging or diagnostics. The "ground truth" here is derived from standardized laboratory tests and measurements.
4. Adjudication method
Not applicable. There was no need for adjudication as the "ground truth" was established through objective tests, not human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance was established through:
- Standardized laboratory testing: ASTM D7661 for condom compatibility, ISO 10993 for biocompatibility, USP <61> and USP <62> for microbial quality.
- Bench testing: For aspects like lubrication duration, viscosity, specific gravity, appearance, color, and odor.
- Realtime and accelerated aging tests: For shelf-life.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this product as it is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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 <61> and USP <62> 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.
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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.
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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
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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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§ 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.