(81 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties and compatibility with condoms. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No
The device is described as a personal lubricant intended to supplement natural lubrication, moisturize, and enhance comfort during sexual activity. It does not claim to treat, mitigate, cure, or prevent any disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is described as a personal lubricant intended to supplement natural lubrication and enhance comfort during intimate activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical product (liquid lubricant) packaged in a tube or sachet, 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 to supplement natural lubrication and enhance comfort during sexual activity. This is a topical application for physical comfort and ease, not for diagnosing a condition or analyzing a biological sample in vitro.
- Device Description: The description details a water-based lubricant for external use. There is no mention of it being used to test or analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The performance studies mentioned (condom compatibility, biocompatibility, preservative effectiveness) are relevant to the safety and functionality of a personal lubricant for its intended use, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
Product codes (comma separated list FDA assigned to the subject device)
85HI, 85 HIS
Device Description
LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas: LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
LifeStyles® Liquid Personal Lubricant was tested by independent laboratories for condom compatibility, biocompatibility, and preservative effectiveness. Independent testing has also demonstrated that LifeStyles® Liquid Personal Lubricant does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoynol-9).
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.
0
DEC 1 9 2003
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510(k) SUMMARY
033076
| Submitted by: | Ansell Healthcare Inc.
1635 Industrial Road
Dothan, AL 36303
USA | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------|
| Contact Person | Lon D. McIlvain
Quality Assurance/Regulatory Manager
Telephone: 334-794-4231 or 334-615-2562
Fax: 334-615-2568 | |
| Date Prepared: | September 25, 2003 | |
| Proprietary Name: | LifeStyles® Liquid Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom (21 CFR §884.5300) | Product Code 85HI |
| Predicate Device: | Astroglide® Personal Lubricant (K935299)
K-Y® Liquid Personal Lubricant (K955648) | |
Description of the Device:
LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas:
LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry
The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.
Intended Use of the Device:
Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. If used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.
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LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
Technological Characteristics:
The LifeStyles® Liquid Personal Lubricant formulations contain ingredients that are substantially the same as those used to manufacture the predicate devices. The strawberry fragrance used in the strawberry formulation contains standard ingredients commonly used in cosmetic applications as well as in drug flavors. The D&C and FD&C red colors are approved for use in drug and cosmetic applications. Aloe and Vitamin E are approved for use and commonly used in cosmetic applications.
The table below compares the technological characteristics of LifeStyles® Liquid Personal Lubricant to the predicate devices, K-Y® Liquid Personal Lubricant and Astroglide®.
| Feature | LifeStyles® Liquid
Personal Lubricant | K-Y® Liquid Personal
Lubricant | Astroglide® |
|---------------------------------------|------------------------------------------|-----------------------------------|--------------|
| Manufacturer | Ansell Healthcare Inc. | McNeil-PPC, Inc. | BioFilm Inc. |
| Contains dionized water | Yes | No | No |
| Contains purified water | No | Yes | Yes |
| Contains glycerine | Yes | Yes | Yes |
| Contains Cellulose
thickeners | Yes | Yes | No |
| Contains Methylparaben | Yes | Yes | Yes |
| Contains Propylparaben | Yes | No | Yes |
| Labeled water soluble | Yes | Yes | Yes |
| Labeled non-staining | Yes | Yes | Yes |
| Labeled condom
compatible | Yes | Yes | Yes |
| Labeled alcohol and
fragrance free | No | No | No |
| Container material | Plastic or Foil/Plastic
Film Laminate | Plastic | Plastic |
| Sterile | No | No | No |
LifeStyles® Liquid Personal Lubricant was tested by independent laboratories for condom compatibility, biocompatibility, and preservative effectiveness. Independent testing has also demonstrated that LifeStyles® Liquid Personal Lubricant does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoynol-9).
Conclusion
LifeStyles® Liquid Personal Lubricant is substantially equivalent to its predicate devices, K-Y® Liquid Personal Lubricant and Astroglide®. All of these products have the same intended use and similar technological characteristics. Therefore, no new safety and effectiveness issues are expected to be raised.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Ms. Cynthia A. Ingram Regulatory Affairs Administrator Ansell Healthcare, Inc. 1635 Industrial Road Dothan, Alabama 36303
Re: K033076
Trade/Device Name: LifeStyles® Liquid Personal Lubricant Long Lasting, Aloe & Vitamin E, and Strawberry Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 25, 2003 Received: September 29, 2003
Dear Ms. Ingram:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K033076
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seghers
(Division Sign-Off) ivision of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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