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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance for LifeStyles® Liquid Personal Lubricant

This report details the acceptance criteria and the results of the study demonstrating the performance of LifeStyles® Liquid Personal Lubricant, as presented in the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily demonstrates substantial equivalence to predicate devices. The acceptance criteria are implicitly derived from the characteristics of these predicate devices and the intended use. The performance of LifeStyles® Liquid Personal Lubricant is then compared against these established characteristics through various tests.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance for LifeStyles® Liquid Personal Lubricant
Composition/Properties	Contains deionized water	Yes
	Contains glycerine	Yes
	Contains Cellulose thickeners	Yes
	Contains Methylparaben	Yes
	Contains Propylparaben	Yes
	Labeled water soluble	Yes
	Labeled non-staining	Yes
	Non-greasy, non-sticky	Yes (described in general description)
	Non-irritating	Yes (described in general description)
Safety	Condom compatibility with latex condoms	Yes (tested in laboratory testing)
	Biocompatibility	Yes (tested by independent laboratories)
	Preservative effectiveness	Yes (tested by independent laboratories)
	Does not affect in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoxynol-9)	Yes (demonstrated by independent testing)
Intended Use	Supplement body's natural lubrication fluids	Yes (stated in intended use)
	Moisturize	Yes (stated in intended use)
	Enhance comfort and ease of intimate sexual activity with or without a latex condom	Yes (stated in intended use)
Classification	Non-sterile	Yes

2. Sample Size and Data Provenance

The 510(k) summary does not explicitly state specific sample sizes for the tests conducted. It mentions that LifeStyles® Liquid Personal Lubricant was "tested by independent laboratories" for condom compatibility, biocompatibility, and preservative effectiveness. It also states that "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)."

Test set sample size: Not explicitly specified for any of the tests.
Data provenance: The data was generated through "independent laboratories" and "independent testing." The country of origin is not specified, but the applicant (Ansell Healthcare Inc.) is based in the USA. The studies would be considered prospective as they were conducted to test the performance of the specific device for this submission.

3. Number of Experts and Qualifications for Ground Truth

The 510(k) summary does not provide information regarding the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the device (personal lubricant) and the types of tests described (e.g., condom compatibility, biocompatibility), the ground truth would likely be established through standardized laboratory test procedures and validated analytical methods rather than expert consensus on diagnostic interpretations.

4. Adjudication Method

The 510(k) summary does not mention any adjudication method. This is expected as the performance evaluation involves objective laboratory tests rather than subjective interpretations requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric. LifeStyles® Liquid Personal Lubricant is not a diagnostic device.

6. Standalone Performance Study

Yes, standalone performance studies were done. The description of tests for "condom compatibility, biocompatibility, and preservative effectiveness," and the demonstration that the product "does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide" are all examples of standalone performance testing of the algorithm (in this case, the product formulation) in isolation, without human-in-the-loop directly influencing the outcome of the specific measurement.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation appears to be based on:

Standardized laboratory test results: For condom compatibility (e.g., burst strength, freedom from pinholes), biocompatibility, and preservative effectiveness.
In-vitro experimental data: For the effect on spermicidal activity.
Material composition and formulation analysis: For confirming ingredients and properties.

It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on objective measurements from these laboratory tests.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. LifeStyles® Liquid Personal Lubricant is a medical device (personal lubricant), not an artificial intelligence or machine learning algorithm that requires a training set for model development. The product's formulation and manufacturing processes are developed based on scientific principles and validated through testing, not through iterative learning from data.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a training set is not applicable to this device, and therefore, the establishment of ground truth for a training set is not relevant.

Summary

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DEC 1 9 2003

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510(k) SUMMARY

033076

Submitted by:	Ansell Healthcare Inc.1635 Industrial RoadDothan, AL 36303USA
Contact Person	Lon D. McIlvainQuality Assurance/Regulatory ManagerTelephone: 334-794-4231 or 334-615-2562Fax: 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 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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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® LiquidPersonal Lubricant	K-Y® Liquid PersonalLubricant	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 Cellulosethickeners	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 condomcompatible	Yes	Yes	Yes
Labeled alcohol andfragrance free	No	No	No
Container material	Plastic or Foil/PlasticFilm 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.

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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.

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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

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Indications for Use

510(k) Number (if known): K033076

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Page 1

Regulation Number and Section

§ 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.