The LifeStyles Lubricated Polyisoprene Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Device Description

The LifeStyles condom is a male contraceptive and prophylactic device fabricated from synthetic rubber polyisoprene latex with a lubricant coating. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple-end) at the closed end to contain semen. The condom has a nominal length of 185 mm and nominal width of 53 mm. The condom is designed to conform to established national and international voluntary standards including ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum.

AI/ML Overview

The provided text describes a 510(k) summary for a condom device and a subsequent FDA clearance letter. It does not contain information about a study proving the device meets acceptance criteria in the context of typical medical image analysis or diagnostic device studies.

Instead, the acceptance criteria for this device (LifeStyles Lubricated Polyisoprene Latex Male Condom) are based on established national and international voluntary standards for condoms. The "study" mentioned isn't a clinical trial in the way it's usually considered for AI/medical imaging, but rather testing to ensure the device conforms to these established standards.

Therefore, for your requested information points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Conforms to ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)	The device "is designed to conform to established national and international voluntary standards including ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)" and "conforms to national and international standards: ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)".
Conforms to ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum	The device "is designed to conform to established national and international voluntary standards including... ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum" and "conforms to national and international standards:... ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms – Requirements and Test Methods, Technical Corrigendum".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. While it states the device conforms to standards, it doesn't detail the specific testing methodology, sample sizes, or data provenance used to verify this conformance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the given text. "Ground truth" in this context would likely refer to the results of standardized physical and mechanical tests on the condoms, not expert interpretation as in medical imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the given text. Adjudication methods are typically relevant for subjective expert reviews, not instrumental testing against predefined standards.

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

This information is not applicable and not provided in the given text. This device is not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided in the given text. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" implicitly used would be the physical and mechanical properties of the condom as measured against the specifications outlined in the ASTM D3492 and ISO 4074 standards (e.g., burst strength, freedom from holes, dimensions).

8. The sample size for the training set

This information is not applicable and not provided in the given text. Training sets are relevant for machine learning algorithms, which this device is not.

9. How the ground truth for the training set was established

This information is not applicable and not provided in the given text.

Summary

{0}------------------------------------------------

II. 510(k) SUMMARY

Submitted by:	Ansell Healthcare Products LLC1635 Industrial RoadDothan, AL 36303USA
Contact Person	Lon D. McIlvainVice President, Regulatory Affairs GlobalTelephone:Fax:	334-794-4231 or 334-615-2562334-615-2568
Date Prepared:	December 13, 2006
Proprietary Name:	LifeStyles Lubricated Polyisoprene Latex Male Condom
Common Name:	Male latex condom
Classification Name:	Condom (21 CFR 884.5300)
Predicate Device:	Suretex Ltd., Latex Condoms with Silicone Oil Lubricant510(k) Document Control Number K941258

Description of the Device:

Intended Use of the Device:

The condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Technological Characteristics:

The basic technological characteristics of the LifeStyles condom are the same as the predicate condom. The LifeStyles condom and the predicate condom are of the same basic design; both are straight-walled, nipple-ended, lubricated condoms with an integral ring at the open end. The condom design conforms to national

{1}------------------------------------------------

and international standards: ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms – Requirements and Test Methods, Technical Corrigendum.

Conclusion:

Based on intended use and technological characteristics, the LifeStyles condom is substantially equivalent to the predicate device; the Suretex Ltd. Latex Condom with Silicone Oil Lubricant (K941258).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2008

Mr. Lon McIlvain Vice President, Regulatory Affairs Global Ansell Healthcare Products LLC 1635 Industrial Road DOTHAN AL 36303

Re: K070800

Trade/Device Name: LifeStyles Lubricated Polyisoprene Latex Male Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: January 25, 2008 Received: January 28, 2008

Dear Mr. McIlvain:

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.

{3}------------------------------------------------

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy 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:

Ko70800

Device Name:

LifeStyles Lubricated Polyisoprene Latex Male Condom

Indications for Use:

Prescription Use

AND/OR Over-The-Counter Use (Per 21 CFR §801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helu Pessen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.