(349 days)
Not Found
No
The device description and intended use are for a physical contraceptive device and do not mention any software, algorithms, or data processing that would involve AI or ML.
No.
The device is described as a male contraceptive and prophylactic device, not as a therapeutic device designed to cure, treat, or mitigate disease.
No
The device is a condom used for contraception and prophylaxis, not for identifying or diagnosing a disease or condition.
No
The device description clearly states it is a physical condom made from synthetic rubber polyisoprene latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and reducing the risk of pregnancy and STDs. This is a physical barrier method, not a test performed on a sample from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The description details a physical device made of synthetic rubber, designed to be worn externally. It does not describe reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or test kits
- Measuring biomarkers or analytes
The device is clearly a medical device, specifically a contraceptive and prophylactic device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
MOL
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.
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)
Not Found
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
II. 510(k) SUMMARY
| Submitted by: | Ansell Healthcare Products LLC
1635 Industrial Road
Dothan, AL 36303
USA | |
|----------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------|
| Contact Person | Lon D. McIlvain
Vice President, Regulatory Affairs Global
Telephone:
Fax: | 334-794-4231 or 334-615-2562
334-615-2568 |
| 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 Lubricant
510(k) Document Control Number K941258 | |
Description of the Device:
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.
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:
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).
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