(90 days)
Not Found
No
The device description and intended use are for a standard latex condom, and there is no mention of AI or ML in the provided text.
No
The device is described as being for contraception and disease prevention, which are not considered therapeutic purposes.
No
The device, a condom, is used for contraception and prophylactic purposes, not for diagnosing any medical condition.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted diseases. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical device (a condom) made of latex. It does not describe reagents, instruments, or software used to analyze biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnostic or monitoring purposes based on laboratory testing.
Therefore, the LifeStyles® Zero® condom is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.
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
K120394
Page 1 of 3
II. 510(k) SUMMARY
Applicant:
Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, AL 36303 USA Phone: (334) 615-2563 Fax: (334) 615-2574
Cynthia Ingram, Regulatory Affairs Manager, Americas Contact Person:
February 02, 2012 Date Prepared:
LifeStyles® Zero® Lubricated Latex Condom Proprietary Name:
Latex Condom Common Name:
Condom (21 CFR 884.5300; Product Code HIS) Classification
Name:
Billy Boy Male Latex Condoms (K103119) Predicate Device(s):
Device Description:
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.
Intendications for Use:
This latex condom has the same intended use as the predicate condom. LifeStyles® Zero® condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Technological Characteristics:
Feemforogroum and the predicate device identified above are made from natural rubber latex, with designs that are biocompatible and in conformance with the requirements of the ASTM D 3492-08 condom standard. Both are straight-walled, requirements or condoms, with a reservoir tip, provided in a foil package. This cymidned, fubricated oonaoms, waate device is scented. The absence of scent has no material impact on safety and effectiveness.
The table below compares specific technological characteristics of the condom to the predicate:
1
K120394
Page 2 of 3
Ansell Healthcare Products, LLC Attachment Page 11
II. 510(k) SUMMARY, Continued
·
| | LifeStyles® Zero® Lubricated
Latex Condom | Billy Boy Male Latex
Condoms |
|-----------------|------------------------------------------------|------------------------------------------------|
| Material | Natural rubber latex | Natural rubber latex |
| Condom Film | Compounded natural rubber
latex formulation | Compounded natural rubber
latex formulation |
| Design | Straight-walled, cylindrical,
reservoir tip | Straight-walled, cylindrical,
reservoir tip |
| Lubricant | Silicone (silicone oil) | Silicone (silicone oil) |
| Primary Package | Foil | Foil |
| Length | 185 mm | 185 mm |
| Width | 51 mm | 52 mm |
| Thickness | 0.04 mm | 0.04 to 0.08 mm |
| Color | Natural | Natural |
| Scented | No | Yes |
Summary:
.
This condom has the same intended use and basic technological characteristics as the predicate device. This condom is as safe and effective as the predicate device.
,
. . . .
.
・
.
。
.
2
K120394
Page 3 of 3
II. 510(k) SUMMARY, Continued
| | LifeStyles® Zero® Lubricated
Latex Condom | Billy Boy Male Latex
Condoms |
|-----------------|------------------------------------------------|------------------------------------------------|
| Material | Natural rubber latex | Natural rubber latex |
| Condom Film | Compounded natural rubber
latex formulation | Compounded natural rubber
latex formulation |
| Design | Straight-walled, cylindrical,
reservoir tip | Straight-walled, cylindrical,
reservoir tip |
| Lubricant | Silicone (silicone oil) | Silicone (silicone oil) |
| Primary Package | Foil | Foil |
| Length | 185 mm | 185 mm |
| Width | 51 mm | 52 mm |
| Thickness | 0.04 mm | 0.04 to 0.08 mm |
| Color | Natural | Natural |
| Scented | No | Yes |
Summary:
This condom has the same intended use and basic technological characteristics as the predicate device. This condom is as safe and effective as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401
MAY - 8 2012
K120394 Re:
Trade/Device Name: LifeStyles® Zero® Lubricated Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 2, 2012 Received: February 8, 2012
Dear Ms. 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. 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
4
Page 2-
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/CDRH0ffices/ucm115809.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, Ph.D.
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
5
Ansell Healthcare Products, LLC
Indications for Use
120394
510(k) Number (if known):
Device Name: LifeStyles® Zero® Lubricated Latex Condom
Indications for Use: The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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)
Richard Renner
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 21394 510(k) Number