(302 days)
Not Found
Not Found
No
The document describes a physical barrier device (condom) and its material properties and performance in preventing transmission of STDs and pregnancy. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as being used for contraceptive and prophylactic purposes, primarily to prevent transmission of venereal disease and reduce the risk of HIV and other STDs, which are preventative rather than therapeutic actions.
No
Explanation: The device, a condom, is described as being used for contraceptive and prophylactic (disease prevention) purposes. It acts as a physical barrier and does not detect or diagnose any medical condition.
No
The device description clearly states the device is a physical condom made of polyurethane, which is a hardware component.
Based on the provided text, 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 by providing a physical barrier during sexual intercourse. This is a direct interaction with the body to prevent physical exchange, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the physical characteristics and material of the condom, emphasizing its function as a physical barrier.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition
The device functions as a physical barrier during sexual activity, which is a medical device function, but not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom is used for contraceptive and for prophylactic purposes (hclping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted discases, including chlamydia, genital warts, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of the condom for other than vaginal intercourse can increase the potential of damage to the condom. For maximum benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs. The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
Product codes
Not Found
Device Description
A condom is a sheath which completely covers the penis with a closely fitting membrane in the case of the subject medical device is made The polyurethanc utilized for the TROJAN® Polyurethane of a polyurethane matcrial. Condom is an aliphatic polyurethane. Unlike an aromatic polyurethane, the aliphatic polyurethane utilized for the TROJAN® Condom does not have the inherent danger of forming methylene dianiline (MDA), a known carcinogen, which can be leached from some aromatic polyurethane materials. The condom provides a physical barrier between the penis and vagina thus. when properly used. reducing the risk of exchange of semen, other body fluids, or microorganisms during sexual intercourse. The subject condom is approximately 59 mm in width and approximately 180 mm in length, with a reservoir tip at the closed end and an integral ring (rim) at the open end. The subject condom is one of two versions intended to be marketed - this version with spermicidal lubricant (nonoxynol-9, 8%) and the other with a silicone lubricant.
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)
In consumer use studies with heterosexual couples, the subject device was found to have equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage.
The barrier properties of the subject polyurethane condom were compared to those of a latex condom in a viral permeability study. The results of this study demonstrate that the subject polyurthanc condom has equivalent barrier properties to that of a typical latex condom for preventing the transmission of small viral particles across the condom membrane.
Toxicological suudies performed provided no indication for toxicological concern.
In consumer use studies with heterosexual couples, the subject polyurethane condom was found to have equivalent performance to that of a typical latex condom with regard to the parameters of breakage and slippage.
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.
TROJAN® Latex Condoms
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
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
Page 827
TROJAN® Polyurethane Condom with Spermicidal Lubricant
510(k) #K955672 - Additional Information
October 30, 1995
510(k) SUMMARY
| Submitted by: | Carter-Wallace, Inc.
Carter Products Division
P.O. Box 1001
Cranbury, NJ 08512
(609) 655-6000 |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky |
| Date Prepared: | October 30, 1995 |
| Name of Device: | TROJAN® Polyurethane Condom
with Spermicidal Lubricant |
| Classification Name: | Condom with Spermicidal Lubricant |
| Predicate Device: | TROJAN® Latex Condoms |
Description of the Device: A condom is a sheath which completely covers the penis with a closely fitting membrane in the case of the subject medical device is made The polyurethanc utilized for the TROJAN® Polyurethane of a polyurethane matcrial. Condom is an aliphatic polyurethane. Unlike an aromatic polyurethane, the aliphatic polyurethane utilized for the TROJAN® Condom does not have the inherent danger of forming methylene dianiline (MDA), a known carcinogen, which can be leached from some aromatic polyurethane materials. The condom provides a physical barrier between the penis and vagina thus. when properly used. reducing the risk of exchange of semen, other body fluids, or microorganisms during sexual intercourse. The subject condom is approximately 59 mm in width and approximately 180 mm in length, with a reservoir tip at the closed end and an integral ring (rim) at the open end. The subject condom is one of two versions intended to be marketed - this version with spermicidal lubricant (nonoxynol-9, 8%) and the other with a silicone lubricant. In consumer use studies with heterosexual couples, the subject device was found to have equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage.
Intended Use of the Device: The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom is used for contraceptive and for prophylactic purposes (hclping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted discases, including chlamydia, genital warts, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of the condom for other than vaginal intercourse can increase the potential of damage to the condom. For
1
510(k) SUMMARY (cont'd)
maximum benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs. The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
- Technological Characteristics: The subject device differs from the predicate device in its material composition, i.e., the subject device is composed of polyurcthane and the predicate device is composed of natural rubber latex. The subject device, therefore, docs not have the inherent potential for latex protein sensitization or latex protein allergic reaction as does a latex condom. Also due to the inherent nature of the polyurethane material as compared to natural rubber latex, the subject condom is stronger (has a higher tensile strength and break force), has a lower ultimate elongation, and is more resistant to deterioration by oil and oilhased materials, UV light, and oxidation. The barrier properties of the subject polyurethane condom were compared to those of a latex condom in a viral permeability study. The results of this study demonstrate that the subject polyurcthane condom has equivalent barrier properties to that of a typical latex condom for preventing the transmission of small viral particles across the condom membrane. Toxicological suudies performed provided no indication for toxicological concern. In consumer use studies with heterosexual couples, the subject polyurethane condom was found to have equivalent performance to that of a typical latex condom with regard to the parameters of breakage and slippage. Thus, although the subject polyurethane condom has different technological characteristics, i.e., a different material composition, than that of the predicate latex condoms, the difference does not raise different questions of safety and efficacy. The subject polyurethane condom is, therefore, substantially equivalent in terms of safety and effectiveness. in helping to prevent prognancy and in helping to reduce the risk of transmission of FIN infection (AIDS) and other sexually transmitted diseases (STDs), to the predicate latex condoms currently marketed.
Ussolye
George H. Ohyc Corporate Vice President Compliance and Regulatory