(383 days)
Pre-1976
Not Found
No
The 510(k) summary describes a physical barrier device (condom) and the performance studies focus on material properties, physical testing, and clinical use outcomes (breakage, slippage). There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for contraception and prophylaxis against STIs, which are preventative measures rather than therapeutic treatments for an existing condition.
No
The device is a condom, used for contraception and reduction of STI transmission, not for diagnosing any condition.
No
The device is a physical condom made of polyurethane, not a software application. The summary describes physical characteristics, materials, and performance studies related to a tangible product.
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 STIs. This is a physical barrier device used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description clearly outlines a physical condom made of polyurethane.
- 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.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition.
The performance studies described focus on the physical properties, barrier effectiveness, and clinical performance (breakage and slippage) of the condom as a physical barrier, not on its ability to diagnose anything.
N/A
Intended Use / Indications for Use
The TROJAN SUPRA® Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, nontextured, nipple-end condom with a nominal length of 190 mm and an nominal flat-width of 58 mm.
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)
Pre-Clinical Safety Studies: Safety information regarding the compound materials and finished products (e.g., chemical degradation studies) was provided and raised no safety concerns. Biocompatibility studies on the non-lubricated condom and on the lubricated finished product include in vitro cytotoxicity extract test and direct contact test: sensitization test: vaginal irritation test: acute systemic toxicity; penile irritation test; 90-day muscle implantation study; bacterial reverse mutation assay; mouse lymphoma assay; and in vitro chromosomal aberration study.
Clinical In-Use Slip/Break Study: A slippage and breakage study following a protocol prepared to meet the FDA guidance: "Clinical Testing Guidance for New Material Male Condoms," was conducted using the 510(k)-subject condom with a standard latex condom serving as control. Over 290 couples were included in the study, the clinical breakage rate for the polyurethane condom was 1.1% compared to 0.9% for the control. The clinical slippage rate was 2.0% for the polyurethane and 1.0% for the control. The polyurethane condom was statistically no different from the control latex condom in both clinical breakage and slippage rate.
Physical testing data: Followed the FDA guidance: "Clinical Testing Guidance for New Material Male Condoms" and included the testing of three (3) lots of the 510(k)-subject condom. Testing included tensile strength, force at break, and elongation and air burst volume and air burst pressure were performed according to ASTM D 6324-08, and water leakage tests were carried out for the same lots in accordance with testing procedure of ISO 4074 (AQL = 0.25). In addition, condoms were tested for tear resistance and propagation according to ASTM D 624-00 ("Standard Test Methods for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers"). Further testing to simulate in-use conditions by performing tensile strength, force at break, and elongation at 37° C, 50% Relative Humidity were completed according to ASTM D 6324-08. The results of physical testing support the performance effectiveness of the 510(k) product.
Package integrity: An evaluation of seal integrity was performed on three lots (3) of the 510(k)-subject device according to ASTM D 6324-08 with satisfactory results.
Barrier Properties/Permeability: Viral Penetration Study: Was performed on three (3) test lots of the 510(k)-subject polyurethane condom and one lot of the commercially available predicate device. Results of testing on a fourth lot of the 510(k)-subject device were submitted at the request of FDA to confirm the prior testing. The cumulative results of the studies demonstrate the barrier effectiveness of the 510(k) device to viral penetration under conditions of the in vitro study.
Shelf-life: Stability of the 510(k)-subject device was established from results of physical testing data using a protocol that followed 21 CFR 801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiring date has been set at 60 months.
Lubricant Compatibility: The subject condom was evaluated for compatibility with water-based, silicone oil-based, and glycol-based personal lubricants. Condom samples were exposed to two brands of each lubricant type for 60 minutes at 37°C. Compatibility was assessed at three different aging conditions. Changes in airburst and tensile properties were evaluated compared to a control (subject condom conditioned but with no additional lubricant). The results of testing demonstrated that the subject condom is not compatible with any lubricant type. The subject condom is labeled accordingly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical breakage rate for the polyurethane condom was 1.1% compared to 0.9% for the control. The clinical slippage rate was 2.0% for the polyurethane and 1.0% for the control.
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.
Pre-1976
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.
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Page 1 of 3
APR - 5 2011
April 4, 2011
510(k) Summary (revised)
| Submitted by: | Church & Dwight, Co. Inc.
469 North Harrison Street
Princeton, NJ 08543 |
|----------------------|-------------------------------------------------------------------------------|
| Contact Person: | Joseph Ciccone
Manager, Regulatory Affairs
(609) 497-7251 |
| Date Prepared: | March 17, 2010 |
| Proprietary Name: | TROJAN SUPRA® Lubricated Polyurethane Male Condom |
| Common Name: | Polyurethane Condom |
| Classification Name: | Condom [21 CFR §884.5300] |
TROJAN-ENZ® Brand Lubricated Latex Male Condom Predicate Device: Pre-1976
Description of Device: The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, nontextured, nipple-end condom with a nominal length of 190 mm and an nominal flat-width of 58 mm.
Intended Use of the Device: The 510(k)-subject condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections, STIs).
Technological Characteristics: There is no difference in the basic technological characteristics of the 510(k)-subject condom and the predicate condom. Both the 510(k)-subject condom and the predicate condom are of the same basic design, both are straight-walled, nipple-ended, lubricated condoms with an integral formed ring at the open-end. The 510(k)-subject condom differs from the predicate condom in the material used to manufacture each condom: the predicate condom is made from natural rubber latex, the 510(k)-subject condom made from a polyurethane resin. With minor exceptions, the labeling for the 510(k)-subject device is the same as the predicate device. Exceptions to the predicate device labeling include: country of origin, the 510(k)-subject condom will be made in Japan; and absence of natural rubber latex warning for latex sensitive users, unlike the predicate device, the 510(k) subject device does not contain natural rubber.
Image /page/0/Picture/10 description: The image shows the logo for Trojan Brand Condoms. The word "TROJAN" is written in bold, sans-serif font. Below the word "TROJAN" is the phrase "BRAND CONDOMS" in a smaller font. To the right of the word "TROJAN" is a profile of a Trojan warrior's helmet.
Church & Dwight Co., Inc.
1
K100767
April 4, 2011
lubricant type for 60 minutes at 37°C. Compatibility was assessed at three different aging conditions. Changes in airburst and tensile properties were evaluated compared to a control (subject condom conditioned but with no additional lubricant). The results of testing demonstrated that the subject condom is not compatible with any lubricant type. The subject condom is labeled accordingly.
Image /page/1/Picture/4 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in bold, black letters. Above the word is an image of a Trojan helmet. Below the word "TROJAN" are the words "BRAND CONDOMS".
Church & Dwight Co., Inc.
2
April 4, 2011
Summary of Studies
Pre-Clinical Safety Studies - Safety information regarding the compound materials and finished products (e.g., chemical degradation studies) was provided and raised no safety concerns. Biocompatibility studies on the non-lubricated condom and on the lubricated finished product include in vitro cytotoxicity extract test and direct contact test: sensitization test: vaginal irritation test: acute systemic toxicity; penile irritation test; 90-day muscle implantation study; bacterial reverse mutation assay; mouse lymphoma assay; and in vitro chromosomal aberration study.
Clinical In-Use Slip/Break Study - A slippage and breakage study following a protocol prepared to meet the FDA guidance: "Clinical Testing Guidance for New Material Male Condoms," was conducted using the 510(k)-subject condom with a standard latex condom serving as control. Over 290 couples were included in the study, the clinical breakage rate for the polyurethane condom was 1.1% compared to 0.9% for the control. The clinical slippage rate was 2.0% for the polyurethane and 1.0% for the control. The polyurethane condom was statistically no different from the control latex condom in both clinical breakage and slippage rate.
Physical testing data – Followed the FDA guidance: "Clinical Testing Guidance for New Material Male Condoms" and included the testing of three (3) lots of the 510(k)-subject condom. Testing included tensile strength, force at break, and elongation and air burst volume and air burst pressure were performed according to ASTM D 6324-08, and water leakage tests were carried out for the same lots in accordance with testing procedure of ISO 4074 (AQL = 0.25). In addition, condoms were tested for tear resistance and propagation according to ASTM D 624-00 ("Standard Test Methods for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers"). Further testing to simulate in-use conditions by performing tensile strength, force at break, and elongation at 37° C, 50% Relative Humidity were completed according to ASTM D 6324-08. The results of physical testing support the performance effectiveness of the 510(k) product.
Package integrity - An evaluation of seal integrity was performed on three lots (3) of the 510(k)-subject device according to ASTM D 6324-08 with satisfactory results.
Barrier Properties/Permeability: Viral Penetration Study - Was performed on three (3) test lots of the 510(k)-subject polyurethane condom and one lot of the commercially available predicate device. Results of testing on a fourth lot of the 510(k)-subject device were submitted at the request of FDA to confirm the prior testing. The cumulative results of the studies demonstrate the barrier effectiveness of the 510(k) device to viral penetration under conditions of the in vitro study.
Shelf-life - Stability of the 510(k)-subject device was established from results of physical testing data using a protocol that followed 21 CFR 801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiring date has been set at 60 months.
Lubricant Compatibility - The subject condom was evaluated for compatibility with water-based, silicone oil-based, and glycol-based personal lubricants. Condom samples were exposed to two brands of each
(continued...)
Image /page/2/Picture/12 description: The image shows a black circle on the left side of the image. The circle is solid black and appears to be a simple shape. On the right side of the image, there is some text, but it is not clear enough to read. The text is in a dark font and is positioned near the bottom right corner of the image.
Image /page/2/Picture/13 description: The image shows the logo for Trojan Grand Condominiums. The logo features the word "TROJAN" in bold, sans-serif font, with the word "GRAND CONDOMINIUMS" in a smaller font below it. To the right of the word "TROJAN" is a stylized image of a Trojan warrior's head, complete with a helmet.
Church & Dwight Co., Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph Ciccone Manager, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street Law Department - Building 100 PRINCETON NJ 08543
APR - 5 2011
Re: K100767
Trade Name: TROJAN SUPRA® Lubricated Polyurethane Male Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: March 23, 2011 Received: March 23, 2011
Dear Mr. Ciccone:
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 of medical device-related
4
Page 2
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/CDRH/CDRHOffices/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert Lenoir us
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number: | K100767 |
|---|---|
| Device Name: | TROJAN SUPRA® Lubricated Polyurethane Male Condom |
| Indications for Use: | The TROJAN SUPRA® Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). |
| Prescription Use | |
| OR Over-the-Counter Use X | |
| (Per 21 CFR §8001.109) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number: K100767
.
Image /page/5/Picture/2 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in large, bold letters, with the words "BRAND CONDOMS" in smaller letters underneath. To the right of the text is a silhouette of a Trojan warrior's helmet. The logo is simple and recognizable, and it is often used in advertising and marketing materials for Trojan condoms.
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Church & Dwight Co., Inc.
·