(333 days)
The TROJAN SUPRA® Lubricate Polyurethane 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).
The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth of 58 mm.
This document describes a 510(k) premarket notification for the TROJAN SUPRA® Lubricated Polyurethane Male Condom. The acceptance criteria and the study that proves the device meets those criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (TROJAN SUPRA® Polyurethane Condom) | Reference (Control Latex Condom) |
|---|---|---|---|
| Clinical Breakage Rate | Not significantly different from a standard latex condom control. | 0.6% | 1.3% |
| Clinically Significant Slippage Rate | Not significantly different from a standard latex condom control. | 1.1% | 0.5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Users/Cases): 206 couples.
- Data Provenance: Prospective, conducted in France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not explicitly provided in the document. The study involved "an In-Use Study" following an FDA guidance, and the outcomes were "clinical breakage rate" and "clinically significant slippage." It's customary for such clinical studies to involve medical professionals in assessing and recording these events, but the specific number and qualifications of experts are not detailed.
4. Adjudication Method for the Test Set
This information is not explicitly provided. Clinical studies often have adjudication committees for adverse events or endpoint assessment, but the document does not specify if one was used or the method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, an MRMC comparative effectiveness study was not conducted as this is a medical device (condom) and not an imaging-based diagnostic or AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical medical device (condom) and does not involve AI algorithms.
7. The Type of Ground Truth Used
The ground truth used was clinical observation and user reporting of objective outcomes, specifically:
- Clinical Breakage Rate: Direct observation/reporting of condom breakage during intercourse.
- Clinically Significant Slippage Rate: Direct observation/reporting of condom slippage during intercourse.
8. The Sample Size for the Training Set
No training set information is applicable or provided as this is a physical medical device, not an AI-based system.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of medical device.
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FEB 2 8 2006
April 1, 2005 Page 3
510(k) Summarv
| Submitted by: | Church & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543 |
|---|---|
| Contact Person: | Stephen C. KolakowskyDirector, Regulatory Affairs(609) 279-7748 |
| Date Prepared: | April 1, 2005 |
| Proprietary Name: | TROJAN SUPRA® Lubricated Polyurethane Male Condom |
| Common Name: | Polyurethane Condom |
| Classification Name: | Condom [21 CFR §884.5300] |
| Predicate Device: | TROJAN SUPRA® Lubricated Polyurethane Male Condom510(k) #K042607 |
Description of Device: The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth 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 (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
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 polyurethane resin material used to manufacture each condom. The labeling for the subject 510(k) device is the same as the predicate device except for the addition of the disclosure of foreign origin and name of the contract manufacturer.
Summary of Studies
Safety Studies - Safety information regarding the component materials and the finished product are provided in the 510(k) Notification and raise 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; and penile irritation test.
In-Use 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 in France using the 510(k) subject condom with a standard latex condom serving as a control. Among the 206 couples included in the study, the clinical breakage rate for the polyurethane condom was 0.6% compared to 1.3% for the control. Clinically significant slippage was 1.1% for the polyurethane condom and 0.5% for the control. Neither difference was significantly difference. The polyurethane condom was therefore significant equivalent to the latex control condom in terms of clinical failure rate.
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Public Health Service
FEB 2 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street Law Department, Building 100 PRINCETON NJ 08543
Re: K050828 Trade/Device Name: TROJAN® SUPRA® Polyurethane Male Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: January 13, 2006 Received: January 17, 2006
Dear Mr. Kolakowsky:
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 (Premarket Approval), 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.
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 (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.
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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.
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 nouffication" (21 CIFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Bigelow
Nancy (). Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K050828 510(k) Number: TROJAN SUPRA® Lubricated Polyurethane Male Condom Device Name: The TROJAN SUPRA® Lubricate Polyurethane Male Condom Indications for Use: is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs). X Over-the-Counter Use _ OR Prescription Use (Per 21 CFR §8001.109) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device 510(k) Number
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§ 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.