(128 days)
The TROJAN® THINTENSITY™ brand male latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is smooth surfaced, straight-walled with a contoured-bulbous section near the closed-end, which terminates with a reservoir tip. The condom has a silicone lubricant. The condom design is within the ASTM standard specifications D-3492, e.q., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 uM.
The provided text describes a 510(k) summary for a male latex condom, focusing on its substantial equivalence to predicate devices and its intended use. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the format requested.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on the administrative aspects of the 510(k) submission, device description, intended use, and technological characteristics, stating conformance with ASTM standard specifications D-3492 as the basis for substantial equivalence. It does not detail the specific test results or study methodologies that would lead to a "reported device performance."
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III. 510(k) SUMMARY
. .
| Submitter's Name and Address: | Church & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543 | |
|---|---|---|
| Contact Person: | Stephen C. KolakowskyDirector, Regulatory Affairs | SEP 1 2 2007 |
| Date Prepared: | September 2007 | |
| Proprietary Name: | TROJAN® THINTENSITY™ brand | |
| Common Name: | Male Latex Condom | |
| Classification Name: | Condom | |
| Predicate Device: | TROJAN® Male Latex CondomsChurch & Dwight Co., Inc.Pre-1976 DeviceandMultiple BrandsSagami Rubber Industries Co., LtdK897129 | |
| Description of the Device: | The condoms are made of a natural rubber latex sheath,which completely covers the penis with a closely fittedmembrane. The condom is smooth surfaced, straight-walled with a contoured-bulbous section near theclosed-end, which terminates with a reservoir tip. Thecondom has a silicone lubricant. The condom design iswithin the ASTM standard specifications D-3492, e.q.,minimum length 160 mm, maximum width 54 mm, andminimum thickness of 30 uM. | |
| Intended Use of the Device: | This latex condom product has the same intendeduse as the predicates. It is used for contraceptionand for prophylactic purposes (to help preventpregnancy and the transmission of sexuallytransmitted diseases.) | |
| Technological Characteristics: | The 510(k) subject condom products would have thesame technological characteristics as the predicatecondom products identified above. The design is inconformance with ASTM Latex Condom StandardD3492 and the condoms are made of natural rubberlatex. |
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Image /page/1/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the circle is a stylized image of three human figures. The figures are drawn with simple, curved lines and appear to be facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 12 2007
Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison St. Law Department. Building 100 PRINCETON NJ 08543
Re: K071272
Trade/Device Name: Trojan® THINtensity™ brand male latex condom with silicone lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: September 6. 2007 Received: September 7, 2007
Dear Mr. Kolakowsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device ve stated in the 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 in interstate of microate of the 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, controls, 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 may risklich further and rederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center, surrounded by the words "Centennial" and "U.S.A.". The logo also includes the dates "1906-2006". Below the logo, there is some text that reads "clating and Promoting Pul". The text appears to be part of a larger phrase, but the rest of the phrase is not visible in the image.
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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.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR.884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 of 3
VIII. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K071272 |
|---|---|
| Device Name: | TROJAN® THINTENSITY™ brand male latex condom with siliconelubricant |
| Indications For Use: | The TROJAN® THINTENSITY™ brand male latex condom is used forcontraception and for prophylactic purposes (to help prevent pregnancy andthe transmission of sexually transmitted diseases). |
Prescription Use _ (Per 21 CFR §801.109)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K071222
§ 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.