(169 days)
Not Found
No
The summary describes a standard latex condom and makes no mention of AI or ML technology.
No
The primary indicated uses are contraception and prevention of sexually transmitted diseases, which are prophylactic rather than therapeutic in nature.
No
Explanation: This device is for contraception and prophylactic purposes (preventing pregnancy and STD transmission), not for diagnosing conditions.
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, the TROJAN-ENZ® brand condom is not an IVD (In Vitro Diagnostic) device.
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 sheath made of latex. It doesn't involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or analytical procedures
Therefore, the TROJAN-ENZ® brand condom falls under the category of a medical device, but specifically a barrier contraceptive and prophylactic device, not an IVD.
N/A
Intended Use / Indications for Use
The TROJAN-ENZ® brand condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
HIS
Device Description
The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condoms are smooth surface straight-walled nipple-end (SWNE) style within ASTM standard specifications D-3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 μM.
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)
TROJAN-ENZ® Male Latex Condoms, K897129
Reference Device(s)
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
长071313
Food and Drug Administration Abbreviated 510(k) Notification
TROJAN-ENZ® Brand Male Latex Condoms 007 26 2007
May 8, 2007
Page 4 of 92
III. 510(k) SUMMARY
| Submitter's Name and Address: | Church & Dwight Co., Inc.
469 North Harrison Street
Princeton, NJ 08543 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky
Director, Regulatory Affairs |
| Date Prepared: | May 2007 |
| Proprietary Name: | TROJAN-ENZ® brand |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom |
| Predicate Device: | TROJAN-ENZ® Male Latex Condoms
Church & Dwight Co., Inc.
Pre-1976 Device
and
Multiple Brands
Sagami Rubber Industries Co., Ltd
K897129 |
| Description of the Device: | The condoms are made of a natural rubber latex sheath,
which completely covers the penis with a closely fitted
membrane. The condoms are smooth surface straight-
walled nipple-end (SWNE) style within ASTM standard
specifications D-3492 Table 1 requirements, e.g.,
minimum length 160 mm, maximum width 54 mm, and
minimum thickness of 30 μM. |
| Intended Use of the Device: | This latex condom product has the same intended
use as the predicates. It is used for contraception
and for prophylactic purposes (to help prevent
pregnancy and the transmission of sexually
transmitted diseases.) |
| Technological Characteristics: | The proposed modified condom product would have
the same technological characteristics as the predicate
condom product identified above. The design is in
conformance with ASTM Latex Condom Standard
D3492 and the condoms are made of natural rubber
latex. The proposed modified condom product are
equivalent to the current TROJAN-ENZ® brand male
latex condoms in all respects except they would be
manufactured by a contract manufacturer utilizing the
contract manufacturer's compounded latex
formulation. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure with three flowing lines above it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 2007
Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church and Dwight Co. Inc. 469 North Harrison Street Law Department, Building 100 PRINCETON NJ 08543
Re: K071313
Trade Name: TROJAN-ENZ® Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 16, 2007 Received: October 17, 2007
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 (PMA), 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.
2
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 not mean 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 liating (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 edectionic 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 10(a)/ marketed predicate device results in a classification for your device and thus, permorts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance produce 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 notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CCDH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Smy all Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
May 8, 2007
Page 18 of 92
VIII. INDICATIONS FOR USE STATEMENT
510(k) Number: Device Name: Indications For Use:
K071313 TROJAN-ENZ® brand Male Latex Condom The TROJAN-ENZ® brand condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the 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)
Harlan Leven
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _