(60 days)
Not Found
No
The device description and performance studies focus on material properties and compatibility, with no mention of AI/ML technologies or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
No.
The device, a male condom, is intended to prevent pregnancy and the transmission of sexually transmitted infections, which are prophylactic measures, not therapeutic treatments for existing conditions.
No
Explanation: This device is a condom, used as a barrier for contraception and prevention of STIs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical condom made of polyurethane, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- This device is a physical barrier. The Trojan Supra Lubricated Polyurethane Male Condom is a physical device intended to prevent the transmission of bodily fluids during sexual activity. It does not analyze or test any biological samples.
The intended use clearly states its purpose is to prevent pregnancy and the transmission of STIs, which is achieved through a physical barrier, not through in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
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, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
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)
Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10. The results did not support that all personal lubricants are compatible with polyurethane condoms. However, a personal lubricant cleared by FDA with labeling for use with polyurethane condoms would be permissible to use.
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.
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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2017
Church & Dwight Co., Inc. Lisa Burns Regulatory Affairs Manager 500 Charles Ewing Blvd. Ewing, NJ 08628
Re: K171639
Trade/Device Name: Trojan Supra Lubricated Polyurethane Male Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: June 1, 2017 Received: June 2, 2017
Dear Lisa Burns:
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.
1
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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171639
Device Name
Trojan Supra Lubricated Polyurethane Male Condom
Indications for Use (Describe)
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY:
| Submitter Name: | Church & Dwight Co., Inc. | Device &
Predicate
Device(s): | K171639 | K100767 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard
Ewing, NJ 08628
Phone: 609-806-1200
E-mail: lisa.burns@churchdwight.com | Condom | | |
| Contact Person: | Lisa Burns
Regulatory Affairs Manager
Church & Dwight Co., Inc.
469 North Harrison Street
Princeton, NJ 08543
Tel: (609) 806.1997
Fax: (609) 403.7415 | Condom
Material | Same as the
predicate | Emulsified polyurethane
containing
polyoxyethylene
alkylether emulsifier |
| Date Prepared: | August 1, 2017 | Nominal
Width | Same as the
predicate | 58 mm |
| Device Trade Name: | TROJAN SUPRA™ Lubricated Polyurethane Male
Condom | Nominal
Length | Same as the
predicate | 190mm |
| Device Common Name: | Polyurethane Condom | Nominal
Thickness | Same as the
predicate | 0.04 mm |
| Product Code: | MOL | Lubricant | Same as the
predicate | Dimethylpoly
siloxane (400
mg/unit max) |
| Classification: | Class II, Condom (21 CFR § 884.5300) | Color
Additives | Same as the
predicate | Non-colored |
| Predicate Device: | K100767: TROJAN SUPRA Polyurethane Condom | Dusting
agent | Same as the
predicate | Hydrated
amorphous
silica