(60 days)
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
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.
The provided text describes a 510(k) submission for a male condom, which is a Class II medical device. The submission focuses on a change to the device's labeling regarding personal lubricant compatibility. This type of device and submission does not fit the typical framework of AI/ML-driven diagnostic devices that would have the requested "acceptance criteria" and "study" details (e.g., test sets, ground truth, expert opinions, MRMC studies).
The information provided pertains to the regulatory review of a medical device (a condom) and its safety and effectiveness. The "performance testing" described is related to the physical properties of the condom and its compatibility with lubricants, not the diagnostic accuracy of an AI algorithm.
Therefore, many of the requested fields cannot be answered from the provided text as they are not applicable to this type of device and submission.
Here's an attempt to answer the applicable parts based on the input:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it implicitly refers to adherence to standards for condom performance. The primary "performance testing" mentioned is for lubricant compatibility.
| Acceptance Criteria (Implicit from standards/predicate device) | Reported Device Performance (Subject Device) |
|---|---|
| Burst volume (expected to be similar to predicate) | 9.4 dm³ |
| Burst pressure (expected to be similar to predicate) | 10.31 kPa |
| Compatibility with cleared personal lubricants | Results did not support all personal lubricants are compatible; permissible with FDA-cleared lubricants labeled for polyurethane condoms. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The document mentions "Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10." The ASTM standard, if referenced, would contain details on sample size, but it's not provided here.
- Data provenance: Not explicitly stated. Likely laboratory testing of manufactured condoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing relates to physical properties (burst, lubricant compatibility) measured against an ASTM standard, not interpretation by human experts.
4. Adjudication method for the test set:
Not applicable and not provided. The testing involves physical measurements, not expert review or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
The "ground truth" here would be defined by the physical specifications and performance requirements for condoms as established in standards (e.g., ASTM D7661-10) and regulatory guidelines, rather than expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device that requires a training set.
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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.
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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 &PredicateDevice(s): | K171639 | K100767 |
|---|---|---|---|---|
| Submitter Address: | 500 Charles Ewing BoulevardEwing, NJ 08628Phone: 609-806-1200E-mail: lisa.burns@churchdwight.com | Condom | ||
| Contact Person: | Lisa BurnsRegulatory Affairs ManagerChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Tel: (609) 806.1997Fax: (609) 403.7415 | CondomMaterial | Same as thepredicate | Emulsified polyurethanecontainingpolyoxyethylenealkylether emulsifier |
| Date Prepared: | August 1, 2017 | NominalWidth | Same as thepredicate | 58 mm |
| Device Trade Name: | TROJAN SUPRA™ Lubricated Polyurethane MaleCondom | NominalLength | Same as thepredicate | 190mm |
| Device Common Name: | Polyurethane Condom | NominalThickness | Same as thepredicate | 0.04 mm |
| Product Code: | MOL | Lubricant | Same as thepredicate | Dimethylpolysiloxane (400mg/unit max) |
| Classification: | Class II, Condom (21 CFR § 884.5300) | ColorAdditives | Same as thepredicate | Non-colored |
| Predicate Device: | K100767: TROJAN SUPRA Polyurethane Condom | Dustingagent | Same as thepredicate | Hydratedamorphoussilica < 20mg/unit |
| Shape | Same as thepredicate | Straightwalled with areservoir tip atthe closed endand ring at theopen end | ||
| Texture | Same as thepredicate | Non-textured | ||
| Burstproperties | Same as thepredicate | Burst volume9.4 dm3Burst pressure10.31 kPa |
The predicate device has not been subject to a design-related recall.
Reason for 510(k) Submission:
The subject device is identical to the predicate device (K100767). The purpose of this submission is to change the personal lubricant compatibility statement in the labeling.
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, 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.
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Intended use of the Device:
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections. The IFU statement is similar to the predicate device.
Comparison of Technological Characteristics:
There is no difference in the technological characteristics of the subject 510(k) condom and the predicate condom. Both the 510(k) subject condom and the predicate condom have the same design, dimensions, and materials. The 510(k) subject condom labeling is the same except for the device labeling has been revised to replace the existing warning of: "DO NOT USE WITH ANY ADDITIONAL PERSONAL LUBRICANTS, as they may damage the condom." This warning is being replaced with: "May be used with
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personal lubricants labeled compatible with polyurethane condoms."
Performance Testing:
Compatibility Testing of Polyurethane Condoms with Cleared Personal Lubricants:
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.
Substantial Equivalence:
Based on the Compatibility Testing of Polyurethane Condoms with Current Commercial Lubricant, Trojan Supra Lubricated Polyurethane Male Condoms are substantially equivalent to the predicate device.
§ 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.