(169 days)
The TROJAN-ENZ® brand 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 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.
This 510(k) notification is for a male latex condom, a Class II medical device, and therefore does not include a study proving device effectiveness in the same way an AI/ML medical device might. The focus of this submission is on demonstrating substantial equivalence to existing predicate devices, primarily by meeting established industry standards for condom manufacturing.
Here's an analysis of the provided information in the context of your request for AI/ML device studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| ASTM Standard D-3492 Table 1 requirements for male latex condoms: | The proposed modified condom product is described as being "in conformance with ASTM Latex Condom Standard D3492" and meeting "ASTM standard specifications D-3492 Table 1 requirements." Specific performance values mentioned are: |
| - Minimum Length | - Minimum length 160 mm |
| - Maximum Width | - Maximum width 54 mm |
| - Minimum Thickness | - Minimum thickness of 30 μM |
| Predicate Device Equivalence (TROJAN-ENZ® Male Latex Condoms & Sagami Rubber Industries Co., Ltd K897129) | The proposed modified condom product is stated to have the "same technological characteristics as the predicate condom product identified above" and to be "equivalent to the current TROJAN-ENZ® brand male latex condoms in all respects except they would be manufactured by a contract manufacturer." |
| Intended Use (Contraception and Prophylactic purposes - preventing pregnancy & STDs) | The device has the "same intended use as the predicates." |
Explanation: For this type of device, meeting industry standards (like ASTM D-3492) and demonstrating material and design equivalence to previously approved devices are the primary "acceptance criteria" and "performance" metrics. The ASTM standard specifies various physical properties necessary for the device to perform its intended function (e.g., burst strength, freedom from holes, dimensions).
Regarding the AI/ML-specific questions (2-9), this document does not contain any information because it's for a traditional medical device (latex condom) and not an AI/ML-driven device.
Here's why each is not applicable and what would typically be expected for an AI/ML device:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This is a physical device, not an AI/ML algorithm. There's no "test set" of data in the AI/ML sense.
- For AI/ML: A test set would comprise a distinct, unseen dataset used to evaluate the final model's performance. Details like size, demographics, clinical setting, and whether data was collected specifically for the study (prospective) or from existing records (retrospective) are crucial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No ground truth establishment by experts is described for a latex condom's physical properties.
- For AI/ML: Ground truth for diagnostic AI often requires multiple expert reviewers to label data. Their number, specialty, and experience heavily influence the credibility of the ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set or expert adjudication is relevant here.
- For AI/ML: Adjudication describes how disagreements among experts are resolved (e.g., 2 experts agree, 1 provides tie-breaker; 3 experts, majority rules; or independent consensus).
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 or classification device.
- For AI/ML: An MRMC study is common for AI tools designed to assist human readers (e.g., radiologists). It measures the change in human performance (e.g., sensitivity, specificity, AUC) when aided by the AI compared to human performance alone, often quantifying the "effect size" of the improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: Not an AI algorithm.
- For AI/ML: Standalone performance evaluates the AI algorithm's ability to perform a task independently, without human intervention. This is relevant for autonomous AI systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Ground truth for a physical product typically relies on physical measurements and material testing against established standards.
- For AI/ML: The "gold standard" or ground truth can vary. For medical images, it might be histopathology results, long-term follow-up/outcomes, or the consensus of multiple highly experienced specialists.
8. The sample size for the training set
- Not Applicable: No AI model, thus no training set.
- For AI/ML: The training set is the data used to teach the AI model. Its size is a critical factor in model performance, with larger and more diverse sets generally leading to better generalization.
9. How the ground truth for the training set was established
- Not Applicable: No AI model or training set.
- For AI/ML: Similar to the ground truth for the test set, the method of establishing labels for the training data (e.g., single expert, multiple experts, automated labeling, linkage to pathology) is essential for understanding the model's foundation.
In summary, this 510(k) notification for a male latex condom demonstrates compliance through adherence to recognized international standards (ASTM D-3492) and substantial equivalence to legally marketed predicate devices, rather than through AI/ML-specific performance studies.
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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 StreetPrinceton, NJ 08543 |
|---|---|
| Contact Person: | Stephen C. KolakowskyDirector, 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 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 condoms are smooth surface straight-walled nipple-end (SWNE) style within ASTM standardspecifications D-3492 Table 1 requirements, e.g.,minimum length 160 mm, maximum width 54 mm, andminimum thickness of 30 μM. |
| 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 proposed modified condom product would havethe same technological characteristics as the predicatecondom product identified above. The design is inconformance with ASTM Latex Condom StandardD3492 and the condoms are made of natural rubberlatex. The proposed modified condom product areequivalent to the current TROJAN-ENZ® brand malelatex condoms in all respects except they would bemanufactured by a contract manufacturer utilizing thecontract manufacturer's compounded latexformulation. |
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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.
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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 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
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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 _
§ 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.