(80 days)
These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).
Not Found
Based on the provided document, which is an FDA 510(k) clearance letter for the HardCover Condoms™ Male Latex Condoms, there is no information available regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth.
The document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.
The letter explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA." This indicates that while design and performance testing were conducted by the manufacturer, the detailed results and methodologies are not part of this public clearance letter.
Therefore, I cannot provide the requested information for the following points as they are not contained within the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- 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 present (and not applicable as this is not an AI/software device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and not applicable as this is not an AI/software device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The only performance-related requirement mentioned in the document is about expiration dating for latex condoms and spermicidal lubricant shelf life, which must be "supported by test data developed under the conditions specified in 801.435(d)". However, the specifics of these tests and their acceptance criteria are not detailed in this letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 1999
Mr. Gerald A. Glazer, CA President HardCover Products Inc. TM 55 Administration Road, Unit 12 Concord, Ontario, Canada, L4K 4G9
Re: K991047
HardCover Condoms™ Male Latex Condoms, (With Spermicide) Dated : March 29, 1999 Received: March 30, 1999 Regulatory Class: II 21 CFR §884.5310/Procode: 85 LTZ
Dear Mr. Glazer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gerald A. Glazer, CA
This letter will allow you to begin marketing your device as described in your 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
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801 435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number: (800) 638-2041 or (301) 443-6597, or at its Internet address: "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
Daniel A. Sezom
CAPT Daniel G. Schultz, M.D.
APT. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: Pending
Device Name: Multiple Brands, Male Natural Rubber Latex Condom
Indications for Use: These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR §801.109) Over-The-Counter Use (Optional Format 1-2-96)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).