(90 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
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for "HardCover Condoms™ Male Latex Condoms," dated June 17, 1999.
It primarily discusses:
- The FDA's determination of substantial equivalence for the device.
- Regulatory classifications and general controls.
- Labeling requirements for latex condoms, specifically regarding expiration dating (21 CFR 801.435).
- Contact information for FDA offices.
- The product's indications for use: contraception and prevention of sexually transmitted diseases and HIV.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The letter pertains to regulatory clearance based on substantial equivalence to predicate devices, not on a detailed performance study as you've outlined for AI/ML device evaluations. The only "test data" mentioned is for supporting the expiration date as per 21 CFR 801.435, and it explicitly states that this data is not to be provided in the 510(k) submission itself but must be maintained by the manufacturer.
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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 or bird symbol, with its wings forming a flowing, abstract shape. Encircling the bird symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1999
Mr. Gerald A. Glazer, CA President HardCover Products Inc. TM 55 Administration Road, Unit 12 Concord, Ontario Canada, L4K 4G9
Re: K990925
HardCover Condoms™ Male Latex Condoms Dated: March 1, 1999 Received: March 19, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
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.
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Page 2 - Mr. Gerald A. Glazer, CA
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.
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(i) 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 products 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 yours,
Urrich br. Beynon
CAPT. 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(12) HARD COUT
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)
Prescription Use (Per 21 CFR §801.109) OR Over-The-Counter Use
David A. Beyer
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number
8
§ 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.