(120 days)
The Oves Cervical Cap is indicated for use in artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed. The Oves Cervical Cap removes scmen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Oves Cervical Cap. This type of document does not typically contain information about acceptance criteria or specific study results showing device performance in the way a clinical study report or a premarket approval (PMA) application summary would.
The letter primarily addresses the substantial equivalence of the Oves Cervical Cap to legally marketed predicate devices and outlines the regulatory requirements, including labeling limitations. It states that the "safety and effectiveness of the Oves Cervical Cap for contraception have not been established." This indicates the device was NOT cleared for contraception, but for "artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed."
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC studies, or standalone performance) from this document. This kind of detail would typically be found in the 510(k) submission itself (which is not publicly available in detail) or a summary of safety and effectiveness if it were a PMA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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MAR 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Peggy S. Czyzak-Dannenbaum Chairman and CEO Veos Ltd. 273 Market Square Court, #12 Lake Forest, Illinois 60045
Re: K993953 Oves Cervical Cap (for artificial insemination) Regulatory Class: II 21 CFR §884.5250/Product Code: 85 HDR Dated: January 11, 2000 Received: January 14, 2000
Dear Ms. Czyzak-Dannenbaum:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially cquivalent (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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling, boxed and in bold font:
The safety and effectiveness of the Oves Cervical Cap for contraception have not been established.
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
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Page 2 - Ms. Peggy S. Czyzak-Dannenbaum
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 Flectronic Product Radiation Control provisions, or other Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(F.) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 vour 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,
David W. Felgal. M.D., M.P.H.
Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993953 510(k) Number:
Device Name: Oves Cervical Cap
FDA's Statement of the Indication for Use for this device:
The Oves Cervical Cap is indicated for use in artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed. The Oves Cervical Cap removes scmen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.
Prescription Use V OR (Pcr 21 CFR 801.109)
Over-the-Counter (OTC) Use ___________________________________________________________________________________________________________________________________________________
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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dovi 510(k) Number
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).