(120 days)
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Not Found
No
The summary describes a physical device (cervical cap) for artificial insemination and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is indicated for use in artificial insemination procedures to address issues like low sperm count, sperm immotility, or a hostile vaginal environment, thus facilitating conception. This addresses a medical condition (infertility due to these factors) and provides a therapeutic benefit.
No
The device is used for artificial insemination procedures to facilitate sperm contact with cervical mucosa, not to diagnose medical conditions.
No
The device description and intended use clearly describe a physical cervical cap, which is a hardware device, not software.
Based on the provided information, the Oves Cervical Cap is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Oves Cervical Cap is a physical device used in vivo (inside the body) to facilitate artificial insemination. It interacts directly with the vaginal environment and the cervix.
- Its function is to physically concentrate sperm at the cervical opening, not to analyze biological samples for diagnostic purposes.
Therefore, the Oves Cervical Cap falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
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 semen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.
Product codes
85 HDR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical os, vaginal environment
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
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