(176 days)
This is not a stand-alone device. It should be used in conjunction with your present contraceptive method.
Ovulation Calculator
I am sorry, but the provided text from the FDA letters for K954183 (Ovurite, Ovulation Calculator) does not contain information about the acceptance criteria for a study, performance data the device, sample sizes, ground truth establishment, or details of comparative effectiveness studies.
The letters are primarily administrative communications from the FDA:
- The July 11, 2022, letter is an administrative change notification regarding the device's regulation number.
- The February 29, 1996, letter is the original substantial equivalence (SE) determination letter, which permits the device to be marketed as an accessory to a contraceptive method and specifies a required labeling statement ("This is not a stand-alone device. It should be used in conjunction with your present contraceptive method").
Neither letter includes the detailed study information you've requested regarding device performance and validation.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 11, 2022
HVR Hector Vides 3652 N. Richmond Chicago, IL 60618
Re: K954183
Trade/Device Name: Ovurite, Ovulation Calculator Regulation Number: 21 CFR§ 884.5350 Regulation Name: Contraceptive diaphragm and accessories. Regulatory Class: II Product Code: MPT
Dear Hector Vides:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 29, 1996. Specifically, because FDA has better categorized your device technology under regulation 884.5350.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica D. Garcia, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-2791, Monica.Garcia@fda.hhs.gov.
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 1996
Mr. Hector Vides HVR 3552 N. Richmond Chicago, Illinois 60618
K954183 Re: Ovurite, Ovulation Calculator Regulatory Class: Unclassified Product Code: 85 MPT Dated: January 20, 1996 Received: January 24, 1996
Dear Mr. Vides:
We have reviewed your Section 510(k) notification of intent to market the device t we have reviewed your become envired the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment co devices marked invice 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 as an accessory to a legally (not). I contraceptive, subject to the general controls provisions of the Act. mhe general controls provisions of the Act include requirements for annual fine general on, listing of devices, good manufacturing practice, labeling, and regions on, Isoling and adulteration. The following statement must be prominently located on the front panel of the device:
"This is not a stand-alone device. It should be used in conjunction with your present contraceptive method".
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 or order in 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 Good Manufacturing Practice equiraline aboutices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will enrify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements in rogarder 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by If you desire specific advice for your device on our labeling regulation FDA. (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices),
{2}------------------------------------------------
Page 2 - Mr. Hector Vides
promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
hLliau Yi
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
§ 884.5350 Contraceptive diaphragm and accessories.
(a)
Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.(b)
Classification. Class II (performance standards).