(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.
§ 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).