(18 days)
A follicle aspiration set used for transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA to Gynétics Medical Products N.V. regarding their device, FAS SET #4551 Follicle Aspiration Set. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory responsibilities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).