(144 days)
The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Mona Lisa Aspiration Needle. It primarily concerns the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Therefore, I cannot provide the requested information based on the given document. The document does not describe a study or specific acceptance criteria for the Mona Lisa Aspiration Needle.
§ 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).