(34 days)
The Wallace Dual Lumen Oocyte Retrieval Sets are sterile single-use devices for ultrasonic-guided transvaginal collection of oocytes from the ovarian follides.
The Wallace Dual Lumen Oocyte Retrieval Sets are sterile, single-use devices for ultrasound ~ guided transvaginal collection of Oocytes from ovarian follicles. The set consists of a dual-lumen stainless needle attached to polyurethane tubing. The needle is 33cm in length and available in 16 gauge or 17 gauge sizes, each having 1cm of echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Retrieval tubing is attached to the proximal end of the hub and is available in two lengths, protruding a total distance of either 60cm, 75cm or 95cm until it passes through a silicone bung. The Retrieval tubing is sleeved at the needle connection with a silicone sleeve (Blue 16g). Flushing tubing is attached to the top of the hub and extends to either 60cm, 75cm before it terminates in a clear female luer connector. A pump adapter component is included in each pouch pack to allow connection of the pink female Luer connector to vacuum tubing with an internal diameter of between 4 and 10.5mm.
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for the "Wallace Dual Lumen Oocyte Retrieval Set," focusing on its substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested information.
§ 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).