(270 days)
The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Endotoxin |
§ 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).