(458 days)
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube, model number Type 2
- . Kitazato OPU Reduced Needle, model number Type 3
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needle based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Tensile Testing: Withstand 22N for needle tube O.D. |
§ 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).