(266 days)
VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.
This product is a disposable, sterile medical device, sterilized by ethylene oxide.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VitaVitro® Oocyte Retrieval Needle.
This document describes a 510(k) premarket notification for a medical device, which typically compares a new device to an existing legally marketed predicate device to demonstrate substantial equivalence. It is important to note that 510(k) submissions generally do not involve clinical trials to prove efficacy against specific clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as the predicate based on technological characteristics and performance testing.
Therefore, many of the questions regarding "study that proves the device meets the acceptance criteria" in a clinical sense, particularly those related to human-in-the-loop performance, effect sizes, and detailed ground truth establishment from patient data, are not typically part of a 510(k) submission for this type of device. The acceptance criteria here are primarily based on non-clinical performance testing demonstrating the device's technical specifications and safety.
1. A table of acceptance criteria and the reported device performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing |
| Irritation (ISO 10993-23:2021) | Non-irritating |
| Mouse Embryo Assay (MEA) | |
| ≥80% embryos developed to expanded blastocyst at 96h (per 2021 FDA guidance) | >80% embryos developed to expanded blastocyst at 96h |
| Endotoxin Testing | |
| ) |
§ 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).