(149 days)
The Single Lumen Needle is intended to obtain oocytes from the body.
The Single Lumen Needle is intended to obtain oocytes from the body. All needles manufactured, will be Gamma Irradiated and or steam sterilized by and in accordance to the guidelines in place.
This document is a 510(k) summary for the ** Single Lumen Needle**, submitted by International, Inc. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) process for medical devices primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical or analytical studies in the same way a Premarket Approval (PMA) would.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No Acceptance Criteria: The document does not specify any quantitative acceptance criteria for the Single Lumen Needle's performance (e.g., success rate of oocyte retrieval, material strength, biocompatibility metrics, etc.).
- No Performance Study: There is no mention of a study (clinical or analytical) designed to demonstrate the device meets any specific performance criteria. The submission focuses on substantial equivalence based on device description, intended use, and manufacturing processes (gamma irradiation/steam sterilization).
- No Standalone or MRMC Study: Since no performance study is described, there's no data to report on standalone performance or a multi-reader multi-case comparative effectiveness study.
- No Ground Truth Information: Without a performance study, there's no ground truth defined, no expert consensus, or sample sizes for test or training sets mentioned.
The document states:
- "No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device."
- "This product is substantially equivalent to several product currently sold in the market."
The FDA's letter confirms: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its similarity to existing devices, not on new performance data against specific acceptance criteria.
§ 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).