(182 days)
The Safety Introducer Needle is an anti-needlestick device that provides access to the vascular system for the introduction of a guidewire.
The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.
The Safety Introducer Needle consists of a standard needle with an user-activated safety mechanism clip, clip puller and needle hub. The Safety Introducer Needle ranges in size from 18 - 21 gauges and has needle lengths between 1.5 - 2.75 inches. The needle can be made with an echogenic tip. An echogenic tip allows the tip of the needle to be located using Ultrasound techniques. The needle hubs are color coded to aid in recognition of needle gauge size. The safety clip mechanism reduces the risk of accidental needlestick injuries by shielding the needle. The safety clip mechanism will activate once the puller is pulled down the length of the needle.
This looks like a 510k submission for a medical device called "Safety Introducer Needle". In this specific document, there is no discussion of acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on the administrative aspects of the 510(k) submission, confirming the device's classification, and its substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information from the given text.
Here's how I can tell the provided text doesn't contain the requested information:
- No mention of "acceptance criteria," "performance study," "test set," "sample size," "ground truth," or "experts." The document is primarily about regulatory approval.
- The "Description" section details the physical characteristics and safety mechanism, but not performance metrics.
- The "SUBSTANTIAL EQUIVALENCE" section compares the new device to existing ones based on indications for use, materials, and function, but not on quantitative performance outcomes from a study.
- The FDA letter confirms regulatory clearance, not a performance evaluation detailed in the submission.
To answer your request, I would need a document that describes the design verification and validation testing, which would typically include acceptance criteria and the results of studies conducted to demonstrate the device meets those criteria.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).