(37 days)
The Seldinger Safety Needle Introducer incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to introduce a guidewire (.018 inches maximum) into the vascular system.
Not Found
This document is a 510(k) clearance letter for a medical device called the "Seldinger Safety Needle Introducer." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance.
The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification... and 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 indicates that the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating performance against specific acceptance criteria.
Thus, the requested details such as:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size and ground truth establishment for the training set
cannot be found in this document.
§ 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).