(220 days)
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects.
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Needle's Eye Snare is provided by their established history of use in medical devices manufactured by the Cook Pacemaker Corporation.
This 510(k) premarket notification for the "Needle's Eye Snare" does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of diagnostic or algorithmic performance.
Instead, this document focuses on:
- Device Description and Intended Use: Percutaneous removal of indwelling catheters, cardiac leads, fragments, and foreign objects.
- Substantial Equivalence: Comparing the device to predicate devices based on materials, construction, indications for use, manufacturing controls, packaging, and sterilization.
- Biocompatibility: Stating that materials have an established history of use in medical devices.
The information typically provided in a 510(k) for devices like the Needle's Eye Snare pertains to mechanical performance, material safety, and substantial equivalence to legally marketed predicate devices, not the kind of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that would necessitate details about ground truth, expert consensus, training sets, or MRMC studies.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, adjudication methods, or AI comparative effectiveness studies, because this type of evaluation is not applicable to the information contained within this specific 510(k) document.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).