(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.
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K961992
11
510(k) Premarket Notification Needle's Eye Snare
DEC 27 1996
510 (K) SUMMARY I.
Submitted By:
Neal E. Fearnot, President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (317) 463-7537 May 16, 1996
Device:
Trade Name:
Common/Usual Name:
Needle's Eye Snare
Snare, Retrieval Basket, Basket Introducer
Proposed Classification Name:
Embolectomy Catheter 21 CFR Part 870.5150 (74DXE)
Predicate Devices:
The Needle's Eye Snare is similar to predicate devices which are used for the intravascular retrieval of foreign bodies, and is also of similar technology in terms of material composition and method of operation.
Device Description:
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.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
§ 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).