HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

• K Number: K091703
• Device Name: HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
• Manufacturer: CONCENTRIC MEDICAL, INC.
• Date Cleared: 2009-10-14 ( 126 days)
• Product Code: QEZ , DXE
• Regulation Number: 870.5150
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K073519
• Predicate For: N/A

Intended Use

The HD Guide Catheter is indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system.

Device Description

The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

AI/ML Overview

The provided text is a 510(k) summary for the Concentric HD Guide Catheter, describing its intended use, design, and a summary of substantial equivalence to a predicate device. However, it does not include detailed information regarding acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth establishment for performance evaluation.

Therefore, I cannot provide the requested table and detailed study information based on the given text. The document states:

• "The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."
• "Any differences in technological characteristics between the HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness."

This indicates that internal testing was performed to support the 510(k) submission, confirming the device's performance and substantial equivalence to the predicate "QuickCat Extraction Catheter (K073519)", but the specifics of those tests, including quantitative acceptance criteria and detailed results, are not present in this summary.

Regulation Number and Section

§ 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).