(275 days)
The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.
This document is a 510(k) summary for the Zenith Flex System, a medical device for revascularization in acute ischemic stroke. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and animal) testing rather than clinical study. Thus, it does not describe a study involving an AI component or complex ground truth establishment for diagnostic output.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of Acceptance Criteria and Reported Device Performance
The document provides extensive tables summarizing non-clinical testing. Here's a consolidated and simplified version of the information, focusing on the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Pyrogenicity | Test article extracts must not cause a febrile reaction > 0.5°C in any individual subject. | Met acceptance criteria. (Leveraged from K171672, as materials/manufacturing are equivalent). |
| Cytotoxicity (MEM Elution) | Cultures treated with the test article must not have a reactivity grade > 2. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Aspiration Tubing Set). |
| Hemolysis | Hemolytic index above negative control article must be |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).