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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:

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: The document does not explicitly state numerical sample sizes for each non-clinical test (e.g., "N=X catheters were tested"). It refers to "test samples" for bench testing and describes animal testing involving "several arteries of swine." For some tests, it states that results were "leveraged" from a previous submission (K171672 or K152202), implying a previous sample size was deemed sufficient for those components/materials.
• Data Provenance: The data is primarily from non-clinical (bench and animal) testing.
  • Animal Testing: Performed on "swine." There's no indication of country of origin for the animal study, but given the FDA submission, it's presumed to be from a facility following GLP (Good Laboratory Practices). The study was prospective in nature for this device.
  • Bench Testing: Performed in a lab setting. No country of origin is specified, but again, standard practice for FDA submissions implies testing in a controlled environment.
  • Leveraged Data: Some results are leveraged from previous 510(k) submissions (K171672 for Zenith Catheter, and K152202 for Corrosion, for an "Intermediate Catheter"). This suggests the data was generated at an earlier time for similar or identical components/processes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of "experts" in the context of establishing ground truth for a test set in the way one would for an AI/diagnostic device. The "ground truth" here is based on:

• Standardized Test Methods: Adherence to ISO, ASTM, and USP standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F1929-12, USP 788, etc.). These methods define the criteria and procedures for measuring various physical, chemical, and biological properties.
• Animal Model Outcomes: In the animal study, effectiveness was assessed via "angiographic assessment of revascularization" and safety via "angiographic assessment and histopathological assessment." These assessments would be performed by qualified veterinary or medical professionals (e.g., veterinarians, pathologists), but their specific number or qualifications are not provided here.
• Physician Feedback: For "Simulated Use - Bench" and "Simulated Use - Usability" tests, it states "simulated use testing by a physician in a benchtop model." The number and specific qualifications of these physicians are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the context of this submission. Adjudication typically applies to human interpretation of diagnostic data, which is not the primary focus here. The assessment of non-clinical tests relies on quantitative measurements against pre-defined acceptance criteria, or expert observation (e.g., pathologist reading histology slides), but not formal adjudication of conflicting expert opinions for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic imaging, which is not relevant for this device. The submission explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device, the Zenith Flex System (catheter, aspiration tubing, pump), is a physical medical device, not a software algorithm or AI tool. Therefore, "standalone" performance in the sense of an algorithm operating independently is not applicable. Its performance is measured through its physical and functional properties, and its interaction with biological systems (in the animal model).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Quantitative Measurements: Direct measurements of physical properties against engineering specifications (e.g., diameter, length, tensile strength, burst pressure, leak rates).
• Biocompatibility Standards: Adherence to ISO 10993 guidelines, which define acceptable biological responses.
• Angiographic and Histopathological Assessment: For the animal study, the "effectiveness" (revascularization) and "safety" (tissue response, thrombus formation) endpoints were evaluated using these clinical and pathological methods. This is the closest to "outcomes data" or "pathology" in your list.
• Physician Feedback: For simulated use, "predetermined user needs" served as the criteria.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (catheter system), not an AI/machine learning device. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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