(169 days)
The Zenith Flex Aspiration System, including the 046 Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke 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 InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.
The provided document is a 510(k) premarket notification for a medical device, the Zenith Flex Aspiration System (046 Zenith Flex Catheter). It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Penumbra 3 Max) and a reference device (071 Zenith Flex System).
The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth in the context of diagnostic AI. Instead, it details the physical and mechanical performance testing of a catheter and its accessories. Therefore, many of the requested details, such as those related to AI algorithm performance, ground truth, expert adjudication, or MRMC studies, are not applicable to this document.
However, I can extract the acceptance criteria and performance information as presented for the physical device.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a comprehensive table of non-clinical tests, their methods, acceptance criteria, and conclusions. Since the "performance" for all these tests is simply stated as having "met the acceptance criteria" or "passed," this table effectively serves as the performance report. I will summarize key categories, as a direct copy of the entire table would be extensive.
| Test Category | Test Method Summary | Acceptance Criteria | Reported Device Performance (Conclusions) |
|---|---|---|---|
| Biocompatibility | ISO 10993 Series (e.g., -4, -5, -10, -11) | - Must not cause febrile reaction > 0.5°C |
- Reactivity grade 0 and that enough samples were tested to demonstrate compliance.
- Data Provenance:
- Non-Clinical (Bench) Testing: This was conducted by InNeuroCo, Inc. (location: Sunrise, Florida, USA). The testing was done in a controlled lab environment.
- Animal Testing: Conducted in swine, implying a prospective study design for the animal component. The document does not specify the country of origin for the animal study, but given the company's US location and FDA submission, it's likely primarily US-based or conducted under equivalent regulatory standards.
- Clinical Data (Literature Review): A review of "published clinical study articles" was conducted. This refers to existing, likely retrospective, clinical data from external sources and studies. No new clinical trials were performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes a physical medical device (catheter system) and its performance validation through bench and animal testing. It does not involve diagnostic imaging or AI for which ground truth established by experts would be relevant. The "ground truth" for this device's performance is objective measurements (e.g., dimensions, burst pressure, tensile strength, successful thrombi removal in models) and histopathological/angiographic assessments in animal models.
- A "physician" was involved in "simulated use testing," but this was for usability and performance in a benchtop model, not for establishing a diagnostic ground truth. Their qualifications are not specified beyond being a "physician."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As an AI/ML related concept, adjudication by multiple experts is not relevant to the physical and mechanical testing of a catheter system.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, not applicable. This document is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical bench testing: The "ground truth" for acceptance was based on predefined physical, mechanical, and performance specifications (e.g., measurements being within specified ranges, successful functional outcomes like thrombi removal, absence of leaks or degradation).
- For animal testing: The "ground truth" for effectiveness and safety was based on angiographic assessment of revascularization and histopathological assessment.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process in that context.
§ 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).