(18 days)
The AngioJet XMI Catheter – Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter.
The AngioJet XMI Catheter – Rapid Exchange is a 135 cm, 4.0 French, sterile, single-use catheter designed for removing thrombus from vascular conduits. High velocity saline jets directed back into the Catheter create a localized low-pressure zone at the distal tip (Bernoulli effect) that results in suction, break-up, and removal of thrombus through the exhaust lumen. The Catheter is designed to track over a 0.014" guidewire and through a 6 French high flow guide wire catheter (0.068 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast medical, if desired.
The provided text is a 510(k) summary for the AngioJet XMI Catheter - Rapid Exchange (XMI-RX). It explains that the device is substantially equivalent to a predicate device and outlines its intended use and a comparison of technological characteristics. However, the document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.
The summary focuses on demonstrating substantial equivalence to a predicate device (AngioJet LF140 Catheter under K972610), which is a regulatory pathway that often relies on demonstrating similar safety and effectiveness without necessarily conducting new clinical trials against specific performance metrics.
Therefore, I cannot populate the table or answer most of your questions based only on the provided text, as the information you are requesting is not present.
Here's a breakdown of what can and cannot be inferred from the provided text:
What can be inferred from the document:
- Device Performance: The document states the device is "indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter." This describes its intended function, but not specific quantitative performance metrics or acceptance criteria.
- Sample Size for Test Set and Data Provenance: Not mentioned.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not mentioned. The approval is based on substantial equivalence, not a direct clinical outcomes study with defined ground truth.
- Sample size for the training set: Not applicable and not mentioned.
- How ground truth for the training set was established: Not applicable and not mentioned.
However, to address the request as directly as possible based on the spirit of the questions and the limited information:
Given that this is a 510(k) submission and the conclusion states "substantially equivalent to the predicate device," the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are implicitly tied to demonstrating this substantial equivalence. This typically involves:
- Bench testing: To show mechanical and functional equivalence to the predicate.
- Biocompatibility testing: To demonstrate material safety.
- Sterilization validation: To ensure the device is sterile.
These tests are performed to demonstrate that the new device is as safe and effective as the predicate device. The "device performance" reported would be that it functions equivalently to the predicate in these various tests.
No information about specific quantitative acceptance criteria or results of such tests are detailed in the provided documents. The summary merely asserts that such comparisons were made and demonstrated equivalence.
Therefore, I cannot fully complete the table or answer the questions with specific data points as they are not present in the provided 510(k) summary.
§ 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).