(190 days)
The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet System.
The AngioJet XPEEDIOR Catheter is designed for operation with the AngioJet Rheolytic Thrombectomy System (AngioJet System). The AngioJet System consists of three components: the Drive Unit, disposable Pump Set, and disposable Catheter.
The AngioJet XPEEDIOR Catheter is a new AngioJet catheter model which has been designed to optimize clot removal performance. As with other AngioJet Catheter models the XPEEDIOR Catheter consists of a manifold, Catheter body, and tip. The manifold contains connections for the high pressure saline supply, an exhaust removal line, and a hemostasis valve for sealing around an 0.035" and smaller diameter guidewire. The Catheter body consists of a stainless steel hypodermic tube extending the length of the catheter which carries high pressure saline to the tip. This tube lies within a single lumen polymeric tube which serves as a lumen for both exhaust and guidewire. The tip contains the portion of the hypotube which has been formed into a toroidal loop. Six small holes are located on the proximal portion of the loop. Jets of saline exit these holes at high velocity and are directed proximally from the tip. These jets flow past a primary set of orifices in the exhaust tube referred to as inflow windows. Thrombus is entrained (via the Bernoulli effect of high velocity creating a vacuum) into these windows and then macerated. The thrombotic debris is propelled by the dynamic pressure of the jets through the exhaust lumen and out of the manifold body to the exhaust bag. A set of secondary orifices referred to as outflow windows are positioned in the exhaust tube proximal to the inflow windows. These aid in recirculating and breaking up the thrombus. The outflow windows are the primary new feature compared to previous AngioJet Catheter models except for the F105, in which 3 low-pressure, radially directed jets were employed. Fluid, which is powered by the dynamic pressure of the jets, flows from these outflow windows and then back to the inflow windows. This recirculation pattern improves the efficacy of the device by increasing the volume of the entrainment zone while still maintaining a minimal catheter profile.
The provided text is a 510(k) summary for the AngioJet XPEEDIOR Catheter, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results or acceptance criteria in the way a clinical trial or AI/ML device submission would.
Therefore, many of the requested categories of information are explicitly not present in this document because they are not typically required for a 510(k) of this nature. The document explicitly states that "Extensive in vitro, physical, functional, animal, and biocompatibility tests have been performed on the XPEEDIOR Catheter. These tests have shown that the XPEEDIOR Catheter performs comparably to the predicate device. All performance results for the XPEEDIOR Catheter and the predicate device exceed physiological requirements for the intended clinical use of the device." This indicates that the "acceptance criteria" here are largely based on meeting performance requirements comparable to the predicate for safety and effectiveness through non-clinical testing.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "reported device performance" in the format one might expect for a new AI/ML diagnostic or therapeutic device. Instead, the "acceptance criteria" are implied to be comparability to the predicate device (AngioJet LF140 Catheter) in non-clinical performance, and exceeding physiological requirements for intended clinical use.
The "reported device performance" is summarized qualitatively: "All performance results for the XPEEDIOR Catheter and the predicate device exceed physiological requirements for the intended clinical use of the device."
The comparison table provided (Table 1) focuses on technical characteristics rather than specific performance metrics (like clot removal rate, safety endpoints, etc.).
| Characteristic | Predicate Device (LF140 Catheter) | Subject Device (XPEEDIOR Catheter) |
|---|---|---|
| Application | Thrombus removal in AV access grafts | Thrombus removal in AV access grafts |
| Intended Guidewire | 0.018" | 0.035" |
| Materials | Same | Same |
| Working Length | 140cm | 60cm |
| Maximum Shaft Diameter | 5 Fr | 6 Fr |
| Flexibility | Enhanced | Standard |
| Exhaust Tubing | 6333 Dual Lumen Pebax | 5333 Single Lumen Pebax |
| Tip Style | Stainless Steel Cap | Polymeric Tapered Flexible |
| Gap length | 0.018" | gap replaced with inflow and outflow windows |
| Drive Unit Operating Mode | Mode 2- 50cc/min | Mode 1- 60cc/min |
| Number of Jets | 6 | 6 |
| Operating Pressure | 7-12 Kpsi | 7-12 Kpsi |
| Performance | "exceed physiological requirements" (implied comparable) | "exceed physiological requirements" |
| Comparability | n/a | Performs comparably to predicate |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document describes non-clinical (in vitro, physical, functional, animal, and biocompatibility) tests, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This is not a study involving expert-derived ground truth for a diagnostic algorithm.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable. This is not for an AI/ML device, nor does it describe a clinical comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device performance (thrombus removal) is assessed through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not explicitly detailed. For non-clinical tests, "ground truth" would be the known physical properties, functional outcomes (e.g., amount of clot removed in an in vitro model), or safety endpoints in animal studies, established by standard scientific measurement and observation.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).