(134 days)
The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infrainguinal peripheral arteries >=3.0 mm in diameter.
The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.
The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System uses high velocity saline jets for percutaneous break-up and removal of thrombus. The 6 FR Catheter has a tapered flexible polymeric tip, and a large outflow lumen for guide wire passage and removal of thrombus debris. A small second lumen contained within the large outflow lumen supplies pressurized saline to the Catheter tip. The Catheter is designed to track over a 0.305" guide wire and through a guide catheter or sheath having an inner diameter of 0.086" or larger, with sufficient clearance to allow manual contrast injection, if desired. The Catheter connects to the AngioJet Pump Set and the multiple-use AngioJet Drive Unit (each packaged separately), which are necessary for operation of the AngioJet System.
The AngioJet Power Pulse Spray Ancillary Kit enables the AngioJet Xpeedior 120 Catheter to deliver a pulsed infusion of a physician-specified fluid to a local treatment area during a peripheral intervention. The Ancillary Kit also enables the Catheter to convert easily back to conventional AngioJet thrombectomy procedure.
The AngioJet Power Pulse Spray Ancillary Kit includes a Y-set that is comprised of two vented bag spikes bonded to PVC tubing with a clamp attached on each tube and a short, larger diameter section of PVC tubing bonded to a Y-junction. The Y-set is used to access the standard intravenous saline solution bag, used with AngioJet thrombectomy, and a second intravenous bag containing physician specified fluid. The tube clamps are used to control the flow of each fluid.
A separate one-way stopcock is included in the kit. This stopcock is placed between the Xpecdior 120 Catheters' outflow port, located on the underside of Catheter manifold, and the outflow tubing.
The Power Pulse Spray Ancillary Kit is an accessory that is to be used only with the AngioJet Rheolytic Thrombectomy System and Xpeedior 120 Catheter and will be packaged independent from the AngioJet System components (i.e. the Drive Unit, Pump Set, and Catheter.)
The provided text is a 510(k) premarket notification for the AngioJet Xpeedior 120 Catheter and AngioJet Power Pulse Spray Ancillary Kit. This type of submission is for medical devices that are substantially equivalent to a predicate device, and it typically does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be found in a De Novo or PMA submission.
Instead, the submission demonstrates substantial equivalence through functional and safety testing, material comparisons, and principles of operation to existing predicate devices.
Therefore, many of the requested details about acceptance criteria, specific study results, and ground truth establishment are not provided in this document.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific quantitative performance metrics. It states that "Representative samples of the device underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing, and animal testing to safety and effectiveness and to demonstrate appropriate functional and performance characteristics."
The "reported device performance" is essentially the finding of "substantial equivalence" to the predicate devices. The assumption is that the device performed equivalently to the predicate devices in the functional and safety tests, thus meeting implicitly defined performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Safety & Effectiveness (e.g., integrity, durability) | Demonstrated through bench testing |
| Biocompatibility | Demonstrated through bench testing |
| Sterility | Demonstrated through bench testing |
| Functional characteristics (e.g., thrombus removal, fluid infusion) | Demonstrated through comparative and animal testing |
| Equivalent to predicate devices in functional design, materials, indications for use, and principles of operation | Substantially equivalent to AngioJet LF140 Catheter (K972610), AngioJet Xpeedior 60 Catheter (K993564), AngioDynamics Power Pulsed Spray Infusion System (K905447 and K951509), and B.Braun Universal Spike Adaptor Y-Set (K780551). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the bench, comparative, or animal testing. It only refers to "Representative samples."
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the submission is a 510(k) for substantial equivalence, not a clinical trial requiring expert ground truth in the context of diagnostic or treatment efficacy.
4. Adjudication method for the test set
This information is 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
No MRMC study was mentioned. This device is a catheter and ancillary kit, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not directly relevant here. The ground truth for this medical device's performance would be established by physical measurements, chemical analyses, and direct observation during the various safety and functional tests, along with comparison to the known performance of predicate devices.
8. The sample size for the training set
This is not applicable, as the device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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).