(165 days)
The AngioJet® Ultra Power Pulse® Kit is intended for use only with AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.
AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red. The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids. The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set.
This document is a 510(k) summary for the AngioJet Ultra Power Pulse Kit. It describes the device, its intended use, and a comparison to a predicate device, as well as performance data.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "X% accuracy," "Y mm deviation"). Instead, it outlines the types of tests performed to demonstrate substantial equivalence to a predicate device. The "acceptance" is implied by the successful completion of these tests, confirming that the new device material (DEHP-free tubing) performs equivalently to the previous version.
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Physiochemical, Pyrogenicity, Hemolysis) | Passed/Conformed to ISO 10993 standards. (Verified new device material is substantially equivalent to predicate devices.) |
| Mechanical Integrity (Clamp open/close, Leak, Component separation) | Passed/Conformed to requirements. (Verified new device material is substantially equivalent to predicate devices.) |
| Functional Design Equivalence | Demonstrated similar functional design to the predicate. |
| Indications for Use Equivalence | Demonstrated same intended use as the predicate. |
| Principles of Operation Equivalence | Demonstrated similar principles of operation to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the bench and laboratory testing. It just states that "Bench and laboratory testing was performed." There is no information about the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant or provided in this document. The testing described is primarily mechanical and biocompatibility, which typically relies on laboratory standards and instrumental measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing did not involve expert adjudication in the context of clinical or diagnostic performance.
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 device is a catheter kit, not an AI-powered diagnostic system. No MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" would be established by the respective ISO 10993 standards and their defined limits for various biological responses. For mechanical integrity, the "ground truth" would be the engineering specifications and performance requirements for the device components (e.g., force required for clamp actuation, acceptable leak rates).
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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).