(82 days)
The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.
The Endeavor Infusion Catheter is intended to deliver solutions to the coronary and peripheral vasculature. The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.
The provided text is a 510(k) premarket notification for the Cordis Endeavor Infusion Catheter, which is an Embolectomy catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study for novel performance claims.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Instead, the document focuses on:
- Intended Use: To deliver solutions (e.g., heparinized saline, thrombolytic agents) to the coronary and peripheral vasculature.
- Device Description: Over-the-wire design with a distal infusion region and a proximal hub, and a central radiopaque marker band.
- Predicate Devices: SciMed Dispatch and Dispatch Gold Infusion Catheters, LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters, Interventional Innovations Segue Infusion Catheter.
- Testing Performed:
- Biocompatibility Testing: "All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Endeavor Infusion Catheter." (No specific criteria or results are given).
- In vitro and In vivo Testing: "A series of in vitro and in vivo tests were performed to assure that the introduction of the Endeavor Infusion Catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications." (Again, no specific criteria or results are provided, nor details on the study design or sample sizes).
- Conclusion: The device is substantially equivalent to the predicate devices due to similar intended uses, design characteristics, and dimensions.
In summary, for a 510(k) submission, the "acceptance criteria" are generally demonstrating that the device is as safe and effective as a legally marketed predicate, rather than meeting specific performance metrics derived from a clinical trial with ground truth established by experts.
§ 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).