(7 days)
The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to:
- . Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures.
- . Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter.
- . To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- . The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.
The GuardWire® Temporary Occlusion and Aspiration System is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the EZ Adaptor device, the Export® Catheter, and the EZ Flator Inflation device.
The GuardWire Temporary Occlusion Catheter is a "balloon-on-a-hypotube-wire" catheter with a distal elastomeric occlusion balloon. It has a lubricious coating and a flexible radiopaque tip. The GuardWire Temporary Occlusion Catheter is packaged with an Introducer Sheath, an EZ Adaptor device, and an EZ Flator Inflation Device. The EZ Adaptor device is used exclusively with the GuardWire Temporary Occlusion Catheter for the purpose of controlled volumetric inflation and deflation of the temporary occlusion balloon.
The EZ Flator device is used exclusively with the GuardWire Temporary Occlusion Catheter during catheter preparation, inflation and deflation of the balloon. The EZ Flator device delivers a controlled volume when inflating the balloon to each occlusion size. It has an integrated deflation syringe used for catheter preparation and balloon deflation and has a reservoir for diluted contrast solution.
The Export Catheter is compatible with the GuardWire Temporary Occlusion Catheter and has a distal radiopaque tip marker and proximal Luer-lock port.
Here's the information about the acceptance criteria and the study for the GuardWire® Temporary Occlusion and Aspiration System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the device against particular criteria. Instead, it states that "The safety and performance of the GuardWire 3-6 Temporary Occlusion and Aspiration System for use in carotid arteries is supported by the MAVErIC I & II clinical trials."
Therefore, I cannot populate a table with specific acceptance criteria and numerical performance results based on this document. The approval seems to be based on the general safety and effectiveness demonstrated in the clinical trials, and substantial equivalence to predicate devices, rather than meeting predefined quantitative targets reported in the summary.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions supporting clinical trials (MAVErIC I & II) but does not specify the sample size for these trials, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) submission for a new device, it is highly probable that the data would be prospective, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. It focuses on the device's performance through clinical trials (MAVErIC I & II) but not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical medical device (a catheter system), not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. Its performance is assessed through its physical interaction within the human body during procedures.
7. Type of Ground Truth Used
Given that this is a physical medical device used in interventional procedures, the "ground truth" for assessing its safety and effectiveness in the MAVErIC I & II clinical trials would likely involve clinical outcomes data related to its intended use, such as:
- Incidence of embolic material containment and aspiration.
- Successful facilitation of diagnostic/therapeutic catheter placement.
- Successful local infusion/delivery of agents.
- Adverse event rates (e.g., stroke, vessel injury).
- Procedural success rates.
However, the document does not explicitly state the specific endpoints or "ground truth" criteria used in the MAVErIC I & II trials.
8. Sample Size for the Training Set
This device is a physical medical device, not an AI algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, the concept of a "training set" and establishing its ground truth is not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).