(30 days)
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.
The CorPath GRX System is composed of the following two functional sub-units:
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- Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
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- Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.
Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
The provided text is a 510(k) summary for the CorPath GRX System, which is a steerable catheter control system used for remote delivery and manipulation of guidewires, rapid exchange catheters, and guide catheters during percutaneous coronary and vascular procedures.
This document describes a submission for a modificiation (K180517) to an already cleared device, the CorPath GRX System (K173288). The modification is specifically "limited to a new bedrail connection design for the Extended Reach Arm component."
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Demonstration of substantial equivalence to predicate device (K173288) after modification (new bedrail connection for Extended Reach Arm component). | "All testing has demonstrated that the device is substantially equivalent to the predicate devices." (Page 5) |
| "The testing demonstrated that the device can be considered substantially equivalent to the predicate devices." (Page 5) | |
| "Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate device, the CorPath GRX System (K173288, cleared February 15, 2018)." (Page 5) | |
| Performance Testing of Extended Reach Arm (specifically related to the new bedrail connection design). | "Performance Testing Extended Reach Arm" was conducted, and the results contributed to the overall finding of substantial equivalence. The document doesn't provide specific quantitative metrics, but states the testing was successful. (Page 5) |
| Compliance with IEC 60601-1 Safety Testing. | "IEC 60601-1 Safety Testing" was conducted, and the results contributed to the overall finding of substantial equivalence. The document doesn't provide specific quantitative metrics, but states the testing was successful. (Page 5) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes non-clinical laboratory tests rather than studies involving human subjects or real-world patient data. Therefore, the concepts of "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as typically applied to clinical or AI performance studies are not directly applicable here. The testing was performed on the device itself and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable. The study involved engineering and safety testing of a medical device, not a diagnostic or prediction task that would require expert-established ground truth on a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
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. This was a 510(k) submission for a robotic catheter control system, not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies. The device itself performs actions (delivery and manipulation of catheters) under human control.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is inherently a "human-in-the-loop" system, as physicians maneuver interventional devices using controls. The testing described focuses on the device's mechanical, electrical, and safety performance following a modification, not on an "algorithm only" performance.
7. The Type of Ground Truth Used:
The "ground truth" for this type of submission is the functional and safety standards (e.g., IEC 60601-1) and the performance characteristics of the predicate device. The testing's purpose was to demonstrate that the modified device's performance meets these established benchmarks and remains substantially equivalent to the original cleared device despite the design change.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning device that involves a training set. The "training" for such a device would be its design, engineering, and manufacturing processes, culminating in verification and validation testing.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).