(122 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 controls the movement and maneuvering of the devices using intuitive controls under independent angiographic fluoroscopy visual guidance 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, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
In addition, the CorPath GRX Software contains the following functionality for automated movements (also referred to as the technIQ automated movements), of the interventional devices:
- . Rotate on Retract - When selected, rotates the guidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the quidewire while it is being navigated to the target location (previously cleared under CorPath GRX System, K173806).
- Wiggle - When selected, this movement enables a small clockwise and counterclockwise rotation of the guidewire while advancing to assist in navigation.
- . Spin - When selected, this movement will enable a large clockwise and counterclockwise rotation of the quidewire while advancing to assist in lesion crossing.
- . Constant Speed - When selected, the guidewire or device joysticks will advance and retract at a constant speed of either 2mm/second or 5mm/second depending on the speed selected by the operator.
- . Dotter - When selected, this movement will enable a linear back and forth motion of the device when advancing to assist in lesion crossing and delivery of therapy.
This document describes a 510(k) premarket notification for the CorPath GRX System, a robotic system for percutaneous coronary and vascular procedures. The submission focuses on software changes introducing four additional automated features (spin, wiggle, dotter, and constant speed) to the already cleared CorPath GRX System.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that "All testing has demonstrated that the device is substantially equivalent to the predicate device." The acceptance criterion is, therefore, demonstrating substantial equivalence to the predicate device (CorPath GRX System, K173806, and K173288).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions as intended with new automated features (Spin, Wiggle, Dotter, Constant Speed). | "All testing has demonstrated that the device is substantially equivalent to the predicate device." "The technIQ automated moves for the CorPath GRX System do not change the safety profile of the device as there is no change to delivery forces and the operator maintains complete control of all movements of the devices." |
| No change in safety profile due to new automated features. | "The technIQ automated moves for the CorPath GRX System do not change the safety profile of the device as there is no change to delivery forces and the operator maintains complete control of all movements of the devices." |
| Continued compliance with relevant regulations and performance standards. | Demonstrated through various non-clinical tests (Functional Testing, Simulated Use Testing, Particulate Testing, Software Verification and Validation testing, Cybersecurity Penetration Testing). |
2. Sample size used for the test set and the data provenance
The document mentions "Simulated Use Testing" and states that "Clinical data from the post-market PRECISION GRX Study was used to help demonstrate substantial equivalence." However, it does not specify the sample size for either the simulated use testing or the PRECISION GRX Study, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective) for the clinical data.
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 in the document. The study appears to be focused on technical verification and validation, and a comparison against a predicate, rather than an expert-adjudicated performance study where "ground truth" would typically be established by multiple experts.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of the testing described (functional, simulated use, software verification), a formal adjudication method by multiple experts is unlikely to have been used in the same way it would be for a diagnostic AI study.
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
There is no indication that an MRMC comparative effectiveness study was done. The device is a "Steerable Catheter Control System," not an AI diagnostic tool, so the concept of "human readers improving with AI assistance" does not directly apply in the context of this submission. The "technIQ automated movements" are intended to assist the physician in manipulating devices, but the document does not include a comparative study of physician performance with vs. without these specific automated features.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a robotic system designed to be operated by a physician ("human-in-the-loop"). The "automated movements" are features within this system, not a standalone AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done and would not be relevant for this type of device. The verification and validation testing would have involved the system with its automated features, likely within simulated use or benchtop environments.
7. The type of ground truth used
For the non-clinical laboratory tests (Functional, Simulated Use, Particulate, Software V&V, Cybersecurity), the "ground truth" would be established by engineering specifications, design requirements, and established testing protocols. For the "Clinical data from the post-market PRECISION GRX Study," the document does not specify the type of ground truth, but for a robotic intervention system, it would typically relate to procedural success, safety outcomes, and possibly ergonomic benefits, rather than a diagnostic "ground truth" like pathology.
8. The sample size for the training set
This information is not applicable/provided. The submission concerns software updates to a robotic control system with "automated movements," which are likely rule-based or control algorithms, rather than a machine learning model that requires a distinct "training set." Therefore, no training set size is mentioned.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as #8. If the automated movements involve control algorithms rather than learned AI models, the "ground truth" for their development would be based on engineering principles, clinical requirements for device manipulation, and pre-defined operational parameters, not a labeled dataset.
§ 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).