(116 days)
Stereotaxis Cronus® Guide Wires are intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Cronus Guide Wires are steerable guide wires that have a nominal diameter of 0.014 in/ 0.36mm and nominal lengths from 180 cm to 300 cm. The guide wires are designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wires, and a PTFE coating covers the proximal end of the wires. This device is sterilized with 100% ethylene oxide. The Cronus Guide Wires are conventional 0.014" hydrophilically coated endovascular guide wire modified to accommodate magnetic actuation and control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site. The finished length of the guide wire is 180cm to 300cm. A taper runs proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The guide wire is used with an introducer sheath to access the human vasculature.
The provided text describes a 510(k) submission for the Stereotaxis Cronus Guide Wires, which are a modification of an existing device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics for a new, independent device.
Therefore, the direct answers to some of your questions may not be explicitly available in the provided text, as the nature of the submission does not require a new clinical study with defined acceptance criteria and performance outcomes for the modified device.
Here's an analysis based on the provided information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics as would be found in a study for a novel device. Instead, it states that the device "met design input criteria" and was "substantially equivalent to the currently marketed predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit quantitative acceptance criteria for performance are listed in this document for the modified device. | The device "met design input criteria" through physical testing. |
| Demonstrated "substantial equivalence" to the currently marketed predicate device in physical testing. | |
| Demonstrated "substantial equivalence" to the currently marketed predicate device in preclinical animal models. |
2. Sample sized used for the test set and the data provenance
- Physical Testing: The sample size for physical testing is not specified. The provenance would be internal laboratory testing by Stereotaxis, Inc.
- Preclinical Animal Performance Data: The sample size for animal testing (number of swine and canine models) is not specified. The provenance would be preclinical animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a study requiring expert-established ground truth in the context of diagnostic accuracy, as it's a device modification relying on substantial equivalence.
4. Adjudication method for the test set
Not applicable. There was no diagnostic test set requiring adjudication in this submission.
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 is not an AI/diagnostic imaging device and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the performance and safety established for the predicate device, against which the modifications are compared to demonstrate substantial equivalence.
- For Physical Testing: Compliance with FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995, and the performance characteristics of the predicate device.
- For Preclinical Animal Performance Data: The established performance and safety profile of the predicate device in animal models.
8. The sample size for the training set
Not applicable. This is a medical device with physical and animal testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.