(220 days)
The Cordis STABILIZER Marker Wire Steerable Guidewire and Cordis WIZDOM Marker Wire Steerable Guidewire are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Cordis Marker Wire Steerable Guidewires have a soft, flexible, highly radiopaque platinum/tungsten coil on the distal tip and radiopaque markers along the length of the guidewire. Guidewire length, diameter, distal tip configuration and radiopaque marker configuration are indicated on the product label. A steering/torquing device may be attached to aid in steering/torquing the guidewire.
The provided text does not contain information about acceptance criteria for a device's performance (beyond biocompatibility), a study that proves the device meets specific performance criteria, or any details about an AI algorithm. The document is a Premarket Notification (510(k)) for a medical device (guidewire) and focuses on describing the device, its intended use, classification, and biological compatibility, and argues for substantial equivalence to existing predicate devices.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The text primarily addresses regulatory aspects of device submission regarding substantial equivalence and biocompatibility, not performance studies against specific criteria for an AI device.
§ 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.