(102 days)
The diagnostic catheter is indicated for cardiac and vascular procedures. It is designed to deliver radiopaque media, guidewires, and therapeutic agents to selected sites in the vascular system. The different configurations of the diagnostic catheter are designed to be used in arteries from access sites such as the radial, brachial, and femoral arteries.
Medtronic's DxTerityTM Catheters are specialized diagnostic intravascular catheters used for the coronary diagnostic angiography performed as part of diagnostic cardiac catheterization. The basic design of DxTerity™ Catheters comprises of a catheter tube having a proximal end and a distal end. A lumen extends from the proximal end of the DxTerity™ catheter to the distal end of the catheter and is configured to serve as a conduit for contrast media delivery, catheter flushing and pressure measurement during cardiac catheterization procedure. The lumen of the catheter is also designed to house a guidewire. The DxTerity™ Catheters are designed to allow access into the arterial vasculature from access sites such as femoral, radial and brachial arteries. DxTerity™ Catheters are single-use use devices sold in a sterile condition.
The provided text describes a 510(k) premarket notification for a medical device (DxTerity™ Diagnostic Angiography Catheters) and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML powered device. The document pertains to a traditional medical device (catheter) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than performance metrics of an AI model.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm-only performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "No clinical investigation was performed on the subject device (DxTerity™ Angiography Catheter)." The evaluations were limited to design verification testing (in-vitro bench testing) and biocompatibility testing.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).