(298 days)
Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Supplied sterile in peel-open packages. Intended for single procedure use.
The EnvyTM Guiding Catheter is used as a support catheter for interventional intracoronary devices. The device will be constructed of nylon and TFE with stainless steel braiding. The EnvyTM Guiding Catheter outside diameter is 6.0 French and will be available in various lengths and various distal curves. It will be supplied sterile, intended for one-time use.
The provided text is a 510(k) Premarket Notification for the Envy™ Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical study with detailed acceptance criteria.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria. The FDA's letter explicitly states that the review determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for market clearance for a 510(k) submission.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or training set.
- Data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
The "Safety and Effectiveness Information" section primarily focuses on stating the device's intended use, materials, and technological characteristics as being similar to the predicate device, the COOK Coronary Guiding Catheter. Substantial equivalence is established based on these similarities and compliance with manufacturing and quality assurance programs, not typically through a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria as would be expected for novel AI/ML devices.
§ 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).