(129 days)
The Paladin System with Integrated Embolic Protection (IEP) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin System with IEP should always be used in conjunction with an available embolic protection device.
The Paladin System is a sterile, single use, rapid exchange (RX) PTA catheter with a nitinol-based filter between the PTA balloon and the distal tip of the catheter. The balloon has radiopaque markers to aid in accurate positioning under fluoroscopic guidance. The dilation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Paladin has balloon diameters Ø of 5.0 mm and 5.5 mm and balloon lengths of 20 mm and 30 mm. The embolic protection filter is composed of a nitinol braid chassis with an overlying polyurethane membrane with radiopaque markers on either end and radiopaque markers on the filter. The catheter has a guidewire lumen, an inflation/deflation lumen, and a filter activation wire lumen. The guidewire lumen permits the passage of a guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal end of the catheter has a handle that controls activation. The filter is identical across all sizes of balloons and can be expanded to a maximum diameter of 7 mm. The Paladin System is designed to be introduced through a 6 French vascular sheath.
The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets those criteria in a format applicable to evaluating AI/ML models (e.g., performance metrics like accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, or ground truth establishment).
The document is a 510(k) summary for the "Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection." It focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
Instead of acceptance criteria and a study proving their fulfillment, the document provides:
- Indications for Use: The Paladin System is indicated for Percutaneous Transluminal Angioplasty (PTA) in carotid arteries and post-dilation of self-expanding stents in carotid arteries, with integrated embolic protection.
- Summary of Non-Clinical Data: This includes design verification in-vitro testing (e.g., dimensional verification, torque response, balloon burst pressure, embolic capture efficiency), biocompatibility testing, and animal testing (acute and chronic studies in swine). These tests are designed to demonstrate the device's physical and biological safety and performance characteristics, but they are not presented as numerical acceptance criteria against reported device performance in the context of an AI/ML system's evaluation.
- Summary of Clinical Data: A multi-center study in Germany with 106 subjects assessing acute safety and clinical performance.
- Primary Outcome: Combined major adverse event (MAE) rate at 30 days (stroke, myocardial infarction, death) was 0.98%.
- Related Events: One major stroke at day 12 (antiplatelet non-compliance), attributed to patient non-compliance, not the device.
- Procedural Success Rate: 100%
- Technical Success Rate: 99%
- Patient Demographics: Age, gender, diabetes, hypertension, hyperlipidemia, smoking status, symptomatic status, lesion length, and percent diameter stenosis.
Therefore, it is not possible to generate the requested table and information as the provided text pertains to a medical device's 510(k) submission, not an AI/ML model's performance evaluation.
The document describes the traditional regulatory process for a medical device (a physical system) and its clinical trial outcomes, not the validation of an algorithmic device with respect to specific performance metrics like those typically outlined for AI/ML.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).