(249 days)
The Selebrek PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Selebrek PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Dilatation Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Selebrek is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semicompliant balloons are available in diameters of 1.5mm and lengths from 6-30mm, and have a rated burst pressure of 14 atm.
The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters).
The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a quide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated.
The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial quidance and rapid exchange of the catheter with a single standard length guidewire.
One radiopaque Platinum/lridium marker band is located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
The provided document is a 510(k) Summary for a medical device (Selebrek PTCA Balloon Dilatation Catheter). It details the device's comparison to a predicate device and non-clinical testing performed to establish substantial equivalence.
However, the document does NOT contain information about AI/ML device performance or acceptance criteria related to AI/ML. There is no mention of an algorithm, AI assistance, human readers, ground truth establishment for AI, or any of the metrics typically associated with AI/ML model evaluation (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and studies. The document only describes a traditional medical device (balloon catheter) and its non-clinical bench testing for mechanical, physical, and biocompatibility properties.
If you are looking for an example of a 510(k) submission that does include AI/ML performance data, you would need to refer to a different type of device, such as an AI-powered diagnostic imaging tool.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.