(20 days)
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).
The Emerge Over-The-Wire (balloon models 1.50-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-5.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Emerge Over-The-Wire (balloon models 2.00-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Emerge™ Monorail™ (MR) PTCA Dilatation Catheter is a sterile, single-use, intravascular medical devices used to widen coronary artery blockages and/or dilate coronary artery stents upon stent placement. The catheter consists of a shaft with a Pebax balloon near the distal tip and is available in a range of balloon sizes.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Emerge Monorail PTCA Dilatation Catheter." This type of submission is for physical medical devices that are substantially equivalent to previously cleared devices. It does not involve Artificial Intelligence (AI) or machine learning algorithms that would require an evaluation of algorithm performance against ground truth and expert consensus.
Therefore, the specific information requested in the prompt, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, "sample sizes used for the test set and data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," is not applicable to this document.
The document describes the submission of a physical device and leverages bench testing and comparisons to a predicate device to demonstrate substantial equivalence. The "Non-clinical Performance Data" section lists various engineering and material tests performed on the catheter (e.g., Effective Length, Crossing Profile, Balloon Fatigue, etc.) to ensure its physical performance and safety. These are not AI/ML-related performance metrics.
In summary, this document does not contain the information requested because it pertains to a traditional physical medical device, not an AI/ML-driven device.
§ 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.