(78 days)
The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
The FLASH Mini Ostial System is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
The provided text describes a 510(k) premarket notification for the FLASH Mini Ostial System, a PTCA Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through performance data and biocompatibility testing. It does not include details about a study evaluating a device's performance against acceptance criteria using a test set, expert ground truth, or human readers, as would be common for AI/ML-based medical devices.
Therefore, many of the requested categories are not applicable to the information provided in this document.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results demonstrate that the FLASH Mini Ostial System meets the established product specifications." and "All test results demonstrated that the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use."
However, the specific quantitative acceptance criteria (e.g., "Balloon Crossing Profile must be
§ 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.