(80 days)
The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. The Sapphire® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.
The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a guiding sheath or guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sapphire II PRO Balloon Dilatation Catheter, focusing on the peripheral use indication:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the device "met all acceptance criteria" and "were similar to the reference devices" for the performed tests.
The performance tests conducted include:
| Test | Reported Device Performance |
|---|---|
| Sterilization | Complete (leveraged from reference device K173680, K163114) |
| Shelf-Life | Complete (leveraged from reference device K173680, K163114) |
| Dimensional Verification | Met acceptance criteria (partially leveraged) |
| Balloon Rated Burst Pressure | Met acceptance criteria (partially leveraged) |
| Shaft Burst | Met acceptance criteria (partially leveraged) |
| Balloon Fatigue | Met acceptance criteria (partially leveraged) |
| Balloon Compliance | Met acceptance criteria (partially leveraged) |
| Balloon Inflation and Deflation Time | Met acceptance criteria (partially leveraged) |
| Catheter Bond Strength | Met acceptance criteria (partially leveraged) |
| Tip Pull Strength | Met acceptance criteria (partially leveraged) |
| Flexibility and Kinking | Met acceptance criteria (partially leveraged) |
| Torque Strength | Met acceptance criteria (partially leveraged) |
| Radiopacity | Met acceptance criteria (partially leveraged) |
| Coating Integrity | Met acceptance criteria (partially leveraged) |
| Visual Inspection (for peripheral use) | Met acceptance criteria (additional testing performed) |
| Balloon Preparation, Deployment, and Retraction (for peripheral use) | Met acceptance criteria (additional testing performed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for any of the tests. It refers to testing being "leveraged from the reference device (K173680, K163114)" for many criteria, and "additional testing was performed" for others.
There is no information on the country of origin of the data, and the studies are retrospective in the sense that existing data from previous clearances (K173680, K163114) were used, supplemented by new (implicitly prospective) tests for the peripheral use indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a medical device clearance for a balloon catheter, not an AI/software device. Therefore, the concept of "experts" establishing ground truth in the context of clinical imagery or diagnostic data is not applicable here. The ground truth for device performance is established through engineering and performance testing against predetermined specifications.
4. Adjudication Method for the Test Set
Not applicable for this type of medical device performance testing. Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases, often in AI development contexts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI system being evaluated for diagnostic or interpretive tasks by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and established performance standards for balloon dilatation catheters. These standards are likely derived from industry best practices, regulatory guidance, and clinical requirements for the safe and effective operation of such devices. For example, balloon burst pressure needs to meet a certain PSI, and shaft flexibility needs to fall within a defined range.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.