(246 days)
The Sapphire NC Coronary Dilatation Catheter 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
• in-stent restenosis
• post-delivery expansion of balloon expandable coronary stents
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use.
The Sapphire NC coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0-4.0mm and lengths from 8-18mm, 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. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA 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 brachial or femoral 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 the study that proves the device meets them:
Device: Sapphire NC Coronary Dilatation Catheter (a PTCA Catheter)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Performance Tests Conducted | Reported Device Performance |
|---|---|---|
| In Vitro Performance Tests | Dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, within stent balloon burst pressure, within stent stent balloon fatigue. | "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire NC PTCA catheter design and construction are suitable for its intended use..." |
| Biocompatibility Tests | Cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity. | "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire NC PTCA catheter design and construction are suitable for its intended use..." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes in vitro performance tests and biocompatibility tests. It does not mention a "test set" in the context of patient data or clinical images. The testing was performed on the device itself.
- Sample Size: Not explicitly stated as a number of devices/units, but implied to be sufficient for rigorous testing.
- Data Provenance: The tests are in vitro and biocompatibility, meaning they were conducted in a laboratory setting, not on patient data. Therefore, there is no country of origin or retrospective/prospective designation relevant to the data provenance in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The device is a physical medical device (catheter) and the testing described is primarily mechanical/physical performance and biocompatibility. "Ground truth" in the context of expert consensus on diagnostic imaging or clinical outcomes is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes pre-market testing for a medical device (catheter) based on in vitro performance and biocompatibility, not a diagnostic imaging AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by the predefined specifications and acceptance criteria for each in vitro and biocompatibility test. These criteria are likely based on industry standards, regulatory guidance (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters), and performance of predicate devices.
8. Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.