(118 days)
The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.
This document concerns the 510(k) premarket notification for the NC TREK NEO™ Coronary Dilatation Catheter (K220634). The information provided does not contain details about acceptance criteria, device performance, and study design typically found in reports for AI/ML-driven medical devices. Instead, it describes a conventional medical device (a PTCA catheter) and establishes substantial equivalence to a predicate device through a comparison of design, materials, manufacturing, sterilization, and non-clinical performance data.
Therefore, many of the requested fields cannot be filled as they are explicitly related to studies and acceptance criteria for AI/ML devices, which are not applicable here.
Here's a breakdown of the available information and what cannot be provided:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted on the device. However, it does not provide a table with specific quantitative acceptance criteria or the reported device performance values for these tests. It only states that the tests supported a determination of substantial equivalence and raised no new safety or performance issues.
Performance Tests Completed (no specific acceptance criteria or reported values provided in this document):
- Tip dimensions
- Crossing Profile
- Guidewire Lumen
- Shaft Dimensions
- Proximal Shaft Marker Location
- Catheter Length
- Catheter Preparation
- Balloon Inflation/Deflation Time
- Balloon Rated Burst Pressure (RBP)
- Maximum Compliance Label
- Balloon Compliance
- Balloon RBP (In-Stent)
- Proximal Seal Tensile Strength
- Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile Strength)
- Proximal Adaption Tensile Strength
- Catheter Tip Tensile Strength
- Inner Member Lumen Collapse
- Balloon Fatigue Resistance
- Balloon Fatigue Resistance (In-Stent)
- Hydrophilic Coating- Dry Adhesion of Coating
- Hydrophilic Coating- Coefficient of Friction
- Kink/Flex
- Torque
- Particulates
- Finished Good Sheath Removal
- Balloon Preparation, Deployment and Retraction
Biocompatibility and Chemical Characterization Tests Completed:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic & Pyrogenicity
- Hemocompatibility
2. Sample size used for the test set and the data provenance:
Not applicable. This is a conventional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices manufactured for bench and biocompatibility testing. The exact number of devices or components used for each test is not specified in this summary, nor is data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert consensus are concepts for AI/ML device validation, which is not relevant for this conventional catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "truth" for this device's performance is determined by established engineering standards, material properties, and biological compatibility testing, not by expert consensus on clinical data or pathology in the context of an AI/ML algorithm.
8. The sample size for the training set:
Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set for an AI/ML algorithm.
§ 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.