(60 days)
Balloon diameters 1.50 mm - 5.00 mm
The MINI TREKTM OTW and TREKTM OTW Coronary Dilatatoin 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 ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
Balloon diameter 1.20 mm
The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery bypass stent graft (≥ 70% stenosis).
The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter are an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
This document describes the acceptance criteria and study proving the device meets the criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (Met/Not Met) |
|---|---|
| Catheter Preparation | Met |
| Balloon Inflation / Balloon Deflation | Met |
| Catheter Shaft Fatigue | Met |
| Catheter Shaft Rupture | Met |
| Distal Catheter Tensile Strength | Met |
| Proximal Adaption Tensile Strength | Met |
| Inner Member Collapse | Met |
| Kink and Flexibility | Met |
| Torque | Met |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation) | Met |
Explanation: The document states that "These in vitro bench and biocompatibility tests demonstrated that the TREK OTW and MINI TREK OTW Coronary Dilatation Catheters met all acceptance criteria and performed similarly to the predicate devices."
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each in vitro bench test or biocompatibility test. It indicates that the tests were conducted "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." This suggests the sample sizes would have been determined by the established guidelines for these types of tests.
The data provenance is in vitro bench tests and biocompatibility tests, not human subject data. Therefore, concepts like "country of origin of the data" and "retrospective or prospective" do not directly apply in the same way they would to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device underwent in vitro bench testing and biocompatibility testing, not studies involving expert evaluation of medical images or patient data to establish ground truth. The "ground truth" for these tests comes from the established physical and chemical standards and guidelines for medical device performance.
4. Adjudication method for the test set
Not applicable. Since the tests were in vitro bench and biocompatibility tests, there was no need for adjudication by experts as would be required in clinical studies involving interpretation of results. The results of these tests are typically objective measurements.
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 document describes the 510(k) submission for a physical medical device (coronary dilatation catheter) and its performance through in vitro and biocompatibility testing. It does not involve AI or human reader interpretation for comparative effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The type of ground truth used
The "ground truth" for this study was based on:
- Established industry standards and regulatory guidance: Specifically, "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010."
- Scientific principles and objective measurements: The performance of the catheter was measured against predefined physical and chemical specifications for attributes like tensile strength, fatigue, inflation/deflation characteristics, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "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 medical 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.