(94 days)
The TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW 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 ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
The TREK RX and MINI TREK RX Coronary Dilatation Catheters are a rapid exchange 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 coaxial shaft consists of a tubular inner and outer member. The inner member 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. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
The TREK OTW and MINI TREK OTW Coronary Dilatation Catheters 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 coaxial 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.
The provided document describes a medical device, the TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters, and its substantial equivalence to predicate devices. However, the document does not contain information about an AI/algorithm-driven device or a study involving human readers and AI assistance. Therefore, it is not possible to fill out many of the requested fields related to AI performance, ground truth, and expert evaluation.
Based on the information provided regarding the Coronary Dilatation Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter Preparation | Met requirements | Met acceptance criteria |
| Catheter Profile (crossing and refolded) | Met requirements | Met acceptance criteria |
| Balloon Inflation and Deflation | Met requirements | Met acceptance criteria |
| Balloon Fatigue and Balloon Fatigue Within a Stent | Met requirements | Met acceptance criteria |
| Balloon Rupture and Balloon Rupture Within a Stent | Met requirements | Met acceptance criteria |
| Balloon Compliance | Met requirements | Met acceptance criteria |
| Catheter Bond Tensile Strength | Met requirements | Met acceptance criteria |
| Catheter Coating Particulate | Met requirements | Met acceptance criteria |
| Kink and Flexibility | Met requirements | Met acceptance criteria |
| Torque | Met requirements | Met acceptance criteria |
| Radiopacity | Met requirements | Met acceptance criteria |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation) | Met requirements | Met acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "The TREK RX, MINI TREK RX, TREK OTW and MINI TREK OTW Coronary Dilatation Catheters were subjected to the following in vitro bench tests..." suggesting that a representative number of units for each catheter type underwent testing.
- Data Provenance: In vitro bench tests. The country of origin for the data is not specified, but the submission is to the FDA in the USA. The tests are "retrospective" in the sense that they are performed on manufactured devices as part of a product release or qualification process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical medical device, not an AI/algorithm-driven one that requires expert-established ground truth from medical images or data. The "ground truth" for these tests is based on engineering specifications and regulatory guidance.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies (often for AI devices). For physical device testing, performance is objectively measured against predetermined specifications.
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 is not an AI/algorithm-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used:
- For the physical tests, the "ground truth" is defined by the acceptance criteria derived from engineering specifications, industry standards, and regulatory guidance documents (e.g., Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010).
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-driven device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm-driven device.
Summary of the Study:
The study was not for an AI/algorithm. Instead, it was a series of in vitro bench tests and biocompatibility tests conducted on the TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters. The purpose of these tests was to demonstrate that the devices met all predetermined acceptance criteria and performed similarly to predicate devices. The acceptance criteria were established based on the requirements outlined in the "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and other relevant engineering and safety standards. The study concluded that the new devices "met all acceptance criteria and performed similarly to the predicate devices," with "no new safety or effectiveness issues...raised." This allowed the FDA to determine that the devices were "substantially equivalent" to legally marketed predicate devices.
§ 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.