(100 days)
The MINI TREK RX, MINI TRETK OTW and MINI TREK II OTW Indications for Use: Coronary Dilatation Catheters (balloon models 1.50 mm - 2.00 mm) are indicated for: · Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion · Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction · Balloon dilatation of a stent after implantation (balloon models 2.00 mm only) · Balloon dilatation of de novo chronic total coronary occlusions (CTO) The MINI TREK RX, MINI TREK OTW and MINI TREK II OTW Coronary Dilatation Catheters (balloon models 1.20 mm) are indicated for: · Initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) Balloon dilatation of de novo chronic total coronary occlusions . (CTO)
The MINI TREK RX Coronary Dilatation Catheter is 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 co-axial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate the 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 MINI TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) 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.
The MINI TREK II OTW Coronary Dilatation Catheter is an over-the-wire (OTW) 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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints related to pre-dilatation) | Reported Device Performance (Total Analysis Population, N=88) | 95% Confidence Interval |
|---|---|---|
| Successful pre-dilatation of the CTO | 93.2% (82/88) | [85.7%, 97.5%] |
| Successful delivery of at least one MINI TREK balloon to and across the target lesion | 96.6% (85/88) | [90.4%, 99.3%] |
| Successful inflation and deflation with at least one MINI TREK balloon | 100.0% (85/85) | [95.8%, 100.0%] |
| Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in TIMI from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK balloon | 97.7% (86/88) | [92.0%, 99.7%] |
| Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure (i.e. after stent implantation) | 98.9% (87/88) | [93.8%, 100.0%] |
Note: The document explicitly states that "These success rates compare favorably with historical averages for this complex lesion class, and are in accordance with the recent trend towards significantly higher success rates among experienced operators utilizing advanced device technology and procedural techniques. These favorable outcome data demonstrate the MINI TREK to be both effective and safe in pre-dilatation of chronic total occlusions." This implies that the reported performance met the implicit acceptance criteria of demonstrating safety and effectiveness comparable to or better than historical averages for CTO treatment.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Total Analysis Population: 88 subjects (for the primary angioplasty pre-dilatation related endpoint).
- Evaluable Population (with core lab angiography data post-MINI TREK pre-dilatation): 65 subjects.
- Data Provenance: The study was a clinical trial (EXPERT CTO trial), suggesting prospective data collection. The document does not explicitly state the country of origin, but the submission to the FDA and use of English implies it was a multi-center trial that likely included locations relevant to FDA submission, potentially including the US or other regions following similar clinical trial guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document refers to an "independent angiographic core laboratory" for assessment of certain criteria (e.g., vessel perforation, flow-limiting vessel dissection, TIMI flow).
- It does not specify the number of experts within this core laboratory or their specific qualifications (e.g., years of experience as a radiologist/cardiologist).
4. Adjudication Method for the Test Set
- The document mentions "independent angiographic core laboratory assessment" for some criteria and "site-reported data" for others, particularly when core lab data was not available immediately following MINI TREK pre-dilatation.
- For the primary endpoint, the "site-reported data for the third component of the endpoint where angiographic core laboratory data was not available" was combined with core lab data. This suggests a hierarchical approach favoring core lab data where available, supplemented by site-reported data. There is no explicit mention of an adjudication process like "2+1" or "3+1" among multiple readers for all data points, although presumably the core lab has its own internal quality control and consensus methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done.
- The study focuses on the performance of the MINI TREK Coronary Dilatation Catheter in pre-dilatation of chronic total occlusions as a standalone device, and in conjunction with stent implantation in the context of the larger EXPERT CTO trial.
- It does not compare human readers with and without AI assistance. Instead, it measures device performance against predefined clinical endpoints.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical medical device (coronary dilatation catheter), not an algorithm or AI system. The "performance" refers to the device's physical and functional capabilities in a clinical setting.
7. The Type of Ground Truth Used
- The ground truth was established through a combination of:
- Clinical Observation/Site-Reported Data: For successful delivery, inflation/deflation, and absence of arrhythmias.
- Independent Angiographic Core Laboratory Assessment: For vessel perforation, flow-limiting vessel dissection, reduction in TIMI flow from baseline, and final TIMI flow 3.
- Outcomes Data: Defined by absence of MACE events (MI, TLR, death) for procedure success.
8. The Sample Size for the Training Set
- This question is not applicable. This document describes a clinical trial evaluating a physical medical device (coronary dilatation catheter), not an artificial intelligence algorithm. Therefore, there is no "training set" in the context of machine learning. The device itself was developed and refined through engineering and bench testing.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as 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.