(91 days)
The MINI TREK™ RX 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The MINI TREK™ OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The MINI TREK RX 1.20 mm 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. All 1.20 mm balloon diameters have a single balloon marker. 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 1.20 mm 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. All 1.20 mm balloon diameters have a single balloon marker. 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 MINI TREK™ RX 1.20 mm Coronary Dilatation Catheter and MINI TREK™ OTW 1.20 mm Coronary Dilatation Catheter. The provided text includes details about the device's design, indications for use, and summaries of performance data, including a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Endpoint) | Reported Device Performance (MINI TREK RX 1.20 mm) |
|---|---|
| Primary Endpoint: | |
| Procedure Success | 98.5% (66/67 subjects) |
| - Successful delivery of balloon | 100.0% (71/71 subjects) |
| - Successful inflation/deflation | 100% (71/71 subjects) |
| - No procedural complications | 0.0% (0/67 subjects) |
| - Final TIMI 3 flow grade | 98.6% (70/71 subjects) |
| Secondary Endpoints: | |
| Device Success | 96.2% (75/78 lesions) |
| Lesion Success | 97.6% (81/83 lesions) |
| Clinical Endpoints (ITT Population): | |
| In-Hospital MACE | 8.5% (6/71 subjects) |
| In-Hospital TLF | 8.5% (6/71 subjects) |
| All Death | 0% (0/71 subjects) |
| All MI | 8.5% (6/71 subjects) |
| Stent Thrombosis (Definite/Probable) | 0% (0/64 subjects) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Clinical Study (Test Set):
- Subjects: 71 subjects were enrolled. Angiographic documentation for endpoint analysis was available for 67 subjects.
- Lesions: 83 target lesions were assessed, with angiographic documentation available for 78 target lesions.
- An additional analysis was performed on a subgroup of 52 subjects who had at least a CK-MB draw at or later than 16 hours post-index procedure.
- Data Provenance: The CROSS clinical trial was a prospective, open-label, single-arm, multi-center, observational study conducted at 4 clinical sites in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish ground truth for the clinical study. It mentions "core lab analysis" for Minimal Lumen Diameter (MLD) and "angiographic core lab assessment" for lesion characteristics. This implies specialized personnel analyzed angiographic data, but their specific roles and expertise level are not detailed.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method like "2+1" or "3+1" for the clinical endpoints or angiographic assessments. It refers to "core lab analysis" which typically implies standardized, expert review, but the multi-reviewer aspect and adjudication process are not detailed.
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:
This document describes a clinical study evaluating the performance of a coronary dilatation catheter. It is not an MRMC comparative effectiveness study involving AI or human reader improvement with AI assistance. The study focuses on the device's technical and clinical success rates in pre-dilatation procedures.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This document is about a physical medical device (coronary dilatation catheter), not an algorithm or AI system. Therefore, a standalone (algorithm-only) performance evaluation is not applicable.
7. The Type of Ground Truth Used:
The ground truth for the clinical study was established through a combination of:
- Clinical Outcomes: Procedure success criteria (e.g., successful balloon delivery, inflation/deflation, absence of complications, final TIMI flow grade), device success criteria (improvement in MLD, absence of complications), and lesion success criteria (final residual percent diameter stenosis, absence of complications, final TIMI flow grade).
- Angiographic Core Lab Assessment: Used for MLD analysis and characterizing lesion location.
- Biochemical Markers: Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) draws for assessing myocardial infarction.
- Clinical Events: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), and stent thrombosis, defined according to standards like the Academic Research Consortium (ARC) definition.
8. The Sample Size for the Training Set:
The document describes a clinical trial (CROSS clinical trial) for post-market surveillance or pre-market approval, primarily serving as a test set for safety and efficacy. It does not mention a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as the document does not describe the development or training of an AI algorithm; it focuses on the performance of a physical 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.