(29 days)
The Maverick XL balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents.
The Maverick XL Percutaneous Transluminal Coronary Angioplasty PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a balloon near the distal tip. The distal catheter segment is dual lumen and coaxial, characteristic of all monorail style catheters. The balloon is located at the distal end of the catheter and is designed to provide an inflatable segment of known diameter and length at recommended pressures.
This document is a 510(k) premarket notification for a medical device called the "Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter." It is a regulatory filing with the FDA, not a clinical study report. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about patient data, expert ground truth, or multi-reader multi-case studies.
The document is primarily focused on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. This is typically achieved through bench testing and, if applicable, comparison to existing clinical data for the predicate device, rather than new clinical trials specifically designed to set and meet acceptance criteria for a novel AI algorithm.
However, I can extract the information that is present in the document related to testing for regulatory purposes:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it states that "Bench testing and first article testing were performed to support a determination of substantial equivalence." The acceptance criteria would be for the physical and functional aspects of the catheter to meet pre-defined engineering and design specifications for safety and performance, which are not explicitly detailed here.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to requirements | Bench testing and first article testing confirmed conformance to requirements for intended use. No new safety or performance issues were raised. |
| Substantial Equivalence | Proposed device is substantially equivalent to the predicate device (P860019) in terms of intended use, scientific technology, design (with one minor modification), materials, sterilization, and packaging. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This document refers to bench testing and first article testing, not a clinical test set with patient data. The "sample" would be the number of catheters tested in various bench tests (e.g., burst pressure, fatigue, trackability), but these numbers are not specified.
- Data Provenance: Not applicable, as no patient data is mentioned. The testing is described as "bench testing and first article testing," implying laboratory-based testing of the physical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. There is no mention of expert-established ground truth because this is not a study involving diagnostic accuracy with human interpretation.
4. Adjudication Method:
- Not applicable. There is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done. This submission is for a physical medical device (catheter), not an AI algorithm for image interpretation or diagnosis.
6. Standalone (Algorithm Only) Performance Study:
- No. This is not an AI algorithm.
7. Type of Ground Truth Used:
- Not applicable. The "ground truth" for a physical device like a catheter would be its adherence to engineering specifications and performance standards through physical and functional testing, not a diagnostic pathology or outcome.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a training set as it's not an AI model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this 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.