(311 days)
Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.
The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a multilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. A second lumen allows access to the distal tip of the catheter for guidewire insertion. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.
The provided document is a 510(k) summary for the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report for an AI/ML powered device.
Therefore, I cannot provide the requested information as it pertains to AI/ML powered medical devices and is not present in the provided text. The document describes a traditional medical device (balloon catheter) and its non-clinical performance testing.
Here's why the specific points in your request cannot be answered from the provided text:
- Acceptance criteria and reported device performance (table): The document lists technical characteristics of the device and the predicate but does not present acceptance criteria in a quantitative, pass/fail manner for performance metrics. It generally states that testing was performed "similar to those in the guidance" and found acceptable.
- Sample size and data provenance: Not applicable in the context of AI/ML evaluation. The document mentions non-clinical (i.e., bench) testing, not a clinical study with a test set of data.
- Number of experts and qualifications: Not applicable. There's no mention of expert review for establishing ground truth as there's no diagnostic output being generated by an AI.
- Adjudication method: Not applicable for the same reason as above.
- MRMC comparative effectiveness study: Not applicable, as this is not an AI/ML device being evaluated for its impact on human reader performance.
- Standalone performance: Not applicable, as it's a physical catheter, not a standalone algorithm.
- Type of ground truth used: Not applicable, as there's no diagnostic task or ground truth to establish. Testing focused on physical properties (e.g., burst strength, compliance).
- Sample size for training set: Not applicable, as there's no AI/ML model to train.
- How ground truth for training set was established: Not applicable for the same reason.
The document primarily demonstrates substantial equivalence through:
- Comparison of intended use.
- Comparison of basic construction and technical characteristics.
- Non-clinical performance testing according to recognized guidance documents (e.g., "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices"). These tests, such as Balloon Minimum Burst Strength, Balloon Compliance, and Bond Strength, are standard for evaluating the physical and mechanical properties of catheters. The document states these tests were "performed similar to those in the guidance" and the catheter was "found acceptable," implying it met internal specifications or industry standards, but specific numerical acceptance criteria are not detailed.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).