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510(k) Data Aggregation
(124 days)
Metacross RX PTA Balloon Dilitation Catheter
The Metacross RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Metacross RX PTA Balloon Dilatation Catheter (Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Metacross RX in PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 6 or 7 Fr have been deemed to be compatible with Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 12.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1350 and 2000 mm.
The Metacross RX is provided with the following accessory device:
. Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.
This document is a 510(k) premarket notification for the Metacross RX PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing, rather than reporting on a clinical study with an AI component. Therefore, much of the requested information about acceptance criteria, study design, and AI performance is not applicable or cannot be extracted from this document.
However, I can extract information regarding the device's performance testing based on acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Metacross RX PTA Balloon Dilatation Catheter underwent various in vitro tests to demonstrate substantial equivalence to predicate devices, following the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' dated September 8, 2010.
While the specific numerical acceptance criteria for each test are not explicitly detailed in this document (e.g., a specific pressure value for burst pressure), the overall conclusion for each test implicitly indicates that the device met its predetermined acceptance criteria.
| Test Category | Acceptance Criteria (Conceptual) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Device dimensions (e.g., balloon diameter, length) meet specifications. | Device met "predetermined acceptance criteria." |
| Balloon Preparation | Balloon is designed for easy preparation for use. | Device met "predetermined acceptance criteria." |
| Deployment and Retraction | Catheter and balloon can be deployed and retracted effectively. | Device met "predetermined acceptance criteria." |
| Balloon Rated Burst Pressure | Balloon withstands specified pressure without bursting. | Device met "predetermined acceptance criteria." |
| Balloon Fatigue | Balloon maintains integrity after repeated inflations. | Device met "predetermined acceptance criteria." |
| Balloon Compliance | Balloon expands to expected dimensions under pressure. | Device met "predetermined acceptance criteria." |
| Balloon Inflation/Deflation Time | Inflation and deflation occur within acceptable timeframes. | Device met "predetermined acceptance criteria." |
| Catheter Bond Strength | Components of the catheter maintain secure bonds. | Device met "predetermined acceptance criteria." |
| Flexibility and Kink Test | Catheter demonstrates adequate flexibility without kinking. | Device met "predetermined acceptance criteria." |
| Torque Strength | Catheter can be torqued without damage or loss of function. | Device met "predetermined acceptance criteria." |
| Radiopacity | Catheter is visible under fluoroscopy. | Device met "predetermined acceptance criteria." |
| Particulate Evaluation | Device does not release excessive particulates. | Device met "predetermined acceptance criteria." |
| Transportation | Device maintains integrity after simulated transportation stress. | Device met "predetermined acceptance criteria." |
| Shelf Life Testing | Device maintains performance and integrity over its specified shelf life. | Device met "predetermined acceptance criteria." |
| Biocompatibility | Materials are safe for biological contact (Cytotoxicity, Sensitization, | |
| Intracutaneous reactivity, Systemic toxicity, Pyrogenicity, | ||
| Hemocompatibility, Genotoxicity). | "Metacross RX is biocompatible for its intended use." |
Overall Conclusion provided: "The Metacross RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
The remaining information requested in your prompt (Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, how ground truth for training set was established) are related to studies involving algorithms or human-in-the-loop performance, particularly in the context of AI/ML devices. This document describes the regulatory submission for a physical medical device (balloon catheter) and does not involve AI/ML. Therefore, these points are not applicable and cannot be extracted from the provided text.
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