(189 days)
Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.
Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.
The Alvision™ Interventional Cardiology Diagnostic Catheter ("Alvision™") and the Alvicath™ Endovascular Diagnostic Catheter ("Alvicath™") are sterile, nonpyrogenic, single lumen catheters with a soft distal tip and a proximal strain relief and luer hub. The tri-layer catheter body construction is constructed of a first extrusion layer, a stainless steel wire braid middle layer, and a radiopaque outer layer of Nylon 12. The catheters are for single-use only.
The Alvision™ and Alvicath™ Diagnostic Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 4, 5, 6 and 7. Alvision Diagnostic Catheters are provided in useable lengths of 80, 100 and 110cm. Alvicath Endovascular Diagnostic Catheters are provided in useable lengths of 45, 60, 65, 80 and 100cm.
This document describes a 510(k) premarket notification for the Alvision Interventional Cardiology Diagnostic Catheter and Alvicath Endovascular Diagnostic Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against predefined clinical criteria in a standalone study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meets established specifications | Passed |
| Dimensional Verification | Meets established specifications | Passed |
| Catheter Sheath Introducer Withdrawal Force | Meets established specifications | Passed |
| Hub Leakage | No leakage beyond acceptable limits | Passed |
| Kink Diameter and Force | Meets established specifications for resistance to kinking | Passed |
| Tensile Strength | Meets established specifications for material strength | Passed |
| Radio-detectability | Sufficiently radiopaque for visualization | Passed |
| Torque Testing | Meets established specifications for torque response | Passed |
| Flow Rate | Meets established specifications for fluid delivery | Passed |
| Power Injection | Withstands power injection forces without failure | Passed |
| Burst Test | Withstands specified pressure without bursting | Passed |
| Leakage | No leakage beyond acceptable limits | Passed |
| Trackability | Meets established specifications for navigating vascular system | Passed |
| Packaging Integrity (Visual inspection, seal strength test) | Maintained integrity | Passed |
| Sterilization (EO sterilization evaluation, EO residuals, endotoxin) | Sterilized and within acceptable EO/endotoxin limits | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Hemolysis, Complement Activation, Thrombogenicity, Pyrogenicity) | Biocompatible per ISO 10993-1 and relevant standards | Passed |
| Device-contacting packaging materials (Cytotoxicity, Physicochemical Testing) | Biocompatible per relevant standards | Passed |
Note: The document states "The collective results of the nonclinical testing demonstrate that the materials chosen and design of the Alvision and Alvicath Diagnostic Catheters meet the established specifications necessary for consistent performance during its intended use." The specific numerical acceptance criteria are not detailed in this summary, but the successful completion of these tests indicates the device met the pre-defined internal specifications.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was performed in support of this premarket notification." Therefore, there is no clinical "test set" in the traditional sense for evaluating device performance against a clinical ground truth. The "test set" here refers to the samples used for the non-clinical, benchtop, and biocompatibility tests. The sample sizes for these individual tests are not specified in the document.
- Data Provenance: The testing was non-clinical (benchtop and lab-based biocompatibility). No geographical or retrospective/prospective data provenance applies to these types of tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical testing was performed, there was no clinical ground truth established by experts for a test set. The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No clinical testing was performed."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This device is a diagnostic catheter, a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was based on:
- Pre-defined engineering specifications for mechanical properties (e.g., tensile strength, flow rate, kink resistance).
- International standards for biocompatibility (e.g., ISO 10993-1) and sterilization.
- Industry standards for packaging integrity.
8. The Sample Size for the Training Set
Not applicable. As no clinical testing or machine learning model training was involved, there is no "training set." The device's design and materials were developed and refined through engineering processes, not by training against a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. There was no training set.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).