(226 days)
AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.
The GL-1 catheter is a guiding catheter for use in the vascular system. Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced. Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.
The provided text describes the 510(k) summary for the AVEM GL-1 Guiding Catheter, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, ground truth, expert opinions, and comparative effectiveness studies are not present as this type of information is typically not included in a 510(k) summary for this class of device.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission, the "acceptance criteria" are implied to be the successful demonstration of substantial equivalence in various engineering and biocompatibility tests compared to legally marketed predicate devices. The "reported device performance" refers to the GL-1 Guiding Catheter meeting the performance standards of these predicate devices in those tests. Clinical performance criteria (like precision, accuracy, sensitivity, specificity) akin to those for diagnostic AI models are not applicable here.
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance | Reference to Predicate Device |
|---|---|---|---|
| Mechanical Performance | Tensile strength | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ |
| Stiffness | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Burst pressure | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Torque | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Natural frequency | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Material/Biocompatibility | Acute intracutaneous reactivity | Biocompatible | ISO 10993 standards |
| Acute systemic toxicity | Biocompatible | ISO 10993 standards | |
| Cytotoxicity | Biocompatible | ISO 10993 standards | |
| Hemolysis | Biocompatible | ISO 10993 standards | |
| Material-mediated pyrogen | Biocompatible | ISO 10993 standards | |
| Sensitization | Biocompatible | ISO 10993 standards | |
| Shelf-Life | Device integrity | Met all performance specifications within labeled shelf-life expiration date | N/A (demonstrated for GL-1) |
| Packaging integrity | Met all performance specifications within labeled shelf-life expiration date | N/A (demonstrated for GL-1) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The studies conducted are described as "tensile, stiffness, burst, torque, and natural frequency testing," and "biocompatibility tests." These are likely bench tests and laboratory assessments rather than clinical studies with human test subjects or patient data. The specific number of devices tested for each, and the origin or retrospective/prospective nature of the data, are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is not applicable to the studies described. The tests conducted are engineering and scientific assessments, where "ground truth" would be established by validated measurement techniques and adherence to ISO standards, performed by qualified laboratory personnel, not clinical experts for diagnostic image interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the studies are engineering and biocompatibility tests, clinical adjudication methods are not relevant.
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
Not applicable. The AVEM GL-1 Guiding Catheter is a physical medical device, not an AI or diagnostic software. Therefore, MRMC studies and AI assistance comparisons are not relevant to its regulatory submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests (tensile, stiffness, etc.), the "ground truth" would be established by recognized physical laws and engineering standards, and verified by calibrated instrumentation. For biocompatibility, the "ground truth" is established by adherence to ISO 10993 standards and validated laboratory test methodologies. This is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The description refers to a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
§ 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).