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510(k) Data Aggregation
(53 days)
The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.
The RADIFOCUS® Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft. The soft tip is approximately 0.51.5 mm long on the 4Fr. Optitorque Catheter. It is approximately 1.02.5mm long on the 5 and 6Fr. Optitorque Catheters.
Device Acceptance Criteria and Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The device documentation does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the performance of the RADIFOCUS® Optitorque Angiographic Catheter is substantially equivalent to the predicate device (Angiographic Catheter, K863137/A) based on a series of verification tests. This "substantial equivalence" acts as the overarching acceptance criterion. The performance is reported in the context of demonstrating this equivalence.
| Performance Test Category | Predicate Device Specification (K863137/A) | RADIFOCUS® Optitorque Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Physical Dimensions | 5 – 8 Fr. (Available Sizes), 500 – 1300 mm (Catheter Length) | 4 – 6 Fr. (Available Sizes), 650 – 1200 mm (Catheter Length) | Demonstrated suitability for angiographic procedures; differences raise no new safety/effectiveness issues. |
| Maximum Injection Pressure | 5, 6 Fr.: 1000 psi; 7 Fr.: 800 psi; 8 Fr.: 700 psi | 4 Fr.: 750 psi; 5, 6 Fr.: 1000 psi | Meets or exceeds pressure capabilities for intended sizes; differences raise no new safety/effectiveness issues. |
| Material Composition | Polyurethane polyamide elastomer with barium sulfate | Polyurethane polyamide elastomer with barium sulfate (with stainless steel mesh) | Differences in materials raise no new issues of safety and effectiveness. |
| Mechanical Performance | Not explicitly listed, but inherent in predicate clearance | Tensile strength (shaft, hub, soft tip), Rigidity, Torque Transmission, Flow Rate, Tip Flexibility | Demonstrated substantial equivalence to predicate device. |
| Delivery of Therapeutic Agents | Not explicitly listed, but inherent in predicate clearance | Demonstrated successful delivery | Demonstrated substantial equivalence to predicate device. |
| Biocompatibility | Tested per relevant standards | Tested per ISO-10993 | Biocompatible for blood-contacting materials with limited contact (≤24 hrs). |
| Risk Analysis | Not explicitly listed, but inherent in predicate clearance | Conducted | No new issues of safety and effectiveness identified. |
| Safety & Effectiveness | Established in predicate clearance | Manufacturing controls verified, biocompatibility demonstrated, risk analysis performed | Substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to predicate device, with no new safety or effectiveness issues. |
2. Sample Size for Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of patient data or clinical trials. The performance verification refers to engineering tests and material characterization performed on the device itself. Therefore, sample sizes would relate to the number of catheters or components subjected to these physical and chemical tests. The document does not provide these specific sample sizes.
Data Provenance: The data provenance is internal to the manufacturer (Terumo Medical Corporation) as these are verification tests performed on the device by the company. There is no mention of country of origin for external data, retrospective or prospective studies involving patients.
3. Number of Experts and Qualifications for Establishing Ground Truth for Test Set
Not applicable for this type of device and study. The "ground truth" for the engineering and material tests would be the established scientific principles, consensus standards (e.g., ISO-10993 for biocompatibility), and the performance characteristics of the predicate device (K863137/A). This doesn't involve expert medical review of a patient-derived test set to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication. The verification tests are objective measurements against defined criteria or internal specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device submission (510(k)) for an angiographic catheter, not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.
6. Standalone (Algorithm Only) Performance Study
No. This submission is for a physical medical device (catheter), not an algorithm or software. Therefore, a standalone algorithm performance study was not conducted.
7. Type of Ground Truth Used
The ground truth used for demonstrating the device's performance is based on:
- Engineering specifications and test methodologies: For mechanical properties like tensile strength, rigidity, torque transmission, flow rate, and tip flexibility.
- Biocompatibility standards: Specifically, ISO-10993 for the biological evaluation of medical devices.
- Performance of the legally marketed predicate device (K863137/A): The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness profile of the predicate device.
8. Sample Size for the Training Set
Not applicable. There is no training set as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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