(31 days)
The SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER is intended for use where angiographic diagnosis is indicated.
The Surefire High Flow Angiographic Catheter (SAC) is used to facilitate advancement of the Surefire High Flow Microcatheter to the target vessel. The SAC is a single lumen, fixed length guide catheter with a Luer Lock Hub. It is compatible with standard 0.038" guide wires, Luer lock infusion syringes, and rotating hemostatic valves (RHVs). The angiographic catheter has an approximate length of 65 cm (usable length). A reinforced proximal section allows for ease of insertion and the barium sulfate filled extrusion provides clear fluoroscopic images of the shaft. A braided tungsten filled shaped tip provides visual feedback for the location of the guide catheter under fluoroscopy. The distal tip is rounded for atraumatic tracking. A shaped tip will assist to deliver the Surefire High Flow Angiographic Catheter to the desired target site. A peel-away Introducer is supplied with the SAC to insert the shaped tip into a catheter sheath introducer. The system is provided sterile (FO) for single patient use. The Angiographic Catheter is packaged in sealed sterile protective pouches and product boxes.
The Surefire® High Flow Angiographic Catheter is intended for angiographic diagnostic use. The study relied on performance and verification testing to establish substantial equivalence to a predicate device, the Angiodynamics Soft-Vu Angiographic Catheter (K112452).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Kink Radius Testing | No kinking that would impede device function or safe use. | Met acceptance criteria. |
| Trackability Testing | Device can be advanced through tortuous paths without damage. | Met acceptance criteria. |
| Pull Strength Testing | Device maintains integrity under specified tensile forces. | Met acceptance criteria. |
| High Pressure Injection Testing | Device withstands high-pressure fluid injection without failure. | Met acceptance criteria. |
| Infusion Agent Compatibility | Device is compatible with specified infusion agents. | Met acceptance criteria. |
| Package Integrity (Pouch Bubble) | Package remains sterile and undamaged. | Met acceptance criteria. |
| Device Corrosion Testing | No corrosion that would compromise device safety or function. | Met acceptance criteria. |
| Biocompatibility Testing | ||
| Cytotoxicity | No cytotoxic effects. | Met acceptance criteria (in accordance with ISO 10993-5). |
| Sensitization | No sensitization effects. | Met acceptance criteria (in accordance with ISO 10993-10). |
| Intra-cutaneous Irritation | No irritation. | Met acceptance criteria (in accordance with ISO 10993-10). |
| Toxicity | No systemic toxicity. | Met acceptance criteria (in accordance with ISO 10993-11). |
| Pyrogenicity | Apyrogenic. | Met acceptance criteria (in accordance with USP and ISO 10993-11). |
| Hemolysis | Minimal to no red blood cell damage. | Met acceptance criteria (in accordance with ASTM F756 and ISO 10993-4). |
| Coagulation | Minimal impact on coagulation cascade. | Met acceptance criteria (in accordance with ASTM F2382). |
| Particulate | Meets particulate limits. | Met acceptance criteria (in accordance with USP 788). |
| Complement System Testing | Minimal activation of complement system. | Met acceptance criteria (in accordance with ISO 10993-4). |
| Thrombogenicity | Minimal thrombus formation. | Met acceptance criteria. |
| Manufacturing Controls | ||
| Visual and Dimensional Inspections | Meets specified visual and dimensional requirements. | Met acceptance criteria. |
| Shape Retention Testing | Device maintains intended shape during use/storage. | Met acceptance criteria. |
| Tensile Testing | Device maintains integrity under tensile forces. | Met acceptance criteria. |
| Torque Testing | Device transmits torque effectively without failure. | Met acceptance criteria. |
| Shelf Life Testing | Device maintains safety and performance over its shelf life. | Met acceptance criteria. |
Note: The document states that a "battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria." Specific numerical acceptance criteria were not provided in the summary.
2. Sample size used for the test set and the data provenance
The information provided specifies bench tests were conducted. Details on the specific sample sizes for each individual test (e.g., number of catheters tested for kink radius, pull strength, etc.) are not explicitly stated in the provided summary. The data provenance is from bench testing, which is performed in a controlled laboratory environment and is not tied to specific countries of origin or retrospective/prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study involved bench testing of a medical device's physical and biological properties, not a clinical study involving experts evaluating patient data or images to establish ground truth.
4. Adjudication method for the test set
This information is not applicable for bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human reviewers assess data.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the physical and biocompatibility performance of a medical device, not on the effectiveness of human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not performed. This device is a physical catheter, not an AI algorithm.
7. The type of ground truth used
For the performance and verification testing, the "ground truth" was established by recognized industry standards (ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, ASTM F2382, USP , USP 788) and internal protocols based on these standards. These standards define the acceptable physical properties, biocompatibility, and safety parameters for such devices.
8. The sample size for the training set
This information is not applicable as this study does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned or implied in this type of device submission.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.