Search Results

The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire® Hi-Flow Microcatheter is an 0.027" lumen microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate deployment and retraction of the Surefire Expandable Tip. The infusion catheter serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs), and embolic particles 700µm or less in size. The proximal end of the device features a female luer lock hub. The microcatheter has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The outer sheath is hydrophilically coated. The usable length of the device is 120cm. The distal soft, pliable, funnel-shaped Surefire Expandable Tip is available in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.

The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures, delivering radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document details the performance testing and verification conducted to demonstrate the device's substantial equivalence to a predicate device, the Surefire Infusion Catheter System (K110459).

1. Acceptance Criteria and Reported Device Performance

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 that were determined to be applicable to the safety and efficacy of the device." While specific numerical acceptance criteria values are not explicitly given in the provided text, the list of tests performed and the overall conclusion of substantial equivalence serve as the reported performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each individual performance and biocompatibility test. It mentions that "test data provided in bench tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the predicate device."

The tests are described as "bench tests," indicating they were conducted in a laboratory setting rather than involving human or animal subjects. The data provenance is industrial/laboratory testing conducted by the manufacturer, Surefire Medical, Inc. The country of origin for the data is not explicitly stated, but the manufacturer has addresses in Westminster, CO, and Miami, FL, implying the testing was done in the USA. The nature of these tests (bench tests) means they are prospective for the purpose of regulatory clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable (N/A) for this device and study. The Surefire® Hi-Flow Microcatheter is a medical device, not an AI/software device that requires expert human interpretation to establish ground truth for image analysis or similar diagnostic tasks. The "ground truth" for this device is established by meeting engineering specifications, biocompatibility standards, and demonstrating functional performance through objective physical tests, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations. The tests described for the microcatheter are objective physical and chemical tests, not involving human interpretation that would require adjudication.

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

This section is N/A. The Surefire® Hi-Flow Microcatheter is a physical medical device, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is N/A. The device is a physical microcatheter, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, tested objectively through bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Surefire® Hi-Flow Microcatheter is established by objective engineering performance specifications, recognized industry standards (e.g., ISO, ASTM, USP), and regulatory requirements. For example:

• Mechanical Integrity: Ground truth is defined by the physical limits the device must withstand (e.g., pull strength, high pressure injection) without failure, as per engineering design and relevant standards.
• Biocompatibility: Ground truth is defined by the absence of toxic, irritating, sensitizing, or thrombogenic reactions when tested against established biological safety standards (e.g., ISO 10993 series, ASTM, USP).
• Functional Performance: Ground truth for infusion efficiency and antegrade flow is defined by the device's ability to perform its intended function within specified parameters, typically benchmarked against predicate device performance or clinical needs.

8. The sample size for the training set

This section is N/A. The device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI or algorithm development.

9. How the ground truth for the training set was established

This section is N/A, as there is no training set for this physical device.

Ask a specific question about this device