(147 days)
The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed .014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.
The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy.
The VISIONS PV .014P catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.
A hydrophilic coating is applied externally to a distal portion of the catheter.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Intravascular Ultrasound (IVUS) Catheter. The primary objective of this submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets new acceptance criteria for a novel technology through a clinical study with AI components.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device or a device with new performance claims are not applicable to this specific 510(k) submission.
This submission focuses on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original, new device (predicate device). The "proof" relies on bench and laboratory testing, not on a clinical effectiveness study with human readers or AI.
Here's a breakdown of the requested information and why most of it is not explicitly addressed in this 510(k) summary:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not presented in a tabular format with specific numerical thresholds for clinical performance. The acceptance criteria for this reprocessed device revolve around demonstrating that its functional and safety characteristics are equivalent to the predicate device after reprocessing. This is shown through various tests of physical and functional integrity.
- Reported Device Performance: The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter." A list of tests is provided (e.g., Cleaning Validation, Sterilization Validation, Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility, Drying Validation, Packaging Validation, Biocompatibility). However, the specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria are not detailed in this summary. The conclusion is that the reprocessed device is "as safe and effective" as the predicate based on these tests.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test. The testing involves reprocessed units of the IVUS catheter.
- Data Provenance: Not applicable in the context of clinical data for performance evaluation. The data comes from internal lab testing conducted by Northeast Scientific, Inc. It is not clinical patient data, therefore, retrospective/prospective or country of origin of data is not relevant here.
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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):
- Not Applicable: This is not a study requiring expert readers to establish ground truth for clinical cases (e.g., image interpretation). The "ground truth" for this submission is established through validated engineering and biological testing methodologies (e.g., confirming sterility, dimensional accuracy, mechanical integrity).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: As above, this applies to studies with human readers interpreting data, which is not the nature of the testing described in this 510(k) summary.
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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: This is not a study assessing the effectiveness of an AI component or the improvement of human readers. This device is an IVUS catheter, an imaging tool; there is no mention of an associated AI component to assist readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: There is no algorithm or AI component discussed for standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this submission is derived from benchmarks and specifications of the original new device and validated test methods (e.g., sterility testing, dimensional measurements, mechanical force testing). The reprocessed device is tested to ensure it meets these established engineering and biological standards, demonstrating equivalence to the predicate.
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The sample size for the training set:
- Not Applicable: This is not a machine learning/AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable: No training set exists for this device.
In summary, for this particular 510(k) submission for a reprocessed IVUS catheter, the "acceptance criteria" and "proof" primarily revolve around demonstrating that the reprocessed device performs equivalently to the original, new device through a battery of non-clinical, benchtop, and laboratory tests. The summary provided does not contain the detailed numerical results or specific sample sizes for these tests, but merely lists the categories of testing performed to support the claim of substantial equivalence. The questions regarding AI, human readers, and clinical ground truth are not relevant to this type of device submission.
§ 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).