(71 days)
The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter.
The VERIPATH™ Peripheral Guiding Catheter is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices, etc. The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system. The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size. The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available. Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter. The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip.
The provided text is a 510(k) Summary for the VERIPATH™ Peripheral Guiding Catheter. It indicates that the device's safety and effectiveness were demonstrated through nonclinical bench tests and analyses. However, it does not contain the detailed information necessary to fully answer all aspects of your request.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The safety and effectiveness of the VERIPATH™ Peripheral Guiding Catheter have been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not provide specific acceptance criteria or the reported performance data from these bench tests. This level of detail is typically included in an exhaustive test report, which is not part of this 510(k) summary.
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 mentions "nonclinical bench tests and analyses." This implies that the testing was performed in a lab setting, not on human subjects. Therefore, there is no "test set" in the sense of patient data, nor is there information about data provenance (country, retrospective/prospective).
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)
Since the testing was nonclinical bench tests, there wouldn't be "experts" establishing ground truth in the context of clinical interpretation or diagnosis. The ground truth for bench tests would be defined by engineering specifications and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this refers to clinical evaluation and consensus building among human readers, which is not mentioned for this device.
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. This device is a physical medical instrument (a guiding catheter), not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For nonclinical bench tests, the "ground truth" would be the engineering specifications and performance targets for characteristics like material strength, dimensional accuracy, flow rates, flexibility, and torqueability. The document does not specify these metrics or their targets.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
In summary, based on the provided 510(k) summary, the VERIPATH™ Peripheral Guiding Catheter demonstrated safety and effectiveness through nonclinical bench tests and analyses. However, the document does not include the detailed performance data, specific acceptance criteria, or information on clinical studies that would be necessary to answer most of your questions. The nature of the device (a physical catheter) means that many of your questions related to AI, clinical imaging, and expert review are not applicable.
§ 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).