(29 days)
The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.
The proposed (6F) VIKING OPTIMA™ Guiding Catheter has a standard working length of 100 cm and a standard overall length of 107 cm, but can be produced in lengths from 40 to 160 cm depending upon physician preference and patient size.
The proposed (6F) VIKING OPTIMA™ Guiding Catheter has a radiopaque shaft, which varies in stiffness at the distal end to accommodate customer preference and give optimal support in each tip shape. The stiffness of the shaft is determined by the durometer of the segment of polymer along the axial length. The lower the durometer of polymer (or polymer blend of Nylon 12 and/or Pebax), the more flexible the guiding catheter. The Pebax raw material durometers vary from 25 to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.
The proposed (6F) VIKING OPTIMA™ Guiding Catheter is manufactured in varying tip shapes. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available with and without sideholes.
The provided text is a 510(k) summary for a medical device called the VIKING OPTIMA™ Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be found in an AI/software device submission.
Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this document. This document is for a physical medical catheter, not an AI or software-based device.
Here's an assessment based on the information provided, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states: "The substantial equivalence of the proposed (6F) VIKING OPTIMA™ Guiding Catheter has been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not specify what those bench tests entailed, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
Study Details (Applicable to AI/Software Devices, Not This Submission)
For the following points (2-9), the information is not applicable or not present because this is a 510(k) for a physical medical device (a catheter) and not an AI or software-based device requiring detailed clinical performance studies with ground truth.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This type of data is common for AI/software evaluations, not for a physical catheter 510(k).
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)
- Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI systems, not for a physical catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
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 / Not Provided. MRMC studies are for evaluating diagnostic accuracy with or without AI assistance, which is not relevant for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This relates to AI algorithm performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided.
8. The sample size for the training set
- Not Applicable / Not Provided. This refers to training data for AI models.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided.
§ 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).