(262 days)
The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an extended dwell (
The provided text is a 510(k) summary for a medical device (The POWERWAND™ Safety Introducer with an Extended Dwell Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It is not a study proving the device meets acceptance criteria for a performance evaluation in the way a clinical study or AI/Machine Learning model validation would be described.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of regulatory submission and information provided.
The document discusses "pre-clinical thrombogenicity tests" to support a labeling claim, but it does not provide the details of these tests in a format that would allow for filling out the requested table or answering questions about sample sizes, adjudication, or ground truth establishment relevant to an AI/ML or diagnostic device performance study.
Here's a breakdown of what can be extracted and what cannot:
Information that can be extracted:
- Type of Study: This is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device, with some pre-clinical testing for a thrombogenicity labeling claim. It is not a clinical trial or AI/ML performance study.
- Sample size for training set: Not applicable (N/A) as this is not an AI/ML device.
- How ground truth for training set was established: N/A as this is not an AI/ML device.
Information that cannot be extracted or is not applicable to this document's content:
- Table of acceptance criteria and reported device performance: The document states that "A series of pre-clinical thrombogenicity tests were conducted to support a thrombogenicity labeling claim." However, it does not provide specific acceptance criteria values (e.g., "Thrombus formation less than X%") or the quantitative results of these tests. It only states that the device "has shown in vivo to be thromboresistant."
- Sample sizes used for the test set and the data provenance: The document mentions "72-hour canine jugular vein thromboresistance studies" for the pre-clinical tests, indicating an animal model. However, it does not specify the number of animals or data provenance (e.g., specific country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For the pre-clinical thrombogenicity tests, "ground truth" would likely be based on pathological/histological analysis, not expert radiology reads.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/ML diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the thrombogenicity tests, it implies pathology/histology ("thrombus on the surface of the catheter and thrombus on the wall of the vein"). For the rest of the 510(k), it's a comparison to a predicate device based on device characteristics and indications for use.
In summary, the provided document details a regulatory submission for substantial equivalence of a medical device, including some pre-clinical animal testing for a specific claim. It does not contain the detailed performance data or study design typically associated with validating a diagnostic device or AI/ML product against specific acceptance criteria.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).