(258 days)
As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
The subject catheter is a short term, single use, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.
This device is a Diagnostic Intravascular Catheter (INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ Catheters) intended to provide access to the vascular system for monitoring blood pressure, sampling blood, or introducing substances into the heart and vessels. The key modification for this 510(k) submission is the explicit clarification that the catheters are suitable for use with power injectors, with a maximum rated pressure of 300 psi.
Based on the provided information, there is no acceptance criteria or study that proves the device meets specific performance metrics in the context of AI/ML or diagnostic accuracy. This document is a 510(k) premarket notification for a medical device (intravascular catheter) where the primary assertion is substantial equivalence to a predicate device, with an added clarification regarding use with power injectors.
Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable or not present:
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A table of acceptance criteria and the reported device performance
There are no specific quantitative acceptance criteria or reported device performance metrics provided in the document related to diagnostic accuracy or AI/ML performance. The basis for clearance is substantial equivalence to a predicate device, with the addition of a clarified intended use with power injectors.
The "performance" referred to in the "Summary of Safety and Efficacy" relates to the inherent function of the catheter, not a diagnostic output. The document states:
Acceptance Criteria (Implied) Reported Device Performance Functional equivalence to predicate device Cleared as substantially equivalent to the Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters. Suitability for intended use with power injectors (300 psi max) Labeling clarified to include use with power injectors up to 300 psi. Safety and Efficacy Assumed through substantial equivalence determination and compliance with general controls. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical medical device (catheter), not an AI/ML diagnostic software. There is no "test set" in the context of an AI/ML algorithm's performance evaluation mentioned in this document.
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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. As this is not an AI/ML diagnostic submission, there is no mention of experts establishing a ground truth for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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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 an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm being submitted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no AI algorithm requiring ground truth data.
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The sample size for the training set
Not applicable. There is no AI algorithm that requires a training set mentioned in this document.
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How the ground truth for the training set was established
Not applicable. There is no AI algorithm or training set discussed.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).