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The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature which includes the descending aorta.

The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 7F vascular introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8 cm. Each balloon can be inflated independently to a variable diameter to control blood flow in the selected vessel. When used in the descending aorta, balloon inflation results in diversion of cardiac output to the upper torso and core organs, e.g., cardiac, spinal and cerebral vasculature. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.

The CoAxia FloControl Catheter (K090970) is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, including the descending aorta. The provided text indicates that no clinical testing of the FloControl catheter was performed to establish its performance against specific acceptance criteria. Instead, substantial equivalence to a predicate device (CoAxia FloControl™ Catheter (K023914)) was demonstrated through non-clinical studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for clinical use, nor can I describe a study proving the device meets clinical acceptance criteria based on this document. The document explicitly states: "Clinical testing of the FloControl catheter was not performed."

However, I can describe the non-clinical studies performed and how performance was deemed acceptable as per the provided text.

Here's a breakdown of the information that can be extracted from the provided text, addressing your points where possible, and indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, a table of clinical acceptance criteria and reported performance cannot be generated, as no clinical testing was performed. However, the document states that the device was tested against relevant ISO and EN standards and FDA guidance for intravascular catheters. These non-clinical tests serve as the basis for "acceptable performance."

2. Sample size used for the test set and the data provenance

The document does not provide details on the sample sizes used for the non-clinical tests (tensile strength, balloon characterization, etc.). It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in more comprehensive study reports, which are not included in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

4. Adjudication method for the test set

This question is not applicable as no clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case comparative effectiveness study was not performed, as no clinical studies were undertaken.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

This question is not applicable as the device is a physical catheter, not an algorithm.

7. The type of ground truth used

For the non-clinical studies, the "ground truth" was established by device specifications, relevant ISO and EN standards, and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. These standards and specifications define what constitutes acceptable performance for each tested attribute (e.g., tensile strength, balloon inflation characteristics, biocompatibility).

8. The sample size for the training set

This question is not applicable as no clinical studies were performed, and the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as no clinical studies were performed, and the device is not an AI/ML algorithm that requires a training set.

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The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.

The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.

The sponsor, CoAxia, Inc., submitted a 510(k) premarket notification for the CoAxia FloControl™ Catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the CoAxia FloControl™ Catheter was tested in accordance with ISO, EN, and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. The testing covered specific performance aspects, and the results are reported to have met the device's specifications.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for each individual test (tensile strength, balloon characterization, etc.). It only broadly states "Testing included..." without providing numerical details for the test sets.

The data provenance is from retrospective testing performed by CoAxia, Inc. in accordance with various standards and guidance documents. The country of origin of the data is implicitly the United States as CoAxia, Inc. is located in Maple Grove, MN, and the submission is to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document describes laboratory and engineering tests, not evaluations by human experts for establishing ground truth as one might see in a clinical study for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable and therefore, not provided. The testing described is primarily laboratory-based engineering and performance testing against predefined specifications, not requiring an adjudication method involving human expert reviewers.

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:

This information is not provided and is not applicable. The device described is a physical catheter for controlling blood flow, not an AI-powered diagnostic or assistive tool for human readers. The document explicitly states: "Clinical testing of the FloControl catheter was not performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided and is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used:

The ground truth for the performance testing described (tensile strength, balloon characterization, dimensional verification, etc.) was based on device specifications, engineering standards (ISO, EN), and FDA guidance for intravascular catheters. These standards and specifications define the acceptable limits and performance characteristics for each test.

8. The sample size for the training set:

This information is not provided and is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

This information is not provided and is not applicable as there is no training set for this type of device.

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