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The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Radial and Femoral Artery Catheter. The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.

This is a 510(k) premarket notification for a Medical Device: Radial and Femoral Artery Catheter by B. Braun Medical, Inc. This device is a catheter. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document does not describe acceptance criteria for the device based on performance studies, nor does it present a study to demonstrate such performance or describe an AI/ML powered device.

However, it does describe the following:

1. Acceptance Criteria and Reported Device Performance:

The document states: "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."

It further explains: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

While specific numeric acceptance criteria and reported performance values are not provided in this 510(k) summary, the general acceptance criteria are:

• Meeting required release specifications.
• Compliance with established physical testing procedures and parameters outlined in Quality Control Test Procedure documents.
• Conformity to product design specifications.
• Suitability of materials for intended use based on ISO Standard 10993 testing.

No quantified device performance metrics are reported in this summary beyond the general statement of meeting release specifications.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a "test set" in the context of an algorithmic performance study. The testing refers to manufacturing quality control and material biocompatibility. Therefore, these details are not applicable as presented in a medical device 510(k) submission for a physical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable. The device is a physical catheter, and the "ground truth" for its safety and effectiveness is established through adherence to manufacturing specifications, material testing (ISO Standard 10993), and comparison to a predicate device. There is no mention of expert-established ground truth for a test set in the context of an algorithm.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of an identified "test set" that would require adjudication in the context of an algorithm-based evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No, a standalone performance study was not done. This document pertains to a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this medical device submission is established through:

• Material Biocompatibility Testing: Adherence to ISO Standard 10993 for material suitability.
• Manufacturing Quality Control: Conformance to established physical testing procedures, product design specifications, and visual examination.
• Substantial Equivalence to a Predicate Device: The Arrow Radial Artery Catheterization Kit, meaning its safety and effectiveness are deemed equivalent to a device already legally marketed.

8. Sample Size for the Training Set:

This information is not applicable as the device is a physical catheter and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is a physical catheter and does not involve AI/ML requiring a training set.

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