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The ER-REBOA™ PLUS Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The ER-REBOA™ PLUS Catheter is a large vessel occlusion catheter. The device consists of an atraumatic distal tip (P-tip®), a compliant occlusion balloon and catheter shaft with a built-in central lumen for blood pressure monitoring. The catheter has a uni-body design and is intended to be placed and advanced without a guidewire. However, the catheter is compatible with straight tipped guidewires up to 0.025″ and may be used with a guidewire if desired to facilitate subsequent vascular procedures. The catheter contains two lumens which traverse the length of the catheter and connect to extension lines with stopcocks. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. Radiopaque marker bands are located on the catheter at the balloon to assist with positioning under fluoroscopy. A peel-away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve.

This submission (K193440) describes the clearance of the ER-REBOA™ PLUS Catheter, which is an updated version of the predicate ER-REBOA™ Catheter (K172790). The primary change in the new device is the ability to be used with a 0.025" or smaller guidewire, which the predicate device could not accommodate.

The provided text discusses Performance Data but does not present a formal table of acceptance criteria and reported performance with quantitative values. However, it states that "Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects." This implies that the device met the acceptance criteria for the tested performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values. The information below is inferred from the description of the performance testing.

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

• Sample Size: The document does not specify the sample size used for the bench tests (tensile strength, blood pressure, guidewire compatibility).
• Data Provenance: The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given that it's bench testing, it is likely laboratory-based and conducted by the manufacturer.

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

• Not Applicable. The described performance testing (tensile strength, blood pressure, guidewire compatibility) are bench tests that do not typically require expert interpretation of results to establish ground truth in the same way clinical imaging studies do. The ground truth would be based on direct measurements and adherence to engineering specifications.

4. Adjudication Method for the Test Set

• Not Applicable. Since the tests described are bench tests and not clinical studies requiring human interpretation of outputs, an adjudication method for a test set is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not mention an MRMC comparative effectiveness study. The submission describes bench testing for a device modification, not AI performance.

6. Standalone (Algorithm only without human-in-the-loop) Performance

• Not Applicable. This device is a physical medical catheter, not an algorithm or AI system, so standalone algorithm performance is not relevant.

7. Type of Ground Truth Used for Performance Testing

• The ground truth for the performance testing (tensile strength, blood pressure, guidewire compatibility) would be based on engineering specifications, physical measurements, and functional verification according to predetermined test protocols. For example, guidewire compatibility would be demonstrated by the physical ability of the specified guidewire to pass through the catheter.

8. Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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