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The AccuCath Ace™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for use with power injectors.

The AccuCath Ace™ Intravascular Catheter system consists of a radiopaque catheter with a valve mechanism delivered over a guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries. The AccuCath Ace IV Catheter is designed to reduce blood exposure during insertion, for use with ultrasound, and for use with the Cue Needle Tracking System.

The information provided indicates that the AccuCath Ace™ Intravascular Catheter did not undergo a new study to prove it meets acceptance criteria for its current submission. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AccuCath™ Intravascular Catheter, K162894) based on a modification to its Indications for Use, which now explicitly includes patients with difficult intravascular access (DIVA).

The document states that a risk analysis determined that no verification or validation activities were required because the modifications to the Indications for Use and labeling "do not include any changes to the design, materials, performance, or risk profile of the cited predicate device."

Therefore, the "acceptance criteria" and "device performance" described below are in reference to the previous clearance of the predicate device and the modifications that had been made to it, for which "Verification, sterilization, biocompatibility, and packaging testing was carried out as necessary for each of these changes at the time of the change." The current submission does not detail these specific tests, their criteria, or results, but rather asserts that the changes "were found to be as safe and as effective and introduced no new or modified risks."

The table below summarizes the information provided regarding the comparison between the subject device (AccuCath Ace™ Intravascular Catheter) and its predicate device (AccuCath™ Intravascular Catheter, K162894), highlighting what is considered "met" based on the substantial equivalence argument rather than new primary testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."

This means there was no new test set specifically for this 510(k) submission to assess the AccuCath Ace™ in the context of the DIVA indication. The claim of equivalence is based on the previously cleared predicate device and earlier incremental changes.

However, the document mentions: "Verification testing was carried out on all changed aspects: the needle, packaging, ultrasound system/Cue compatibility, tracking accuracy, and magnetization. All acceptance criteria was met".

• Sample Size: Not specified.
• Data Provenance: Not specified, but these prior tests would likely have been internal validation tests conducted by the manufacturer.

The submission also cites "a body of literary evidence demonstrating that the AccuCath Ace Intravascular Catheter has equivalent or better outcomes in DIVA patients compared to catheters with no guidewire." This refers to clinical literature, not a new test set conducted by the manufacturer for this submission. The specifics of this literature (e.g., sample sizes, countries of origin, retrospective/prospective) are not provided within this document.

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

Not applicable, as a new test set requiring expert ground truth establishment was not conducted for this 510(k) submission. For the "body of literary evidence," the ground truth would be established by the clinicians and researchers involved in those studies, but their specific numbers and qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable, as a new test set was not conducted for this 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done as part of this submission. The submission relies on existing clinical literature (not a new study conducted for this submission) that suggests improved outcomes for DIVA patients with the AccuCath Ace™ Intravascular Catheter compared to catheters without a guidewire. No "effect size of how much human readers improve with AI vs without AI assistance" is relevant or provided, as this is a medical device, not an AI-assisted diagnostic tool for human readers.

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

Not applicable, as this is a medical device (intravascular catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the previously conducted "verification testing" for incremental changes (e.g., Cue compatibility), the ground truth would have been established through objective measurement and engineering standards.

For the claim regarding DIVA patients, the submission refers to "a body of literary evidence demonstrating that the AccuCath Ace Intravascular Catheter has equivalent or better outcomes in DIVA patients compared to catheters with no guidewire. These outcomes include improved first attempt success, reduction of insertion complications, improved completion of therapy, increased dwell time of the catheter, and overall patient and clinician satisfaction." This implies that the ground truth for these claims comes from outcomes data reported in clinical literature.

8. The Sample Size for the Training Set

Not applicable, as this is a medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a medical device, not a machine learning model.

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