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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

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The AccuCath Ace™ Intravascular Catheter is indicated for vascular access, including both the external and internal jugular veins, to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used 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 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™ Intravascular Catheter is designed to reduce blood exposure during insertion. The devices are single use, sterile, intravascular catheters offered in 18, 20, and 22 gauge configurations. All lumens are power injectable at their labeled flow rate. The AccuCath Ace™ Intravascular Catheter is offered in Emergent Access Kit configurations with various components provided for the convenience of the end user.

The provided text describes the AccuCath Ace™ Intravascular Catheter, which is a medical device for vascular access. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are typically framed in terms of meeting established industry standards and functional requirements that are substantially equivalent to the predicate.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" as a pass/fail threshold for a specific performance metric in a clinical study. Instead, it demonstrates compliance with recognized standards and performs a series of engineering tests to show substantial equivalence to a predicate device.

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

The document describes engineering bench tests and compliance with standards, not a clinical study on human subjects with a "test set" in the sense of patient data.

• Sample size for bench tests: Not explicitly stated for each test (e.g., number of catheters tested for burst pressure).
• Data provenance: Not applicable in terms of country of origin or retrospective/prospective, as these are lab-based engineering performance tests, not clinical data sets.

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

This is not applicable as the submission focuses on functional and safety performance, not diagnostic accuracy where expert ground truth would be needed. The "ground truth" for these tests are the defined parameters and methodologies of the relevant ISO standards.

4. Adjudication method for the test set

Not applicable for engineering bench tests.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to assess human performance with and without AI assistance. This device is an intravascular catheter, and the submission is for substantial equivalence based on safety and functional performance, not diagnostic accuracy or AI assistance.

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

This question is not applicable to an intravascular catheter. There is no algorithm for this device that would operate standalone or with human-in-the-loop.

7. The type of ground truth used

The "ground truth" for the tests performed are the specifications and requirements defined by recognized consensus standards (e.g., ISO 10993-1, AAMI/ANSI/ISO 11135:2014, ISO 14971, ISO 10555-1:2013) as well as internal engineering specifications for functional parameters like burst pressure and tensile strength.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or diagnostic tool that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

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