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The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.

The MRI-Caddy® is a cart with an integrated chassis, which is equipped with three Medex syringe pumps and a power supply. The MRI-Caddy's mechanical construction makes it possible to position the system with the MR-room. For this purpose the system was equipped with adequate screening following the principle of a Faraday cage. The function principle corresponds to that of the Medex syringe pumps already on the market.

The provided 510(k) summary for the MRI-Caddy Infusion Pump does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Medex syringe pumps Model 3001 and Medfusion Model 2001) based on design, materials, chemical composition, and operational principles, as well as compliance with a general safety standard.

Here's an breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission does not define specific performance metrics or acceptance criteria for the MRI-Caddy beyond compliance with a general safety standard. It asserts that the function principles correspond to existing Medex syringe pumps.

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

No test set or clinical data is mentioned. The submission explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

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

Not applicable, as no test set or clinical studies were conducted.

4. Adjudication method for the test set

Not applicable, as no test set or clinical studies were conducted.

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

Not applicable. This device is an infusion pump, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The equivalence is primarily based on device design and manufacturing, not clinical performance data with ground truth.

8. The sample size for the training set

Not applicable, as no AI model or training was performed.

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

Not applicable, as no AI model or training was performed.

Summary of the Study and Basis for Equivalence (as reported in the document):

The submission for the MRI-Caddy Infusion Pump relies on two key aspects to establish substantial equivalence to legally marketed predicate devices:

• Non-Clinical Testing and Standards Compliance: The company cites compliance with EN 60601-1 / IEC 601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety" including its amendments. This suggests that the device underwent engineering and safety testing to meet general electrical and medical device safety standards.
• Design and Functional Equivalence to Predicate Devices: The core argument for substantial equivalence is that "The basic design, material, chemical composition of the Medex pump series 2000 used in the MRI-Caddy are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, features, and form as their predicate devices, and represent no technological differences." The MRI-Caddy essentially integrates pre-existing, legally marketed Medex syringe pumps into a new housing designed for an MR-environment, with appropriate screening (Faraday cage).

Conclusion:

The K030323 submission does not involve specific acceptance criteria or a performance study as would be seen for a novel diagnostic or therapeutic device. Instead, it leverages the substantial equivalence pathway by demonstrating that the MRI-Caddy is fundamentally the same in design, materials, and operation as existing, cleared infusion pumps, with the added feature of an MR-compatible housing that meets safety standards. No clinical studies were conducted or relied upon for this submission.

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