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The Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

• 2- 65 ml syringes (K935668)
• 96" Low Pressure Connector Tube/T-connector assembly (K943189) .
• . Fluid Delivery Device (Spike) - (K810624)
• Normally closed check-valve B. Braun/Burron (K790062) ●
• Female/Female Luer Adapter B.Braun/Burron (K942391) .
  The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.
  The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.
  The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.
  All other components of the kit are identical to those in K943189.
  The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.

Here's an analysis of the provided text regarding the Medrad Disposable MRI Kit with Check Valve, focusing on acceptance criteria and the supporting study information:

It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, the level of detail regarding comprehensive studies and acceptance criteria is different from what might be found in a full efficacy study report for a new drug or high-risk medical device. The focus here is on demonstrating that the new device does not raise new issues of safety or effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly present acceptance criteria in a quantitative, pass/fail table format, nor does it detail a standalone study proving the device meets specific performance metrics with numerical results for each criterion regarding its primary function (fluid delivery). Instead, it demonstrates substantial equivalence by comparing features and performing validation tests related to manufacturing and safety attributes.

However, we can infer some "acceptance criteria" based on the validation tests performed and the comparison to the predicate devices. The "reported device performance" is primarily stated as compliance with established standards and equivalence to the predicate.

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

• Sterility Validation:

  • Sample Size: 50 test products per half-cycle verification run. There were three half-cycle verification runs, totaling 150 test products.
  • Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin, but it is implied to be internal testing conducted by Medrad, Inc. as part of their sterilization validation process for a new device submission. This would be prospective testing for the specific device.

• Residual Levels:

  • Sample Size: Not specified for the pre-release testing.
  • Data Provenance: Implied as internal prospective testing.

• Shelf Life Testing:

  • Sample Size: Not specified for the accelerated aging tests or the subsequent flow/pressure/ARO tests.
  • Data Provenance: Implied as internal prospective testing.

• Biocompatibility/Pyrogenicity:

  • Sample Size: Not specified.
  • Data Provenance: Implied as internal prospective testing.

For the functional aspects of the check-valve and luer adapter, the document states "Device Verification and Validation Testing has been performed" but does not provide details on sample sizes or specific test results, instead relying on a comparison of features to the predicate device and the fact that other components are identical to a previously cleared device (K943189).

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

This type of information is not applicable to the provided document. The Medrad Disposable MRI Kit with Check Valve is a hardware device (disposable kit) for fluid delivery, not a diagnostic algorithm or a device requiring expert interpretation of results. Therefore, there's no "ground truth" in the medical imaging or diagnostic sense established by human experts for the device's functional performance or safety. The "ground truth" for the device's properties (like sterility, biocompatibility, luer fitting compliance) is established through technical standards, laboratory tests, and reference protocols.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical image reading) to resolve discrepancies. This device does not involve such human interpretation in its primary function or testing for a 510(k) submission.

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

This is not applicable. An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of human readers, sometimes comparing performance with and without AI assistance for tasks like disease detection or classification. This device is a fluid delivery kit and does not involve AI or human diagnostic reading in its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a physical medical kit, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established reference for the characteristics being tested. For this device, the ground truth types are:

• Technical Standards and Reference Protocols: For sterility (ANSI/AAMI ST27-1988), residual levels (ANSI/AAMI ST29-1988 and ST30-1989), pyrogenicity (USP Rabbit Testing, USP LAL), biocompatibility (ANSI-AMMI/ISO 10993-1 through 11, USP XXII <87 & 88>), and luer fitting compliance (ANSI 70.1). These external, validated standards serve as the "ground truth" for compliance.
• Predicate Device Characteristics: The existing Medrad Qwik-Fit MRI Disposables Kit (K943189) and its components serve as a ground truth for substantial equivalence, specifically for features that are identical or closely matched.
• Functional Specifications: The intended behavior of the check-valve (restricting flow, preventing trickle) and the luer adapter (fluid transfer) define the functional "ground truth" against which device performance is validated internally.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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