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The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert System) is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality.

The DyeVert System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.

The DyeVert System has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.

The document provided is a 510(k) premarket notification for the DyeVert NG Contrast Modulation System. It describes the device, its intended use, and compares it to a predicate device. This is a submission for a modified device, and the review explicitly states "No clinical testing was performed to support this Special 510(k) Premarket Notification." This means that the device was approved based on its similarity to a previously cleared device (predicate device) and extensive bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in human subjects.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in a clinical context with human readers, ground truth, and sample sizes) cannot be fully provided from this document as no clinical study was conducted.

However, I can extract the information related to bench testing and how its results demonstrated the device met pre-established acceptance criteria, even though those specific criteria aren't enumerated in detail.

Here's the breakdown of the available information:

No clinical study was performed for the DyeVert NG Contrast Modulation System.

The device's substantial equivalence was established through a comparison to a predicate device and extensive non-clinical (bench) testing. Therefore, many of the requested categories related to clinical study design and outcomes are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Device performance testing was performed and leveraged for flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations."
• "Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength."
• "All testing passed and demonstrated product performance met all prior established acceptance criteria."
• "Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009... All testing passed and meet prior established acceptance criteria."
• "Shelf-life, shipping and distribution testing... All testing passed and demonstrated product performance met all prior established acceptance criteria."

Specific Acceptance Criteria (Not explicitly detailed in the document):

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests.
• Data Provenance: Non-clinical (bench) testing performed by Osprey Medical. The country of origin for this bench testing data is not specified, but the company is based in Minnetonka, Minnesota, USA. The testing is retrospective in the sense that it's performed on the finalized device design.

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

• Not applicable. No clinical study was performed that would require expert-established ground truth for a test set. Bench testing relies on objective measurements against pre-defined engineering and material specifications.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study involving human assessment was performed.

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

• No. No MRMC study was performed. The device is for contrast modulation, not for diagnostic interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a mechanical device, not an AI or algorithm-driven system. Its "performance" is mechanical and fluid dynamic, evaluated through bench tests.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was the established design specifications, engineering standards (e.g., ISO, ASTM), and chemical/biological safety standards (e.g., ISO 10993). For instance, a flow rate measurement would be compared to a target flow rate specification.

8. Sample Size for the Training Set:

• Not applicable. This refers to a supervised learning algorithm context, which is not relevant for this device.

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

• Not applicable.

In summary, the K161505 submission for the DyeVert NG Contrast Modulation System is a "Special 510(k)" for a modified device. Approval was based on demonstrating substantial equivalence to a predicate device and comprehensive bench testing, which confirmed the device met all prior established performance, material, and safety acceptance criteria. No new clinical trials were conducted to support this specific submission.

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