(30 days)
The DyeVert™ NG Contrast Reduction 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 mg/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.
The DyeVert™ Plus Contrast Reduction System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mg/ mL.
The Osprey Medical DyeVert" NG and DyeVert" Plus Contrast Reduction Systems are compatible to manual contrast injections and provide fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as "refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in the total contrast agent volume during coronary or peripheral imaging to the patient; while maintaining adequate image quality.
The provided text is a 510(k) summary for the DyeVert™ NG and DyeVert™ Plus Contrast Reduction Systems. This document pertains to the regulatory clearance of a medical device intended to reduce contrast media volume during angiographic procedures. It's important to note that the information focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy studies for a novel AI algorithm.
Therefore, many of the requested categories related to AI performance, such as MRMC studies, effect size of human improvement with AI, standalone AI performance, ground truth establishment for AI training, and associated sample sizes, are not applicable or cannot be extracted from this document, as the device described is not an AI-powered diagnostic or predictive tool.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in a summary format with specific quantitative targets and results for each. Instead, it describes general compliance with "prior established acceptance criteria" and successful completion of various tests.
However, based on the non-clinical testing summary, the acceptance criteria implicitly related to the device's functionality and safety can be inferred:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Confirmatory Device Performance | - Flow Rate: Met prior established acceptance criteria. |
| - Peak Pressure: Met prior established acceptance criteria. | |
| - Contrast Diversion: Met prior established acceptance criteria. | |
| - Mechanical Testing (High Pressure Use, Leak, Tensile Strength): Passed, met prior established acceptance criteria. | |
| - Visual Verifications: Met design specifications for specific contrasts and catheter configurations. | |
| - Durability Testing (Cycling): Lev-eraged, and results passed, indicating compliance with acceptance criteria. | |
| Sterilization Validation | - Sterility Assurance Level (SAL): Achieved 10⁻⁶ in accordance with ISO 11135-1:2014. All testing passed. |
| Simulated Use (Bench) / Design Validation (Usability) | - Ease of Use: Passed, indicating compliance with acceptance criteria. |
| - System Set Up: Passed, indicating compliance with acceptance criteria. | |
| - Device Priming Ability: Passed, indicating compliance with acceptance criteria. | |
| - Injection Pressure (Validation): Passed, indicating compliance with acceptance criteria. | |
| - Contrast Diversion (Validation): Passed, indicating compliance with acceptance criteria. | |
| - Image Analysis Testing (Validation): Passed, indicating compliance with acceptance criteria. | |
| Packaging, Shelf Life & Distribution | - Distribution Testing (ASTM D4169:2016): Included visual inspection, cycle testing, dye leak/penetration test, seal strength test, and functional testing. All testing passed and demonstrated product performance met all prior established acceptance criteria. Packaging deemed compliant with ISO 11607 part 1 and 2:2006. |
| Biocompatibility | - ISO 10993-1:2009 Testing: Included cytotoxicity, sensitization, acute systemic toxicity, and hemocompatibility. All testing passed and met prior established acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document primarily describes non-clinical bench and lab testing. Therefore, the concept of a "test set" in the context of patient data or clinical images (which would typically have provenance like country of origin or retrospective/prospective) is not directly applicable here. The "sample size" refers to the number of units or iterations tested in the various non-clinical evaluations. Specific quantities for each test are not provided (e.g., number of devices tested for leak, or number of cycles for durability).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI algorithm requiring expert adjudication for establishing ground truth on a test set of medical images or data. The "ground truth" for the non-clinical tests would have been objective physical measurements or established pass/fail criteria according to international standards (e.g., sterility, material properties).
4. Adjudication method for the test set
Not applicable. As noted above, expert adjudication for a "test set" of medical data is not relevant for the non-clinical evaluation of this direct medical device.
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 is not an AI-assisted diagnostic device, so no MRMC study or AI-related effectiveness assessment was performed or reported in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical contrast reduction system, not an algorithm.
7. The type of ground truth used
For this purely physical device and its non-clinical testing, the "ground truth" was established by:
- Objective physical measurements: For parameters like flow rate, peak pressure, leak, tensile strength, and distribution performance.
- Adherence to established standards: Such as ISO 11135-1:2014 for sterilization, ASTM D4169:2016 for distribution testing, and ISO 10993-1:2009 for biocompatibility. These standards define the acceptable criteria for performance and safety.
- Design specifications: The device's performance was measured against its internal design specifications.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm that requires a training set.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.