(102 days)
The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: Iodixanol 320 mg/mL and Iopanidol 370 mg/l mL.
The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.
The provided text describes a 510(k) premarket notification for the DyeVert™ Contrast Modulation System. This application is for a medical device that aims to modulate contrast media injection, not an AI or imaging device, therefore many of the typical AI/ML acceptance criteria sections are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific quantitative thresholds alongside reported device performance for each criterion. Instead, it states that "All testing passed and demonstrated product performance met all prior established acceptance criteria." This general statement is common for medical device submissions where the specific metrics are typically internal company documents.
However, based on the text, we can infer the types of performance criteria tested:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Performance | |
| Flow rate | Passed / Met established acceptance criteria |
| Peak pressure | Passed / Met established acceptance criteria |
| Leak testing | Passed / Met established acceptance criteria |
| Contrast diversion | Passed / Met established acceptance criteria |
| Mechanical cycle testing | Passed / Met established acceptance criteria |
| Visual verifications | Passed / Met established acceptance criteria |
| Sterilization | |
| Sterility Assurance Level | 10^-6 (Validated per ISO 11135-1:2007) |
| Packaging & Shelf Life | |
| Distribution testing (visual inspection) | Passed / Met established acceptance criteria |
| Distribution testing (cycle test) | Passed / Met established acceptance criteria |
| Distribution testing (dye leak test) | Passed / Met established acceptance criteria |
| Distribution testing (seal strength test) | Passed / Met established acceptance criteria |
| Distribution testing (functional testing) | Passed / Met established acceptance criteria |
| Biocompatibility | |
| Cytotoxicity | Passed / Met established acceptance criteria |
| Sensitization | Passed / Met established acceptance criteria |
| Irritation | Passed / Met established acceptance criteria |
| Systemic toxicity | Passed / Met established acceptance criteria |
| Hemocompatibility | Passed / Met established acceptance criteria |
| Simulated Use (Usability) | |
| Ease of use | Passed / Met established acceptance criteria |
| System setup | Passed / Met established acceptance criteria |
| Device priming ability | Passed / Met established acceptance criteria |
| Injection pressure testing | Passed / Met established acceptance criteria |
| Contrast diversion testing | Passed / Met established acceptance criteria |
| Image analysis testing | Passed / Met established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the bench tests mentioned. It only states that "Bench testing was performed."
Data Provenance: The data provenance is from "Bench testing" and "Simulated Use (Cath Lab) and Design Validation," indicating in-vitro and simulated environment testing. There is no mention of country of origin for this testing, nor is it categorized as retrospective or prospective since it is not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish "ground truth" for the test set. The testing described (flow rate, pressure, leak, mechanical cycle, sterilization, packaging, biocompatibility) are objective, engineering, and laboratory-based tests that do not typically require expert interpretation for ground truth establishment in the way an AI/ML diagnostic device would.
For "Simulated Use (Cath Lab) and Design Validation," it mentions an "assessment of the ease of use, system set up and device priming ability (usability)." While this implies involvement of individuals who would typically use such a device (e.g., cath lab personnel or physicians), their number, specific qualifications, or their role in establishing "ground truth" (as in expert consensus for a diagnostic finding) are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective bench or lab tests, not subjective interpretations requiring adjudication.
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/ML device, and no MRMC study was performed. The device is a mechanical system for modulating contrast media.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device with an algorithm. It is a mechanical device that is operated by a human.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the various bench and lab tests, the "ground truth" would be established by predefined engineering specifications, standardized testing protocols (e.g., ISO, ASTM standards), and objective measurements. For simulated use/usability, it would likely be based on pre-defined functional requirements and user feedback. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are typically associated with diagnostic or therapeutic devices where clinical outcomes or interpretations are central.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for 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.