(112 days)
The AVERT™ Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/ml, Iohexol 300 or 350 mg1/ml, and Iopamidol 370 mg[/ml.
Similar to the first generation AVERT Contrast Modulation System (weighted), the Osprey Medical second generation AVERT Contrast Modulation System consists of a reusable, non-sterile apparatus (contrast modulator or RMS), which applies a force to a disposable modulation reservoir. The system also includes a wheeled stand for which to mount the RMS. The RMS applies a force directly to the single use sterile, detachable modulation reservoir, which has a pressure dampening effect during contrast delivery, similar to the weighted AVERT System. The RMS utilizes an internal mechanism to apply force to the modulation reservoir. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The RMS is attached to the wheeled stand and is positioned near the patient, outside of the sterile field. The disposable components of the AVERT Contrast Modulation System include a modulation reservoir, which is connected to a standard, off-the-shelf 4-way stopcock and extension line that are all provided sterile.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it refers to general performance categories and states that the device "met the established performance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Flow Rate | Met established performance criteria |
| Peak Pressure Reduction | Met established performance criteria |
| Flow Rate Adjustability | Met established performance criteria |
| Mechanical Cycle Testing | Met established performance criteria |
| Distribution & Package Testing | Met established performance criteria |
| Biocompatibility | Deemed not necessary as no material changes to patient-contacting components; predicate device testing applicable. |
| Sterilization (for single-use modulation reservoir kit) | Minimum Sterility Assurance Level (SAL) of 10^-6 achieved in validation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the in vitro bench testing. It only states that "All test results demonstrated..."
- Data Provenance: The testing was "in vitro bench testing." The document does not mention the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The study involved in vitro bench testing, not human expert evaluations of medical images or conditions to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. The study involved in vitro bench testing, so there was no adjudication method for a test set based on expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an Angiographic Injector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is a medical device (Angiographic Injector), not an AI algorithm. The performance evaluation was based on the device's physical and mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for the in vitro bench testing was the "established performance criteria" for the device's mechanical and functional characteristics (e.g., flow rate, peak pressure reduction, adjustability, mechanical cycles, sterility). This is based on engineering and manufacturing standards rather than medical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. Refer to point 8.
§ 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.