(256 days)
The ACIST|CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Hand Controller Kit must be discarded after each patient procedure.
The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
The ACIST CVi® Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit, and a hospital provided angiographic patient catheter. The CVi Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi Contrast Delivery System are catheterization or radiological laboratories.
This document is a 510(k) premarket notification for a medical device, the ACIST|CVi® Contrast Delivery System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of technological characteristics and performance data from bench and biocompatibility testing. The information provided does not detail an AI/ML-based device or a clinical study that would typically establish accuracy metrics like sensitivity, specificity, or AUC based on expert review.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving its performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for AI/ML models) are not applicable or extractable from this document.
However, I can extract the general "acceptance criteria" through the lens of device performance for this type of non-AI device, which is primarily demonstrating fundamental functional safety and equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like this, "acceptance criteria" are defined by meeting specifications for physical performance (e.g., flow rate, pressure, durability) and safety (biocompatibility, microbial ingress, cross-contamination). The qualitative reported performance against these criteria is that the device "meets specification and performs as intended." No specific quantitative performance metrics are provided in the summarized data.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance (Qualitative) |
|---|---|
| Functional performance (flow, pressure, life, burst, bond pull, durability) | "meets specification and performs as intended" |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis) | All tests "completed" and "no new safety or performance issues were raised" |
| Microbial ingress & Cross contamination | "meets specification and performs as intended" for microbial ingress and cross-contamination (implied by "no new safety or performance issues") |
| Software validation | Software validation was performed. |
| System level testing | Performed. |
| Human factors testing | Performed. |
2. Sample sized used for the test set and the data provenance
The document refers to "bench and biocompatibility testing, software validation, system level testing, and human factors testing." It does not specify sample sizes for these tests, nor does it mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for this type of device's 510(k) submission focused on physical and functional safety.
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/ML device requiring expert ground truth for classification or prediction tasks. The "ground truth" for this device's performance would be established through engineering specifications and standardized test methods.
4. Adjudication method for the test set
Not applicable. No expert adjudication for a test set is relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This is not an AI/ML diagnostic or assistive device that would undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contrast delivery system, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for performance is based on engineering specifications, standardized bench testing protocols, and established biocompatibility testing methods. There's no clinical "ground truth" in the sense of pathology, outcomes data, or expert consensus on image interpretation, as it's not a diagnostic AI.
8. The sample size for the training set
Not applicable. As this is not an AI/ML product, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model.
§ 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.