(90 days)
The ACIST system is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
This device is a modification to the Acist Angiographic Injector System. The modification is a means to use various types of radiographic contrast containers with the injector system. The present system is optimized for use with bottles of radiographic contrast. The modification is a hanger style holder and will work with the more recent types of radiographic contrast containers, such as bags, as well as bottles. The modification is designed to work with all types of radiographic contrast containers including bags and bottles of various sizes.
The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor).
The system includes a remote hand controller which is responsive to the command signal from the clinician. Based upon that command signal, the controller controls flow rate of the radiographic contrast material from the pump to the outlet.
The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.
The modification consists of:
- a new holder for the contrast container. The new holder which . resembles a saline bag hanger and will accommodate various form factors of contrast media containers including bags and various sizes and shapes of bottles.
- a new mechanical means to support the contrast empty sensor .
- a new sensor to detect the presence/absence of contrast .
- minor software changes to support the new sensor .
Here's an analysis of the provided text regarding the ACIST Angiographic Injector System, structured to answer your questions about acceptance criteria and the supporting study:
The provided 510(k) summary focuses on a modification to an existing device, specifically a new contrast container holder (hanger style holder) and associated components. As such, the "study" described is primarily a series of verification and validation tests to ensure the modification functions correctly, doesn't introduce new hazards, and doesn't adversely affect the established performance of the original device. It is not a clinical "study" in the sense of a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a list of tests conducted, but it does not explicitly state specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it generally states that "All testing of the product yielded acceptable results."
| Category of Test | Acceptance Criteria (Implicit from description) | Reported Device Performance |
|---|---|---|
| Functional Testing (Modification-Specific) | - Correct mechanical fit with various contrast containers (bags and bottles of various sizes/shapes). |
- Sensor correctly detects contrast present/not present.
- System functions associated with changes (e.g., fill syringe) operate correctly. | "functioned correctly for all types of contrast containers", "sensor correctly detects contrast present/not present", "functions...function correctly" |
| Safety Testing (UL2601-1/IEC 601-1 selected portions) | - No sharp edges that could damage surgical gloves or harm users. - Passes 10-degree tip test (stability).
- Meets mechanical strength requirements.
- Meets rough handling (drop, roll) requirements. | "no sharp edges", "test according to the 10 degree tip test", "mechanical strength requirements", "rough handling (drop, roll) requirements" (all implicitly passed for "acceptable results") |
| Reliability/Life Testing | - Sensor door withstands specified number of cycles/duration. - Continues operation after rough handling. | "sensor door life test", "operation after rough handling" (all implicitly passed for "acceptable results") |
| Environmental Constraints Testing | - Operates correctly in the presence of dried contrast. - Operates correctly under various ambient light conditions.
- Continues operation after rough handling. | "operation in the presence of dried contrast", "operation under various ambient light conditions", "operation after rough handling" (all implicitly passed for "acceptable results") |
| Regression Testing | - Performance of the overall system (not just the modification) has not been adversely affected. | "performance has not been affected" (implicitly passed for "acceptable results") |
| Software Testing | - Code review meets standards. - Changes to software function correctly. | "Code review of affected units", "Testing of the changes" (all implicitly passed for "acceptable results") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact numerical sample sizes for the various tests. For example, it mentions "various types of radiographic contrast containers" without stating how many types or how many units of each were tested. Similarly, for reliability/life testing or rough handling, specific numbers of cycles or drops are not provided.
- Data Provenance: The data is prospective as it describes testing specifically performed for this 510(k) submission. The document doesn't explicitly state the country of origin of the data, but given the submission is to the FDA in the US, it is reasonable to assume the testing was conducted either in the US or in a manner compliant with US regulatory requirements (though not explicitly stated).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the verification and validation testing of a mechanical/software modification for an injector system. There isn't a "ground truth" to be established by experts in the same way there would be for an AI diagnostic device. The ground truth for functional tests would be whether the device physically performs as intended (e.g., container fits, sensor detects, software executes).
4. Adjudication Method for the Test Set
Not applicable for this type of device modification testing. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation tasks where there might be disagreement among human readers or between AI and human readers. For mechanical and software functional tests, the outcome is usually objectively pass/fail based on predetermined criteria.
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
No. An MRMC study is not relevant here. This submission is for modifications to a mechanical and software system for injecting contrast, not for an AI diagnostic or interpretive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a mechanical injector system with integrated software; it's not a standalone algorithm that could perform without human interaction. The "software testing" mentioned refers to the functionality of the control software, not an interpretive algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is primarily engineering specifications and functional requirements. For example:
- Mechanical fit: Verified by physically attempting to fit various containers. "Ground truth" is that the container should fit.
- Sensor detection: Verified by observing the sensor's output when contrast is present/absent. "Ground truth" is the actual presence or absence of contrast.
- Safety tests (UL/IEC): Verified against the specified limits and procedures in the relevant standards.
- Software changes: Verified against the intended behavior defined in software requirements.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a training set. The software changes are deterministic programming logic, not a learned model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.