(412 days)
The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. The system is designed to be configured as cither an Angiographic injector or as a CT injector.
The system includes a microprocessor controlled DC servo motor which drives a lead serve ram against the piston of a single use syringe. The operation of the servo is programmed by the operator using a touch screen on an electroluments on display. The system is powered by AC line voltage at 100 Volts, 130 Volts, or 240 Volts. System power is less than 1500 Walls.
A typical Angiomat Illumena system includes a power pack, console, powerhead, syringe holder assembly, ac power cable assembly, start cable assembly, and console cable assembly. Other options include ECCG trigger systems, syringe heater, air detection and warning system, pedestal mounting system. wall/rack/ceiling mounting systems, interface cabling, powerhead and console extension cabling. Start switch variations, and printer system.
The system is designed to deliver contrast from either a prefilled syringe or an unfilled wringe which is filled at the start of the procedure. A reusable, sterilizable syringe is also available.
The system will interface with an X-ray system allowing either the start of injection initiated by the X-ray system or start of X-ray initiated by the injector.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Angiomat Illumena Injector:
Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailed, statistically rigorous clinical trials common for novel devices or software. As such, some of the requested information (like specific sample sizes for test sets, the number of experts for ground truth, or MRMC studies) is not typically included in this type of submission and is therefore not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device's ability to perform "to specification within ranges equivalent to the predicate devices with accuracy and precision superior to the predicate devices." The performance reported is that the device meets these specifications.
| Characteristic/Feature | Acceptance Criteria (Implicit from Predicates & Superiority Claim) | Reported Device Performance |
|---|---|---|
| Major Functional Parameters | Performance to specification within ranges equivalent to predicate devices with superior accuracy and precision. | Meets product specifications for the Angiomat Illumena. |
| Programmed flow rate | Equivalent to or superior to predicate devices (0.01 to 40 ml/sec for 125/150 ml syringe) | Meets product specifications. Accuracy validated. |
| Programmed volume | Equivalent to or superior to predicate devices | Meets product specifications. Accuracy validated. |
| Injection duration | Equivalent to or superior to predicate devices | Meets product specifications. |
| Pressure limit | Equivalent to or superior to predicate devices (75 to 1200 PSI) | Meets product specifications. Accuracy validated. |
| Injection/X-ray delay | Equivalent to or superior to predicate devices (e.g., 0-300 sec for both) | Meets product specifications. |
| Operational Robustness | Operation to specification for all conditions of operation, including extremes. | Tests demonstrate operation to specification for all conditions of operation. |
| Fluid Delivery Accuracy | Accurate delivery of programmed volume. | Validated. Delivered volume measured via calibrated equipment, compared to programmed and displayed volumes. |
| Pressure Limit Accuracy | Accurate achievement and display of programmed pressure limit. | Validated. Back pressure accurately measured via calibrated equipment, compared to programmed and displayed values. |
| Flow Rate Delivery Accuracy | Correct algorithm for flow rate, accurate timing, correct drive system incrementation, and accurate achieved flow rate. | Validated. (Four-step process: algorithm verification, servo electronics timing, volume validation, achieved flow rate comparison to spec). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated in terms of number of injections or individual tests. The document refers to "a comprehensive set of tests" and "tests were performed using extremes of operating parameters."
- Data Provenance: The tests directly involve the physical device (Angiomat Illumena Injector) delivering water. This implies the data is prospective as it's generated during the testing phase of the new device. The country of origin for the testing is not specified, but given the company's address and the FDA 510(k) submission, it would likely be in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for these performance tests is based on direct physical measurements using calibrated equipment (e.g., for volume, pressure, time) and comparison against the device's own specifications and programmed parameters. There are no human "experts" establishing a subjective ground truth for these engineering performance metrics.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "adjudication" is based on objective measurements from calibrated equipment compared against predefined specifications. These are not subjective assessments requiring multiple reviewers.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an injector, not an imaging analysis or diagnostic AI tool. Its performance is measured by its mechanical and electronic accuracy in delivering contrast medium, not its impact on human reader interpretation of medical images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the described performance tests essentially are standalone performance tests. The device's ability to accurately deliver programmed flow, volume, and pressure is evaluated directly, without a human operator's influence on the measured output (beyond programming the device). The tests verify the device's inherent mechanical and electronic accuracy.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for these performance tests is objective physical measurement derived from calibrated reference equipment. For example:
- For volume accuracy: Measured delivered volume using calibrated equipment.
- For pressure accuracy: Measured back pressure using calibrated equipment.
- For flow rate accuracy: Verification of algorithms, timing with measurement equipment, and measured delivered volume over time using calibrated equipment.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware injector with embedded software for control, not a machine learning or AI algorithm that "trains" on data in the conventional sense. The "training" for such a system would involve engineering design, calibration, and iterative development rather than a dataset of clinical cases with established ground truth.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device that uses a "training set" with ground truth in the typical sense. The "ground truth" for its development would be based on engineering specifications, physical laws, and performance requirements derived from its intended use and predicate devices.
§ 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.