(385 days)
The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.
The Optistar MR is a contrast delivery system that is designed to inject image enhancing contrast media into the vascular system of a human during an MRI (Magnetic Resonance Imaging) procedure. The main components of the Optistar MR system are the console, power pack, and powerhead. The console resides in the control room of the MR suite, while the power pack and powerhead remain in the scanning room with the patient. The parameters of the injection, such as volume and flow rate are programmed by the operator using a touch screen on the console. The console is powered by AC line voltage at 110 Volts at 60 Hz. The console communicates with the 24 VDC powerpack which in turn supplies power and the injection parameters to the powerhead. The powerhead performs the injections by driving one or two lead screw rams. The rams push the plunger of a syringe, which expels fluid from the barrel of the syringe.
Here's a breakdown of the acceptance criteria and the study details for the Optistar MR Injector System, based on the provided document:
Acceptance Criteria and Device Performance
The document states that performance testing was conducted to verify the Optistar MR Injector System's ability to achieve its specified parameters, as outlined in the substantial equivalence chart. The "substantial equivalence chart" itself effectively serves as the acceptance criteria for various parameters by comparing the new device to the predicate device. The performance testing section then reports that the device "successfully delivered" or "fell within the specified range" for these criteria.
| Characteristic/Feature | Acceptance Criteria (from predicate or defined by Optistar MR) | Reported Device Performance (Optistar MR) |
|---|---|---|
| Volume Accuracy | "Accurately measured and compared to the volume programmed" (implicit acceptance of close agreement). The predicate device's volume limits are 1-63 ml in 1 ml increments. Optistar MR specifies 1-61 ml (60ml syringe) and 1-27 ml (25ml syringe). | "Over the range of volumes programmed, the Optistar MR Injector system successfully delivered the programmed volume within the allowable specification accuracy. This held true regardless of syringe size (25 ml or 60 ml), injection side (A or B) or phase type (single or dual). " |
| Flow Rate Accuracy | Flow rates should be within the specified range (0.1 to 10 ml/sec for 60ml syringe, 0.1 to 8.0 ml/sec for 25ml syringe, 0.1 to 7.0 ml/sec for flushing fluid). | "Any injection accurately measured, that was not pressure limited, fell within the specified range. If pressure-limited, flow rate reduces, but the programmed volume is still delivered." |
| Pressure Monitoring | Monitored pressure should be within the upper limit set for each syringe type. The device's displayed pressure should be within an accuracy range of the measured pressure. Predicate max pressure limit is 300 psi. Optistar MR is 200 psi (25ml syringe) and 150 psi (60ml syringe). | "In all cases the injector was within the accuracy range" (referring to the comparison between measured and displayed pressure). |
| Drip Mode Accuracy | Expected volume (calculated from programmed increment, time interval, flow rate, and measuring time) should match the actual measured volume within a specified accuracy range. | "Over the range of various drip mode parameters, the system fell within the specified accuracy range for all cases." |
| Manual Speeds Accuracy | 1 ml/s for single key press, 5 ml/s for accelerator key press, within a specified accuracy range. | "The tested speeds were within a specified accuracy range for both slow and fast speeds, for both A and B side, and for both 25 ml and 60 ml syringes." |
| General System Capability | Ability to perform all functions outlined in the substantial equivalence chart, safely and effectively. | "The Optistar MR Injector System proved its ability to perform within its specified parameters. As a result, its performance is deemed acceptable and substantially equivalent to the predicate device." |
Study Information
The document describes "Performance Testing" to verify the device's capabilities, primarily to support the claim of substantial equivalence to the predicate device (Medrad Spectris MR Injection System K935668).
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Over the range of volumes programmed," "During the test injections," "In all cases," "Over the range of various drip mode parameters," and "The tested speeds." This suggests that a range of parameters and configurations were tested, but no specific number of injections or test cases is provided.
- Data Provenance: The testing was performed internally by Liebel-Flarsheim. The location is Cincinnati, OH, USA, as indicated by the company address. This is a prospective validation of the device's technical specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a performance validation of a medical device's physical functions (e.g., flow rate, volume delivery), not an diagnostic imaging study requiring expert interpretation of medical images. The "ground truth" for the test set was defined by the device's design specifications and accurately measured physical quantities (e.g., actual delivered volume, measured flow rate, actual pressure).
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Adjudication method for the test set:
- Not applicable. This was a physical performance test, not a subjective assessment requiring adjudication. Measurements were taken and compared against specifications.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This study is a performance validation of the injector system's mechanical and software functions (flow, volume, pressure, etc.), not a diagnostic imaging study involving human readers and AI for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance testing described is a standalone evaluation of the device's mechanical and software performance against its specifications, without a human operator's "performance" being part of the primary measured outcome (beyond programming the desired parameters). The device's ability to inject as programmed is the focus.
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The type of ground truth used:
- Defined Performance Specifications / Measured Physical Quantities: The ground truth was established by the design specifications of the device for parameters like volume, flow rate, pressure limits, and speeds. The "truth" for the comparison was then actual physical measurements taken during the tests (e.g., measured volume, calculated flow rate, physical pressure readings).
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The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no training set. The device operates based on programmed logic and physical mechanisms.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device validation.
§ 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.