(151 days)
The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.
The Premica™-CT Contrast Media Delivery System consists of the following components:
- the console consisting of the pump, the main control panel, and the power . supply,
- . the remote control panel,
- the remote test injection trigger (handswitch), and .
- associated cables. .
- . bottle insulators, and
- pedestal, connector, and wheels. .
The printer is provided as an accessory.
The Premica™-CT Contrast Media Delivery System is a contrast media injector for CT scans. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the MEDRAD® ENVISION CT™ Injector System (K934086), with a focus on safety and effectiveness, particularly concerning differences in multi-patient use and disposables.
Here's a breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner as might be seen for a new device's clinical performance. Instead, it relies on demonstrating that the differences from the predicate device do not raise new issues of safety and effectiveness, primarily through functional equivalence and specific testing related to the identified differences.
| Characteristic (Acceptance Area) | Acceptance Criteria (Implied) | Reported Device Performance / Justification |
|---|---|---|
| Bacterial Contamination (Multi-patient use) | Normal use of disposables does not introduce microbial contamination. | Bacteriological testing demonstrated that normal use of the disposables of the Premica™-CT System does not introduce microbial contamination into the contrast, and that Sets are not susceptible to microbial contamination when the System is used according to instructions for normal operation. |
| Cross-Contamination (Infected Patient) | Risk of cross-contamination from an infected patient is negligible. | Studies demonstrated that the risk of cross-contamination from an infected patient is negligible, as the retrograde migration of microorganisms and viruses was limited solely to the distal end of the Patient Set. |
| Prevention of Disposable Re-use (Bottle Spike) | Design prevents re-use of the Bottle Spike. | The design of the Bottle Spike prevents re-use since the tip breaks off within the bottle upon Spike removal. |
| Prevention of Disposable Re-use (Day Set & Patient Set) | Software control prevents re-use of Day Set and Patient Set past intended durations. | Software control prevents re-use of the Day Set and Patient Set, past their intended durations of use. Validation activities demonstrated that the System fulfills this specification. |
| Functional Equivalence | Performance characteristics are comparable to the predicate or differences do not impact safety/effectiveness. | See Table J-1 and J-1 (Continued) in the 510(k) summary (Characteristics like flow rate range, injection volume, pressure limit, test injection defaults, injection capabilities, interphase delay, protocol storage, saline flush, and audible scan delay signal were either similar to the predicate or the differences were not considered to raise new issues of safety or effectiveness. For example, the Premica™-CT has an air sensor where the predicate does not, which implies an improvement in safety rather than a new risk.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of patient numbers or specific sample sizes for each test mentioned (bacteriological testing, cross-contamination studies, validation activities). The information focuses on the type of testing performed rather than detailed sample sizes.
- Data Provenance: The studies were conducted by Nycomed Amersham Imaging. The specific country of origin for the studies is not mentioned, but it's part of a US regulatory submission. The studies appear to be prospective in nature, as they involve testing the device's performance under simulated or controlled conditions related to its use and re-use prevention.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a contrast media injector, a hardware device. The "ground truth" for its performance would typically involve engineering specifications, microbiology testing, and functional validation against established standards or protocols. It does not involve human interpretation of medical images, so there isn't a concept of "experts establishing ground truth" in the way it applies to diagnostic AI.
- The bacteriologic and cross-contamination studies would have been overseen by microbiology experts, and the validation activities by engineering/quality assurance experts, but no specific number or qualifications are provided in the summary.
4. Adjudication method for the test set
- Not applicable as the tests relate to device function and microbiology, not human diagnostic interpretation requiring adjudication of discrepancies. The results of the tests (e.g., presence/absence of contamination, functionality of re-use prevention) would be objectively measurable.
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 MRMC study was done. This device is a medical device for delivering contrast media, not a diagnostic imaging AI algorithm. Therefore, there is no concept of "human readers" or "AI assistance" in the context of diagnostic interpretation. The studies focused on physical and microbiological performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The performance evaluations mentioned, such as the bacteriological testing, cross-contamination studies, and validation of software control for re-use prevention, are assessments of the device (or its components/software) performing its intended function without direct human intervention in the outcome being measured for that specific test (e.g., observing if bacteria migrate, or if the spike breaks). While a human operates the device, the performance being tested is intrinsic to the device's design.
7. The type of ground truth used
- Microbiological assays: For bacterial and cross-contamination studies (e.g., standard microbiological culture techniques to detect presence or absence of contamination, or specific assays for viral detection).
- Engineering specifications and functional testing: For device re-use prevention mechanisms (e.g., physical inspection for spike breakage, software logs/testing for duration limits).
- Industry standards/guidelines: For general device safety and performance.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning model that requires a training set in the conventional sense. The "training" of the device is its design and manufacturing process, validated through the testing described.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for its design and manufacturing would be established through engineering principles, regulatory standards, scientific research in materials and microbiology, and testing protocols.
§ 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.