(277 days)
The CT Expres™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The CT Expres™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set disposable must be discarded after each patient procedure.
The CT Expres™ 3D 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 CT Exprès™ 3D Contrast Media Delivery System (CT Exprès™ 3D) is designed for the controlled, automatic administration, on the venous side, of water-soluble radiographic medical imaging products for contrast enhancement of computed tomography (CECT) imaging. The positive pressure necessary for the injection is generated by a rotary peristaltic pump that is part of the disposable Patient Set. The system is designed to protect the patient against air injection and occlusion by incorporating sensors to detect air and pressure within the fluid pathway.
The system consisting of the CT Exprès™ 3D injector unit, main and remote control panels, hand switch, bottle insulators, floor stand and disposables (Bottle Spike Type B, Day Set III HP, Patient Set), is specifically designed for the delivery of Isovue® (Iopamidol Injection) contrast media and saline. The Isovue is supplied for use in the CT Exprès™ 3D System as an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media per Day Set III HP disposable or 10 hours, whichever comes first.
The CT Exprès™ 3D Contrast Media Delivery System is a combination product. As stated above, the CT Exprès™ 3D is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), (submitted in the supplemental New Drug Application sNDA to the Isovue NDA 20-327 (S011)).
The provided text describes a medical device, the CT Exprès 3D Contrast Media Delivery System, and its substantial equivalence to a predicate device (CT Exprès III) based on non-clinical performance testing. It does not contain information about acceptance criteria and device performance in the context of an AI/ML-driven medical device study. Therefore, I cannot fulfill your request for that specific information from this document.
However, I can extract information related to the device itself and the non-clinical testing performed, which serves a similar purpose to acceptance criteria in the context of device validation.
Here's an attempt to structure the information based on your request, as much as possible with the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of an AI/ML study. Instead, it details design verification and validation testing for the CT Exprès™ 3D Contrast Media Delivery System and compares it to a predicate device. The performance values listed are implicitly the accepted performance for the device.
| Performance Characteristic | Acceptance Criteria (Implied) & Reported Device Performance (CT Exprès™ 3D) | Predicate Device Performance (CT Exprès™ III™) |
|---|---|---|
| Injection capabilities | Up to 24 phases per patient (8 phases per injection; up to 3 injections per patient) | Up to 15 phases (5 phases per injection; up to 3 injections per patient) |
| Injection rates for contrast media | 0.5 – 9.0 mL/s | 0.5 – 9.9 mL/s |
| Injection rates for saline | 0.1 – 9.0 mL/s | 0.5 – 9.9 mL/s |
| Injection Volume per injection | 10 – 200 mL per injection | 0 – 200 mL |
| Flow rate and Volume accuracy | ± 10% for a programmed injection volume between 10mL and 59mL | |
| ± 6% for a programmed injection volume between 60mL and 200mL | ± 6% | |
| Needle Size | 16-24G | 16-27 G |
| Injection pause | 0 - 400 sec | 0-99 sec |
| Scan delay | 0 - 400 sec | 0-99 sec |
| Priming rate | 1.5mL/s (manual) | |
| 6.0mL/s (automatic) | 1 mL/s | |
| Air Detection Technical Limit | 0.04mL | 0.04mL |
| Air Detector Alarm Limit | For programmed injection volume ≤ 35mL CM, 1.25mL | |
| For programmed injection volume >35mL CM, 1.25mL if fragment air bubble, otherwise an additional air volume of 0.75mL is tolerated. | 0.3 mL | |
| Occlusion Detection Alarm Limit | 132 PSI ± 17.4 PSI (9.1 bar ± 1.2 bar) | 8 bar ± 1 bar |
| Biocompatibility | Conformance confirmed (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, pyrogenicity) | N/A (tested as part of predicate submission, assumed to conform) |
| Electrical safety, EMC | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Software V&V | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Reliability | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Sterilization validation | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Real time aging | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Packaging validation | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Transportation testing | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Cleaning/disinfection | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Microbial ingress | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Cross-contamination | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Chemical compatibility | Conformance demonstrated | N/A (tested as part of predicate submission, assumed to conform) |
| Simulated use usability validation | Users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device. | N/A (tested as part of predicate submission, assumed to conform) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance testing and simulated use usability validation. It does not mention a "test set" in the context of an AI/ML study, nor does it specify sample sizes for data used in such a context. The testing appears to be primarily laboratory-based or simulated.
- Non-clinical performance testing: No specific sample sizes for tests like electrical safety, reliability, flow rate accuracy, etc., are provided, other than the general statement that they were performed to demonstrate conformance.
- Simulated use usability validation: This involved "users" but no specific number of participants or data provenance information is given.
The document is a 510(k) submission to the FDA (USA), implying the evaluation occurred within a regulatory framework applicable to the US market. The manufacturer is Bracco Injeneering S.A., based in Switzerland. The data provenance for the non-clinical testing and simulated use is not explicitly stated beyond these general facts. The testing conducted would be considered prospective for the device under review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the document describes a medical device, a contrast media delivery system, not an AI/ML algorithm that requires expert ground truth labeling in the way a diagnostic AI would. The "ground truth" for this device would be established through engineering specifications, physical measurements, and adherence to medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable as the document describes a contrast media delivery system, not an AI/ML diagnostic or assistive device that would involve human readers interpreting output with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the reported non-clinical performance and simulated use testing, the "ground truth" would be established by:
- Engineering specifications and standards: For characteristics like electrical safety, electromagnetic compatibility, dimensions, weight, power requirements.
- Physical measurements and laboratory testing: For accuracy of injection volume, flow rate, air detection limits, occlusion detection limits, tubing dimensions.
- Biocompatibility standards: For disposable materials.
- Validated testing protocols: For sterilization, aging, packaging, transportation, microbial ingress, cross-contamination, chemical compatibility.
- Usability assessments: For "users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device" through observation and feedback in a simulated environment.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the performance characteristics measured or validated in this submission.
8. The sample size for the training set
This information is not applicable as the document describes a deterministic medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.