(144 days)
The CT Exprés III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The system consists of the CT Exprés III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.
This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.
This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.
The CT Exprés III™ Contrast Media Delivery System (CMDS) is a programmable, software driven, electromechanical, high-pressure contrast media injection system.
The positive pressure necessary for the injection is generated by a disposable rotary peristaltic cassette, located inside one of the disposable (Patient Set).
The CT Exprés III™ Contrast Media Delivery System consists of the main following elements:
- . The instrument, i.e. the main unit (injector unit and power supply), the main control panel, and associated cables.
- . Accessories, i.e. the handswitch.
- Detachable parts, i.e. the remote control panel, the bottle insulators, and the pedestal pole. .
- Three associated proprietary disposables creating a complete fluidic pathway from the . bottle of CM to the patient, i.e. the "Bottle Spike", the "Day Set III" and the "Patient Set".
The printer and ceiling mount are provided as optional devices for use in combination with the CT Exprés III™.
The provided document is a 510(k) summary for the CT Exprés III™ Contrast Media Delivery System (CMDS). It details the device's intended use and compares it to a predicate device (Premica™-CT CMDS). However, it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, typically found in detailed performance study reports.
The document primarily focuses on establishing substantial equivalence to the predicate device by comparing:
- Intended Use: Both are for controlled administration of contrast media for CT scans. The CT Exprés III™ expands usage to all patients, unlike the predicate device which excluded those under 16 years.
- Physical Design: Similar components (remote panel, single-patient disposables, multi-dose container compatibility, prevention of reuse features), with slight weight differences.
- Operational Characteristics: Similar programmable flow rates (0.5 - 9.9 mL/s vs 0.2 - 9.9 mL/s), identical programmable injection volume (0 - 300 mL), 9 min 59 sec maximum injection duration, identical pressure limit (8 bar/120 psi), test injection, saline flush, connecting tubing length, and storage for 100 protocols.
- Differences:
- Injection Capabilities: CT Exprés III™ can handle up to 5 phases (Saline pre-flush, CM phase one, Saline intermediate flush, CM phase two, Saline post-flush), while the predicate device could only handle up to 3 phases (CM phase one, CM phase two, Saline post-flush).
- Fluid Containers: CT Exprés III™ can simultaneously accommodate two contrast media bottles and one saline container, whereas the predicate handled only two fluid containers.
- Access Gauge: CT Exprés III™ accepts 16-27 G, including smaller needles (23-27 G), with an automatic safety feature to prevent injection if the programmed rate exceeds limits for small gauges. The predicate only accepted 16-22 G.
The document states, "These differences are explained for in the CT Exprés III™ operator's manual and software programming capabilities and do not raise any new questions of safety or effectiveness." This implies that the differences observed are not considered substantial enough to warrant extensive new clinical or performance studies for regulatory approval in the context of a 510(k) submission.
Due to the nature of this 510(k) summary, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth details, training set size) is not explicitly present because the submission hinges on substantial equivalence rather than a de novo clinical validation study with specific performance metrics against pre-defined acceptance criteria.
Here's an attempt to answer based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission seeking substantial equivalence to a predicate device, explicit "acceptance criteria" for novel performance metrics are not typically defined in the same way as for a PMA (Premarket Approval) or a de novo submission. Instead, the "acceptance criteria" are implied to be that the new device performs at least as well as, or introduces only minor differences from, the predicate device without raising new safety or effectiveness concerns.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CT Exprés III™ CMDS) |
|---|---|---|
| Intended Use | Controlled administration of contrast media for CT scans, with no new safety/effectiveness concerns. Potential to broaden patient population without adverse impact. | Indicated for controlled automatic administration of CM to human subjects undergoing CT scans. Can be used with all patients (unlike predicate's age restriction). |
| Flow Rate | Functionally equivalent to 0.2 - 9.9 mL/s. | Programmable 0.5 - 9.9 mL/s. (Slightly narrower low end, but deemed equivalent; also acknowledges flow rate may be limited with very small needles due to pressure limit). |
| Injection Volume | Equivalent to 0 - 300 mL per injection. | Programmable 0 - 300 mL per injection. |
| Maximum Injection Duration | Equivalent to 9 min 59 sec. | 9 min 59 sec. |
| Pressure Limit | Equivalent to 8 bar (ca. 120 psi) for safety alarms. | 8 bar (ca. 120 psi). Incorporated with pressure sensors for occlusion alarms. |
| Injection Phases | At least up to 3 phases. | Up to 5 phases: Saline (pre-flush), CM (phase one), Saline (intermediate flush), CM (phase two), Saline (post-flush). (Improved capability over predicate). |
| Number of Fluid Containers | Accommodate at least two fluid containers. | Can simultaneously accommodate two bottles of contrast media and one container with saline. (Improved capability over predicate). |
| Access Gauge | Accept 16-22 G needles. | Accepts 16-27 G needles. Includes very small sizes (23-27 G) with a safety feature: automatically displays information and prevents function if an unsafe injection rate is programmed for small gauges. (Improved capability and safety over predicate for smaller gauges). |
| Safety Features | Presence of pressure sensors and Air-In-Line sensors. | Incorporates pressure sensors (8 bar alarm) and Air-In-Line sensors for patient safety. |
| Disposables | Single patient use, designed to prevent reuse. | Single patient use ("Patient Set"). Disposables have design features that prevent their reuse. |
| Temperature Control | Passive temperature control for heated contrast. | Bottle insulators for passive temperature control. |
| Storage Protocols | Equivalent to 100 protocols. | Stores 100 protocols. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The 510(k) submission does not describe a clinical test set with human or animal subjects for performance evaluation against specific criteria. It relies on a comparison of technical specifications and design features to a legally marketed predicate device.
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)
Not applicable/Not provided. No "test set" requiring expert ground truth establishment is described in this 510(k) summary. The comparison is based on engineering specifications and design.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No test set or adjudication process is detailed.
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
Not applicable/Not provided. This device is an electromechanical contrast media injector, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related effectiveness assessment is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a hardware system with software controls, not a standalone algorithm. Its performance is inherent in its electromechanical function, not an "algorithm-only" assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. The ground truth in this context would be the predicate device's established performance and the engineering specifications used for the new device. No clinical outcomes data or pathology reviews are presented here.
8. The sample size for the training set
Not applicable/Not provided. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no training set mentioned, the establishment of its ground truth is not applicable.
§ 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.