(168 days)
The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.
The Stellant CT Injector System with XDS accessory is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications. The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated within the sensors' field of view.
The provided text describes the MEDRAD Stellant CT Injector System with the Extravasation Detection System (XDS) accessory, which is designed to aid in the detection of intravenous contrast media extravasation during CT applications.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states the intended performance of the XDS accessory without explicitly defining "acceptance criteria" in a separate table. The key performance characteristic mentioned for the XDS accessory is its ability to detect extravasation before 20ml of fluid is extravasated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detect extravasation of intravenous contrast media. | The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications. |
| Detect extravasation before a specific volume is accumulated. | "The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated within the sensors' field of view." |
| Provide alerts upon detection. | "Audible and visual alert if an extravasation of up to 20ml is detected under sensor region." |
| Halt the injector system upon extravasation detection. | "Will halt the Stellant injector system in the event of an extravasation event." |
| Does not replace existing healthcare professional duties. | "The XDS accessory does not replace or change the existing duties of the healthcare professionals performing a CT scan. This accessory provides a supplemental monitoring function to normal extravasation diligence and therefore does not impose additional risk to the patient." |
| Designed for adults and antecubital injections only. | "The XDS System is designed for use on adults in antecubital injections only. The system is not validated for use on the back of the hand or in pediatrics." (This is a contraindication but also defines the scope of validated performance). |
| Compatible with specific Stellant CT Injector models. | "The Control Room Module/Stellant Interface signal output is not intended to be used with any equipment other than with Medrad Stellant CT Injector models Sx and Dx." (Also a contraindication, implying validated performance within this compatibility). |
| Does not alter injector system's primary functions or performance. | "This accessory does not otherwise alter the injector system's primary functions or performance during a CT procedure." |
| Patient Sensor Technology | Gold-plated antenna shrouded in ferro-plastic absorber covered by a silicone overmold. (This describes the design element for detection, rather than a performance metric, but is relevant to how it meets its detection goal). |
| Material Biocompatibility and Sterilization | Mention of material compositions (e.g., medical grade tape, polyethylene, acrylate adhesive), EtO sterilization, and Limulus Amebocyte Lysate (LAL) test to USP requirements for pyrogen-freeness, indicating compliance with general medical device safety standards for patient contact. |
| Compatibility with existing injector functions (e.g., flow rate) | The comparison table (Table 1) consistently notes that all operational parameters and features of the proposed device related to injection (e.g., flow rate, pressure limit, syringe types, programming) are "Same" as the predicate device, implying that the XDS accessory does not negatively impact these core functionalities. |
Note: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It highlights the design intent and performance claims of the new accessory rather than presenting detailed study results with quantitative metrics against formal acceptance criteria in the way a clinical study report might. It implies that these performance characteristics were verified during the development and testing process for regulatory submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies supporting the XDS accessory. 510(k) summaries often focus on design and functional verification rather than detailed clinical trial data, especially for accessories that don't directly modify the primary therapeutic or diagnostic output of the main device. The information indicates that the XDS accessory "provides a supplemental monitoring function" and "does not impose additional risk to the patient," suggesting that extensive clinical trials might not have been deemed necessary for this type of device accessory to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used or their qualifications to establish ground truth for any test set. Given the nature of extravasation detection (a physical event during an injection), the "ground truth" during testing would likely be based on direct observation of fluid leakage, either in vitro models or potentially controlled in vivo animal studies, rather than expert interpretation of images or clinical outcomes from human subjects.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of detail is usually found in clinical trial protocols where expert consensus is needed to define an endpoint or ground truth, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The XDS accessory is described as a supplemental monitoring function and does not replace human diligence. Therefore, a study comparing human readers with and without AI assistance (which would be the purpose of an MRMC study if the XDS were an AI diagnostic tool) is not applicable or described in this submission. Its function is to alert, not to interpret images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
While not explicitly called a "standalone study", the core functional description of the XDS accessory implies a standalone performance objective: "The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated... Will halt the Stellant injector system in the event of an extravasation event." This suggests that the detection mechanism operates independently to identify extravasation and trigger an alert/halt, regardless of human interaction. The device's ability to detect extravasation up to 20ml and then alert/halt the injector system is its standalone performance claim. However, no specific study data or methodology for proving this standalone performance is detailed in the summary.
7. The Type of Ground Truth Used
Given the function of the device, the ground truth for extravasation detection would most likely be direct physical observation of fluid extravasation, either in in-vitro models designed to simulate antecubital injections or potentially in-vivo animal models. The document does not specify the exact method for establishing ground truth, but for a physical detection system, it wouldn't typically involve expert consensus on images or pathology as it would for a diagnostic imaging AI. It's about physically sensing the presence of extravasated contrast.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. The XDS accessory, based on its description (gold-plated antenna, ferro-plastic absorber), appears to be leveraging sensor technology to detect changes related to extravasation rather than being a machine learning or AI-driven system that would traditionally require a "training set" in the context of image analysis or algorithm development. Therefore, the concept of a training set as typically understood for AI/ML devices might not be directly applicable, or if any calibration/parameterization was done, it's not detailed.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" or AI/ML components for which a training set ground truth would be established, this information is not provided in the document.
Summary of what's provided for studies:
The 510(k) summary primarily focuses on describing the device, its intended use, contraindications, and demonstrating substantial equivalence to a predicate device by comparing features and operational parameters. It states the functional goal of the XDS accessory (detecting extravasation before 20ml and halting the injector) but does not include detailed information about specific studies, sample sizes, expert involvement, or adjudication methods that would typically be found in a clinical study report for an AI/ML device or a device requiring extensive clinical validation. The nature of the device as a physical sensor-based detection system, rather than an image interpretation system, likely means the validation approach focused on engineering performance, reliability, and safety in simulated or bench environments to demonstrate its functional claims.
§ 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.