(65 days)
The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.
The Medrad Spectris Solaris EP MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially undein a manner similar to the predicate device. The Spectris Solaris EP MR Injector is comprised of the same two main components as the predicate device - Injector Head/Stand (HSU) and Display Control Unit (DCU).
The provided text is a 510(k) summary for the Medrad Spectris Solaris EP MR Injector System, which is a device intended for delivering contrast media during MR applications. This document does not contain information on acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.
Here's what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided document. The submission focuses on comparing features and operational parameters to a predicate device, not on quantitative performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not available. No test set or data provenance is mentioned as this is a 510(k) submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. There is no mention of a test set or ground truth established by experts.
4. Adjudication method for the test set:
This information is not available. No test set or adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/available. The device is an injector, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/available. The device is an injector and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/available. No ground truth is mentioned.
8. The sample size for the training set:
This information is not applicable/available. No training set is mentioned.
9. How the ground truth for the training set was established:
This information is not applicable/available. No training set or ground truth is mentioned.
Summary of what the document does provide regarding device comparison:
The document outlines the similarities and differences between the new device (Medrad Spectris Solaris EP MR Injector System) and its predicate device (Medrad Spectris Solaris MR Injector System K033247). The core argument for substantial equivalence relies on the "same intended use, similar operational parameters, similar labeling and is essentially unde in a manner similar to the predicate device."
Detailed comparison tables show that for most features, the new device is "Same" as the predicate device. The only feature with a slight difference mentioned appears to be the "Flow Rate Injector" where the predicate device specifies two ranges:
- 1 ml/sec to 10 ml/sec +/- (10% +/- 0.02 ml/sec)
- 0.01 ml/sec to 0.99 ml/sec +/- (10% + 0.005 ml/sec)
The new device simply states "Same" for this feature, implying it meets these specifications.
Another minor difference is in the "Syringe System" under "Disposable System," where the new device lists "2 total, 1- 115 ml syringe and 1- 65 ml syringe, 2 - 65 ml syringes" while the predicate lists "2 total, 1- 115 ml syringe and 1- 65 ml syringe." This seems to indicate an additional option for syringe configurations.
The FDA's decision to grant 510(k) clearance is based on the determination that the device is "substantially equivalent" to the predicate device, not necessarily on a detailed study demonstrating performance against specific acceptance criteria in the way a clinical trial for a new drug or novel medical algorithm would.
§ 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.