(108 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 Stellant CT Injector System is comprised of the same main components as the predicate device: an Injector Head, a Display Control Unit, and sterile disposables.
The provided document is a 510(k) summary for the Medrad Stellant CT Injector System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the manner one might find for a novel diagnostic algorithm.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and sample sizes for AI/algorithm performance are not applicable to this document as it describes a medical device (an injector system), not an artificial intelligence or machine learning diagnostic tool.
However, I can extract the information relevant to the device's comparison to its predicate and the testing conducted for its clearance.
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The acceptance criteria for the Medrad Stellant CT Injector System, as presented in this 510(k) summary, are primarily focused on demonstrating substantial equivalence to its predicate device, the Medrad EnVision CT Injector System (K934086 and K993728). This means the device must share the same intended use, similar operational parameters, similar labeling, and be used in a similar manner.
The "study" in this context is the design verification and validation testing conducted as part of Medrad's Quality System, in compliance with FDA's Quality System Regulations (QSRs). The results of these tests demonstrated that the design specifications for the Stellant CT Injector System were met and that it meets applicable requirements of international standards.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use: Inject intravenous contrast media into humans for diagnostic studies in CT applications. | Same (Explicitly stated to maintain the same intended use as the predicate). |
| Operational Parameters: Demonstrated similarity or improvement while maintaining safety and effectiveness. | Similar or Improved: While most parameters are similar, some show advancements (e.g., color LCD vs. monochrome, 1-6 phases vs. 1-10 phases, multi-layered software stops vs. electrical stop with software backup, increased programmable pressure limit, Auto Dock/Retract/Advance, Remote Check for Air). These changes were verified to meet design specifications. |
| Labeling: Similar to predicate. | Similar. |
| Safety: Design controls, risk analysis, and verification/validation testing confirm safety. | Met: Risk analysis performed, and design verification and validation testing conducted. Test results demonstrate design specifications were met and applicable international standards were met. Safety features like "Multi-layered software stops with backup monitoring" are detailed. |
| Components: Comprised of same main components. | Same: Injector Head, Display Control Unit, and sterile disposables. |
| Sterilization & Materials: Similar to predicate. | Same for packaging, sterilization (EtO), Luer fittings (ISO compliant), syringe barrel/plunger materials, and connector tubing materials/length. Max pressure for connector tubing is higher (400 vs 355). |
Details of the "Study" (Design Verification and Validation Testing)
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Sample size used for the test set and the data provenance:
- Not applicable (N/A). This is a hardware device (injector system). The "test set" would refer to physical units of the device and its components undergoing engineering and performance testing rather than a dataset for an algorithm. The document does not specify the number of units tested.
- Data Provenance: The testing was conducted by Medrad Inc. as part of its internal Quality System. The country of origin of the data would therefore be the USA, where Medrad Inc. is located. It is inherently prospective with respect to the device's development and clearance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). "Ground truth" in this context is established by engineering specifications, international performance standards, and comparisons against the predicate device's established performance. The "experts" would be the engineering and quality control teams at Medrad, verifying that the device meets these specifications. Their qualifications would be expertise in medical device design, manufacturing, and regulatory compliance.
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Adjudication method for the test set:
- Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for human expert review of uncertain cases in diagnostic studies. For a hardware device, performance is evaluated against predefined engineering tolerances and standards. Any discrepancies would likely be resolved through further engineering analysis and re-testing until specifications are met.
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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 (N/A). This is not a diagnostic AI device or image reading assistance tool. Therefore, no MRMC study or AI-assistance effectiveness was performed or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable (N/A). This device is a hardware injector system, not an algorithm. Its "standalone" performance refers to its functional operation as a medical device.
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The type of ground truth used:
- For a hardware device like this, the "ground truth" relates to engineering specifications, performance standards (e.g., flow rate accuracy, pressure limits, safety mechanism functionality), and comparison to the predicate device's established capabilities. It's about meeting quantifiable design outputs and demonstrating functional equivalence/improvement.
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The sample size for the training set:
- Not applicable (N/A). There is no "training set" in the context of an AI/ML algorithm for a hardware medical device like an injector system.
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How the ground truth for the training set was established:
- Not applicable (N/A). As there is no training set, this question is not relevant.
§ 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.