(269 days)
The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
This submission for the Medtronic® Angiographic Catheter (K980973) is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance studies that would typically be required for a novel device.
Therefore, the provided text does not contain the detailed acceptance criteria or a comprehensive study report as would be expected for a product with complex software or AI components. The information is limited to a general statement about meeting specifications and substantial equivalence.
Here's an analysis based on the provided text, while acknowledging the limitations for your specific request:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All applicable specifications | "Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use." |
| Biocompatibility | "All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic® Angiographic Catheters." |
| Substantial Equivalence | The device is considered substantially equivalent to the Medtronic Cascade® Angiographic Catheter and USCI® Angiographic Catheter. |
Study Information (Based on the provided text)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not explicitly stated. The submission refers to "Test results" generally, implying laboratory or engineering testing rather than a clinical human subject study with a "test set" as typically understood in AI/medical imaging contexts.
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 stated. This submission does not involve an AI device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for a physical device like a catheter would be its physical properties, dimensions, material integrity, and functionality, which are assessed through engineering and materials testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable/Not stated. This is relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution. For a physical medical device, testing typically involves objective measurements against established engineering standards.
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
* No. This device is a diagnostic intravascular catheter, not an AI or imaging interpretation system. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
* Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not explicitly detailed, but implied to be engineering specifications and material standards. For a catheter, ground truth would relate to its physical dimensions, material strength, biocompatibility, flow rates, pressure measurement accuracy, and resistance to kinking, all measured against predetermined engineering and safety standards.
8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model requiring a "training set."
9. How the ground truth for the training set was established
* Not applicable. This is a physical device, not an AI model.
Summary of Limitations for your Request:
This 510(k) submission for a physical medical device (catheter) precedes the era of widespread AI in medical devices and therefore does not provide the type of detailed information on AI algorithm performance, test set characteristics, expert involvement, or ground truth establishment that your questions are designed to elicit. The "study" mentioned is likely a series of laboratory and engineering tests to ensure the catheter meets its design specifications and is safe and effective for its stated indications for use, in comparison to existing predicate devices.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).