(270 days)
The Royal Flush® Plus High-Flow Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
The Royal Flush® Plus High-Flow Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Plus High-Flow Catheter is available in 5.0 and 6.0 French sizes and is manufactured in lengths of 25 to 110 centimeters. Each configuration includes a luer lock adapter and a single lumen shaft. For catheters with a labeled length 110 cm or longer, the length is measured from the proximal end of the strain relief to the distal end of the catheter (with pigtail curled if present). For other sizes, the length is measured from the distal end of the strain relief to the distal end of the catheter (with pigtail curled if present).
This FDA 510(k) summary describes a medical device, the Royal Flush® Plus High-Flow Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/ML-based performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance with ANSI AAMI ISO 10993-1:2009(R)2013 | Predetermined acceptance criteria were met. |
| Tensile Testing (Hub-to-Shaft Bond): Peak load value in accordance with BS EN ISO 10555-1:2013, Annex B | Predetermined acceptance criterion was met. |
| Tensile Testing (Tip-to-Shaft Bond): Peak load value in accordance with BS EN ISO 10555-1:2013, Annex B | Predetermined acceptance criterion was met. |
| Liquid Leakage Testing: No liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C | Predetermined acceptance criterion was met. |
| Air Leakage Testing: No air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D | Predetermined acceptance criterion was met. |
| Static Burst Testing: Characterized catastrophic failure pressure in accordance with BS EN ISO 10555-1:2013, Annex F | Testing successfully characterized the catastrophic failure pressure. |
| Dimensional Verification Testing: Dimensional requirements within specified tolerance | Predetermined acceptance criteria were met. |
| Hub Pressure Testing: Hub pressure (at maximum flow rate) does not exceed static burst pressure | Testing successfully characterized the hub pressure and verified it does not exceed the static burst pressure. |
2. Sample size used for the test set and the data provenance
The document does not specify quantified sample sizes for each test. It refers to "applicable testing" and "the subject device" being subjected to tests, implying a sufficient number of units were tested to demonstrate compliance with the standards. The tests appear to be conducted on manufactured devices, likely in a lab setting by Cook Incorporated in the USA, and are prospective in nature for regulatory submission. Data provenance is internal to Cook Incorporated, likely conducted in their facilities in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument (catheter), not an AI/ML-based diagnostic or imaging device. Its performance is evaluated through engineering and biocompatibility testing against established consensus standards, not by expert interpretation of data or images.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, quantitative measurements against international standards (e.g., ISO, AAMI). There is no "adjudication" in the sense of reconciling differing expert opinions.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the performance tests are the established international consensus standards (e.g., ANSI AAMI ISO 10993-1, BS EN ISO 10555-1) and internal design specifications, which define acceptable parameters for physical and biological characteristics of medical devices of this type.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The "training" in device development refers to iterative design, prototyping, and testing, not statistical model training.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set. The design and development of the device would be guided by engineering principles, clinical requirements, and regulatory standards.
§ 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).