(269 days)
The Royal Flush® Catheters are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.
The Royal Flush® Catheter subject of this submission is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Catheter is available in a 3.0 French size and is manufactured in lengths of 30 to 75 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen shaft.
Here's an analysis of the acceptance criteria and study information for the Royal Flush Catheter based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance with applicable sections of AAMI ANSI ISO 10993-1:2009(R)2013 | Predetermined acceptance criteria were met. |
| Tensile Testing of Hub to Shaft Joint | Peak load value of the hub-to-shaft connection shall be in accordance with applicable values of BS EN ISO 10555-1:2013, Annex B. | Predetermined acceptance criterion was met. |
| Tensile Testing of Tip to Shaft Joint | Peak load value of the tip-to-shaft connection shall be in accordance with applicable values of 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 | Characterization of catastrophic failure pressure for the catheter in accordance with BS EN ISO 10555-1:2013, Annex F. (Implied acceptance is successful characterization, and the value meets safety standards, though specific numeric criteria are not provided). | Catastrophic failure pressure was successfully characterized. |
| Dimensional Verification Testing | Dimensional requirements of the subject devices are within a specified tolerance. | Predetermined acceptance criteria were met. |
| Tensile Testing of Sideports | Peak load values of the sideported area of the catheter shaft shall be in accordance with applicable values of BS EN ISO 10555-1:2013, Annex B. | Predetermined acceptance criterion was met. |
| Hub Pressure Testing | Hub pressure, when tested at maximum flow rate, does not exceed the static burst pressure. (Implied acceptance is meeting this condition). | Hub pressure was successfully characterized, and it was verified that it does not exceed static burst pressure. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It states that "the Royal Flush® Catheter, subject of this submission, was subjected to applicable testing." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given the nature of device testing (mechanical, physical, and biocompatibility), these tests are typically conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The studies described are in vitro and ex vivo engineering and biocompatibility tests, not clinical studies requiring expert interpretation of patient data or images to establish a 'ground truth'. The 'ground truth' here is based on objective measurements and established international standards (e.g., ISO, AAMI).
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth from subjective data. The tests performed are objective, with results either meeting or not meeting predefined criteria.
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
This section is not applicable. The Royal Flush Catheter is a medical device (intravascular catheter) for contrast media delivery, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. As stated above, the Royal Flush Catheter is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for these tests is based on objective measurements against established international and industry standards. For example:
- Biocompatibility: Adherence to AAMI ANSI ISO 10993-1:2009(R)2013 standards for cytotoxicity, sensitization, systemic toxicity, etc.
- Mechanical Tests (Tensile, Leakage, Burst): Adherence to BS EN ISO 10555-1:2013 standards.
- Dimensional Verification: Conformance to specified manufacturing tolerances.
8. The Sample Size for the Training Set
This section is not applicable. The Royal Flush Catheter is not an AI/ML device that requires a training set. The "training" for such a physical device involves robust design, materials selection, and manufacturing processes, followed by rigorous testing as described.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
§ 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).