(20 days)
The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, . or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The AngioDynamics, Inc. Morpheus® PICC and Procedure Kits are currently available in sizes ranging from 3F - 5F Single Lumen and 5F - 7F Dual Lumen Catheters. The catheter shaft has ink markings spaced 1 cm apart. These markings start at the hub and proceed distally to the catheters' tip. The markings provide the physician a guide to use when trimming the catheter to the desired length. The Morpheus® CT PIC Catheter is to be labeled at the following CT Injection Flow Rates:
This 510(k) summary describes a special 510(k) premarket notification for a device modification to the AngioDynamics Morpheus® CT PICC and Procedure Kit. This submission focuses on non-clinical performance data (bench testing) to demonstrate substantial equivalence to predicate devices, particularly regarding the ability to withstand specified CT injection flow rates.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly defined by the reported performance metrics of the various catheter sizes, which are then compared to a predicate device or internal standards to ensure reliability and safety for their intended use, particularly for power injections of contrast media. The device must demonstrate sufficient static and dynamic burst pressure resistance for its labeled CT flow rates.
| Catheter Size | Catheter Length | Acceptance Criteria (Implied) - Withstand pressure at specified CT Flow Rate | Reported Device Performance (Avg. Static Burst Pressure) | Reported Device Performance (Avg. Dynamic Burst Pressure) | Labeled CT Flow Rate |
|---|---|---|---|---|---|
| 3F Single | 65 cm | Sufficient to allow 1 mL/sec CT Flow | 311 psi | 742 psi | 1 mL/sec |
| 4F Single | 65 cm | Sufficient to allow 4 mL/sec CT Flow | 303 psi | 817 psi | 4 mL/sec |
| 5F Single | 65 cm | Sufficient to allow 7 mL/sec CT Flow | 260 psi | No burst resulted at extremely high flow rates | 7 mL/sec |
| 5F Dual | 65 cm | Sufficient to allow 5 mL/sec CT Flow | 217 psi | 611 psi | 5 mL/sec |
| 6F Dual | 65 cm | Sufficient to allow 7 mL/sec CT Flow | 262 psi | 620 psi | 7 mL/sec |
| 7D Dual | 65 cm | Sufficient to allow 8 mL/sec CT Flow | 260 psi | No burst resulted at extremely high flow rates | 8 mL/sec |
Note: The acceptance criteria are implicitly met if the device demonstrates these burst pressures at the indicated flow rates, ensuring safe operation within the specified parameters. The "Acceptance Criteria (Implied)" column indicates the functional requirement that the device is intended to meet.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for each specific test (e.g., number of catheters tested for burst pressure). However, the tests are described as "non-clinical tests" and "bench testing." Therefore, the data provenance is from laboratory tests, not human or patient data. The country of origin for the data is implicitly the United States, given the manufacturer's location and FDA submission. The nature of the data is prospective, as these tests are conducted specifically to evaluate the modified device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission relies on non-clinical (bench) testing, not on expert evaluation of clinical data or images. The "ground truth" is established through physical measurements and engineering standards.
4. Adjudication Method for the Test Set
Not applicable. As this involves bench testing, there is no adjudication method in the sense of expert review of discrepancies. The results are physical measurements. Quality control procedures and adherence to test protocols would ensure the reliability of the measurements.
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 a 510(k) submission for a non-AI medical device (a catheter) and involves non-clinical performance data. Therefore, an MRMC study or AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a 510(k) submission for a non-AI medical device (a catheter). There is no algorithm or standalone performance in the context of AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the physical performance characteristics of the catheter, specifically its resistance to burst pressure under various flow conditions. This is established through direct, quantifiable physical measurements in a laboratory setting, such as:
- Pressure readings (psi): Measured by specialized equipment during static and dynamic burst tests.
- Flow rates (mL/sec): Precisely controlled by infusion pumps during testing.
- Observation of catheter integrity: Visual confirmation of whether a burst occurs.
This is a form of engineering/performance data ground truth.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model. The modification is evaluated through direct performance testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model. The product's intended performance is established through engineering design, material selection, and rigorous physical testing.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”