(143 days)
The AngioDynamics, Inc. Morpheus® SMART PICC CT 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 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits device description is as follows:
• 6 French outside diameter, reversed tapered shaft design
• Catheter usable length is 55 cm
• Shaft inner lumen is a triple lumen design
• Catheter shaft tubing is marked with depth indicators
• The catheter has one power injectable lumen
• The product labeling warns against power injection procedures through the two small lumens, which are clearly identified as non CT.
• Three extension legs to facilitate injection through each lumen of the catheter shaft.
The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is a medical device. The provided text describes the device, its intended use, and the verification activities undertaken to demonstrate its safety and effectiveness, primarily through comparison to predicate devices.
Here's the detailed breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Proposed Device Acceptance Criteria | Proposed 6F Triple Catheter (K093406) T=0 (Initial) | Proposed 6F Triple Catheter (K093406) T=1 (After Accelerated Aging/Sterilization) |
|---|---|---|---|
| Tip Whip | Tip "whipping" must be less than or equal to predicate devices | Pass | Pass |
| Tip Displacement | Tip displacement must be less than or equal to predicate devices | Pass | Pass |
| CT Injection - Catheter Flow Rate | Flow Rate = 5mL/sec ± 0.5mL/sec with 95% confidence that 95% of the population meets specification | (Value not explicitly stated, but assumed to pass as no failure indicated) | (Value not explicitly stated, but assumed to pass as no failure indicated) |
| CT Injection - CT Lumen Integrity | CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 5mL/sec with a 95% confidence that 80% of the population meets specification | Pass | Pass |
| Aspiration | Minimum aspiration rate to be 3cc/min using a 10cc syringe without total collapse (all three catheter lumens) with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Gravity Flow Rate | Minimum gravity flow rate to be 750 ml/hr for CT lumen and 182 ml/hr for non-CT lumens with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Stylet Withdrawal Testing | Stylet withdrawal force must be less than 2 lbs with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Wire Withdrawal Testing | Guidewire withdrawal force must be less than 2 lbs with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Static Burst | Catheter burst pressure must be greater than 150 psi with 95% confidence that 95% of the population meets the specification | Pass | Pass |
| Dynamic Burst | Catheter dynamic burst pressure must be greater than 300 psi with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Extension Leg to Natural Color Hub - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Non-CT Extension Leg to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| CT Extension Leg to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Shaft to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Catheter Shaft (at nominal OD) - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Pressure Monitoring | No difference observed between SVS and catheter in mean pressure, systolic pressure and diastolic pressure as compared to predicate devices | Pass | Pass |
| Natural Frequency | The natural frequency must be equal to or greater than the predicate device | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of devices (sample size) used for each individual test. Instead, acceptance criteria are generally expressed with statistical confidence levels (e.g., "95% confidence that 95% of the population meets specification" or "95% confidence that 80% of the population meets specification"), implying that a sufficient sample size was used to achieve these statistical guarantees.
The data provenance is not specified regarding country of origin or specific details of test conditions beyond the type of tests. The studies are described as "verification/validation activities completed on the proposed device," which are typically laboratory-based engineering and performance tests rather than clinical trials with patient data. Thus, the data would be prospective in the sense that the tests were specifically designed and executed for this device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the studies described. The "ground truth" for these tests (e.g., a catheter's flow rate, tensile strength, or burst pressure) is determined by objective measurements and engineering standards, not by expert consensus or interpretation of clinical findings.
4. Adjudication Method for the Test Set
This is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the engineering and performance characteristics of the device, primarily comparing it to predicate devices based on objective technical specifications. It's a physical medical device, not an AI or imaging diagnostic tool that would typically involve MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This is not applicable. The device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on engineering specifications and objective measurements of the device's physical and functional properties, and comparison to the performance of legally marketed predicate devices. This includes:
- Physical durability (tensile strength, burst pressure)
- Flow rates (CT injection, gravity flow, aspiration)
- Mechanical behavior (tip whipping, tip displacement, stylet/wire withdrawal force)
- Biocompatibility (tested per ISO 10993)
8. The Sample Size for the Training Set
This is not applicable. The studies described are performance and safety verification tests for a physical medical device, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for a physical medical device.
§ 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.”