(378 days)
Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC) are indicated for short or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The maximum pressure setting/limit of power injectors used with the Turbo-Flo PICC may not exceed 300 psi for the 5 Fr single lumen and 200 psi for the 4 Fr single lumen and 5 Fr double lumen. The Turbo-Flo PICC is indicated for a single injection of contrast media through a power injection.
Turbo-Flo® PICCs are polyurethane peripherally inserted central venous catheters 60 cm in length, available in 4 & 5 Fr single lumen and 5 Fr double lumen for short and long-term use. Catheters are inserted using an obturator version or an over-the-wire version.
The provided document describes a Premarket Notification (510(k)) for the Cook Turbo-Flo® PICC, a peripherally inserted central venous catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through clinical trials. Therefore, the information requested about acceptance criteria and a study proving those criteria are met, particularly in the context of AI/MRMC studies, ground truth establishment, and training sets, is not fully applicable or present in this document.
However, I can extract the relevant information regarding the device's performance claims and the testing conducted to support its substantial equivalence.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit, quantifiable acceptance criteria with corresponding performance metrics in a tabular format as would be seen in a de novo approval or a study with predefined endpoints. Instead, it states that the device "has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use equivalent to predicate devices."
The types of testing conducted are listed:
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit – "Equivalent to predicate devices") |
|---|---|
| Tensile Strength | Met requirements for safe and effective use. |
| Flow Rate | Met requirements for safe and effective use. |
| Leakage | Met requirements for safe and effective use. |
| Stability | Met requirements for safe and effective use. |
| Biocompatibility | Met requirements for safe and effective use. |
| Power Injector Limits: | |
| 5 Fr Single Lumen | Capable of withstanding 300 psi (maximum). |
| 4 Fr Single Lumen | Capable of withstanding 200 psi (maximum). |
| 5 Fr Double Lumen | Capable of withstanding 200 psi (maximum). |
Note: The FDA letter explicitly adds a limitation based on these tests: "The safe and effective use of the 4 Fr Single Lumen and 5 Fr Double Lumen Turbo-Flo PICC catheters with power injector pump pressure settings above 200 psi has not been established." This indicates that while the device was tested, the performance at higher pressures for these specific configurations was not deemed sufficiently proven.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Testing included tensile, flow rate, leakage, stability, and biocompatibility," but does not detail the number of units tested for each.
- Data Provenance: Not specified. It can be assumed these were laboratory (bench) tests conducted by Cook Incorporated, likely in the US (Bloomington, IN). The data is retrospective in the sense that it was generated prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This is a medical device 510(k) Pre-Market Notification, not a study evaluating expert performance or AI. The "ground truth" for the device's physical and mechanical properties would be established by standard engineering and materials science testing methodologies, not by expert consensus in diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI algorithm for diagnostic imaging, and therefore, human reader performance with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This document is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the tests mentioned (tensile, flow rate, leakage, stability, biocompatibility) would be based on:
- Engineering Specifications/Standards: Established industry standards (e.g., ASTM, ISO), internal Cook specifications, or regulatory guidelines for medical device materials and performance.
- Physical Measurements: Direct measurements of tensile strength, flow rates, leakage volumes, and material stability through laboratory instrumentation.
- Biological Assays: For biocompatibility, established in vitro and/or in vivo biological testing methods according to standards like ISO 10993.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device 510(k) for a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
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.”