(42 days)
The Turbo-Ject® PICC is 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 Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Turbo-Ject® PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
The Turbo-Ject® PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The currently marketed Turbo-Ject® PICCs are available in the following configurations: 4.0 Fr single lumen, 5.0 Fr single lumen, and 5.0 Fr double lumen. The currently marketed Spectrum® Turbo-Ject® PICCs are available in the following antimicrobial agent impregnated configurations: 3.0 Fr single lumen, 4.0 Fr single lumen, 5.0 Fr single lumen, 5.0 Fr double lumen, and 6.0 Fr triple lumen. The proposed devices add two additional non-impregnated configurations, a 3.0 Fr single lumen catheter and a 6.0 Fr triple lumen catheter.
The provided text describes a Special 510(k) submission for a device modification, not a study evaluating an AI device or algorithm. Therefore, many of the requested categories (such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and data provenance) are not applicable to this document.
The document focuses on demonstrating substantial equivalence for modifications to existing Peripherally Inserted Central Venous Catheters (PICCs) by Cook Incorporated. The "acceptance criteria" discussed are for the physical and functional performance of the medical device itself, not for the performance of an AI algorithm.
Here's a summary of the information that can be extracted relevant to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Static Failure Pressure Testing | Pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter; catheter should not fracture or rupture. | Predetermined acceptance criteria met. (Implies the device did not fracture or rupture and clinical pressures were below burst pressure). |
| Flow Rate Testing | Pressure exerted at the maximum flow rate during proper clinical use should not fracture or rupture the catheter. | Predetermined acceptance criteria met. (Implies the device performed as expected without fracture/rupture at specified flow rates). |
| Tensile Strength Testing | Tensile strength during proper clinical use should not fracture or rupture the catheter. Conformance with BS EN ISO 10555-1:2009. | Predetermined acceptance criteria met. (Implies conformance to standard and no fracture/rupture under clinical tensile forces). |
| Biocompatibility Testing | Device is biocompatible. Conformance with BS EN ISO 10993-1:2009. | Predetermined acceptance criteria met. (Implies conformance to standard and biocompatibility). |
Note on Flow Rates: The document also specifies performance for maximum flow rates and injection pressure limits, which are part of the device's functional performance:
| Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting | Device Performance (Achieved) |
|---|---|---|---|
| 3.0 Fr Single Lumen | 2 mL/sec | 325 psi | 2 mL/sec @ 325 psi |
| 4.0 Fr Single Lumen | 4 mL/sec | 325 psi | 4 mL/sec @ 325 psi |
| 5.0 Fr Single Lumen | 7 mL/sec | 325 psi | 7 mL/sec @ 325 psi |
| 5.0 Fr Double Lumen | 5 mL/sec | 325 psi | 5 mL/sec @ 325 psi |
| 6.0 Fr Triple Lumen** | 7 mL/sec | 325 psi | 7 mL/sec @ 325 psi |
| *Flow rates verified using room temperature Omnipaque 300® contrast and a Medrad Stellant® CT injector system. | |||
| **Lumen #1 only. |
Information Not Applicable to this Document (as it's not an AI/algorithm study):
- Sample size used for the test set and the data provenance: Not applicable. This document describes physical device testing, not data-driven algorithm validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is typically based on engineering standards and measurements, not expert consensus on images/data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" for the tests mentioned (Static Failure Pressure, Flow Rate, Tensile Strength, Biocompatibility) would be established by validated engineering tests and adherence to international standards (e.g., BS EN ISO 10555-1:2009 for tensile strength, BS EN ISO 10993-1:2009 for biocompatibility).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.”