(21 days)
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended 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 proposed Turbo-Ject® PICCs 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 proposed devices are minimally tapered 4.0 Fr single and double lumen catheters. A taper is a design element meant to help "wedge" the catheter into the tract by having a transition from a larger Fr size to the labeled Fr size. The proposed minimal taper design provides the same wedge feature only a △1 Fr versus Δ2 Fr from the manifold to the labeled Fr size of the catheter. The primary advantage of the 1 Fr size minimal taper is ease of insertion.
The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide and other convenience components. The set is supplied sterile and is intended for one-time use.
This document describes the 510(k) summary for the Cook Turbo-Ject® Peripherally Inserted Central Venous Catheter Set (K132334). The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K072625) through design modifications and performance testing, rather than a clinical study involving human readers or extensive ground truth establishment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance testing to support substantial equivalence. The "acceptance criteria" are implied by conformance to standards and successful test outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Peak load value greater than 10 N (per ISO 10555-1:1995) | Testing demonstrated that the peak load value was greater than 10 N. |
| Catheters did not fail during simulated dynamic pressure use | Testing demonstrated that the catheters did not fail during simulated use. |
| Static failure pressure was at or above the acceptance criterion | Testing demonstrated that static failure pressure was at or above the acceptance criterion. |
| Catheter did not leak liquid | Testing demonstrated that the catheter did not leak liquid. |
| Catheter did not exhibit air leakage | Testing demonstrated that the catheter did not exhibit air leakage. |
| (Implied) Flow Rate Acceptance for 4.0 Fr Single Lumen | The proposed 4.0 Fr single lumen device labeling could be modified to a maximum flow rate of 5 mL/sec from the 4 mL/sec in the predicate labeling, indicating it met or exceeded the predicate's performance for this parameter. |
2. Sample Size Used for the Test Set and the Data Provenance
The document primarily describes bench testing for physical and mechanical properties of the device.
- Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many catheters were tested for tensile strength).
- Data Provenance: The data provenance is from laboratory bench testing of the manufactured device. There is no information regarding country of origin for data or whether it's retrospective or prospective, as this is laboratory testing, not clinical data.
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 engineering and laboratory performance testing, not expert-adjudicated clinical data requiring ground truth establishment by healthcare professionals for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. As this is bench testing of physical properties, there is no adjudication method in the context of clinical interpretation or diagnostic performance. Test results are objective measurements against 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
Not applicable. This is a submission for a medical device (PICC catheter), not an artificial intelligence (AI) or imaging diagnostic device. Therefore, no MRMC study or AI-assisted assessment of human readers was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described would be the physical and mechanical properties of the catheter as measured in a controlled laboratory environment against established engineering and international performance standards (e.g., ISO 10555-1:1995).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.”