(85 days)
The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.
The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations.
The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The provided text describes a 510(k) summary for the "Health Line CT CVC" device. This device is a central venous catheter (CVC).
Important Note: The document states that the device is identical to the predicate device (Orion™ II CT CVC, K113622) in its final finished form, with only minor changes to labeling, instructions for use, and the addition of an optional suture wing component. These changes are explicitly stated to not impact the performance or safety and effectiveness of the device compared to the predicate. Therefore, the "study that proves the device meets the acceptance criteria" for this specific 510(k) is primarily based on the demonstration of substantial equivalence to the legally marketed predicate device, leveraging the predicate's existing performance and biocompatibility data.
This is not a typical AI/ML-based device submission that would involve ground truth establishment, reader studies, or detailed algorithm performance metrics. Instead, it's a traditional medical device submission relying on established equivalence principles.
Given this context, I will address the requested points, noting where the information is not applicable due to the nature of this 510(k) submission for a non-AI/ML device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are primarily met through demonstrating equivalence to the predicate device and compliance with relevant standards. The performance is demonstrated through in vitro testing and biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Health Line CT CVC) |
|---|---|---|
| Material & Design | Identical materials (e.g., Polyurethane catheter, Rigid PVC Luer connectors, Acetal pinch clamps, ABS informational clamp inserts) | All materials are identical to the predicate device. |
| Intended Use | Identical indications for use and intended use, including short-term access ( |
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).