(33 days)
The Medcomp PRO-LINE® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE® CT Power Injectable CVC may not exceed 300 psi.
- Designed for central vein catherization .
- Comprised of a polyurethane material with purple pigment to indicate it for power injection.
- The lumen is connected to the extensions by a hub with a suture wing for . placement.
- Depth markings on the lumen and French size on the hub. ●
- Clamps are provided on the extension tubes to prevent air/fluid communication. ●
- A female luer connector provides the connection for intravenous administration. .
- Maximum recommended pressure limit setting 300 psi. ●
- Maximum indicated power injection flow rate 5cc/sec. .
This document describes a 510(k) submission for the PRO-LINE® CT Pressure Injectable CVC. The submission aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about an AI/ML device or a study designed to evaluate its performance against specific acceptance criteria in the context of diagnostic accuracy, which would typically involve sensitivity, specificity, or similar metrics for an AI medical device.
Therefore, the following information is not present in the provided text:
- Acceptance Criteria Table and Reported Device Performance: This document describes a medical device (a CVC) and its physical properties and intended use. There are no performance metrics specified in terms of diagnostic accuracy that would typically be associated with AI/ML device acceptance criteria (e.g., sensitivity, specificity, AUC). The performance tests mentioned are related to biocompatibility and compliance with general catheter standards, not AI performance.
- Sample Size Used for Test Set and Data Provenance: No test set is described as this is not an AI/ML device.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there is no diagnostic AI/ML device or ground truth establishment.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance Study (Algorithm Only): Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for the Training Set: Not applicable.
- How Ground Truth for the Training Set Was Established: Not applicable.
What is present in the document:
The device's performance is demonstrated through compliance with established international standards for medical devices and biocompatibility, as well as substantial equivalence to predicate devices.
Summary of Safety and Performance Tests (as described):
The document states that:
- Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met.
- Performance testing was conducted in accordance with:
- ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Requirements
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings
- Results of these tests, in conjunction with substantial equivalence claims, effectively demonstrate that the PRO-LINE® CT Pressure Injectable CVC is substantially equivalent to the cited predicate device.
Conclusion:
This 510(k) summary is for a physical medical catheter, not an AI/ML-driven medical device. Therefore, the questions posed about acceptance criteria, study design, and ground truth establishment, which are typically relevant for AI/ML performance evaluation, are not applicable to the provided document. The "study" here refers to the performed biocompatibility and performance tests against existing medical device standards to prove substantial equivalence.
§ 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.”