(161 days)
Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.
Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen configurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.
This document is a Summary of Safety and Effectiveness Information for medical devices (PICC and Midline Catheters). It does not describe an AI/ML powered device, therefore, the information requested in your prompt (e.g., acceptance criteria for an algorithm, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable to the provided text.
The document focuses on the safety and effectiveness of a physical medical device (catheter) based on engineering and biocompatibility tests, not on the performance of a software algorithm.
Here's a breakdown of what the document does provide in relation to traditional medical device testing:
1. A table of acceptance criteria and the reported device performance:
The document provides a table of tests and their conclusions, which implicitly refer to meeting acceptance criteria for each physical test. The column "Conclusion" being "Passed" indicates that the device met the pre-defined acceptance criteria for that specific test.
| Test | Conclusion |
|---|---|
| Flow rate | Passed |
| Tensile strength of body | Passed |
| Tensile strength of catheter to hub | Passed |
| Catheter stiffness | Passed |
| Catheter elongation | Passed |
| Leakage at hub joint | Passed |
| Burst pressure (positive pressure) | Passed |
| Catheter collapse (negative pressure) | Passed |
| Biocompatibility per ISO 10993 | Passed |
| Sterilization | Passed |
The remaining points (2-9) are not applicable to this physical device submission. This document details the physical and biological performance of a catheter, not an AI system.
§ 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.”