(85 days)
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
The PAINfusor Catheter is a closed tip multi-holed catheter with a fenestrated length that incorporates micro-holes in a helical pattern that allow for homogenous flow of analgesia into a surgical wound. The PAINfusor Catheter is radiopaque and has graduated markings along the length of the catheter for positional reference. It is supplied and packaged as a kit with a peel-away introducer needle, occlusive wound dressing and catheter securement adhesive.
The PAINfusor Catheter has been validated through various tests, however, it is important to note that the provided text describes equivalence to predicate devices and does not detail a study involving AI or human readers. Therefore, several sections of your request related to AI performance, human reader improvement, and ground truth for training/test sets cannot be filled from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Flow rate reduction with elastomeric infusion pumps | Low rate of flow reduction ( |
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).