(274 days)
The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
The PAJUNK Plexolong sets are single use sterile, Latex free and nonpvrogenic needles, with a plastic cannula and catheter intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
This document is a 510(k) Summary of Safety and Effectiveness for the PAJUNK Plexolong Sets. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets reported performance metrics.
The 510(k) process is primarily a premarket notification to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove specific performance against acceptance criteria in the way a clinical trial or a formal validation study would.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on:
- Device Description: What the device is composed of and how it works.
- Intended Use: The medical purpose for which the device is designed.
- Predicate Device: The legally marketed device to which the new device is compared for substantial equivalence.
- Technological Characteristics: How the new device's components compare to the predicate device.
- Conclusion: A statement that the device is as safe and effective as the predicate device.
- FDA Clearance Letter: Confirmation of substantial equivalence.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or number of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used or how it was established for training or testing.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).