(88 days)
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot is intended for the administration of regional anaesthesia to the epidural space employing single-shot technique also including optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF is intended for the administration of spinal, epidural or combined spinal-epidural regional anaesthesia, single-shot or continuous technique, optional localization via electrical stimulus.
PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Spinal single shot is intended for the administration of regional anaesthesia to the spinal space employing single-shot technique also including optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus.
PAJUNK® s Generic Convenience Tray for Regional Anesthesia: Spinal continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSE is intended for the administration of anaesthesia via CSE-technique, single-shot/ continuous technique, optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of spinal, epidural and CSE-technique applied anaethesia, single-shot/ continuous technique, optional localization via electrical stimulus regional anaethesia. Neither needle nor catheter is included.
The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in spinal, epidural and CSEprocedures. The tray complies with FDA's guidance "Sterilized convenience kits".
This document is a 510(k) Premarket Notification for a medical device: PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF. It is not a study detailing the device's performance against specific acceptance criteria.
The information provided describes the device, its intended use, predicate devices, and regulatory classification, aiming to establish substantial equivalence to previously cleared devices. It does not contain data from a clinical or performance study that would typically include acceptance criteria and reported device performance metrics in the way a diagnostic AI device submission would.
Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance for a study, nor can I fill in details about sample sizes, ground truth establishment, or multi-reader multi-case studies, because this type of information is not present in the provided text.
The document states:
- The convenience tray is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure.
- The tray complies with FDA's guidance "Sterilized convenience kits".
- Sterilization method, biocompatibility, shelf life, and impact of sterilization and storage have been validated and proven safe and effective.
- The conclusion is based on comparison between the predicate devices and the proposed devices and the validated sterilization process, demonstrating substantial equivalence.
- The tray components are marketed in similar combinations in Europe for more than ten years now and are safe and effective.
This indicates that the submission relies on the established safety and effectiveness of its component devices and the validation of processes like sterilization, rather than a new performance study with specific acceptance criteria that would typically be seen for a novel diagnostic device.
§ 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).