(88 days)
SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.
Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide.
The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.
This submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) summary for Regional Anesthesia Trays, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.
Specifically, the document states:
- "There were no nonclinical or clinical tests submitted with this submission." and "There were no nonclinical or clinical tests submitted with this submission:".
- It mentions "Testing of the epidural catheter connector was performed in accordance with BS 6196. Performance testing of the proposed modification to the epidural catheter connector demonstrates that it performed equal to or better than our current epidural catheter connector." However, this is a summary statement about testing a component (epidural catheter connector) and the standard it followed (BS 6196), not a detailed study description for the entire Regional Anesthesia Tray device, nor does it provide specific acceptance criteria or performance metrics.
Therefore, I cannot extract the requested information regarding acceptance criteria or a study that proves the device meets them from the provided text.
§ 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).