(138 days)
The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ.
The combo tray is intended for Surgical or OB regional anesthesia blocks.
The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ.
The combo tray is intended for Surgical or OB regional anesthesia blocks. The rational for combining the epidural and spinal needles into one kit is as follows; an epidural block takes approximately 25 minutes for onset of the anesthetic, whereas, a spinal block takes approximately 5 min. for onset of Therefore, the patient benefits from both quick pain anesthetic. relief associated with a spinal and long-term pain relief associated with an epidural.
The procedure is as follows, the clinician will first place the epidural needle in the patient's epidural space. The spinal needle is then inserted through the epidural needle into the spinal cavity. The anesthetic is then administered through the spinal needle for quick pain relief. The spinal needle is then removed and an epidural catheter is inserted through the epidural needle into the epidural space. The catheter provides a conduit for the administration and re-administration of anesthetic into the epidural space to provide long term pain relief.
This document is a 510(k) summary for a medical device called the "Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices, not a study evaluating the performance or acceptance criteria of a novel diagnostic or AI device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and study types (MRMC, standalone) is not applicable to this document.
This 510(k) summary focuses on establishing substantial equivalence based on:
- Intended Use: Surgical or OB regional anesthesia blocks.
- Components: Combining a Tuohy Epidural Needle and a Whitacre Spinal Needle in a single tray.
- Comparison to Predicate Devices:
The 510(k) process is about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. It does not typically involve the type of performance studies, acceptance criteria, and ground truth establishment that would be performed for a novel diagnostic device or AI algorithm for the purposes of evaluating its accuracy, sensitivity, or specificity against defined metrics.
§ 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).