(172 days)
The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.
The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.
This document, K961075, describes a Regional Anesthesia Kit. This type of device, a sterile kit for administering anesthesia, is typically subject to performance testing for sterility, biocompatibility, and functional aspects (e.g., needle integrity, fluid path patency, luer lock connections). However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or study designs to prove that the device meets any such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It describes the device's intended use and technological characteristics, but not its performance against predefined criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance. No such data is present.
- Sample size used for the test set and the data provenance. No test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This is not applicable as no "ground truth" or expert review process is described for this type of device in the provided text.
- Adjudication method for the test set. Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done. Not applicable, as this is not an AI/imaging device.
- If a standalone performance (algorithm only) was done. Not applicable, as this is not an algorithm or AI device.
- The type of ground truth used. Not applicable.
- The sample size for the training set. Not applicable, no training set for an AI/algorithm.
- How the ground truth for the training set was established. Not applicable.
The document is purely descriptive of the device and its intended uses, asserting its similarity to existing predicate devices. It does not present any performance data or studies that would fall under the categories you've requested.
§ 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).