(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.
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SEP - 6 1996
510(k) Summary: (D)
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- Name of Device: (2)
Regional Anesthesia Kit
Classification Name:
Anesthesia Conduction Kit
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(3) Identification of Predicate Devices:
Regional Anesthesia Kits: -
- Spinal
-
- Epidural/Caudal
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- Nerve Block
-
Kendall HealthCare Products Company (a) Mansfield, MA 02048
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(4) Description of Device Subject to Premarket Notification:
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.
(ર) Intended Use of the Device:
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.
(6) Technological Characteristics
The MedCare Regional Anesthesia Kit is similar to the predicate devices in that all of the devices provide a variety of components for the administration of regional anesthesia. All the devices provide flexibility in componentry selection for customization to the user and the particular type of regional anesthesia being performed; spinal, epidural-caudal, or nerve block.
§ 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).