(165 days)
The QEVO System with KINEVO 900 is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
The subject device is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:
. QEVO System - QEVO Endoscope Control Unit (ECU) + QEVO endoscope
KINEVO 900 surgical microscope .
The KINEVO 900 can be operated by the surgeon and surgical assistant as a standard optical surgical microscope, using tubes and evepieces to view the surgical anatomy. When used with the QEVO System, the KINEVO 900 provides the additional capability to view images from the hand-held QEVO endoscope during neurological and spinal procedures.
The KINEVO 900 is physically connected (via power cable, HDMI/DVI cable, and Ethernet cable) to the QEVO Endoscope Control Unit (ECU). The QEVO endoscope plugs into the QEVO ECU outlet provided on the KINEVO 900.
This document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints for diagnostic accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (QEVO System with KINEVO 900), focusing on demonstrating substantial equivalence to a predicate device.
The "studies" mentioned are primarily non-clinical performance tests designed to show the device's compliance with established safety, electrical, and physical standards, rather than evaluating its clinical effectiveness or diagnostic accuracy against a ground truth.
Here's an analysis based on the provided text, addressing the points you requested where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes. Instead, the "performance" is reported as compliance with various standards and safety requirements.
| Category | Acceptance Criteria (Implied by Standards/Testing) | Reported Device Performance |
|---|---|---|
| Sterilization | Achieve a sterility assurance level (SAL) of 10^-6^ for steam sterilization. | "The steam sterilization process was validated to achieve a sterility assurance level (SAL) of 10^-6^." |
| Biocompatibility | Compliance with ISO 10993 for Tissue/Bone/Dentin Communicating, |
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).