(165 days)
VSII Visionsense Stereoscopic Vision System (K082355
Not Found
No
The summary describes a standard surgical visualization system with an endoscope and microscope, and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as a system for viewing internal surgical sites during procedures, primarily for visualization, not for providing therapy or treatment.
No
The device is described as a system for "viewing internal surgical sites" during procedures and for "visualization of ventricles and structures within the brain." Its primary function is to provide visual information for guidance during surgery, rather than to diagnose a medical condition.
No
The device description explicitly lists hardware components (QEVO Endoscope Control Unit, QEVO endoscope, KINEVO 900 surgical microscope, cables) and the performance studies include testing of physical attributes like sterilization, biocompatibility, optical safety, thermal safety, electrical safety, and electromagnetic compatibility. This indicates it is a hardware-based system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "viewing internal surgical sites during general surgical procedures" and for "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". This describes a device used during a surgical procedure to aid the surgeon's visualization.
- Device Description: The description confirms it's a system for "viewing internal surgical sites during surgical procedures" and consists of an endoscope and a surgical microscope.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens. It is a tool for direct visualization within the body during surgery.
Therefore, the QEVO System with KINEVO 900 is a surgical visualization system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal surgical sites, ventricles and structures within the brain, anterior and posterior spinal procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon and surgical assistant
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Sterilization: The steam sterilization process was validated to achieve a sterility assurance level (SAL) of 10-6.
- Biocompatibility: The only patient contacting component of the subject device is the Insertion tube. The contact category for this component is 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).
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Carl Zeiss Meditec Ag % Calley Herzog Senior Consultant Biologics Consulting 400 N. Washington St. Suite 100 Alexandria, Virginia 22314
Re: K170667
Trade/Device Name: QEVO System with KINEVO 900 Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: July 18, 2017 Received: July 19, 2017
Dear Calley Herzog:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
2
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the QEVO System with KINEVO 900 is provided below.
| Device Common Name: | Neurological endoscope |
|---|---|
| Device Trade Name: | QEVO System with KINEVO 900 |
| Applicant: | Carl Zeiss Meditec AG |
| Goeschwizer Strasse 51-52 | |
| D-07745 Jena | |
| Germany | |
| Contact: | Dr. Christian Muenster |
| Director Regulatory and Clinical Affairs | |
| +49 7364 206985 | |
| christian.muenster@zeiss.com | |
| Prepared by: | Calley Herzog |
| Biologics Consulting Group, Inc. | |
| (720) 883-3633 | |
| cherzog@biologicsconsulting.com | |
| Date Prepared: | August 11, 2017 |
| Classification Regulation: | 882.1480, Class II |
| Classification Name: | Neurological endoscope |
| Panel: | Neurology |
| Primary Product Code: | GWG |
| Predicate Device: | VSII Visionsense Stereoscopic Vision System (K082355 |
Indication for Use:
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.
Device Description:
The subject device is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:
4
- . 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.
Non-Clinical Testing
Sterilization:
The steam sterilization process was validated to achieve a sterility assurance level (SAL) of 10°.
Biocompatibility:
The only patient contacting component of the subject device is the Insertion tube. The contact category for this component is Tissue/Bone/Dentin Communicating,