(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, < 24 hours contact. (Specific tests: Cytotoxicity, Irritation, Skin Sensitization, Systemic Toxicity) | "The materials were testing in accordance with ISO 10993." |
| Design Verification | The system complies with established system requirements. (Specific requirements not detailed in this summary) | "The purpose of the design verification is to demonstrate that the system complies with the established system requirements." |
| Optical Safety | Conformity with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). | "The QEVO Endoscope and ECU were assessed for conformity with the relevant requirements of IEC 62471:2006... and were found to comply." |
| Thermal Safety | Maximum temperature of the QEVO endoscope does not exceed established limits in IEC 60601-1 when operated in intermittent mode. | "When operated in intermittent mode, the maximum temperature of the QEVO endoscope did not exceed the limits established in IEC 60601-1." |
| Software | Documentation for a MODERATE Level of Concern device is provided. (Implied acceptance criteria are that the documentation meets FDA's guidance for moderate concern software). | "Software documentation for a MODERATE Level of Concern device is provided in support of the subject device." |
| Electrical Safety | Conformity with IEC 60601-1:2005 (Edition 3.1, including US deviations) and IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment). | "The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1... and IEC 60601-2-18... and were found to comply." |
| EMC Testing | Conformity with IEC 60601-1-2 (4th Edition). | "The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1-2... and was found to comply." |
| Image Resolution | 2 Mega Pixel (Full HD imager) and 642 TV lines (optical resolution at 15% MTF). (These are specifications rather than acceptance criteria per se, but serve as performance metrics.) | Reported: "2 Mega Pixel (Full HD imager)" and "642 TV lines (optical resolution at 15% MTF)". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document for any of the non-clinical tests. The number of devices or components tested, or the origin of any data, is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical engineering and safety tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical engineering and safety tests, not clinical evaluations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This device is an endoscope/microscope visualization system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The device is a visualization system and does not appear to incorporate an AI algorithm for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is typically defined by the standards themselves (e.g., sterilization efficacy requirements, electrical safety limits, biocompatibility criteria). Chemical, physical, and biological analyses are performed against these predetermined thresholds or methods, rather than against clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device (visualization system), not an AI algorithm requiring a training set in the machine learning sense.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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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
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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 AGGoeschwizer Strasse 51-52D-07745 JenaGermany |
| Contact: | Dr. Christian MuensterDirector Regulatory and Clinical Affairs+49 7364 206985christian.muenster@zeiss.com |
| Prepared by: | Calley HerzogBiologics Consulting Group, Inc.(720) 883-3633cherzog@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:
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- . 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, < 24 hours. The materials were testing in accordance with ISO 10993.
Performance Data:
The following performance testing is provided to support the substantial equivalence of the subject device:
- Design Verification Testing The purpose of the design verification is to demonstrate . that the system complies with the established system requirements.
- Optical Safety The OEVO Endoscope and ECU were assessed for conformity with the . relevant requirements of IEC 62471:2006: Photobiological safety of lamps and lamp systems and were found to comply.
- Thermal Safety When operated in intermittent mode, the maximum temperature of the . QEVO endoscope did not exceed the limits established in IEC 60601-1.
Software Documentation:
Software documentation for a MODERATE Level of Concern device is provided in support of the subject device.
Electrical Safety Testing:
The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (Edition 3.1, including the US deviations) and were found to comply.
The QEVO endoscope and ECU were assessed for conformity with the relevant requirements of IEC 60601-2-18:2009 (3rd edition): Particular requirements for the basic safety and essential performance of endoscopic equipment and were found to comply.
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Electromagnetic Compatibility Testing:
The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1-2 (4th Edition) and was found to comply.
Standards:
The table below provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence:
| StandardsOrganization | StandardsNumber | Standard Title | StandardVersion/Date |
|---|---|---|---|
| AAMI ANSI | 60601-1 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance | 2005 |
| IEC | 60601-2-18 | Medical electrical equipmentPart 2: Particular requirements for the basic safetyand essential performance of endoscopic equipment | Ed. 3 / 2009 |
| IEC | 60601-1-2 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests | Ed. 4 / 2014 |
| IEC | 62471 | Photobiological safety of lamps and lamp systems | Ed. 1 /2006 |
| AAMI / ANSI /ISO | 17665-1 | Sterilization of health care products -- moist heat --part 1: requirements for the development, validation,and routine control of a sterilization process formedical devices | 2006 / (R)2013 |
| ANSI/AAMI | ST81 | sterilization of medical devices - information to beprovided by the manufacturer for the processing ofresterilizable medical devices | 2004/(R)2010 |
| ANSI/AAMI | ST79 | Comprehensive guide to steam sterilization andsterility assurance in health care facilities | 2010/A1:2010/A2:2011/A3:2012/A4:2013/(R)2014 |
| AAMI ANSIISO | 10993-1 | Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk managementprocess | 2009 |
| AAMI ANSIISO | 10993-5 | Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity | 2009 |
| AAMI ANSIISO | 10993-10 | Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization | 2010 |
| AAMI ANSIISO | 10993-11 | Biological evaluation of medical devices - Part 11:Tests for systemic toxicity | 2006 |
Clinical Testing
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
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Substantial Equivalence Discussion
The predicate device is the previously cleared VSII Visionsense Stereoscopic Vision System (K082355). A detailed comparison of the subject device to the predicate device can be found in the table below.
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | Carl Zeiss Meditec AG | VISIONSENSE, LTD. |
| 510(k) Number | TBD | K082355 |
| Device Name | KINEVO 900 with QEVO System | VisionSense VSII |
| ClassificationRegulationProduct Code | 882.1480, Class IINeurological endoscopeGWG | 888.1100, Class IIArthroscopeHRX882.1480, Class IINeurological endoscopeGWG |
| SystemComponents | Rigid endoscope, ECU | Rigid endoscope, ECU |
| LightTransmission | Light source in endoscope mainbody, light transmission throughinsertion tube via fiber optics | Light source in endoscope main body, lighttransmission through insertion tube viafiber optics |
| Light Source | Integrated LED (intensityadjustable) | Integrated LED (intensity adjustable) |
| ImageTransmission | Rigid rod lenses + CMOS imagingsensor in endoscope main body | CCD imaging sensor at distal tip |
| Direction ofView | 45° | 0-70° |
| Field of View | 100° | 70° |
| Depth of Field | 5-30mm | 7-30mm |
| ImageResolution | 2 Mega Pixel (Full HD imager) | 2 Mega Pixel (Full HD imager) |
| 642 TV lines (optical resolution at15% MTF) | N/A (optical resolution) | |
| Image Display | External monitor | External monitor |
| 2D / 3DImaging | 2D Only | 2D & 3D |
| Recording | Via USB-port | Via USB-port |
| Attribute | Subject Device | Predicate Device |
| Insertion TubeWorkingLength | 120mm | 175mm |
| Insertion TubeOuterDiameter | 3.6mm | 4mm |
| Single Use/Reusable | Reusable | Reusable |
| Reprocessing | Manual and automated cleaning,steam sterilization | Manual cleaning, sterilization |
| ElectricalSafety | IEC60601-1, IEC60601-1-2 andIEC60601-2-18 compliant | IEC60601-1, IEC60601-1-2 andIEC60601-2-18 compliant |
Device Comparison Table
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Substantial Equivalence Conclusion
The subject device and predicate device have the same intended use, for viewing internal surgical sites during general surgical procedures.
The specifications and functionality of the subject device is similar to the predicate devices. Any differences between the devices do not raise new questions of safety and effectiveness. Performance testing demonstrated that the device meets its specifications and intended uses. Therefore, the subject device can be found substantially equivalent to the Visionsense VSII as cleared in K082355.
§ 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).