QEVO System with KINEVO 900

K170667 · Carl Zeiss Meditec, AG · GWG · Aug 18, 2017 · Neurology

Device Facts

• Record ID: K170667
• Device Name: QEVO System with KINEVO 900
• Applicant: Carl Zeiss Meditec, AG
• Product Code: GWG · Neurology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

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.

Device Story

QEVO System with KINEVO 900 is a reusable neurological endoscope system. Input: optical images of internal surgical sites captured via rigid rod lenses and CMOS sensor in the endoscope main body. Transformation: light transmitted through insertion tube via fiber optics; images processed by QEVO Endoscope Control Unit (ECU) and displayed on an external monitor. Used in OR by surgeons/assistants during neurological and spinal procedures (e.g., nucleotomy, discectomy, foraminotomy). KINEVO 900 microscope provides standard optical visualization; QEVO endoscope provides additional endoscopic views. Output: 2D video feed on external monitor. Benefit: enhanced visualization of surgical anatomy to assist clinical decision-making during surgery.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including design verification, optical safety (IEC 62471), thermal safety (IEC 60601-1), electrical safety (IEC 60601-1, IEC 60601-2-18), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Reusable rigid endoscope with 3.6mm diameter insertion tube. Sensing: CMOS imaging sensor. Light source: Integrated adjustable LED. Connectivity: HDMI/DVI and Ethernet to ECU. Sterilization: Steam sterilization (SAL 10^-6). Compliance: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 62471. Biocompatibility: ISO 10993.

Indications for Use

Indicated for patients undergoing general, neurological, or spinal surgical procedures requiring visualization of internal surgical sites, ventricles, or brain structures.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• VSII Visionsense Stereoscopic Vision System (K082355)

Submission Summary (Full Text)

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Public Health Service

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Goeschwizer Strasse 51-52<br>D-07745 Jena<br>Germany |
| Contact: | Dr. Christian Muenster<br>Director Regulatory and Clinical Affairs<br>[phone]<br>[e-mail] |
| Prepared by: | Calley Herzog<br>Biologics Consulting Group, Inc.<br>[phone]<br>[e-mail] |
| 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:

| Standards<br>Organization | Standards<br>Number | Standard Title | Standard<br>Version/Date |
|---------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| AAMI ANSI | 60601-1 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | 2005 |
| IEC | 60601-2-18 | Medical electrical equipment<br>Part 2: Particular requirements for the basic safety<br>and essential performance of endoscopic equipment | Ed. 3 / 2009 |
| IEC | 60601-1-2 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests | Ed. 4 / 2014 |
| IEC | 62471 | Photobiological safety of lamps and lamp systems | Ed. 1 /2006 |
| AAMI / ANSI /<br>ISO | 17665-1 | Sterilization of health care products -- moist heat --<br>part 1: requirements for the development, validation,<br>and routine control of a sterilization process for<br>medical devices | 2006 / (R)2013 |
| ANSI/AAMI | ST81 | sterilization of medical devices - information to be<br>provided by the manufacturer for the processing of<br>resterilizable medical devices | 2004/(R)2010 |
| ANSI/AAMI | ST79 | Comprehensive guide to steam sterilization and<br>sterility assurance in health care facilities | 2010/A1:2010/A2:2011<br>/A3:2012/A4:2013/(R)2<br>014 |
| AAMI ANSI<br>ISO | 10993-1 | Biological evaluation of medical devices -- Part 1:<br>Evaluation and testing within a risk management<br>process | 2009 |
| AAMI ANSI<br>ISO | 10993-5 | Biological evaluation of<br>medical devices - Part 5: Tests for in vitro<br>cytotoxicity | 2009 |
| AAMI ANSI<br>ISO | 10993-10 | Biological evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | 2010 |
| AAMI ANSI<br>ISO | 10993-11 | Biological evaluation of medical devices - Part 11:<br>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 |
| Classification<br>Regulation<br>Product Code | 882.1480, Class II<br>Neurological endoscope<br>GWG | 888.1100, Class II<br>Arthroscope<br>HRX<br>882.1480, Class II<br>Neurological endoscope<br>GWG |
| System<br>Components | Rigid endoscope, ECU | Rigid endoscope, ECU |
| Light<br>Transmission | Light source in endoscope main<br>body, light transmission through<br>insertion tube via fiber optics | Light source in endoscope main body, light<br>transmission through insertion tube via<br>fiber optics |
| Light Source | Integrated LED (intensity<br>adjustable) | Integrated LED (intensity adjustable) |
| Image<br>Transmission | Rigid rod lenses + CMOS imaging<br>sensor in endoscope main body | CCD imaging sensor at distal tip |
| Direction of<br>View | 45° | 0-70° |
| Field of View | 100° | 70° |
| Depth of Field | 5-30mm | 7-30mm |
| Image<br>Resolution | 2 Mega Pixel (Full HD imager) | 2 Mega Pixel (Full HD imager) |
| | 642 TV lines (optical resolution at<br>15% MTF) | N/A (optical resolution) |
| Image Display | External monitor | External monitor |
| 2D / 3D<br>Imaging | 2D Only | 2D & 3D |
| Recording | Via USB-port | Via USB-port |
| Attribute | Subject Device | Predicate Device |
| Insertion Tube<br>Working<br>Length | 120mm | 175mm |
| Insertion Tube<br>Outer<br>Diameter | 3.6mm | 4mm |
| Single Use/<br>Reusable | Reusable | Reusable |
| Reprocessing | Manual and automated cleaning,<br>steam sterilization | Manual cleaning, sterilization |
| Electrical<br>Safety | IEC60601-1, IEC60601-1-2 and<br>IEC60601-2-18 compliant | IEC60601-1, IEC60601-1-2 and<br>IEC60601-2-18 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.