QEVO System

K232159 · Carl Zeiss Meditec, AG · GWG · Sep 21, 2023 · Neurology

Device Facts

• Record ID: K232159
• Device Name: QEVO System
• Applicant: Carl Zeiss Meditec, AG
• Product Code: GWG · Neurology
• Decision Date: Sep 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Indications for Use

The QEVO System 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 consists of rigid endoscope and Endoscope Control Unit (ECU); captures internal surgical site images via rod lenses and CMOS sensor; transmits light via fiber optics from integrated LED source. System integrates with validated Zeiss host display devices (microscopes/monitors) for visualization. Used in OR by surgeons for general, neurological, and spinal procedures. Provides 2D visualization to assist surgical navigation and decision-making; benefits include enhanced visualization of internal anatomy during minimally invasive or open procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included optical safety (IEC 62471:2006) and biocompatibility (ISO 10993) for the insertion tube.

Technological Characteristics

Rigid endoscope with 45° view, 100° FOV, 5-30mm depth of field. 2MP CMOS sensor, 642 TV lines resolution. Integrated LED light source. Reusable; manual/automated cleaning and sterilization. Electrical safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.

Indications for Use

Indicated for patients undergoing general, neurological (ventricles/brain structures), or spinal (nucleotomy, discectomy, foraminotomy) surgical procedures requiring visualization of internal surgical sites.

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

• QEVO System with KINEVO 900 (K170667)

Submission Summary (Full Text)

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September 21, 2023

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Carl Zeiss Meditec, Inc. % Chaitali Gawde Senior Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568

## Re: K232159

Trade/Device Name: QEVO System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: August 23, 2023 Received: August 24, 2023

## Dear Chaitali Gawde:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232159

Device Name QEVO System

### Indications for Use (Describe)

The QEVO System 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 spinal procedures, such as nucleotomy, discectory, and foraminotomy.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 807 Subpart C)</div> |

| > Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.92 the 510(k) Summary for the QEVO System is provided below.

#### 1. SUBMITTER

| Applicant: | Carl Zeiss Meditec AG<br>Goeschwizer Strasse 51-52<br>D-07745 Jena<br>Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Chaitali Gawde<br>Senior Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone<br>E-mail: [e-mail] (preferred) |
| Secondary Correspondent | Maria Golovina<br>Head of Regulatory Affairs<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone<br>E-mail: [e-mail]<br>(preferred) |
| Date Prepared: | |

September 21, 2023

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#### DEVICE 2.

| Device Trade Name: | QEVO System |
|--------------------|----------------------------------------|
| Common Name: | Neurological endoscope |
| Classification: | 21 CFR 882.1480 Neurological endoscope |
| Regulatory Class: | II |
| Product Code: | GWG |

#### 3. PREDICATE DEVICE (K170667)

| Predicate Device: | QEVO System with KINEVO 900 |
|-------------------|----------------------------------------|
| Manufacturer: | Carl Zeiss Meditec AG |
| Classification: | 21 CFR 882.1480 Neurological endoscope |
| Regulatory Class: | II |
| Product Code: | GWG |

#### 4. DEVICE DESCRIPTION

The QEVO System comprises of the QEVO ECU (Endoscope Control Unit) and QEVO endoscope. The system is intended for viewing internal surgical sites and for use in visualization during general and certain neurosurgical and spinal procedures.

The QEVO System has to be installed and integrated with a host display device (surgical microscope, a monitor, etc). Requirements for physical integration, connectivity, power supply, display resolution, and software integration are established and tested.

#### INTENDED USE/INDICATIONS FOR USE న్.

The QEVO System 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 procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.

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#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

| Table 1. Subject to Predicate Device Comparison Table | |
|-------------------------------------------------------|--|
|-------------------------------------------------------|--|

| Device Comparison<br>Table Attribute | QEVO<br>System<br>(K232159)<br>Subject Device | QEVO System with KINEVO 900<br>(K170667)<br>Predicate Device | Equivalency Analysis |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| 510(k) Number | K232159 | K170667 | N/A |
| Device Name | QEVO System | QEVO System with KINEVO 900 | N/A |
| Intended Use | The QEVO System is intended for<br>viewing internal surgical sites during<br>general surgical procedures and for use<br>in visualization of ventricles and<br>structures within the brain during<br>neurological surgical procedures as well<br>as for viewing internal surgical sites<br>during anterior and posterior spinal<br>procedures, such as nucleotomy,<br>discectomy, and foraminotomy. | The KINEVO 900 with QEVO System<br>is intended for viewing internal surgical<br>sites during general surgical procedures<br>and for use in visualization of<br>ventricles and structures within the<br>brain during neurological surgical<br>procedures as well as for viewing<br>internal surgical sites during anterior<br>and posterior spinal procedures, such as<br>nucleotomy, discectomy, and<br>foraminotomy. | Equivalent<br>Since, system is<br>disconnected from a<br>specific model of<br>surgical microscope<br>while the QEVO System<br>portion remains<br>identical. |
| Classification Regulation<br>Product Code | 882.1480, Class II<br>Neurological endoscope<br>GWG | 882.1480, Class II<br>Neurological endoscope<br>GWG | Identical |
| System Components | Rigid endoscope, ECU | Rigid endoscope, ECU | Identical |
| Compatible Host Display<br>Device | Any Zeiss device that is validated to meet<br>the QEVO requirements for physical<br>integration, connectivity, power supply,<br>display resolution, and software<br>integration | KINEVO 900 | Equivalent<br>Connectivity parameters<br>identical to those on the<br>KINEVO 900 are<br>available on other Zeiss<br>devices. |
| Light Transmission | Light source in endoscope main body,<br>light transmission through insertion tube<br>via fiber optics | Light source in endoscope main body,<br>light transmission through insertion<br>tube via fiber optics | Identical |
| Device Comparison<br>Table Attribute | QEVO<br>System<br>(K232159)<br>Subject Device | QEVO System with KINEVO 900<br>(K170667)<br>Predicate Device | Equivalency Analysis |
| Light Source | Integrated LED (intensity adjustable) | Integrated LED (intensity adjustable) | Identical |
| Image Transmission | Rigid rod lenses + CMOS imaging sensor<br>in endoscope main body | Rigid rod lenses + CMOS imaging sensor<br>in endoscope main body | Identical |
| Direction of View | 45° | 45° | Identical |
| Field of View | 100° | 100° | Identical |
| Depth of Field | 5-30mm | 5-30mm | Identical |
| Image Resolution | 2 Mega Pixel (Full HD imager)<br>642 TV lines (optical resolution at 15% MTF) | 2 Mega Pixel (Full HD imager)<br>642 TV lines (optical resolution at 15% MTF) | Identical |
| Image Display | External monitor | External monitor | Identical |
| 2D / 3D Imaging | 2D Only | 2D Only | Identical |
| Recording | Via USB-port | Via USB-port | Identical |
| Insertion Tube Working<br>Length | 120mm | 120mm | Identical |
| Insertion Tube Outer<br>Diameter | 3.6mm | 3.6mm | Identical |
| Single Use/ Reusable | Reusable | Reusable | Identical |
| Reprocessing | Manual and automated cleaning,<br>sterilization | Manual and automated cleaning,<br>sterilization | Identical |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-18 compliant | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-18 compliant | Identical |

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#### 7. SUMMARY OF STUDIES

### Sterilization and Shelf Life

The QEVO endoscope is used sterile but is not provided sterilized before first use. It must also be end user cleaned and sterilized between uses. The reprocessing instructions have not been modified and are identical to the predicate device.

## 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 Testing - Bench

There have been no changes in the System Requirements and Verification since the predicate. The following performance testing was provided, to support the substantial equivalence of the subject device:

- . Optical Safety - The QEVO 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.
The determination of substantial equivalence was not based on an assessment of performance data.

#### 8. CONCLUSION

The OEVO System and the predicate device are both intended to be used for viewing internal surgical sites during surgical procedures. The indications for use are identical to those of the predicate device with an exception, that the subject device isn't intended to be used with a specific model of surgical microscope.

The technological characteristics and risk profile of the subject device is identical to the predicate device; and therefore, are identical in their relationship to safety and effectiveness.

Testing methods are identical to those of the predicate device; are identical in their relationship to safety and effectiveness.

Therefore, the subject device meets the requirements for substantial equivalence to the predicate device.