(63 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices. The performance testing focuses on optical safety, not algorithmic performance.
No
The device is described as a viewing system for internal surgical sites, indicating it is used for visualization during surgery rather than for treatment or therapy.
No
The device description states its intended use is "for viewing internal surgical sites" and "for use in visualization", which indicates it is an imaging and visualization tool rather than a diagnostic device that interprets or analyzes data to identify health conditions.
No
The device description explicitly states that the QEVO System comprises both the QEVO ECU (Endoscope Control Unit) and the QEVO endoscope, which are hardware components.
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" and "visualization" during surgical procedures. This is a direct interaction with the patient's body for visual guidance during surgery.
- Device Description: The description reinforces this by stating it's for "viewing internal surgical sites" and "visualization" during procedures. It's an endoscope system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, tissue, urine) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of specimens.
The QEVO System is a surgical visualization tool, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / 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 spinal procedures, such as nucleotomy, discectory, and foraminotomy.
Product codes (comma separated list FDA assigned to the subject device)
GWG
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.
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
Not Found
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)
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,
§ 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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce - S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce - S" is shown. Below this text, the date "2023.09.21" and time "08:32:09 -04'00'" are shown.
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
2
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 807 Subpart C) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Chaitali Gawde
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(224) 300-3992 Phone
E-mail: chaitali.gawde@zeiss.com (preferred) |
| Secondary Correspondent | Maria Golovina
Head of Regulatory Affairs
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-1078 Phone
E-mail: maria.golovina@zeiss.com
(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.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.
| Table 1. Subject to Predicate Device Comparison Table | |
|---|---|
| ------------------------------------------------------- | -- |
| Device Comparison
Table Attribute | QEVO
System
(K232159)
Subject Device | QEVO System with KINEVO 900
(K170667)
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
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 KINEVO 900 with 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. | Equivalent
Since, system is
disconnected from a
specific model of
surgical microscope
while the QEVO System
portion remains
identical. |
| Classification Regulation
Product Code | 882.1480, Class II
Neurological endoscope
GWG | 882.1480, Class II
Neurological endoscope
GWG | Identical |
| System Components | Rigid endoscope, ECU | Rigid endoscope, ECU | Identical |
| Compatible Host Display
Device | Any Zeiss device that is validated to meet
the QEVO requirements for physical
integration, connectivity, power supply,
display resolution, and software
integration | KINEVO 900 | Equivalent
Connectivity parameters
identical to those on the
KINEVO 900 are
available on other Zeiss
devices. |
| Light Transmission | Light source in endoscope main body,
light transmission through insertion tube
via fiber optics | Light source in endoscope main body,
light transmission through insertion
tube via fiber optics | Identical |
| Device Comparison
Table Attribute | QEVO
System
(K232159)
Subject Device | QEVO System with KINEVO 900
(K170667)
Predicate Device | Equivalency Analysis |
| Light Source | Integrated LED (intensity adjustable) | Integrated LED (intensity adjustable) | Identical |
| Image Transmission | Rigid rod lenses + CMOS imaging sensor
in endoscope main body | Rigid rod lenses + CMOS imaging sensor
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)
642 TV lines (optical resolution at 15% MTF) | 2 Mega Pixel (Full HD imager)
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
Length | 120mm | 120mm | Identical |
| Insertion Tube Outer
Diameter | 3.6mm | 3.6mm | Identical |
| Single Use/ Reusable | Reusable | Reusable | Identical |
| Reprocessing | Manual and automated cleaning,
sterilization | Manual and automated cleaning,
sterilization | Identical |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2, IEC
60601-2-18 compliant | IEC 60601-1, IEC 60601-1-2, IEC
60601-2-18 compliant | Identical |
6
7
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,