(231 days)
Not Found
No
The document explicitly states the deprecation of a previous ML algorithm and its replacement with a traditional algorithm.
No
The device is a guidance system that helps surgeons during spinal procedures by overlaying pre-operative 3D images with real-time intra-operative 2D radiographic images. It does not directly provide therapy or interact with the patient's anatomy in a therapeutic manner. Its primary function is to assist in planning and guiding surgical tools.
No
The VUZE System is described as a system for surgical guidance and planning, involving real-time overlay of pre-operative and intra-operative images to support device guidance during interventional spinal procedures. It does not perform a diagnostic function of identifying or classifying a disease or condition.
No
The device description explicitly lists multiple hardware components as part of the system, including a workstation, housing, touchscreen, mouse, isolation transformer, video acquisition device, wheeled cart, cables, and optional sensors and foot pedal.
Based on the provided information, the VUZE System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The system's intended use is to support device guidance during interventional spinal procedures by overlaying pre-operative 3D images with intra-operative 2D radiographic images. This is a surgical guidance system, not a diagnostic test performed on biological samples.
- Device Description: The description details hardware components like a workstation, touchscreen, and imaging acquisition device, all related to image processing and display for surgical guidance. There is no mention of components for analyzing biological samples.
- Input Imaging Modality: The inputs are medical images (CT, CBCT, 2D X-ray), not biological samples like blood, urine, or tissue.
- Anatomical Site: The system is used on the patient's spine during surgery.
- Intended User/Care Setting: The intended user is an Interventional Spine Surgeon in a surgical suite. IVD devices are typically used in laboratories or point-of-care settings for diagnostic testing.
- Performance Studies: The performance studies focus on quantitative accuracy related to image registration and guidance during simulated surgical procedures, not on the accuracy of diagnosing a disease or condition based on biological samples.
In summary, the VUZE System is a surgical guidance system that utilizes medical imaging. It does not perform diagnostic tests on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The VUZE System (the "System") enables users to load 3D images and planning data then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation. fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.
The System offers optional pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intra-operative 2D images onto a patient's pre-operative 3D images.
The System's main components include:
- A workstation running the VUZE Planning and Procedure software (pre-installed)
- A housing for the workstation, with a front door for user access as well as a back service door
- A 32" touchscreen
- A mouse
- An isolation transformer
- An internal video acquisition device (frame grabber)
- A minimal-footprint, wheeled cart on which the above-listed items are placed.
- DVI cable with galvanic isolator
- An optional standalone planning station (planning software running on a commercial PC with identified specifications)
- Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle (Note: The orientation sensor may also be referred to under an acronym of IMU)
- Optional OTS foot pedal and associated Bluetooth dongle
Mentions image processing
Yes
Mentions AI, DNN, or ML
- Deprecation of the previous ML algorithm for determining window size parameters. Same functionality is now done by a traditional algorithm that calculates the filter for several window sizes and chooses the best one.
Input Imaging Modality
pre-operative 3D images, intra-operative 2D radiographic images, CT / CBCT, 2D X-ray
Anatomical Site
spinal, S1 through T7, Thoracic and Lumbar Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interventional Spine Surgeon, Surgical Suite
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)
The modified VUZE System was verified and validated in accordance with 21 CFR 820.30. The following tests assessed comprehensively the changes in the system and were completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device successfully completed all of the evaluations and testing shown below. The standards shown in the following section were used, where applicable, to conduct testing and evaluate results.
- Hardware component / assembly functional verification
- Software Verification / Validation at the unit, integration and system levels (full execution of all software-based testing from original 510(k) with protocol modifications where necessary to fully test changes)
- Electrical Safety and EMC
- Full system functional verification against inputs and specifications
- Simulated Use / Quantitative Accuracy
- Formative Usability Validation
As listed above, quantitative accuracy performance of the VUZE System was evaluated in comparison to its performance specifications and found to meet all specifications. Key results shown as:
Results of the Root Mean Square (RMS) analysis at Recommend and Minimal Angle Differences between X-ray Images:
| Parameter | Direction error [deg] | Tip deviation from GT trajectory [mm] | Predicted tip deviation from GT trajectory [mm] | Depth error [mm] |
|---|---|---|---|---|
| VUZE System Recommended Angles | 0.3094 | 0.2833 | 0.3572 | 0.8196 |
| Minimal Angle Difference (worst case) | 0.4537 | 0.4107 | 0.5199 | 1.0194 |
| RMS specification limit | ≤3° | ≤2 mm | ≤2 mm | ≤4 mm |
| All results within RMS specification limit | Pass | Pass | Pass | Pass |
Summary of results for all combinations of X-Ray machines and CT/CBCT data:
| Parameter | Specification | Quantile | Test Result | Using VUZE System Recommended Angles (Quantile Estimate) | Using VUZE System Recommended Angles (95% Conf. Limit of Quantile) | Using Minimal Angle Difference (Quantile Estimate) | Using Minimal Angle Difference (95% Conf. Limit of Quantile) |
|---|---|---|---|---|---|---|---|
| Direction error [deg] | -6.5 mm | 2.5% | Pass | -1.371 | -1.424 | -1.939 | -2.053 |
| Depth error [mm] Upper |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
VUZE Medical Ltd. % Clay Anselmo Principal Quality and Regulatory Consultant Shriner & Associates, Inc. 429 Whitepine Creek Road Trout Creek, Montana 59874
May 9, 2024
Re: K232976
Trade/Device Name: VUZE System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 2, 2024 Received: April 2, 2024
Dear Clay Anselmo:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232976
Device Name VUZE System
Indications for Use (Describe)
The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K232976
Introduction:
This document contains the 510(k) Summary for the VUZE Medical - VUZE System. The content of this summary is based on the requirements set forth in 21 CFR 807.92(c).
Submitter Information:
| Applicant / Manufacturer
Name and Address | VUZE Medical Ltd.
3/84 Rav Ashi St.
Tel Aviv 6939537, Israel |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter / Preparer | Clay Anselmo
Principal Quality and Regulatory Consultant
Shriner & Associates
429 Whitepine Creek Road
Trout Creek, MT 59874
clay.anselmo@shrinerandassociates.com |
| 510(k) Contact Person | David Tolkowsky
VUZE Medical, Ltd.
3/84 Rav Ashi St.
Tel Aviv 6939537, Israel
davidt@vuzemedical.com
+972-(0)733983000 |
| Date prepared | 08-May-2024 |
| Device Identification | |
| Trade names | VUZE System |
| Common name | VUZE Medical Imaging System for spinal
interventions |
| Classification name | Medical Image Management and
Processing System |
| Regulation Number | 21 CFR Part 892.2050 |
| Classification | Class II |
| Product Code | Primary: LLZ |
4
Predicate Device
| Trade names: | VUZE System |
|---|---|
| 510(k) number: | K210830 |
Device Description:
The VUZE System (the "System") enables users to load 3D images and planning data then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation. fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.
The System offers optional pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intra-operative 2D images onto a patient's pre-operative 3D images.
The System's main components include:
- A workstation running the VUZE Planning and Procedure software (pre-installed) ●
- A housing for the workstation, with a front door for user access as well as a back ● service door
- A 32" touchscreen ●
- A mouse ●
- An isolation transformer ●
- An internal video acquisition device (frame grabber) ●
- A minimal-footprint, wheeled cart on which the above-listed items are placed. ●
- DVI cable with galvanic isolator ●
- An optional standalone planning station (planning software running on a ● commercial PC with identified specifications)
- Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle ● (Note: The orientation sensor may also be referred to under an acronym of IMU)
- . Optional OTS foot pedal and associated Bluetooth dongle
Indications for Use:
The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative quidance and tool trajectory / position confirmation.
5
Technological Characteristics Comparison:
Substantial Equivalence: The VUZE System is substantially equivalent to the original VUZE System (a.k.a. original device) K210830.
The 510(k) Substantial Equivalence Decision-making Process (detailed) from FDA Guidance - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] was followed as described below:
- . The modified VUZE System has the same intended use and the same indications for use as the Predicate device (original version of the VUZE System).
- . The VUZE System uses identical fundamental technology as the Predicate device and very similar detailed technological solutions.
- . The following summary of technological changes from the originally cleared device and the modified VUZE System are being made through this 510(k):
Planning Software: O
- Added option for planning-only station that contains only the planning . software which runs on commercial PC meeting certain specified requirements. Option includes export to USB functionality for transferring planning data to VUZE System.
- I Elimination of the need to generate pre-operative data during planning. New feature allows DRR generation in real-time during procedure.
- 트 Addition of a new feature incorporating horizontal line angle control into the Coronal cross-section, supplementing the existing Sagittal cross-section controls.
- 트 Add a check of 3D scan slice thickness to ensure it is equal to or greater than slice interval. Discard scans that do not meet this requirement.
- 트 Add feature that requires the user to indicated whether the skin level is visible in the axial view or not.
- Add support for loading DICOM-CTs generated by 3D C-arm machines (CBCT).
- 트 Minor graphical user interface improvements for usability (e.g. view zoom, display simplifications, display pixel spacing, reset button addition, button re-arrangement).
- Resolution of non-safety related software anomalies.
ം VUZE System and Procedure Software
- Implement a modification to the CT to X-ray registration algorithm to replace . the reliance on pre-operative data for generating the initial-guess registration. This algorithm performs in real-time similar calculations that were previously done preoperatively.
- . Implement a registration success score to assess the System's confidence in the CT to X-ray registration result. This score assesses the System's confidence in the registration and establishes a specific threshold to determine registration failure.
- Addition of a Bluetooth C-arm orientation sensor and associated Bluetooth dongle to allow compatibility with additional X-ray systems.
6
- . Deprecation of the previous ML algorithm for determining window size parameters. Same functionality is now done by a traditional algorithm that calculates the filter for several window sizes and chooses the best one.
- 트 Add option to load CT images and planning data from USB media.
- . Add support for additional C-arm systems for 2D X-ray image acquisition: * Philips Zenition 70
-
- GE: OEC Elite CFD
- � Ziehm: Vision FD and Vision RFD 3D (2 different Flat Detector types)
-
- 트 Add support for Siemens NXS protocol for image acquisition via a LAN connection as an alternative to using a frame grabber. This option is available only the Siemens Cios Spin C-arms.
- Add a new "live DRR" display, also known as "Simulated X-ray view" that activates when the C-arm rotates and displays a 2D projection image derived from the 3D CT / CBCT scan data in accordance with the current angles of the C-arm.
- 트 Add a verification and associated alert to ensure that tool length marking is not shorter than 40mm and that the position of the marked tool is not further than 200 pixels from that marked in the planning data.
- Add a feature to enable users to instantly view the newly acquired X-ray image prior to its processing, with no dark background.
- . Add a feature that allows the user to verify proper positioning of all the tools (e.g. k-wires prior to screw placement) with two additional AP X-ray images capturing all the tools at once.
- . Add a feature that allows the System to be used in an offline mode so that newly acquired X-ray images aren't input and analyzed by the VUZE System.
- . Generate cross-sections in the background. If generation fails, the software will suggest acquiring images from different C-arm angles, in advance. If the generation is successful, the user can then view the generated crosssections within the software by pressing "Generate Cross-Sections".
- . Addition of a system verification that alerts the user when the tool trajectory changes significantly from what was previously accepted.
- Addition of an optional Bluetooth foot pedal with associated Bluetooth dongle for the System as an input device that activates the default action from the GUI at the time of activation.
- . Upgrade GPU model from RTX-2080 to RTX-3090 to support faster CT to X-ray registration.
- . Addition of DVI galvanic Isolator and replace existing optical video cable with DVI cable.
- . Minor graphical user interface improvements for usability (e.g., snap to tool, screenshot tool, magnification view, display incision site, C-arm angles display in title bar, always provide next image angle suggestions, text changes).
- . Resolution of non-safety related software anomalies.
- The differences in technology do not raise different questions of safety or . effectiveness and were evaluated through comprehensive bench verification and validation testing including a usability study. The results of testing provide assurance that the device is as safe and effective as the Predicate.
7
For a more detailed comparison refer to the Substantial Equivalence comparison table included below.
Performance Data:
There are no identified special controls or performance standards for this device.
The modified VUZE System was verified and validated in accordance with 21 CFR 820.30. The following tests assessed comprehensively the changes in the system and were completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device successfully completed all of the evaluations and testing shown below. The standards shown in the following section were used, where applicable, to conduct testing and evaluate results.
- Hardware component / assembly functional verification ●
- Software Verification / Validation at the unit, integration and system levels (full ● execution of all software-based testing from original 510(k) with protocol modifications where necessary to fully test changes)
- Electrical Safety and EMC
- Full system functional verification against inputs and specifications .
- Simulated Use / Quantitative Accuracy
- Formative Usability Validation ●
As listed above, quantitative accuracy performance of the VUZE System was evaluated in comparison to its performance specifications and found to meet all specifications. The following tables present the results of this performance testing.
| Parameter | ||||
|---|---|---|---|---|
| CT Angle Settings | Direction | |||
| error | ||||
| [deg] | Tip | |||
| deviation | ||||
| from GT | ||||
| trajectory | ||||
| [mm] | Predicted | |||
| tip | ||||
| deviation | ||||
| from GT | ||||
| trajectory | ||||
| [mm] | Depth | |||
| error | ||||
| [mm] | ||||
| VUZE System Recommended Angles | 0.3094 | 0.2833 | 0.3572 | 0.8196 |
| Minimal Angle Difference (worst case) | 0.4537 | 0.4107 | 0.5199 | 1.0194 |
| RMS specification limit | $\u22643\u00b0$ | $\u22642$ mm | $\u22642$ mm | $\u22644$ mm |
| All results within RMS specification limit | Pass | Pass | Pass | Pass |
Results of the Root Mean Square (RMS) analysis at Recommend and Minimal Angle Differences between X-ray Images
8
| Parameter | Specification | Quantile | Test
Result | Using VUZE
System
Recommended
Angles | | Using Minimal
Angle Difference | |
|----------------------------------------------------|---------------|----------|----------------|-----------------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|
| | | | | Quantile
Estimate | 95% Conf.
Limit of
Quantile | Quantile
Estimate | 95% Conf.
Limit of
Quantile |
| Direction error [deg] | -6.5 mm | 2.5% | Pass | -1.371 | -1.424 | -1.939 | -2.053 |
| Depth error [mm] Upper |