(290 days)
No
The summary does not mention AI or ML, and the description focuses on image registration and overlay based on pre-operative and intra-operative images, which are standard techniques in image-guided surgery and do not inherently require AI/ML.
No.
The device supports device guidance and provides planning and confirmation, but it does not directly treat or diagnose a disease or condition.
No
The VUZE System is described as a device that supports device guidance during interventional spinal procedures by overlaying pre-operative 3D images with intra-operative 2D radiographic images. It also offers pre-operative surgical planning and intra-operative guidance and tool trajectory/position confirmation. These functions are for guiding surgical procedures and planning, not for diagnosing a patient's medical condition.
No
The device description explicitly lists hardware components such as a workstation, housing, touchscreen, isolation transformer, internal video acquisition device (frame grabber), and a wheeled cart. The performance studies also include "Hardware component and functional unit verification and validation."
Based on the provided information, the VUZE System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- VUZE System Function: The VUZE System's intended use and description clearly state that it is a surgical guidance system that uses pre-operative and intra-operative medical images (radiographic images, CT) to assist surgeons during spinal procedures. It does not analyze biological specimens.
- Lack of IVD-Specific Information: The document does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing based on bodily fluids or tissues.
The VUZE System falls under the category of medical devices used for surgical planning and guidance, specifically in the field of interventional spinal procedures.
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 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. 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 pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative quidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intraoperative 2D images onto a patient's pre-operative 3D images.
The main system components include:
- Workstation running the VUZE Planning and Procedure software (pre-installed)
- Housing for the workstation, with a front door for user access as well as a back ser- vice door
- 32" touchscreen
- Isolation transformer
- Internal video acquisition device (frame grabber)
- Wheeled cart on which the above-listed items are placed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pre-operative 3D images, intra-operative 2D radiographic images, CT
Anatomical Site
S1 through T7 (Spinal procedures), 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 VUZE System was verified and validated in accordance with 21 CFR 820.30. The following tests 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 and functional unit verification and validation
- Packaging / Transportation Validation
- Software Verification / Validation at the unit, integration and system levels
- IEC 60601-1 Basic Safety and Essential Performance
- IEC 60601-1-2 Electromagnetic Compatibility (EMC)
- Simulated Use / Quantitative Accuracy
- Qualitative Image Output Validation
- Summative Usability Validation
No animal or human clinical data were needed to demonstrate substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "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
Re: K210830
February 8, 2022
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
Dear Clay Anselmo:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 3, 2022. Specifically, FDA is updating this SE Letter due to a typo in the clearance date, which was incorrectly dated as January 3, 2021, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6167, jessica.lamb(@fda.hhs.gov.
Sincerely.
Jessica Lamb
Jessica Lamb Assistant Director Mammography Ultrasound and Imaging Software Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
January 3, 2021
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
VUZE Medical Ltd. % Clay Anselmo Principal Quality and Regulatory Consultant Shriner & Associates Inc. 429 Whitepine Creek Road TROUT CREEK MT 59874
Re: K210830
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: November 18, 2021 Received: November 23, 2021
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 (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
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 mediation-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
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210830
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 — K210830
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 | VUZE Medical Ltd. |
|---|---|
| Name and Address | 13 Zarhin St. |
| Ra'Anana 4366241, Israel |
| 510(k) contact person | Clay Anselmo |
|---|---|
| Principal Quality and Regulatory Con- sultant | |
| Shriner & Associates | |
| 429 Whitepine Creek Road | |
| Trout Creek, MT 59874 | |
| clay.anselmo@shrinerandassociates.com | |
| (303) 907-2955 | |
| Date prepared | 16-March-2021 |
Device Identification
| Trade names | VUZE System |
|---|---|
| Common name | VUZE Medical Imaging System for spinal |
| interventions | |
| Classification name | Medical Image Management and Pro- |
| cessing System | |
| Regulation Number | 21 CFR Part 892.2050 |
| Classification | Class II |
| Product Code | Primary: LLZ |
| Predicate Device | |
| Trade names: | Innova Vision Applications |
| 510(k) number: | K092639 |
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Reference Device
| Trade names: | Renaissance |
|---|---|
| 510(k) number: | K140167 |
Device Description:
The VUZE System (the "System") enables 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. 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 pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative quidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intraoperative 2D images onto a patient's pre-operative 3D images.
The main system components include:
- Workstation running the VUZE Planning and Procedure software (pre-installed) ●
- Housing for the workstation, with a front door for user access as well as a back ser-● vice door
- 32" touchscreen
- Isolation transformer ●
- Internal video acquisition device (frame grabber) ●
- Wheeled cart on which the above-listed items are placed. ●
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.
Technological Characteristics Comparison:
Substantial Equivalence: The VUZE System is substantially equivalent to the Innova Vision Application (a.k.a. TrackVision) K092639. A reference device, (Mazor Robotics Renaissance System K140167) was used to address minor technology differences between the VUZE System and the TrackVision device.
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:
6
- The VUZE System device has the same intended use and similar indications for use as the Predicate device.
- The VUZE System device uses the same fundamental technology as the Predicate . device and very similar detailed technological solutions as follows:
- o The VUZE System utilizes 3D imaging data of the patient's target anatomy and pre-operative surgical planning information registered against intraoperative 2D x-ray images to support the correct placement of interventional devices (trajectory and position).
- This approach to presenting co-registered 3D and 2D imaging information for о the purposes of aiding tool guidance and tool placement confirmation is the same as the predicated device.
- The minor differences between the VUZE System device and the Predicate do not ● raise new types of questions of safety or effectiveness.
- o The differences in technology do not raise different questions of safety or effectiveness and were evaluated through comprehensive bench and usability verification and validation testing. The results of testing provide assurance that the device is as safe and effective as the predicate.
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 VUZE System was verified and validated in accordance with 21 CFR 820.30. The following tests 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 and functional unit verification and validation ●
- Packaging / Transportation Validation ●
- Software Verification / Validation at the unit, integration and system levels ●
- IEC 60601-1 Basic Safety and Essential Performance ●
- IEC 60601-1-2 Electromagnetic Compatibility (EMC) ●
- Simulated Use / Quantitative Accuracy ●
- Qualitative Image Output Validation ●
- Summative Usability Validation ●
No animal or human clinical data were needed to demonstrate substantial equivalency.
The device has been designed and tested in conformance to the following voluntary recognized consensus standards:
- ANSI / AAMI / IEC 60601-1: 2005 /(R)2012 +A1:2012: Medical Electrical Equipment ● - Part 1: General Requirements for Basic Safety and Essential Performance (FDA Recognition #19-4)
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- IEC 60601-1-2: Edition 4.0, 2014-02 Medical Electrical Equipment Part 1-2: Gen-● eral Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests Sections 7, 8 professional healthcare facility environment (FDA Recognition #19-8).
- IEC 62304:2006/A1:2016, Medical Device Software Software Lifecycle Processes ● (FDA Recognition #13-79)
- IEC 62366-1:2015: Medical devices Part 1: Application of usability engineering to . medical devices (FDA Recognition #5-114)
- IEC 62366-1-6:2013-10 Edition 3.1: Medical Electrical Equipment Part 1-6: Collat-. eral Standard - Usability (FDA Recognition #5-89)
- ISO 14971:2019 Medical Devices: Application of Risk Management to Medical De-. vices (FDA Recognition #5-125)
- ISO 15223:2016 Medical devices Symbols to be used with medical devices labels, . labeling, and information to be supplied - Part 1: General requirements (FDA Recognition #5-117)
- NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine (DI-● COM) Set (FDA Recognition #12-300)
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers . and Systems (FDA Recognition #14-499)
| Substantial Equivalence Comparison: | |
|---|---|
| ------------------------------------- | -- |
| Device | Renaissance | |||
|---|---|---|---|---|
| Characteristic | VUZE | |||
| (Subject Device) | Innova Vision Applications | |||
| (Predicate, K092639) | (Reference | |||
| Device, | ||||
| K140167) | Conclusion | |||
| Intended Use | Intended as an imaging aid | |||
| for interventional proce- | ||||
| dures to allow comparison | ||||
| of planned tool paths | ||||
| against actual tool place- | ||||
| ment | Intended as an imaging aid | |||
| for interventional procedures | ||||
| to allow comparison of | ||||
| planned tool paths against | ||||
| actual tool placement | N/A | Identical to | ||
| Predicate | ||||
| 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 guid- | ||||
| ance during interventional spinal | ||||
| procedures. The system also offers | ||||
| pre-operative surgical planning | ||||
| including implant sizing, entry loca- | ||||
| tion, and trajectory determination | ||||
| along with intra-operative quidance | ||||
| and tool trajectory / position con- | ||||
| firmation. | Innova Vision Applications | |||
| software is intended to ena- | ||||
| ble users to load 3D da- | ||||
| tasets and overlay and regis- | ||||
| ter in real time these 3D da- | ||||
| tasets with radioscopic or | ||||
| radiographic images of the | ||||
| same anatomy in order to | ||||
| support catheter/device | ||||
| guidance during interven- | ||||
| tional procedures. | N/A | Substantially | ||
| Equivalent | ||||
| Device Class | II | II | II | Identical to |
| All | ||||
| Procodes | LLZ | LLZ | OLO, HAW, | |
| LLC | Identical to | |||
| Predicate | ||||
| Device | Renaissance | |||
| Characteristic | VUZE | |||
| (Subject Device) | Innova Vision Applications | |||
| (Predicate, K092639) | (Reference | |||
| Device, | ||||
| K140167) | Conclusion | |||
| Anatomy | Thoracic and Lumbar Spine | Not specific. Anywhere ra- | ||
| diographic images of the | ||||
| anatomy are available. | Spine | Subset of | ||
| Predicate, | ||||
| Identical to | ||||
| Reference | ||||
| Device; | ||||
| Substantially | ||||
| Equivalent | ||||
| Surgical Access Type | Percutaneous | Percutaneous | Open and | |
| Perc. | Identical to | |||
| Predicate | ||||
| Patient Population | General Spine Surgery | All tool-based interventions, | ||
| not limited to specific clinical | ||||
| indication | General | |||
| Spine Sur- | ||||
| gery | Subset of | |||
| Predicate: | ||||
| Substantially | ||||
| Equivalent | ||||
| Target User | Interventional Spine Sur- | |||
| geon | Interventional Surgeons in- | |||
| cluding Ortho and Spine | ||||
| surgeons | Interventional | |||
| Spine / Or- | ||||
| thopedic | ||||
| Surgeon | Subset of | |||
| Predicate, | ||||
| Identical to | ||||
| Reference | ||||
| Device; | ||||
| Substantially | ||||
| Equivalent | ||||
| Environment | Surgical Suite | Catheter Lab, Surgical Suite | Surgical | |
| Suite | Subset of | |||
| Predicate; | ||||
| Substantially | ||||
| Equivalent | ||||
| Hardware Platform | Dedicated Workstation | Dedicated Workstation | Proprietary | |
| HW platform | Identical to | |||
| Predicate | ||||
| Work-Flow | 3D imaging, planning, 2D | |||
| imaging, 3D to 2D co- | ||||
| registration, intervention, | ||||
| confirmation | 3D imaging, planning, 3D & | |||
| 2D imaging, 3D to 3D/2D co- | ||||
| registration, intervention, | ||||
| confirmation | 3D imaging, | |||
| planning, 2D | ||||
| imaging, 3D | ||||
| to 2D co- | ||||
| registration, | ||||
| intervention, | ||||
| confirmation | Subset of | |||
| Predicate, | ||||
| Identical to | ||||
| Reference | ||||
| Device; | ||||
| Substantially | ||||
| Equivalent | ||||
| 3D Image Data Source | CT | Cone-Beam CT | CT | Substantially |
| Equivalent | ||||
| Interoperative Image | ||||
| Co-Registration | 3D image to X-ray using | |||
| Digitally Reconstructed Ra- | ||||
| diographs (DRR's) | 3D Image to Fluoroscopy | |||
| and / or X-ray using X-ray | ||||
| position data. | 3D image to | |||
| X-ray using | ||||
| DRR's | Subset of | |||
| Predicate, | ||||
| Identical to | ||||
| Reference | ||||
| Device; | ||||
| Substantially | ||||
| Equivalent | ||||
| Tool Use | Free hand | Free hand | Robotic | |
| Assistance | Identical to | |||
| Predicate |
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Conclusion:
The VUZE System is substantially equivalent to the Innova Vision Applications (K092639).