(167 days)
Not Found
No
The summary describes standard image processing and computational modeling functionalities without mentioning AI or ML, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device aids in preoperational planning and does not directly provide therapy or interact physically with the patient. It offers clinical decision support rather than direct therapeutic intervention.
No
Explanation: The device is described as a "clinical decision support system" for preoperational planning and is explicitly stated as not being intended to "eliminate, replace or substitute for... the healthcare provider's judgment and analysis of the patient's condition." This indicates it aids in planning rather than directly diagnosing.
Yes
The device is explicitly described as a "stand-alone software application that runs on any standard Windows or Mac OSX based computer" and processes existing CT scan data. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- SurgicalPreview's Function: SurgicalPreview processes and visualizes medical images (CT scans) of the patient's cerebral blood vessels. It does not analyze biological specimens (blood, tissue, etc.) taken from the patient.
- Intended Use: The intended use is for preoperational planning and sizing for neurovascular interventions and surgery, and computational modeling of device placement. This is a clinical decision support tool based on imaging data, not a diagnostic test performed on a biological sample.
The device description explicitly states it works with DICOM CT scan images and does not contact the patient. This further reinforces that it is not an IVD.
N/A
Intended Use / Indications for Use
SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview also allows for the ability to computationally model the placement and deployment of neurointerventional devices.
General functionalities are provided such as:
- Segmentation of neurovascular structures
- Automatic centerline detection
- Visualization of CT scan images for 2D review and 3D reconstruction
- Measurement and annotation tools
- Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Product codes (comma separated list FDA assigned to the subject device)
PZO
Device Description
SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery.
SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files.
The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan images
Anatomical Site
cerebral blood vessels (neurovascular structures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a clinical decision support system during the preoperative planning of endovascular surgery.
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 subject device is designed in conformance with:
- ACR/NEMA Digital Imaging Communications in Medicine (DICOM) Version 3.1
- ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices
- IEC 62304:2006 Medical Device Software Software Life-Cycle Processes
All specifications of the SurgicalPreview™ software are validated by a bench test before release. Bench testing includes:
- Tests of importation of DICOM images
- Patient manager tests
- Tests of image display and processing
- Functioning tests for visualization of anatomic reconstruction
- Functioning tests for computational modeling of Codman Enterprise Vascular Reconstruction Device and Pipeline Embolization Device
- Measurement tests
- Reports creation and visualization tests
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.
EndoSize (K160376)
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.
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2017
EndoVantage, LLC % H. Semih Oktay, Ph.D. Regulatory Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K171534
Trade/Device Name: SurgicalPreview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PZO Dated: October 6, 2017 Received: October 10, 2017
Dear Dr. Oktay:
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, 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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171534
Device Name EndoVantage SurgicalPreview
Indications for Use (Describe)
SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview also allows for the ability to computationally model the placement and deployment of neurointerventional devices.
General functionalities are provided such as:
- · Segmentation of neurovascular structures
- · Automatic centerline detection
- · Visualization of CT scan images for 2D review and 3D reconstruction
- · Measurement and annotation tools
- · Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
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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Image /page/3/Picture/0 description: The image shows the logo for Endovantage. The logo is red and features a stylized globe-like graphic on the left side. The text "endovantage" is written in a bold, sans-serif font and is also red.
SurgicalPreview™
| 510(k) SUMMARY | K171534 |
|---|---|
| Submitter: | EndoVantage, LLC |
| 8444 N. 90th Street | |
| Suite 125 | |
| Scottsdale, AZ 85258 | |
| Contact Person: | Robert S. Green |
| President | |
| Phone: (480) 291-5031 | |
| Email: simulate@endovantage.com | |
| Summary Date: | October 6, 2017 |
| Device Trade Name: | SurgicalPreviewTM |
| Device Common Name: | Radiological Image Processing Software |
| Device Classification Name: | Software for visualization of vascular anatomy and |
| intravascular devices | |
| Regulatory Description: | Picture Archiving and Communication System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PZO |
| Regulatory Classification: | Class II |
| Predicate Device: | EndoSize (K160376) |
Device Description
SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery.
SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files.
The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or
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Image /page/4/Picture/1 description: The image shows the logo for Endovantage. The logo features a stylized globe-like graphic on the left, with red lines forming a grid pattern. To the right of the graphic is the word "endovantage" in red, with a slightly blurred effect. The font is sans-serif and appears to be bolded.
substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.
Indications for Use
SurgicalPreview™ enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices.
General functionalities are provided such as:
- Segmentation of neurovascular structures ●
- Automatic centerline detection
- Visualization of CT scan images for 2D review and 3D reconstruction ●
- Measurement and annotation tools ●
- Reporting tools ●
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.
Technological Characteristics
SurgicalPreview™ is a software-only device that runs on a standard computer that meets the minimum requirements. SurgicalPreview™ is not intended for use on mobile devices.
SurgicalPreview™ can use local DICOM files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.
Performance Data
The subject device is designed in conformance with:
- ACR/NEMA Digital Imaging Communications in Medicine (DICOM) Version 3.1 ●
- ISO 14971:2007 Medical Devices Application of Risk Management to Medical ● Devices
- IEC 62304:2006 Medical Device Software Software Life-Cycle Processes ●
All specifications of the SurgicalPreview™ software are validated by a bench test before release. Bench testing includes:
- Tests of importation of DICOM images ●
- Patient manager tests
- Tests of image display and processing
- Functioning tests for visualization of anatomic reconstruction
- Functioning tests for computational modeling of Codman Enterprise Vascular Reconstruction Device and Pipeline Embolization Device
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Image /page/5/Picture/0 description: The image shows the word "endovantage" in red font. The word is written in a stylized font, with the letters connected to each other. There is a graphic to the left of the word that looks like a red dome with a gray grid pattern on it. The word "endovantage" is the main focus of the image.
- Measurement tests ●
- Reports creation and visualization tests ●
Predicate Device Comparison
The predicate device for the SurgicalPreview™ software is EndoSize (K160376). Both SurgicalPreview™ and its predicate device have similar intended use for preoperational planning of endovascular procedures using image data from a medical scanner. A summary comparison of technological characteristics is provided in Table 1.
| Characteristic | SurgicalPreviewTM | Predicate: EndoSize |
|---|---|---|
| 510(k) Number | K171534 | K160376 |
| Indications for Use | SurgicalPreviewTM enables visualization | |
| and measurement of vessels for | ||
| preoperational planning and sizing for | ||
| neurovascular interventions and surgery. | ||
| SurgicalPreviewTM also allows for the | ||
| ability to computationally model the | ||
| placement and deployment of | ||
| neurointerventional devices. | EndoSize enables visualization and | |
| measurement of structures of the | ||
| heart and vessels for preoperational | ||
| planning and sizing for | ||
| cardiovascular interventions and | ||
| surgery, and for postoperative | ||
| evaluation | ||
| Interface to Image | ||
| Sources | DICOM image data | Same |
| Import of Patient Data | Manual through keyboard/mouse, | |
| automatic import with image file, study | ||
| creation list | Same | |
| List Image Functionality | Deleting, anonymizing, search | Same |
| Image Processing | Segmentation by EndoVantage operator | |
| with end-user clinician review and | ||
| comment | By clinician | |
| 3D Assessment | Linear (length and diameter) | |
| measurements, volume measurements | Same | |
| Image and 3D Display | Orthogonal, color volume rendering, 2D | |
| slice review, active presets, 3D view of | ||
| assemblies of devices | Same | |
| DICOM Support | Compatible with all scanner vendor | |
| DICOM datasets, storage SCP, import | ||
| DICOM files, DICOM compliance for | ||
| CT and enhanced CT, import from | ||
| DICOMDIR, storage SCU, | ||
| query/retrieve SCU | Same | |
| Computer OS | ||
| Compatibility | MS Windows and Mac OS | Same |
| Data Interchange / | ||
| Transfer Method | Secure Internet File Server | Personal computer |
| Output File Format | Web browser via WebGL | Personal computer |
| Characteristic | SurgicalPreviewTM | Predicate: EndoSize |
| Preoperational Planning | Yes | Same |
| Patient Contact | No | Same |
| Human Intervention for | ||
| Interpretation of Images | Yes | Same |
Table 1 - SurgicalPreviewTM and Predicate Comparative Analysis
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Image /page/6/Picture/0 description: The image shows the word "endovantage" in red font. The word is slightly blurred, and there is a red graphic to the left of the word. The graphic is a curved shape with a grid pattern inside.
Substantial Equivalence Conclusion
Based on the information provided in this 510(k) submission, SurgicalPreview™™ has the same intended use as the predicate device. SurgicalPreview™ underwent bench testing to simulate clinical use. The performance data and software verification results demonstrated that the differences in technological characteristics between SurgicalPreview™ and the predicate device do not raise different questions of safety and effectiveness and that SurgicalPreview™™ should perform as intended in the specified use conditions. Endo Vantage concludes that SurgicalPreview™ is substantially equivalent to the predicate device identified in this submission.