(38 days)
No
The summary describes a standard medical image viewer with manipulation and comparison capabilities. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is a medical image viewer software application used for examining and manipulating medical images, not for treating any medical condition.
No
The device is an image viewer that allows clinicians to examine and manipulate medical images obtained from various scanning modalities. It aids in the viewing and comparison of images but does not independently diagnose conditions or provide medical conclusions; it is explicitly a "medical image viewer software application."
Yes
The device is explicitly described as a "medical image viewer software application" and "software" throughout the description. It is an option within a cleared software platform (Vitrea) and its function is to display, navigate, manipulate, and quantify medical images. There is no mention of any accompanying hardware component being part of the 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Multi Modality Viewer is a software application that displays, navigates, manipulates, and quantifies medical images obtained from various imaging modalities (MRI, CT, etc.). It works with images already acquired from the patient, not with specimens taken from the patient.
- Intended Use: The intended use is for the examination and manipulation of medical images for clinical review and comparison. This is distinct from analyzing biological samples.
The device is clearly a medical image viewer and processing software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Product codes
LLZ
Device Description
Multi Modality Viewer is a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, CR, DX, RG, RF, XA, PET, PET/CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinicians, including physicians, radiologists and technologists
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
The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Vital Images, Inc. % Ms. Susan Atwood Principal Quality Engineer 5850 Opus Parkway, Suite 300 MINNETONKA ME 55343
Re: K163574
Trade/Device Name: Multi Modalitv Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 16, 2016 Received: December 19, 2016
Dear Ms. Atwood:
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 801); medical device reporting (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Multi Modality Viewer
Indications for Use (Describe)
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif.
510K Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).
| Basis for the
Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to obtain
510(k) clearance for the Multi Modality Viewer software which is
substantially equivalent to the FDA cleared Multi Modality Viewer
(previous version) Software (K161419). |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Susan Atwood
Principal Quality Engineer
Phone: 952-487-9759
Fax: 952-487-9510
E-mail: satwood@vitalimages.com |
| | Alternate Contact Person:
Vince Swenson
Sr. Director of Quality and Regulatory
Phone: 952-487-9548
Fax: 952-487-9510
E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | December 16, 2016 |
| Device Trade Name: | Multi Modality Viewer |
| Device Common
Name/ Regulatory
Description: | Radiological Image Processing Software, Picture Archiving and
Communications System |
| Device Classification
Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |
4
Image /page/4/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and appear to be slightly blurred, giving them a soft appearance.
Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Multi Modality Viewer | ||
| Software | Vital Images, Inc. | K161419 |
Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Mirada RT (marketed as | ||
| Mirada XD) | MIRADA MEDICAL LTD. | |
| Mill Street | ||
| Innovation House | ||
| Oxford, Oxfordshire, GB Ox2 0JX | K102687 | |
| VitalConnect | Vital Images, Inc. | |
| 5850 Opus Parkway, Suite 300, | ||
| Minnetonka, Minnesota 55343 U.S.A. | K071362 |
Device Description:
Multi Modality Viewer is a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
Existing Features:
General image display:
- Display of images, volumes, and time sequences from MRI and CT modalities ●
- Display of derived modality images and secondary capture (SC) images
- 2D image display, MPR display, cine and 4D cine display for appropriate modalities
- Maximum, minimum, or average intensity projection for MPR with adjustable thickness .
- Display of high-resolution (1024 matrix) CT images .
Image cross-reference and comparison:
- Single MPR plane, 3-plane orthogonal MPR, and oblique MPR display ●
- Linked scrolling of MPR images and 2D images in the same plane ●
- . Linked pan, zoom, and matched presentation of images in the same plane
- Cross-reference lines and MPR cross-hairs to indicate orthogonal planes ●
- Focus tool to pinpoint the same location in all series ●
- Automatic linking of series with the same frame of reference ●
- Manually set reference point for linking separately acquired series ●
5
Image /page/5/Picture/1 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and appear to be in bold.
Hanging and viewing adjustments
- Ability to load only one study or including all priors ●
- User-defined, flexible hanging layouts ●
- Automatic initial hanging, manual hanging using drag & drop thumbnails .
- Scroll, pan, zoom, W/L. W/L presets, fit to view, reset ●
- Image flip, rotate clockwise/counterclockwise, invert
- Demographics more, less, on/off, reference lines on/off, linking on/off
Measurement, annotation, and snapshots:
- . Ruler, angle, and Cobb angle measurement
- Ellipse ROI and freehand ROI with pixel value statistics ●
- HU measurement for CT ●
- Time-Intensity Analysis ROI
- Arrow and text annotation ●
- Manual snapshots. Auto snapshot on measurement or annotation ●
- Ability to restore the presentation state of a snapshot .
Derived series and specialized tools:
- . MPR batch series generation
- Direct access to MRI Stitching application ●
- . Access to all other applications on Vitrea system
New Features Since the Last 510(k) Clearance K161419:
General image display:
- Display of images and time sequences from projection modalities (CR, DX, RG, RF, and ● XA)
- . Display of PET images in grayscale or with a color map
- Display of PET/CT images acquired with the same frame of reference ●
- Fused display of PET/CT images acquired with the same frame of reference ●
- Rotating MIP display of PET hotspots .
Image cross-reference and comparison:
-
Linking of PET hotspots in MIP and MPR views ●
Measurement, annotation, and snapshots: -
SUV measurement for PET .
Derived series and specialized tools: -
Image subtraction of two compatible series .
Intended Use / Indications for Use:
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
6
Image /page/6/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.
Intended for Disease / Condition / Patient Population:
Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended for disease, condition, and patient population is not applicable.
Substantial Equivalence Comparison:
Regulatory Comparison:
| | Subject Device | | Predicate
Device | |
|---------------------|----------------------------------------------|----------------------------------------------|--------------------------------|--|
| Characteristic | Multi Modality
Viewer | Multi Modality
Viewer
(K161419) | Comparison | |
| Classification Name | System, Image
Processing,
Radiological | System, Image
Processing,
Radiological | Same | |
| Regulatory Number | 892.2050 | 892.2050 | Same | |
| Product Code | LLZ | LLZ | Same | |
| Classification | Class II | Class II | Same | |
| Review Panel | Radiology | Radiology | Same | |
| Decision Date | Under Review | May 20, 2016 | Predicate device
is cleared | |
7
Image /page/7/Picture/1 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
| Indications for Use Comparison with Predicate Device: | |
|---|---|
| ------------------------------------------------------- | -- |
| Criteria | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Multi Modality Viewer | Multi Modality Viewer (K161419) | ||
| Indications for Use | Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. | Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. | Similar |
| Added support for the ability to examine and manipulate medical images obtained from CR, DX, RG, RF, XA, PET and PET/CT modalities which was not part of the predicate device's indications for use. | |||
| Intended Users | Physicians, Radiologists, Clinicians or Technologists | Physicians, Radiologists, Clinicians or Technologists | Same |
| Patient Population | Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended disease, condition, and patient population is not applicable. | Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended disease, condition, and patient population is not applicable. | Same |
| Modality Support | MRI, CT, CR, DX, RG, RF, XA, PET and PET/CT | MRI and CT | Similar |
| Added support for the ability to examine and manipulate medical images obtained from CR, DX, RG, RF, XA, PET and PET/CT modalities which was not part of the predicate device's | |||
| Criteria | Subject Device | Predicate Device | Comparison |
| Multi Modality | |||
| Viewer | Multi Modality Viewer | ||
| (K161419) | |||
| Data Loading | |||
| Image | |||
| Communication | |||
| Standard: DICOM | Yes | Yes | Same |
| Data Viewing Support | |||
| 2D Image Review | Yes | Yes | Same |
| 2D Comparative | |||
| Review | Yes | Yes | Same |
| Features and Capabilities | |||
| Multi-Planner | |||
| Reformatting | Yes | Yes | Same |
| Maximum and | |||
| Minimum Intensity | |||
| Projection | |||
| (MIP/MinIP) | Yes | Yes | Same |
| Image Editing, | |||
| Setting, Saving | Yes | Yes | Same |
| Annotation & | |||
| Tagging Tools | |||
| (Label) | Yes | Yes | Same |
| Display Options | |||
| (e.g. thickness) | Yes | Yes | Same |
| Quantitative | |||
| Measurements | Yes | Yes | Same |
| Snapshot | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
8
Image /page/8/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced.
Similarities in Technology with Predicate Device:
9
|--|
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality | ||
| Viewer | Multi Modality Viewer | ||
| (K161419) | |||
| Color Image Display | Yes | Yes | Same |
| Simultaneous | |||
| Multiple Studies | |||
| Review | Yes | Yes | Same |
| Cross-reference | |||
| Lines Support | Yes | Yes | Same |
| Display of Selected | |||
| Images, Series, or | |||
| Entire Study | Yes | Yes | Same |
| Comparison of | |||
| Multiple Series or | |||
| Studies | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Image | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Same |
| Flip Image - | |||
| Horizontal | Yes | Yes | Same |
| Rotate Image - | |||
| Clockwise | Yes | Yes | Same |
| Rotate Image - | |||
| Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Auto Window | |||
| Level/Width Setting | Yes | Yes | Same |
10
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Multi Modality Viewer | Multi Modality Viewer (K161419) | Comparison |
| Measurement of Distance | Yes | Yes | Same |
| Measurement of Angle | Yes | Yes | Same |
| Measurement of Cobb Angle | Yes | Yes | Same |
| Identification and Display of Ellipse Regions of Interest (ROIs) | Yes | Yes | Same |
| Identification and Display of Freehand Regions of Interest (ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction of two series/datasets | Yes | Yes | Same |
| Study and Series Linking | Yes | Yes | Same |
| Semi-automated Image Stitching | Yes | Yes | Same |
| Time Intensity Analysis | Yes | Yes | Same |
| Batch Save of MPR Reformats | Yes | Yes | Same |
| Examination and manipulation of a series of medical images obtained from MRI and CT datasets | Yes | Yes | Same |
11
Image /page/11/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are all capitalized except for the "i".
| Differences in Technology with the Predicate Device: |
|---|
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | Multi Modality Viewer (K161419) | |
| Feature: Support for PET and PET/CT Modality Data | Yes | No | Multi Modality Viewer allows the examination and manipulation of medical images obtained from PET and PET/CT scanners in addition to MRI and CT scanners. |
Note: The added PET and PET/CT modalities are similar to the features available on the Mirada XD software (“Reference Device”), which was cleared by the FDA under K102687. Therefore, this added feature does not raise different questions of safety and effectiveness. |
| Feature: Support for CR, DX, RG, RF, and XA Modality Data | Yes | No | Multi Modality Viewer allows the examination and manipulation of medical images obtained from CR, DX, RG, RF, and XA modalities in addition to MRI and CT scanners.
Note: The added CR, DX, RG, RF, and XA modalities are similar to the features available on the VitalConnect 4.1 software (“Reference Device”), which was cleared by the FDA |
12
Image /page/12/Picture/1 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot on the "i", which is red. The letters are evenly spaced and the word is centered.
| Criteria | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Multi Modality Viewer | Multi Modality Viewer (K161419) | ||
| under K071362. | |||
| Therefore, this added | |||
| feature does not raise | |||
| different questions of | |||
| safety and | |||
| effectiveness. |
Similarities in Technology with the Reference Device
| Subject Device | Reference Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | Mirada XD (K102687) | |
| Modality | |||
| Support for PET | |||
| and PET/CT | |||
| Modality Data | Yes | Yes | Same |
| Support for | |||
| following | |||
| measurements: | |||
| • Becqerel per | |||
| milliliter (BQML) | |||
| • SUV body weight | |||
| (SUVbw) | |||
| • SUV body | |||
| surface area | |||
| (SUVbsa) | |||
| • SUV lean body | |||
| mass (SUVIbm) | Yes | Yes | Same |
| PET/CT Fusion | |||
| View | Yes | Yes | Same |
| PET/CT Fusion | |||
| Blending | Yes | Yes | Same |
| Window/width | |||
| Functionality for | |||
| PET & CT Images | Yes | Yes | Same |
| PET & CT | |||
| window/width | |||
| Presets | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Subject Device | Reference Device | Comparison | |
| Criteria | Multi Modality Viewer | Mirada XD (K102687) | |
| Scroll Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Tool | |||
| (triangulate) | Yes | Yes | Same |
| Ruler | |||
| Measurement Tool | Yes | Yes | Same |
| Ellipse ROI | Yes | Yes | Same |
| Fixed ROI | Yes | Yes | Same |
| Label | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Reset Image | Yes | Yes | Same |
| Snapshots | Yes | Yes | Same |
| View Current and | |||
| Prior Scans | Yes | Yes | Same |
| CT & PET MPR | |||
| Display & | |||
| Manipulation | Yes | Yes | Same |
| PET MIP Display & | |||
| Manipulation | Yes | Yes | Same |
| CT & PET 2D | |||
| Views | Yes | Yes | Same |
| PET Color Overlay | Yes | Yes | Same |
| Update/correct | |||
| Parameters | |||
| (height, weight, | |||
| dose) | Yes | Yes | Same |
13
Image /page/13/Picture/1 description: The image shows the word "ViTAL" in black letters. The "i" in "ViTAL" has a red dot above it. The letters are all capitalized and in a sans-serif font.
14
Image /page/14/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white.
Similarities in Technology with the Reference Device
| Subject Device | Reference Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | VitalConnect | |
| (K071362) | |||
| Modality | |||
| Support for CR, | |||
| DX, RF, RG, and | |||
| XA Modality Data | Yes | Yes | Same |
Software Development Environment Description:
The Multi Modality Viewer software was designed, and tested according to IEC 62304:2004 standard for Medical Device Software: Software Life Cycle Processes.
The following design control measures were applied to the development of the Multi Modality Viewer software:
- Risk Management
- Software Requirements Reviews ●
- Code Designs ●
- . Code Development Testing
- Code Reviews
- . Design Reviews
- Verification of the software that included performance and safety testing ●
- . Validation of the software – that included simulated usability testing by experienced professionals.
Risk Management
Each risk associated with the Multi Modality Viewer software has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least "Improbable." Because of the risk control measures, it is believed that the risk for the Multi Modality Viewer software as a whole, is extremely low.
During the final risk management review, the following conclusions were reached:
- All Occurrence Factors for Hazards were mitigated as low as possible ●
- Of the unresolved defects remaining in the released application, each has been carefully . evaluated and it has been determined that the software can be used safely and effectively.
- . The medical benefits of the device outweigh the residual risk for each individual risk and all risks together.
15
Image /page/15/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The letters are spaced evenly apart and are all capitalized. The background is white.
Verification and Validation:
The software was designed, developed, tested, verified, and validated according to written procedures. Verification confirmed that the feature functions according to its requirements.
Software testing was completed to ensure the Multi Modality Viewer software functions according to its requirements and operates on the Vitrea software platform without degrading the existing functionality of the Vitrea software platform. Performance testing for the Multi Modality Viewer software included internal verification and external validation. The Multi Modality Viewer software has achieved all product release criteria.
Summary of Clinical Tests:
The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
Confidentiality
The Vitrea software platform (K150258) relies on built in Windows Login security to limit access to the system. The Vitrea software platform can only be installed and configured by an administrator of the Windows machine.
Integrity
The Vitrea software platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.
Availability
The Vitrea software platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
Accountability
The Vitrea software platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea software platform audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
16
Image /page/16/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
The Multi Modality Viewer software complies with the following voluntary recognized consensus standards:
| Standard No. | Standards
Organization | Standard Title | Version | Date |
|-------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1- 3.20 (2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in Medicine
(DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |
Substantial Equivalence Analysis Conclusion:
Vital Images believes the Multi Modality Viewer software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Multi Modality Viewer (K161419). The added features to allow for the examination and manipulation images obtained from PET and PET/CT scanners is similar to the features in the reference device, Mirada RT which was cleared by the FDA under K102687. Additionally, the ability to view and manipulate images obtained from CR, DX, RG, RG and XA scanners is similar to the feature in the reference device, VitalConnect, which was cleared by the FDA under K071362.
Furthermore, the verification and validation testing performed demonstrate the subject device is as safe and effective as the predicate and reference devices and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the addition of the examination and manipulation of a series of medical images obtained from CR, DX, RG, RF, XA, PET, and PET/CT scanners in the Multi Modality Viewer software does not alter the fundamental scientific technology, safety or intended use of the device.
Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.