(111 days)
Not Found
No
The summary describes standard medical image processing and visualization techniques (MPR, MIP, 3D rendering, calcium scoring algorithms) and explicitly states the principles of operation and technological characteristics are the same as the predicate device, which does not mention AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The device is described as an advanced imaging solution that aids in interpreting medical images and does not include any therapeutic functions.
No
The device is intended to provide tools for interpreting medical images and manipulating them for viewing, including cardiac calcium scoring using accepted algorithms, but it does not independently interpret or diagnose medical conditions from the images. It's an aid for professionals, not a diagnostic tool itself.
Yes
The device description explicitly states it is a "Zero Download 3D" advanced imaging solution that "employs server-based rendering and browser-based viewing," indicating it is a software application accessed remotely, without requiring dedicated hardware installation on the user's end. While it processes medical images from hardware modalities (CT, MRI, PET), the device itself is the software solution for viewing and manipulating these images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DR Systems Z3D is a software tool used for interpreting medical images (CT, MRI, PET). It processes and displays these images to aid physicians in diagnosis and analysis.
- Input Data: The input data is medical image volumes, not biological samples from the body.
- Intended Use: The intended use is to provide tools for interpreting medical images, reformatting and manipulating them, and performing specific image analysis like coronary calcium scoring. This is distinct from performing a diagnostic test on a biological sample.
While the device aids in the diagnostic process by providing tools for image interpretation, it does not perform a diagnostic test in vitro on a biological specimen. It is a medical image processing and viewing software.
N/A
Intended Use / Indications for Use
DR Systems Z3D is intended to provide reading physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including:
· Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET.
· Reformatting images, including creation of MPRs, MinIPs, color/monochrome 3D volume rendered images
· Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
· Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.
• Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
Product codes
LLZ
Device Description
DR Systems Z3D (Zero Download 3D) advanced imaging solution supports MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D volume rendering, and cardiac calcium scoring. The system employs server-based rendering and browser-based viewing. Reading physicians, referring physicians, and other appropriate healthcare personnel and can employ advanced image processing and display from local or remote locations.
Viewing Modes: Multiplanar reconstruction Two 3-D viewing modes, one showing 4 images, and one showing 6 images Cardiac calcium scoring DR Systems Z3D is similar to the predicate device, Voxar 3D. Both are PACS system accessories that allow the user to view and manipulate 3D image data sets. DR Systems Z3D does not have an AvelP analysis tool. The principles of operation and technological characteristics of the new and predicate device are the same.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant medical image volumes, such as CT, MRI, and PET.
Anatomical Site
Coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
reading physicians, and other appropriate healthcare professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: DR Systems Z3D was designed, developed and tested according to DR System's written procedures. Testing included verification, validation and evaluation of human factors and usability. The following quality assurance measures were applied to the development of Z3D: . Risk analysis ● Requirements reviews Design reviews ● Performance testing (verification) ● Simulated use testing (validation and human factors and ● usability)
Clinical Testing: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060505 - Voxar 3D Product Family
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that appears to be three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
DR Systems, Inc. % Ms. Kimberly J. Meade Manager, Regulatory Affairs/Quality Assurance 10140 Mesa Rim Road SAN DIEGO CA 92121
Re: K143318
Trade/Device Name: DR Systems Zero Download 3D Viewer (Z3D) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 18, 2015 Received: February 18, 2015
Dear Ms. Meade:
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,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143318
Device Name DR Systems Zero Download 3D Viewer (Z3D)
Indications for Use (Describe)
DR Systems Z3D is intended to provide reading physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including:
· Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET.
· Reformatting images, including creation of MPRs, MinIPs, color/monochrome 3D volume rendered images
· Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
· Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.
• Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
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 DR Systems. The logo consists of the letters "D" and "R" in white on a blue square. To the right of the square, the word "Systems" is written in blue.
Section 5 – 510(k) Summary
| Submitter: | DR Systems, Inc.
10140 Mesa Rim Road
San Diego, CA 92121
Phone: (858) 625-3344
FAX: (858) 625-3335 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kimberly J. Meade, MSQA, ASQ CQA
Manager, Regulatory Affairs/Quality Assurance
Phone: (858) 625-3344, x2260
kmeade@drsys.com |
| Date Prepared: | November 17, 2014 |
| Trade Name: | DR Systems Zero Download 3D Viewer (Z3D) |
| Common Name: | Digital Image Processing |
| Classification Name: | Systems, Image processing, Radiological |
| Classification
Regulation: | 21 CFR 892.2050, Class II |
| Product Code: | 90 LLZ |
| Predicate Device: | K060505 - Voxar 3D Product Family |
| Device Description: | DR Systems Z3D (Zero Download 3D) advanced imaging solution supports
MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D
volume rendering, and cardiac calcium scoring. The system employs
server-based rendering and browser-based viewing. Reading physicians,
referring physicians, and other appropriate healthcare personnel and can
employ advanced image processing and display from local or remote
locations.
Viewing Modes:
Multiplanar reconstruction Two 3-D viewing modes, one showing 4 images, and one showing 6 images Cardiac calcium scoring DR Systems Z3D is similar to the predicate device, Voxar 3D. Both are
PACS system accessories that allow the user to view and manipulate 3D
image data sets. DR Systems Z3D does not have an AvelP analysis tool.
The principles of operation and technological characteristics of the new and
predicate device are the same. |
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Image /page/4/Picture/0 description: The image shows the logo for DR Systems. The logo consists of the letters "D" and "R" inside of a blue square. To the right of the square, the word "Systems" is written in blue.
Technical Specifications
| Specifications | |
|---|---|
| Processor | o Intel® Core™ i5 3 GHz or faster: |
| o Quad-core minimum. | |
| Operating | |
| system | ■ Microsoft® Windows® 7/8.1 |
| ■ Apple® Mac OS ® X v10.6, v10.7, or v10.8 | |
| Hard drive | 160 GB 7200 RPM minimum |
| Available hard | |
| drive space | 20 GB with a minimum free disk space of at least 15%, for program files |
| and to copy exams to the comnputer's local drive | |
| RAM | 4 GB (minimum) |
| Keyboard and | |
| mouse | Standard or USB keyboard and a 5-button optical mouse is required. |
| NIC | Integrated. Ethernet data rate: |
| ■ Minimum: 100 Mb/s | |
| ■ Recommended: 1 Gb/s | |
| Monitor | 17" 1280 x 1024 resolution (minimum) |
| 20" 1600 x 1200 resolution | |
| 24" 1920 x 1200 resolution | |
| Network | |
| Interface | For connection to the PACS local area network (LAN) |
| 100 Mbit connection recommended | |
| Internet | |
| browser | ■ Standard web browser that supports Adobe Flash Player 10 or greater and |
| Silverlight 4 or greater: | |
| o Internet Explorer® starting with 8. | |
| o Mozilla Firefox® starting with 17 | |
| o Google Chrome™ starting with version 32 | |
| o Apple Safari® starting with 5.0 | |
| Access | ■ Application Gateway Server (AGS) |
| ■ Web address. For example: http:///DRPacs/zda/ |
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Image /page/5/Picture/0 description: The image shows the logo for DR Systems. The logo consists of the letters "D" and "R" in white, set against a blue square. To the right of the blue squares, the word "Systems" is written in blue.
Intended Use/ DR Systems Z3D is intended to provide reading physicians, referring Indications for Use: physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including: Displaying DICOM compliant medical image volumes, such as ● CT, MRI, and PET. . Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images. ● Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. Creating series of DICOM images and individually captured ● images that can be displayed and stored in a PACS. ● Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. Z3D receives and processes image volumes from cross-sectional DICOM Technological medical imaging examinations such as CT, MRI, and PET. The system Characteristics: provides a graphical user interface to enable healthcare professional to execute the functions supporting the intended use. Image processing is performed on a secure image server, and images are then displayed using a browser-based viewer. Nonclinical Testing: DR Systems Z3D was designed, developed and tested according to DR System's written procedures. Testing included verification, validation and evaluation of human factors and usability. The following quality assurance measures were applied to the development of Z3D: . Risk analysis ● Requirements reviews Design reviews ● Performance testing (verification) ● Simulated use testing (validation and human factors and ● usability)
Clinical Testing: N/A
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Image /page/6/Picture/0 description: The image shows the logo for DR Systems. The letters "D" and "R" are in white and are inside of blue squares. The word "Systems" is in blue and is to the right of the blue squares.
Conclusion:
The information in this 510(k) submission demonstrates that based on the nonclinical testing, the subject, Zero Download 3D Viewer is substantially equivalent to the predicate device with respect to safety, effectiveness, and performance.