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.

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.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria, especially in the context of clinical accuracy or effectiveness. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing.

Here's what can be extracted from the document regarding testing and device characteristics, but it lacks the specific details requested concerning acceptance criteria and clinical study results:

Information on Nonclinical Testing (Verification, Validation, Usability):

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." (Page 5)
Quality Assurance Measures applied:
- Risk analysis
- Requirements reviews
- Design reviews
- Performance testing (verification)
- Simulated use testing (validation and human factors and usability) (Page 5)

Missing Information:

The document explicitly states "Clinical Testing: N/A" (Page 6). This means there was no clinical study performed to evaluate the diagnostic accuracy or clinical effectiveness of the device when used by healthcare professionals. Therefore, the following requested information cannot be provided from this document:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

In summary: The provided 510(k) submission for the DR Systems Zero Download 3D Viewer (Z3D) focuses on demonstrating substantial equivalence through nonclinical testing (verification, validation, usability, risk analysis) and does not include details on acceptance criteria for clinical performance, clinical study results, or the other specific points requested about clinical validation.

Summary

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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.

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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

· Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5 – 510(k) Summary

Submitter:	DR Systems, Inc.10140 Mesa Rim RoadSan Diego, CA 92121Phone: (858) 625-3344FAX: (858) 625-3335
Contact:	Kimberly J. Meade, MSQA, ASQ CQAManager, Regulatory Affairs/Quality AssurancePhone: (858) 625-3344, x2260kmeade@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
ClassificationRegulation:	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 supportsMIP (maximum intensity project), MPR (multiplanar reconstruction), 3Dvolume rendering, and cardiac calcium scoring. The system employsserver-based rendering and browser-based viewing. Reading physicians,referring physicians, and other appropriate healthcare personnel and canemploy advanced image processing and display from local or remotelocations.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 arePACS system accessories that allow the user to view and manipulate 3Dimage data sets. DR Systems Z3D does not have an AvelP analysis tool.The principles of operation and technological characteristics of the new andpredicate device are the same.

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Technical Specifications

Specifications
Processor	o Intel® Core™ i5 3 GHz or faster:o Quad-core minimum.
Operatingsystem	■ Microsoft® Windows® 7/8.1■ Apple® Mac OS ® X v10.6, v10.7, or v10.8
Hard drive	160 GB 7200 RPM minimum
Available harddrive space	20 GB with a minimum free disk space of at least 15%, for program filesand to copy exams to the comnputer's local drive
RAM	4 GB (minimum)
Keyboard andmouse	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 resolution24" 1920 x 1200 resolution
NetworkInterface	For connection to the PACS local area network (LAN)100 Mbit connection recommended
Internetbrowser	■ Standard web browser that supports Adobe Flash Player 10 or greater andSilverlight 4 or greater:o Internet Explorer® starting with 8.o Mozilla Firefox® starting with 17o Google Chrome™ starting with version 32o Apple Safari® starting with 5.0
Access	■ Application Gateway Server (AGS)■ Web address. For example: http:///DRPacs/zda/

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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.

Regulation Number and Section

§ 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).