(129 days)
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems.
The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices. It is designed to work on generic PC hardware that meets minimum system requirements.
The OnePacs System is comprised of following main interrelated software elements/ components:
- OnePacs Cloud (OPS)
- OnePacs Workstation (OPW)
- OnePacs Workstation for macOS (OPX)
- OnePacs Webviewer (OPWEBV)
- OnePacs Study Retriever (OPSR)
- OnePacs Gateway (OPG)
The OnePacs System is an image management system intended to provide scalable DICOM compatible PACS solutions for hospitals and related institutions.
Here's an analysis of its acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the "Technological Characteristics and Substantial Equivalence" section (pages 4-6) serves as the primary means to demonstrate the device meets its intended purpose by comparing its features and functionalities to legally marketed predicate devices. The implicit acceptance criteria are that the OnePacs System performs comparably to or better than the predicate devices across a comprehensive set of PACS functionalities and adheres to relevant standards.
The table below summarizes the key functionalities and the OnePacs System's reported performance (implicitly, that it possesses these functionalities):
| Acceptance Criteria (Functionality/Standard Adherence) | Reported Device Performance (OnePacs System) |
|---|---|
| Image management system for various modalities (CR, CT, DR, MR) | Yes, archives, distributes, retrieves, and displays images and data from all hospital modalities. |
| Display of structured reports | Yes |
| Display of mammography images (DICOM "For Presentation") | Yes, includes standard features and tools for analyzing mammography images. |
| Restriction: Lossy compressed mammographic images and digitized film screen images for primary diagnosis | Must not be reviewed for primary diagnosis or image interpretation. |
| Restriction: Mammographic images for primary diagnosis | Post-process DICOM "for presentation" images must be used. |
| Restriction: Monitor for mammographic images | Should only be viewed with an FDA-approved monitor for viewing mammographic images. |
| DICOM compatibility (Query, Import, Send, Receive DICOM images) | Yes |
| Image Printing | Yes |
| Export of DICOM images to optical media | Yes |
| Reporting (save, email, DICOM send, print to standard printers) | Yes |
| Image analysis tools (W/L, zoom, pan, stack, move, rotate, flip, delete) | Yes |
| Measurement and annotation | Yes |
| Multi-monitor awareness | Yes |
| Image layout | Yes |
| Image thumbnails | Yes |
| Reference lines and spatial locator for tomographic images | Yes |
| User annotations of images | Yes |
| Synchronized stacking | Yes |
| Probe tool | Yes |
| Shutters | Yes |
| Key image marking | Yes |
| Multiplanar Reformat (MPR) | Yes |
| Lossy and lossless compression | Yes |
| Automatic routing of images | Yes |
| Image archiving | Yes |
| Patient information and workflow management components | Yes |
| Image streaming from server | Yes |
| Enterprise distribution of images and data via Internet or Intranet | Yes |
| Web-delivered viewing software | Yes |
| Conformity to NEMA PS 3.1 - 3.20 (2016) Digital Imaging And Communications In Medicine (Dicom) Set | Yes |
| Conformity to IEC/ISO 10918-1, Edition 1 (1994-02-15), Information Technology - Digital Compression And Coding Of Continuous-Tone Still Images | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithmic performance evaluation. The "performance testing" referenced is primarily "comprehensive software validation" and compliance with standards. There is no mention of a specific dataset of medical images or patient cases used to test the device's diagnostic accuracy or functionality beyond standard software testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no specific test set for algorithmic performance was described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set
Not applicable. No test set for algorithmic performance was described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The submission does not contain any data from clinical testing."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire submission focuses on the OnePacs System as an image management system which includes software components for archiving, distributing, retrieving, and displaying images, as well as tools for analyzing them. It is not an AI or algorithm-only device designed for standalone diagnostic interpretation. Therefore, a "standalone algorithm only" performance study in the sense of an AI interpreting images was not done. The device's functionality is inherently intended to be used by a human (e.g., a radiologist).
7. The type of ground truth used
For the software validation and adherence to standards, the "ground truth" would be the successful execution of functions as per design specifications and compliance with DICOM and JPEG standards. There is no mention of ground truth based on expert consensus, pathology, or outcomes data for diagnostic accuracy.
8. The sample size for the training set
Not applicable. The OnePacs System is an image management system, not a device employing machine learning or AI that requires a "training set" of medical images for learning diagnostic patterns. Its "training" would be the software development and testing process.
9. How the ground truth for the training set was established
Not applicable, as no training set (for machine learning) is relevant to this device's description.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" written in blue text.
October 11, 2018
OnePacs, LLC Justin Falk Director of IT 530 Lytton Ave PALO ALTO, CA 94301
Re: K181460
Trade/Device Name: OnePacs System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: May 29, 2018 Received: September 11, 2018
Dear Justin Falk:
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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 comprehensive regulatory information about medical devices and radiation-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,
Hse 2. Nils
for Robert A. Ochs, Ph.D. 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)
Device Name OnePacs System
Indications for Use (Describe)
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
| 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)
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SECTION 5
510(k) Summary
1. Sponsor
OnePacs, LLC 530 Lytton Ave Palo Alto, CA 94301 Phone: 877-881-7227 x117 Fax: 201-399-6580 Contact: Justin Falk Email: jfalk@onepacs.com
Summary Preparation Date: May 29, 2018
2. Device
| Trade Name | OnePacs System |
|---|---|
| Common Name | Picture archiving and communications system (PACS) |
| Classification | Class II |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Review Panel | Radiology |
3. Predicate Device
4. Device Description
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems.
The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices. It is designed to work on generic PC hardware that meets minimum system requirements.
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The OnePacs System is comprised of following main interrelated software elements/ components:
- · OnePacs Cloud (OPS)
- · OnePacs Workstation (OPW)
- · OnePacs Workstation for macOS (OPX)
- · OnePacs Webviewer (OPWEBV)
- · OnePacs Study Retriever (OPSR)
- · OnePacs Gateway (OPG)
5. Indications for Use
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images
6. Technological Characteristics and Substantial Equivalence
The proposed OnePacs System is substantially equivalent to the referenced predicate devices in regard to the intended use, fundamental scientific technology, and technological characteristics, as outlined in the following table:
| Characteristic | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| Trade Name | OnePacs System | ClearCanvas RIS/PACS (K110332) | OsiriX MD (K101342) |
| Submitter | OnePacs LLC | ClearCanvas Inc. | Pixmeo, Sarl |
| Classification | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 |
| Indications for Use | The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and | The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and | OsiriX MD is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS(K110332) | OsiriX MD (K101342) |
| sites, which will archive,distribute, retrieve anddisplay images and datafrom all hospital modalities(such as CR, CT, DR, MR,and other devices) andinformation systems. Thisalso includes the display ofstructured reports andmammography imagesthat have been createdaccording to DICOM "ForPresentation", and willinclude standard featuresand other tools foranalyzing mammographyimages.Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primarydiagnosis or imageinterpretation. For primarydiagnosis, post processDICOM "for presentation"images must be used.Mammographic imagesshould only be viewed witha monitor approved byFDA for viewingmammographic images. | related institutions andsites, which will archive,distribute, retrieve anddisplay images and datafrom all hospitalmodalities (such as CR,CT, DR, MR, and otherdevices) and informationsystems. This alsoincludes the display ofstructured reports andmammography imagesthat have been createdaccording to DICOM "ForPresentation", and willinclude standard featuresand other tools foranalyzing mammographyimages.Lossy compressedmammography imagesand digitized film screenimages must not be usedfor primary imageinterpretations.Mammography imagesmay only be interpretedusing an FDA approvedmonitor that offers at least5 mega-pixel resolutionand meets other technicalspecifications approvedby the FDA. | imaging systems wheninstalled on suitablecommercial standardhardware.Images and data can becaptured, stored,communicated,processed, and displayedwithin the system and oracross computernetworks at distributedlocations.Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primarydiagnosis or imageinterpretation. For primarydiagnosis, post processDICOM "for presentation"images must be used.Mammographic imagesshould only be viewedwith a monitor approvedby FDA for viewingmammographic images.It is the User'sresponsibility to ensuremonitor quality, ambientlight conditions, andimage compression ratiosare consistent with theclinical application. | |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS(K110332) | OsiriX MD (K101342) |
| Prescription /Over-The-Counter (OTC)Use | Prescription Use | Prescription Use | Prescription Use |
| DeviceDescription andKeyComponents | The OnePacs Systemsoftware is primarilywritten in Java/ Javascript.The system is designed towork on generic PChardware that meetsminimum systemrequirements.The OnePacs System iscomprised of followinginterrelated softwarecomponents:OnePacs CloudOnePacs ApplicationServer is inherentlyenterprise wide, deployedin multi-tenant cloudarchitecture. The OnePacsCloud allows medicalstudies to be securelytransmitted so that aphysician may view andinterpret the study andcomplete the medicalreport.OnePacs Workstation(OPW) & OnePacsWorkstation for macOS(OPX)Communicates withOnePacs Server for imageretrieval and metadata.The OPW and OPXprovide navigation andvisualization of multi-modality andmultidimensional images.They act as DICOM viewercapable of connecting to aDICOM networkOnePacs Web Viewer(OPWEBV)enables the display and | ClearCanvas RIS/PACSsoftware is primarilywritten in C#, employingthe most current bestpractices in objectoriented and component-oriented softwarearchitecture resulting in ahighly scalable andextensible design. Thesystem is also designedto work on generic PChardware that meets theminimum systemrequirements.The ClearCanvasRIS/PACS is a system ofinterrelated softwarecomponents:ClearCanvas Workstationa desktop client that isprimarily used to retrieve,display, enhance andanalyze medical images.Access to patientdemographic data is alsopossible through theWorkstation whenworking with the RISserver.ClearCanvas Webstationa browser-based webapplication that allows theuser to retrieve imagesfrom the ImageServer forreview. Primarily intendedfor referring physiciansand as an image viewerfor EMR systems, theimages are JPEG-compressed.ClearCanvasImageServer | The OsiriX MD software isan interactive imagedisplay and navigationprogram that wasdesigned to displaymedical imagingmodalities. It supports alltypes of imagesgenerated by variety ofimaging equipment andscanners available today.lt supports the DICOMstandard for imagecommunication as well asa variety of other imageformats used in academicand research community.OsiriX MD is tailored forlarge sets ofmultidimensional andmulti-modality imagessuch as combined PET-CT studies that requirethree-dimensional imagefusion and volumerendering. The software isdeveloped on aMacintosh platform takingadvantage of theunderlying UNIX kernel ofthe Mac OS X operatingoptimized 3D graphiccapabilities of Open GLgraphic standard that iswidely used for computergames and animationsand is highly optimized onthe Macintosh platform fortaking advantage of anyhardware graphicaccelerator boards thatwould be available. Thesoftware was developedin Objective-C in AppleCocoa developmentenvironment. In thedesign of the software a |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS(K110332) | OsiriX MD (K101342) |
| review of medical imagesOnePacs Study Retriever(OPSR)facilitates the securetransmission of medicalimages from the OnePacsCloud servers to the localdesktop of a radiologist.OnePacs Gateway (OPG)a gateway or bridge to theOnePacs Cloud. The OPGsoftware enables accessto the cloud by offering thefollowing functionality. Itprovides DICOM imagerouting, security, andcompression, HL7mapping connectivity andmapping | a server application thatreceives images fromimaging modalities, storesand archives them, anddistributes them to clientapplications.ClearCanvas RISa server application thatacts as an onlinetransaction processor forthe managementof patient and workflowinformation.ClearCanvasIntegrationServera server applicationcomposed of optionalmodules that implementintegration andinteroperability, such asan inbound and outboundHL7 processor.ClearCanvasEnterpriseServer a serverapplication that providesenterprise-wide facilitiessuch as userauthentication,authorization andauditing. | special attention wasgiven to adapt the userinterface to navigatingthrough large sets ofimage data. The graphicaluser interface also usesthe Macintosh interface.Users can change andcustomize the software byadding and removingtools and items from theprogram toolbar andmenu bars. This allowsfor adapting the softwarefor number of functionsand avoiding the users tobe overwhelmed by anexcessive number ofunnecessary tools andfunctions that are notalways needed. | |
| Operatingsystem/platform | Windows, Mac OS X(Apple), Linux | Windows | Mac OS X (Apple) |
| Device type/form | Software device thatoperates on off-the-shelfhardware | Software device thatoperates on off-the-shelfhardware | Software device thatoperates on off-the-shelfhardware |
| Mode ofdelivery/installation | OnePacs System is to bedownloaded fromOnePacs Cloud.The OPX component isprovided as a macOSpackage download. Thepackage is installedthrough the macOSInstaller tool. | Installation from opticalmedia and/or downloadfrom the server | OsiriX MD is provided asa DMG (Apple DiskImage) download. Whenmounted, the DMG offersan installer application tobe executed by the user. |
| CharacteristicTrade Name | Subject DeviceOnePacs System | Predicate DeviceClearCanvas RIS/PACS(K110332) | Predicate DeviceOsiriX MD (K101342) |
| Functions andCapabilities | |||
| Query, Import,Send, ReceiveDICOM images | Yes | Yes | Yes |
| Image Printing | Yes | Yes | Yes |
| Export ofDICOM imagesto opticalmedia | Yes | Yes | Yes |
| Reporting –save, email,DICOM send,or print tostandardprinters | Yes | Yes | Yes |
| Image analysistools W/L,zoom, pan,stack, move,rotate, flip, anddelete | Yes | Yes | Yes |
| Measurementand annotation | Yes | Yes | Yes |
| Multi-monitorawareness | Yes | Yes | Yes |
| Image layout | Yes | Yes | Yes |
| Imagethumbnails | Yes | Yes | Yes |
| Reference linesand spatiallocator fortomographicimages | Yes | Yes | Yes |
| Userannotations ofimages | Yes | Yes | Yes |
| Synchronizedstacking | Yes | Yes | Yes |
| Probe tool | Yes | Yes | Yes |
| Shutters | Yes | Yes | Yes |
| Key imagemarking | Yes | Yes | Yes |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS(K110332) | OsiriX MD (K101342) |
| MultiplanarReformat(MPR) | Yes | Yes | Yes |
| Lossy andlosslesscompression | Yes | Yes | Yes |
| Automaticrouting ofimages | Yes | Yes | Yes |
| Imagearchiving | Yes | Yes | Yes |
| Patientinformation andworkflowmanagementcomponents- | Yes | Yes | Yes |
| Imagestreaming fromserver | Yes | Yes | Yes |
| PET/CT fusion | No | Yes | Yes |
| Enterprisedistribution ofimages anddata viaInternet orIntranet | Yes | Yes | Yes |
| Web-deliveredviewingsoftware | Yes | Yes | Yes |
| Conformity toStandards | |||
| DICOM•standardfor dataexchange | NEMA PS 3.1 - 3.20(2016) Digital Imaging AndCommunications InMedicine (Dicom) Set | Conformity to theessential requirements ofthe DICOM standard fordata exchange (PS 3.3 -PS 3.12) | Conformity to theessential requirements ofthe DICOM standard fordata exchange (PS 3.3 -PS 3.12) |
| JPEG•standardfor imagecompression | IEC/ ISO 10918-1, Edition1 (1994-02-15),Information Technology -Digital Compression AndCoding Of Continuous-Tone Still Images:Requirements AndGuidelines [Including:Technical Corrigendum 1(2005) | IEC/ ISO 10918-1, Edition1 (1994-02-15),Information Technology -Digital Compression AndCoding Of Continuous-Tone Still Images:Requirements AndGuidelines [Including:Technical Corrigendum 1(2005) | IEC/ ISO 10918-1, Edition1 (1994-02-15),Information Technology -Digital Compression AndCoding Of Continuous-Tone Still Images:Requirements AndGuidelines [Including:Technical Corrigendum 1(2005) |
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The indications for use of the OnePacs System are similar to the indications for use of the referenced predicate devices. No new indications are claimed for the OnePacs System. Fundamentally, the OnePacs System is the referenced predicate devices in that it is an image management system. As detailed above in the comparison table, most of their specifications and features are also same and comparable,
The ClearCanvas Workstation is chosen as one of the predicates for this submission for comparing the 'OnePacs Workstation for Windows' i.e. the OPW element of OnePacs System. The OPW was designed to use the ClearCanvas Workstation (CCW) as an application framework. The core implementation of the CCW was relatively complete as a viewer, but was also designed to be highly extensible. The maiority (but not all) of OPW-specific functionality has been implemented as plug-ins, leaving the base CCW code mostly as-is, except where such functionality was not possible via the plug-in interface.
The OsiriX MD is chosen as one of the predicates for this submission for comparing the OnePacs Workstation for macOS i.e. the OPX element of OnePacs System. The final free/open source version of OsiriX released as version 5.8 was used as the starting point to develop OnePacs Workstation for macOS (OPX). The OsiriX was rebranded to Horos without introduction of any new features. OnePacs further rebranded Horos to OPX with the changes described further in this section.
The differences between the OnePacs System and the predicate devices ClearCanvas and OsiriX MD mainly relate to the changes in GUI, plugins, defaults, reporting, rebranding, Region Preferences and Certifications. These differences have been addressed through comprehensive software validation performed by OnePacs; and thereby do not raise any new concerns of safety or effectiveness.
7. Non-clinical Bench (Performance) testing
The performance testing includes the comprehensive software validation as provided in the submission. In addition, the OnePacs System complies with the following performance standards:
- . NEMA PS 3.1 - 3.20 (2016) Digital Imaging And Communications In Medicine (Dicom) Set
- . IEC/ ISO 10918-1, Edition 1 (1994-02-15), Information Technology - Digital Compression and Coding Of Continuous-Tone Still Images: Requirements And Guidelines [Including: Technical Corrigendum 1 (2005)
8. Clinical Testing
The submission does not contain any data from clinical testing.
9. Conclusion:
Based on the intended use, technological characteristics and performance data provided in the submission; the proposed 'OnePacs System' is substantially equivalent to the referenced predicate devices.
§ 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).