(129 days)
Not Found
No
The document describes a standard PACS system for image management and display, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
This device is an image management system (PACS) that archives, distributes, retrieves, and displays medical images and data. It is not intended to provide therapy.
No
The device is an image management system (PACS) that archives, distributes, retrieves, and displays images. It specifically states that it is not for primary diagnosis or image interpretation for certain image types, indicating its role is for management and display, not direct diagnostic interpretation or analysis.
Yes
The device description explicitly states, "The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices." It is designed to run on generic PC hardware, further supporting its classification as software-only.
Based on the provided information, the OnePacs System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The OnePacs System is an image management system that archives, distributes, retrieves, and displays medical images from various modalities (CR, CT, DR, MR, etc.). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is focused on image management and display. The description clearly states its purpose is to handle and display medical images and related data for diagnostic review by physicians.
- The device description aligns with a PACS (Picture Archiving and Communication System). PACS systems are used for managing medical images, not for performing diagnostic tests on biological specimens.
Therefore, the OnePacs System falls under the category of a medical imaging device or a medical image management system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, DR, MR, and other devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and related institutions and sites. Prescription Use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ClearCanvas RIS/ PACS (K110332), OsiriX MD (K101342)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains 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
1
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
2
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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3
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.
4
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 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. | 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 | |||
| mammography images | |||
| and digitized film screen | |||
| images must not be used | |||
| for primary image | |||
| interpretations. | |||
| Mammography images | |||
| may only be interpreted | |||
| using an FDA approved | |||
| monitor that offers at least | |||
| 5 mega-pixel resolution | |||
| and meets other technical | |||
| specifications approved | |||
| by the FDA. | imaging systems when | ||
| installed on suitable | |||
| commercial standard | |||
| hardware. | |||
| Images and data can be | |||
| captured, stored, | |||
| communicated, | |||
| processed, and displayed | |||
| within the system and or | |||
| across computer | |||
| networks at distributed | |||
| locations. | |||
| 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. | |||
| It is the User's | |||
| responsibility to ensure | |||
| monitor quality, ambient | |||
| light conditions, and | |||
| image compression ratios | |||
| are consistent with the | |||
| clinical 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 |
| Device | |||
| Description and | |||
| Key | |||
| Components | The OnePacs System | ||
| software is primarily | |||
| written in Java/ Javascript. | |||
| The system is designed to | |||
| work on generic PC | |||
| hardware that meets | |||
| minimum system | |||
| requirements. | |||
| The OnePacs System is | |||
| comprised of following | |||
| interrelated software | |||
| components: | |||
| OnePacs Cloud | |||
| OnePacs Application | |||
| Server is inherently | |||
| enterprise wide, deployed | |||
| in multi-tenant cloud | |||
| architecture. The OnePacs | |||
| Cloud allows medical | |||
| studies to be securely | |||
| transmitted so that a | |||
| physician may view and | |||
| interpret the study and | |||
| complete the medical | |||
| report. | |||
| OnePacs Workstation | |||
| (OPW) & OnePacs | |||
| Workstation for macOS | |||
| (OPX) | |||
| Communicates with | |||
| OnePacs Server for image | |||
| retrieval and metadata. | |||
| The OPW and OPX | |||
| provide navigation and | |||
| visualization of multi- | |||
| modality and | |||
| multidimensional images. | |||
| They act as DICOM viewer | |||
| capable of connecting to a | |||
| DICOM network | |||
| OnePacs Web Viewer | |||
| (OPWEBV) | |||
| enables the display and | ClearCanvas RIS/PACS | ||
| software is primarily | |||
| written in C#, employing | |||
| the most current best | |||
| practices in object | |||
| oriented and component- | |||
| oriented software | |||
| architecture resulting in a | |||
| highly scalable and | |||
| extensible design. The | |||
| system is also designed | |||
| to work on generic PC | |||
| hardware that meets the | |||
| minimum system | |||
| requirements. | |||
| The ClearCanvas | |||
| RIS/PACS is a system of | |||
| interrelated software | |||
| components: | |||
| ClearCanvas Workstation | |||
| a desktop client that is | |||
| primarily used to retrieve, | |||
| display, enhance and | |||
| analyze medical images. | |||
| Access to patient | |||
| demographic data is also | |||
| possible through the | |||
| Workstation when | |||
| working with the RIS | |||
| server. | |||
| ClearCanvas Webstation | |||
| a browser-based web | |||
| application that allows the | |||
| user to retrieve images | |||
| from the ImageServer for | |||
| review. Primarily intended | |||
| for referring physicians | |||
| and as an image viewer | |||
| for EMR systems, the | |||
| images are JPEG- | |||
| compressed. | |||
| ClearCanvas | |||
| ImageServer | The OsiriX MD software is | ||
| an interactive image | |||
| display and navigation | |||
| program that was | |||
| designed to display | |||
| medical imaging | |||
| modalities. It supports all | |||
| types of images | |||
| generated by variety of | |||
| imaging equipment and | |||
| scanners available today. | |||
| lt supports the DICOM | |||
| standard for image | |||
| communication as well as | |||
| a variety of other image | |||
| formats used in academic | |||
| and research community. | |||
| OsiriX MD is tailored for | |||
| large sets of | |||
| multidimensional and | |||
| multi-modality images | |||
| such as combined PET- | |||
| CT studies that require | |||
| three-dimensional image | |||
| fusion and volume | |||
| rendering. The software is | |||
| developed on a | |||
| Macintosh platform taking | |||
| advantage of the | |||
| underlying UNIX kernel of | |||
| the Mac OS X operating | |||
| optimized 3D graphic | |||
| capabilities of Open GL | |||
| graphic standard that is | |||
| widely used for computer | |||
| games and animations | |||
| and is highly optimized on | |||
| the Macintosh platform for | |||
| taking advantage of any | |||
| hardware graphic | |||
| accelerator boards that | |||
| would be available. The | |||
| software was developed | |||
| in Objective-C in Apple | |||
| Cocoa development | |||
| environment. In the | |||
| design 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 images | |||
| OnePacs Study Retriever | |||
| (OPSR) | |||
| facilitates the secure | |||
| transmission of medical | |||
| images from the OnePacs | |||
| Cloud servers to the local | |||
| desktop of a radiologist. | |||
| OnePacs Gateway (OPG) | |||
| a gateway or bridge to the | |||
| OnePacs Cloud. The OPG | |||
| software enables access | |||
| to the cloud by offering the | |||
| following functionality. It | |||
| provides DICOM image | |||
| routing, security, and | |||
| compression, HL7 | |||
| mapping connectivity and | |||
| mapping | a server application that | ||
| receives images from | |||
| imaging modalities, stores | |||
| and archives them, and | |||
| distributes them to client | |||
| applications. | |||
| ClearCanvas RIS | |||
| a server application that | |||
| acts as an online | |||
| transaction processor for | |||
| the management | |||
| of patient and workflow | |||
| information. | |||
| ClearCanvas | |||
| IntegrationServer | |||
| a server application | |||
| composed of optional | |||
| modules that implement | |||
| integration and | |||
| interoperability, such as | |||
| an inbound and outbound | |||
| HL7 processor. | |||
| ClearCanvas | |||
| EnterpriseServer a server | |||
| application that provides | |||
| enterprise-wide facilities | |||
| such as user | |||
| authentication, | |||
| authorization and | |||
| auditing. | special attention was | ||
| given to adapt the user | |||
| interface to navigating | |||
| through large sets of | |||
| image data. The graphical | |||
| user interface also uses | |||
| the Macintosh interface. | |||
| Users can change and | |||
| customize the software by | |||
| adding and removing | |||
| tools and items from the | |||
| program toolbar and | |||
| menu bars. This allows | |||
| for adapting the software | |||
| for number of functions | |||
| and avoiding the users to | |||
| be overwhelmed by an | |||
| excessive number of | |||
| unnecessary tools and | |||
| functions that are not | |||
| always needed. | |||
| Operating | |||
| system/ | |||
| platform | Windows, Mac OS X | ||
| (Apple), Linux | Windows | Mac OS X (Apple) | |
| Device type/ | |||
| form | Software device that | ||
| operates on off-the-shelf | |||
| hardware | Software device that | ||
| operates on off-the-shelf | |||
| hardware | Software device that | ||
| operates on off-the-shelf | |||
| hardware | |||
| Mode of | |||
| delivery/ | |||
| installation | OnePacs System is to be | ||
| downloaded from | |||
| OnePacs Cloud. | |||
| The OPX component is | |||
| provided as a macOS | |||
| package download. The | |||
| package is installed | |||
| through the macOS | |||
| Installer tool. | Installation from optical | ||
| media and/or download | |||
| from the server | OsiriX MD is provided as | ||
| a DMG (Apple Disk | |||
| Image) download. When | |||
| mounted, the DMG offers | |||
| an installer application to | |||
| be executed by the user. | |||
| Characteristic | |||
| Trade Name | Subject Device | ||
| OnePacs System | Predicate Device | ||
| ClearCanvas RIS/PACS | |||
| (K110332) | Predicate Device | ||
| OsiriX MD (K101342) | |||
| Functions and | |||
| Capabilities | |||
| Query, Import, | |||
| Send, Receive | |||
| DICOM images | Yes | Yes | Yes |
| Image Printing | Yes | Yes | Yes |
| Export of | |||
| DICOM images | |||
| to optical | |||
| media | Yes | Yes | Yes |
| Reporting – | |||
| save, email, | |||
| DICOM send, | |||
| or print to | |||
| standard | |||
| printers | Yes | Yes | Yes |
| Image analysis | |||
| tools W/L, | |||
| zoom, pan, | |||
| stack, move, | |||
| rotate, flip, and | |||
| delete | Yes | Yes | Yes |
| Measurement | |||
| and annotation | Yes | Yes | Yes |
| Multi-monitor | |||
| awareness | Yes | Yes | Yes |
| Image layout | Yes | Yes | Yes |
| Image | |||
| thumbnails | Yes | Yes | Yes |
| Reference lines | |||
| and spatial | |||
| locator for | |||
| tomographic | |||
| images | Yes | Yes | Yes |
| User | |||
| annotations of | |||
| images | Yes | Yes | Yes |
| Synchronized | |||
| stacking | Yes | Yes | Yes |
| Probe tool | Yes | Yes | Yes |
| Shutters | Yes | Yes | Yes |
| Key image | |||
| marking | Yes | Yes | Yes |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS | |
| (K110332) | OsiriX MD (K101342) | ||
| Multiplanar | |||
| Reformat | |||
| (MPR) | Yes | Yes | Yes |
| Lossy and | |||
| lossless | |||
| compression | Yes | Yes | Yes |
| Automatic | |||
| routing of | |||
| images | Yes | Yes | Yes |
| Image | |||
| archiving | Yes | Yes | Yes |
| Patient | |||
| information and | |||
| workflow | |||
| management | |||
| components- | Yes | Yes | Yes |
| Image | |||
| streaming from | |||
| server | Yes | Yes | Yes |
| PET/CT fusion | No | Yes | Yes |
| Enterprise | |||
| distribution of | |||
| images and | |||
| data via | |||
| Internet or | |||
| Intranet | Yes | Yes | Yes |
| Web-delivered | |||
| viewing | |||
| software | Yes | Yes | Yes |
| Conformity to | |||
| Standards | |||
| DICOM | |||
| • | |||
| standard | |||
| for data | |||
| exchange | NEMA PS 3.1 - 3.20 | ||
| (2016) Digital Imaging And | |||
| Communications In | |||
| Medicine (Dicom) Set | Conformity to the | ||
| essential requirements of | |||
| the DICOM standard for | |||
| data exchange (PS 3.3 - | |||
| PS 3.12) | Conformity to the | ||
| essential requirements of | |||
| the DICOM standard for | |||
| data exchange (PS 3.3 - | |||
| PS 3.12) | |||
| JPEG | |||
| • | |||
| standard | |||
| for image | |||
| compressio | |||
| n | 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) | 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) | 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) |
5
6
7
8
9
10
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.