(154 days)
Not Found
No
The summary describes a PACS software for displaying medical images on mobile devices. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on image display quality and comparison to a predicate device.
No.
The device is described as a diagnostic, review, and analysis tool for medical images, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists."
Yes
The device is explicitly described as "software-based" and its function is to provide communication, storage, processing, rendering, and display of medical images on general purpose computing servers and mobile devices. While it relies on hardware (servers and mobile devices), the device itself is the software component. The performance studies focus on the software's performance on different mobile devices, not on the hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a software-based Picture Archiving and Communication System (PACS) used for the communication, storage, reformatting, rendering, and display of medical images (CT and MR). It is intended for use as a diagnostic, review, and analysis tool for trained professionals.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of Specimen Examination: The ResolutionMD Mobile software does not examine specimens from the human body. It processes and displays medical images that are generated by other diagnostic modalities (CT and MR).
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device. It is a medical image viewing and analysis tool.
N/A
Intended Use / Indications for Use
The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.
The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The ResolutionMD Mobile is not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The ResolutionMD™ Mobile 3.1 software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and highresolution Apple Inc. iOS and Google Inc. Android OS-based wireless mobile devices for the display and advanced visualization of medical image data. It provides for communication, storage, processing, rendering on the server and the display of DICOM 3.0 compliant image data derived from CT and MRI on the mobile device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to qualify an Android smartphone and an Android as devices whose off-the-shelf performance in combination with the overall attributes of the ResolutionMD Mobile solution provides acceptable image quality for diagnostic radiology.
The tests were performed in accordance with the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by an ISO 17025-certified third party to ensure high quality laboratory results. The test equipment and calibration was certified traceable to NIST.
Nine tests of display performance were conducted for each mobile device running ResolutionMD Mobile and both devices passed all of the tests.
Clinical testing was conducted by a panel of three board-certified radiologists in the United States. The radiologists conducted a side-by-side comparative assessment of the Android mobile devices running ResolutionMD Mobile with the predicate iOS devices. A series of typical CT and MR cases were reviewed on each device. Comparative assessments of image quality and diagnostic confidence were made by each radiologist.
All three radiologists agreed that the Android mobile devices, both the smartphone and tablet, were comparable to the predicate iPhone and iPad devices and of adequate quality for clinical use. They were comfortable with the diagnoses made on the Android mobile devices using the ResolutionMD Mobile software. All agreed that the overall clinical image display quality on the Android devices was equivalent to the iOS devices for the identification of clinically-relevant pathology. There were similar comments on image contrast and sharpness with comments including "very comparable" and "is diagnostic". No image artifacts were noted by the reviewers.
All three radiologists indicated that the software and devices provide acceptable quality for regular use and they were comfortable reviewing images on the devices.
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.
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
MAR 1 4 2013
5 510(k) Summary As required by 21 CFR Part 807 87(h)
| Submitter: | Kyle Peterson
Director, Regulatory & Corporate Affairs
Calgary Scientific Inc.
Suite 208, 1210 - 20th Ave. SE
Calgary, Alberta
T2G 1M8
CANADA |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | (403) 767-7945 |
| Fax Number: | (403) 270-2771 |
| Name / Address of Manufacturer: | Calgary Scientific Inc.
Suite 208, 1210 - 20th Ave. SE
Calgary, Alberta
T2G 1M8
CANADA |
| Date of Submission: | September 14, 2012 |
| Identification of the Device | |
| Device Proprietary Name: | ResolutionMD Mobile 3.1 |
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | Picture Archiving and Communication System per
21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
Marketed Device to which Equivalence is claimed:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| ResolutionMD Mobile | Calgary Scientific Inc. | K111346 |
ﺘﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
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Device Description:
The ResolutionMD™ Mobile 3.1 software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and highresolution Apple Inc. iOS and Google Inc. Android OS-based wireless mobile devices for the display and advanced visualization of medical image data. It provides for communication, storage, processing, rendering on the server and the display of DICOM 3.0 compliant image data derived from CT and MRI on the mobile device.
Indications for Use:
The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.
The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The ResolutionMD Mobile is not to be used for mammography.
Technological Characteristics
The ResolutionMD™ Mobile 3.1 software adds support for mobile devices running the Android operating system and has the same uses and applications as the predicate device. Both the device and predicate are used by the clinician as a diagnostic, review, and analysis tool for radiological images.
Software Verification and Validation Testing
Verification testing consisting of more 160 separate testers, each executed multiple times by different testers, was performed for this device. Testing included functional, smoke and regression tests and was complemented by beta tests performed by Calgary Scientifie's OEM distribution partners. The vast majority of tests passed our testing criteria. Any defects found or reported were either fixed or logged in the Unresolved Anomalies report included with this submission and annotated as to any impact on safety or effectiveness including applicable workarounds.
Validation testing based on typical clinical workflows was performed by trained radiology personnel. Validation includes usability assessment and consistency across three client platforms; Web, iOS and Android (the subject of this submission and both phone and tablet devices.
Image /page/1/Picture/11 description: The image shows the text 'K123186' enclosed in a rounded rectangular box. The text is in a simple, sans-serif font and is horizontally centered within the box. The box is outlined with a thin, dark line, providing a clear boundary for the text.
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Performance Testing
Performance testing was conducted to qualify an Android smartphone and an Android as devices whose off-the-shelf performance in combination with the overall attributes of the ResolutionMD Mobile solution provides acceptable image quality for diagnostic radiology.
The tests were performed in accordance with the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by an ISO 17025-certified third party to ensure high quality laboratory results. The test equipment and calibration was certified traceable to NIST.
Nine tests of display performance were conducted for each mobile device running ResolutionMD Mobile and both devices passed all of the tests.
Clinical Testing
Clinical testing was conducted by a panel of three board-certified radiologists in the United States. The radiologists conducted a side-by-side comparative assessment of the Android mobile devices running ResolutionMD Mobile with the predicate iOS devices. A series of typical CT and MR cases were reviewed on each device. Comparative assessments of image quality and diagnostic confidence were made by each radiologist.
All three radiologists agreed that the Android mobile devices, both the smartphone and tablet, were comparable to the predicate iPhone and iPad devices and of adequate quality for clinical use. They were comfortable with the diagnoses made on the Android mobile devices using the ResolutionMD Mobile software. All agreed that the overall clinical image display quality on the Android devices was equivalent to the iOS devices for the identification of clinically-relevant pathology. There were similar comments on image contrast and sharpness with comments including "very comparable" and "is diagnostic". No image artifacts were noted by the reviewers.
All three radiologists indicated that the software and devices provide acceptable quality for regular use and they were comfortable reviewing images on the devices.
Safety and Effectiveness
The device is designed and manufactured under Quality System Regulations as outlined in 21 CFR 820. All requirements of Picture Archiving and Communications System (21 CFR 892.2050) are met, and software is in compliance with ISO 14971 and ISO 62304.
Substantial Equivalence:
Based on the above considerations, Calgary Scientific Inc. believes that the ResolutionMD Mobile 3.1 software is substantially equivalent to the predicate device. The device and the predicate are both post-processing and provide the same features of visualization of radiological data on mobile devices.
Image /page/2/Picture/12 description: The image contains the text 'K123186'. The text appears to be a code or identifier, possibly related to a product or document. The text is in a simple, sans-serif font and is presented in a straightforward manner.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and conveys the department's focus on health and human welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Kyle Peterson Director, Regulatory and Corporate Affairs Calgary Scientific Inc. Suite 208, 1210 - 20th Avenue SE CALGARY, ALBERTA T2G 1M8 CANADA
Re: K123186
Trade/Device Name: ResolutionMD™MD™ Mobile 3.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2013 Received: February 19, 2013
Dear Mr. Peterson:
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. Iisting 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.
4
Page 2-Mr. Peterson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sm.h.P)
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 4
Applicant: Calgary Scientific, Inc., Suite 208 - 1210 20th Ave. SE, Calgary, Alberta, CANADA T2G 1M8
510(k) Number: K123186
Device Name: ResolutionMD™ Mobile 3.1
Indications for Use:
The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0compliant CT and MR medical images as well as reports on the mobile device.
The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The ResolutionMD Mobile is not to be used for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510 (k) K123186
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