(234 days)
No
The summary describes standard PACS functionalities like image processing, storage, and viewing, but there is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function. The testing described focuses on display performance and system validation, not the performance of an AI/ML model.
No
The device is a software application for viewing and managing medical images, which is not considered a therapeutic function. Its purpose is to aid in diagnostic image review, not to provide therapy or treatment.
Yes
The 'Intended Use / Indications for Use' section states that "Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammographic images...". This indicates the device is used for diagnostic purposes.
Yes
The device is described as a "software application" and its components are listed as "software modules". While it interacts with hardware (scanners, displays, mobile devices), the device itself is the software that processes, stores, and displays the images. The testing described focuses on the software's performance and its interaction with various displays, not on the design or manufacturing of the hardware itself.
Based on the provided information, IntelePACS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- IntelePACS Function: IntelePACS is a software application designed to receive, process, store, and display medical images from various imaging modalities (CT, MR, ultrasound, etc.). It facilitates the review and interpretation of these images by medical professionals, primarily radiologists.
- No Specimen Analysis: The description of IntelePACS does not involve the analysis of any biological specimens. Its function is centered around the handling and display of medical images.
Therefore, IntelePACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IntelePACS is a software application that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPR). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
When used with a mobile device. IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IntelePACS, (version 5), is based upon the predicate device IntelePACS, version 4.9.1 (K150707). Both the subject device and the predicate are from Intelerad Medical Systems Inc. IntelePACS is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.
The main components are:
- InteleViewer is an image viewing system, providing access to the tools required for reviewing images and searching to find studies and reports. InteleViewer features DICOM support, including DICOM Query/Retrieve, Store, and Print. The software module includes a thumbnail display, real-time cine playback, MPR, annotations and measurements, etc. The web-enabled InteleViewer software uses JPEG 2000 compression and an advanced streaming protocol to provide lossless or lossy image viewing and manipulation. The user can examine multiple studies simultaneously and define customized image layouts. With a mouse click, the User can stack, rotate, zoom, take measurements, and view reports.
- InteleConnect Enhanced Viewer (used on Mobile Devices) is a web-based portal for medical images review that can be used on the desktop and on mobile devices without requiring software installation. This is a new module which is not in the Primary Predicate but is available in the Reference Predicate device.
InteleConnect EV is designed to run in modern web browsers, including Chrome, Firefox and Safari, mobile browsers running on IOS and Android devices, as well as Microsoft Edge and, with some limitations, Internet Explorer 11. It is also accessible on mobile devices such as iPhones and iPads. The mobile version of InteleConnect EV was not designed as a native application but rather as another, self-contained web application, re-using much of the same front-end infrastructure as the desktop version.
- InteleBrowser which is a web-based administrative interface for IntelePACS, and allows the facility System Administrator to customize and configure the facility radiological workflow and corporate branding. The System Administrator can administer hundreds or thousands of IntelePACS users by taking advantage of the user management and access granting tools.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist
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
The following mobile devices have been tested:
- iPad Pro 2017
- iPhone 8
- iPhone XS
- iPad Air (2019)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
The IntelePACS system has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by IntelePACS, and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
In the overall effort to characterize the suitability of the Enhanced Viewer for diagnostic use in non-mammography applications, we have followed the FDA guidelines for Display Devices for Diagnostic Radiology. The following mobile devices have been tested:
- iPad Pro 2017,
- iPhone 8,
- iPhone XS and
- iPad Air (2019)
Based on the guidance provided in "Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report and AAPM report 270 - Display Quality Assurance", we have analyzed the test results as follows:
- Spatial Resolution: Devices tested provide high resolution displays with high pixels per inch counts, with pixel pitch well below 250 um. The guidance provided in AAPM report 270 states that for LCD and OLED panels, which typically provide some black material between the pixel structure, it is recommended to ensure that they use a digital interface and to inspect to see if the pixel structure is not visible at typical viewing distance. All devices tested, satisfy this criterion.
- Pixel Defects Devices were visually inspected for any pixel defects and none were detected.
- Artifacts – A test lab evaluated for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time. At the end of the test, a visual observation was performed and confirmed that no such occurrence of either artifact, for all devices tested.
- Temporal Response – A test lab measured the rise and fall time constants for 5–95% and 40-60% luminance transitions. All devices tested present a reasonable response time in the 40-60% luminance transitions, namely around 30ms or better.
- Luminance - Maximum luminance is well above 350 cd/m² for all devices tested.
-Conformance to DICOM GSDF All devices tested only conform to DICOM GSDF within 20% over subsets of the JND range. While some mobile devices performed better than others, any one of the mobile devices did not fully satisfy the criteria. Multiple mitigations have been established for the user to make an appropriate assessment as to the suitability of their device and lighting conditions given the possible limitations. - Color Tracking - All values for delta D65(u',v') are within acceptable range for all devices tested.
- Mitigations and Instructions for Use In order to mitigate the potential risks due to device calibration limitations, the following has been implemented, as based on the recommendations of AAPM report No.260 Considerations for the Use of Handheld Image Viewers:
- Devices not explicitly tested, display a "Not for diagnostic use" permanent label. Mammography is excluded for any device and hence the label "Not for diagnostic use" persists when a mammography study is displayed, regardless of the device used.
- A screen and reading environment quality check built into the device. The User is presented with two standard patterns, along with instructions to identify specific parts of the pattern. If the User cannot identify these areas of the pattern, the "Not for diagnostic use" label will continue to be displayed. The result of the test is persisted for the rest of the day; however, the user will be prompted to validate again when using on a future date.
Based on the performance as documented in the V&V Testing, IntelePACS was found to have a safe and effectiveness profile that is similar to the predicate device.
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.
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
Intelerad Medical Systems, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 215 E. University Drive. Suite B DENTON TX 76209
April 2, 2020
Re: K192176
Trade/Device Name: IntelePACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 12, 2020 Received: February 14, 2020
Dear Mr. Alletto:
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (Sections 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192176
Device Name IntelePACS
Indications for Use (Describe)
IntelePACS is a software application that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPR). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
When used with a mobile device, IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the alphanumeric string "K192176" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the entire string easily readable. The string appears to be a code or identifier, possibly a serial number or product key.
Image /page/3/Picture/1 description: The image shows the logo for Intelerad. The logo consists of a red icon on the left and the word "Intelerad." on the right. Below the word "Intelerad." is the phrase "Making a difference in healthcare."
510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
Intelerad Medical Systems Incorporated 800, Boul. De Maisonneuve Est. 12th Floor Montreal, Canada H2L 4L8 Email: luce.caron@intelerad.com
Contact Person: Ms. Luce Caron, Quality Management Systems Manager Date Prepared: March 25, 2020
II. DEVICE
Name of Device: IntelePACS
Common or Usual Name: Picture Archiving Communications System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ
III. PREDICATE DEVICES
Primary Predicate Device IntelePACS, (K150707) v4.9.1 by Intelerad Medical Systems, Inc. CFR 892.2050, Product Code LLZ.
Reference Predicate Device eUnity, (K172490) by Client Outlook Inc. CFR892.2050, Product code: LLZ
IV. DEVICE DESCRIPTION
IntelePACS, (version 5), is based upon the predicate device IntelePACS, version 4.9.1 (K150707). Both the subject device and the predicate are from Intelerad Medical Systems Inc. IntelePACS is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.
The main components are:
- . InteleViewer is an image viewing system, providing access to the tools required for reviewing images and searching to find studies and reports. InteleViewer features DICOM support, including DICOM Query/Retrieve, Store, and Print. The software module includes a thumbnail display, real-time cine playback, linked stacking, MPR, annotations and measurements, etc. The web-enabled InteleViewer software uses JPEG 2000 compression and an advanced streaming protocol to provide lossless or lossy image viewing and manipulation. The user can examine multiple studies simultaneously and define customized image layouts. With a mouse click, the User can stack, rotate, zoom, take measurements, and view reports.
- InteleConnect Enhanced Viewer (used on Mobile Devices) is a web-based portal for medical images review that can be used on the desktop and on mobile devices without requiring software installation. This is a new module which is not in the Primary Predicate but is available in the Reference Predicate device.
InteleConnect EV is designed to run in modern web browsers, including Chrome, Firefox and Safari, mobile browsers running on IOS and Android devices, as well as Microsoft Edge and, with some limitations, Internet Explorer 11. It is also accessible on mobile devices such as iPhones and iPads. The mobile version of InteleConnect
4
Image /page/4/Picture/1 description: The image shows the logo for Intelerad, a healthcare technology company. The logo consists of a stylized red figure with a circular head and outstretched arms, positioned to the left of the company name. The company name "Intelerad." is written in a simple, sans-serif font, and below it is the tagline "Making a difference in healthcare" in a smaller font.
EV was not designed as a native application but rather as another, self-contained web application, re-using much of the same front-end infrastructure as the desktop version.
- InteleBrowser which is a web-based administrative interface for IntelePACS, and . allows the facility System Administrator to customize and configure the facility radiological workflow and corporate branding. The System Administrator can administer hundreds or thousands of IntelePACS users by taking advantage of the user management and access granting tools.
V. INDICATIONS FOR USE
IntelePACS is a software application that receives digital images and data from various sources (such as CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPR). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
When used with a mobile device. IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The subject device and primary predicate are both PACS. which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device is the next version of the primary predicate device and they are substantially equivalent in the areas of general function, application, and intended use. The subject device is adding a mobile viewing function which was not available on the primary predicate but is available on the reference predicate.
Any differences between the subject device and the predicates and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
| Item | Functionality | INTELEPACS, v
5 Subject Device | INTELEPACS,
v4.9.1 Primary
Predicate
K150707 | eUNITY,
Reference
Predicate
K172490 | Difference? |
|------|--------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------|-----------------------------|
| 1 | Intended use | Acquire, view,
edit, and store
radiographic
images | Similar | Similar | No difference |
| 2 | Intended user | radiologist | radiologist | radiologist | No difference |
| 3 | Network | 10/100/100
Ethernet | 10/100/100
Ethernet | 10/100/100
Ethernet | No difference |
| 4 | User interaction/input | Mouse, keyboard,
or touch monitor | Mouse,
keyboard, or
touch monitor | Mouse, keyboard,
or touch monitor | No difference |
| 5 | Import / export
images | Yes | Yes | Yes | No difference |
| 6 | Image search
available | Yes | Yes | Yes | No difference |
| 7 | Image storage | Yes | Yes | Yes | No difference |
| 8 | Image viewing | Yes | Yes | Yes | No difference |
| 9 | Image measurement | Yes | Yes | Yes | No difference |
| 10 | Image annotation | Yes | Yes | Yes | No difference |
| 11 | DICOM 3.0
compatibility | Yes | Yes | Yes | No difference |
| 12 | Thumbnail viewing | Yes | Yes | Yes | No difference |
| 13 | Panning | Yes | Yes | Yes | No difference |
| 14 | Magnify glass | Yes | Yes | Yes | No difference |
| 15 | Fit image | Yes | Yes | Yes | No difference |
| 16 | Resident workflow
module | Yes | No | Unknown | Yes, there is a difference. |
| 17 | Image Ingestion
Failure Notification | Yes | No | Unknown | Yes, there is a difference. |
| 18 | Bi-directional notes
integration for HL7
(Sending notes
between
systems) | Yes | No | Unknown | Yes, there is a difference. |
| 19 | Email alert for TAT
breach | Yes | No | Unknown | Yes, there is a difference. |
| 20 | Cloud archive on
AWS (Cloud storage
of images) | Yes | No | Unknown | Yes, there is a difference. |
| 21 | Peer review -
retrospective reviews | Yes | No | Unknown | Yes, there is a difference. |
| 22 | Proxied DICOM
query/retrieve for
InteleViewer/InteleCo
nnect/InteleBrowser | Yes | No | Unknown | Yes, there is a difference. |
| 23 | InteleViewer Tool
Customization
(Mouse) | Yes | No | Unknown | Yes, there is a difference. |
| 24 | Bridge Reporting
Workflow Gap -
Proxy Signing | Yes | No | Unknown | Yes, there is a difference. |
| 25 | Bridge Reporting
Workflow Gap -
Transcription Edits | Yes | No | Unknown | Yes, there is a difference. |
| 26 | Study Tagging | Yes | No | Unknown | Yes, there is a difference. |
| 27 | Support for DICOM
6000 Image Overlays
in (InteleConnect)
Enhanced Viewer | Yes | No | Unknown | Yes, there is a difference. |
| 28 | View Reports in
(InteleConnect)
Enhanced Viewer | Yes | No | Unknown | Yes, there is a difference. |
| 29 | Mobile Version of
(InteleConnect)
Enhanced Viewer | Yes | No | Yes | Yes, there is a difference. |
5
510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for Intelerad, a healthcare technology company. The logo features a red abstract figure of a person with their arms raised above their head. To the right of the figure is the company name, "Intelerad," in a gray sans-serif font. Below the company name is the tagline, "Making a difference in healthcare," also in gray.
VII. PERFORMANCE DATA
Nonclinical Testing:
The IntelePACS system has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions,
6
Image /page/6/Picture/1 description: The image shows the logo for Intelerad. The logo features a red abstract figure to the left of the company name. Below the company name is the tagline "Making a difference in healthcare."
output functions, and actions performed by IntelePACS, and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Summary:
In the overall effort to characterize the suitability of the Enhanced Viewer for diagnostic use in non-mammography applications, we have followed the FDA guidelines for Display Devices for Diagnostic Radiology. The following mobile devices have been tested:
- iPad Pro 2017, ●
- . iPhone 8,
- iPhone XS and
- . iPad Air (2019)
Based on the guidance provided in "Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report and AAPM report 270 - Display Quality Assurance", we have analyzed the test results as follows:
- Spatial Resolution: Devices tested provide high resolution displays with high pixels per ● inch counts, with pixel pitch well below 250 um. The guidance provided in AAPM report 270 states that for LCD and OLED panels, which typically provide some black material between the pixel structure, it is recommended to ensure that they use a digital interface and to inspect to see if the pixel structure is not visible at typical viewing distance. All devices tested, satisfy this criterion.
- Pixel Defects Devices were visually inspected for any pixel defects and none were ● detected.
- Artifacts – A test lab evaluated for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time. At the end of the test, a visual observation was performed and confirmed that no such occurrence of either artifact, for all devices tested.
- Temporal Response – A test lab measured the rise and fall time constants for 5–95% and 40-60% luminance transitions. All devices tested present a reasonable response time in the 40-60% luminance transitions, namely around 30ms or better.
- Luminance - Maximum luminance is well above 350 cd/m² for all devices tested.
- Conformance to DICOM GSDF All devices tested only conform to DICOM GSDF within ● 20% over subsets of the JND range. While some mobile devices performed better than others, any one of the mobile devices did not fully satisfy the criteria. Multiple mitigations have been established for the user to make an appropriate assessment as to the suitability of their device and lighting conditions given the possible limitations.
- Color Tracking - All values for △D65(u',v') are within acceptable range for all devices tested.
- Mitigations and Instructions for Use In order to mitigate the potential risks due to device ● calibration limitations, the following has been implemented, as based on the recommendations of AAPM report No.260 Considerations for the Use of Handheld Image Viewers:
- o Devices not explicitly tested, display a "Not for diagnostic use" permanent label. Mammography is excluded for any device and hence the label "Not for diagnostic use" persists when a mammography study is displayed, regardless of the device used.
- A screen and reading environment quality check built into the device. The User is O presented with two standard patterns, along with instructions to identify specific parts of the pattern. If the User cannot identify these areas of the pattern, the "Not for diagnostic use" label will continue to be displayed. The result of the test
7
510(k) Summary
Image /page/7/Picture/1 description: The image shows the logo for Intelerad. The logo features a red abstract figure on the left, resembling a person with outstretched arms. To the right of the figure is the company name, "Intelerad," in a gray sans-serif font. Below the name is the tagline, "Making a difference in healthcare," also in gray.
is persisted for the rest of the day; however, the user will be prompted to validate again when using on a future date.
Based on the performance as documented in the V&V Testing, IntelePACS was found to have a safe and effectiveness profile that is similar to the predicate device.
The following Standards were used to develop IntelePACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
- . ANSI AAMI IEC 62304:2006. Medical device software - Software life cycle processes. FDA Recognized Standard #13-32.
- NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard. FDA Recognized Standard #12-300.
- JPEG Standard IEC/ISO10918-1 First edition 1994-02-15, Information technology -Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]. FDA Recognized Standard #12-261.
- ISO 14971:2007/(R)2010 (Corrected 4 October 2007). Medical devices - Applications of risk management to medical devices. FDA Recognized Standard #05-40.
- FDA Display Devices for Diagnostic Radiology: Guidance for Industry and Food and ● Drug Administration Staff.
VIII. CONCLUSIONS
The 510(k) Pre-Market Notification for IntelePACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.