(29 days)
Yes
The document explicitly states that BriefCase "uses an artificial intelligence algorithm to analyze images".
No
The device is a radiological computer-aided triage and notification software for workflow prioritization, not a device that applies therapy.
No
The product description explicitly states multiple times: "The device does not alter the original medical image and is not intended to be used as a diagnostic device." It is intended for workflow triage and notification, not primary diagnosis.
Yes
The device description explicitly states that BriefCase is a "radiological computer-assisted triage and notification software device" and details its software components (operating system, applications, modules) without mentioning any accompanying hardware that is part of the medical device itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: BriefCase analyzes CT, CTPA, and CTA images, which are generated by imaging equipment and are not biological samples.
- The intended use is workflow triage and notification: The primary purpose of BriefCase is to assist in prioritizing medical images for review by flagging potential findings. It explicitly states that it is not intended for diagnostic use.
Therefore, BriefCase falls under the category of medical imaging software or computer-aided detection/triage software, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Haemorrhage (ICH).
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CT images (but not dedicated CTPA protocol) CT. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device in intended to work with GE and Siemens scanners only.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL. DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., CSF). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
cervical spine CT images
non-enhanced head CT images
non-enhanced head CT and CTPA images
abdominal CT images
contrast-enhanced chest CTs (but not dedicated CTPA protocol)
head CTA images
Anatomical Site
cervical spine
Head
Head and chest
Abdomen
Chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and appropriately trained medical specialists
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 data was not needed to support this modification to BriefCase. The 510(k) Summary for K190896 describes the data that was used to support initial clearance of BriefCase.
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K180647 describes the data that was used to support initial clearance of BriefCase.
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K190072 describes the data that was used to support initial clearance of BriefCase.
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K193298 describes the data that was used to support initial clearance of BriefCase.
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K201020 describes the data that was used to support initial clearance of BriefCase.
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K192383 describes the data that was used to support initial clearance of BriefCase.
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.
BriefCase (K190896), Aidoc Medical BriefCase (K180647), BriefCase (K190072), BriefCase (K193298), BriefCase (K201020), BriefCase (K192383)
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.
Qure.ai Technologies qER (K200921)
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
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
December 29, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K203508
Trade/Device Name: BriefCase Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: November 30, 2020 Received: November 30, 2020
Dear Dr. Smith:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or post-marketing 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
510(k) Number (if known) K203508
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
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 NEEDEDThis 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.qov
3
510(k) Number (if known)
K203508 Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Haemorrhage (ICH).
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care..
Type of Use (Select one or both, as applicable)
区 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
4
510(k) Number (if known)
K203508
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in coniunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
| 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
"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."
5
510(k) Number (if known) K203508 Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. .
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
6
510(k) Number (if known) K203508 Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CT images (but not dedicated CTPA protocol) CT. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device in intended to work with GE and Siemens scanners only.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Type of Use (Select one or both, as applicable)
| Z Prescription Use (Part 21 CFR 801 Subpart D)
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
7
510(k) Number (if known) K203508 Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
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
8
510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)
| Submitter: | Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel |
|----------------------|---------------------------------------------------------------------------|
| Phone: | +972-73-7946870 |
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software
device |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K190896) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL. DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., CSF). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
9
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.
A table comparing the key features of the subject and predicate devices is provided below.
| Predicate Device | Subject Device | |
|---|---|---|
| Aidoc Briefcase (K190896) | Aidoc Briefcase (K203508) | |
| Intended Use / Indications for | ||
| Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated for | ||
| use in the analysis of cervical | ||
| spine CT images. The device is | ||
| intended to assist hospital | ||
| networks and trained radiologists | ||
| in workflow triage by flagging | ||
| and communication of suspected | ||
| positive findings of linear | ||
| lucencies in the cervical spine | ||
| bone in patterns compatible with | ||
| fractures. | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated for | ||
| use in the analysis of cervical | ||
| spine CT images. The device is | ||
| intended to assist hospital | ||
| networks and appropriately | ||
| trained medical specialists in | ||
| workflow triage by flagging and | ||
| communication of suspected | ||
| positive findings of linear | ||
| lucencies in the cervical spine | ||
| bone in patterns compatible with | ||
| fractures. | ||
| BriefCase uses an artificial | ||
| intelligence algorithm to analyze | ||
| images and highlight cases with | ||
| detected findings on a | ||
| standalone desktop application | ||
| in parallel to the ongoing | ||
| standard of care image | ||
| interpretation. The user is | ||
| presented with notifications for | BriefCase uses an artificial | |
| intelligence algorithm to analyze | ||
| images and highlight cases with | ||
| detected findings on a | ||
| standalone desktop application | ||
| in parallel to the ongoing | ||
| standard of care image | ||
| interpretation. The user is | ||
| Predicate Device | Subject Device | |
| Aidoc Briefcase (K190896) | Aidoc Briefcase (K203508) | |
| cases with suspected findings. | ||
| Notifications include compressed | ||
| preview images that are meant | ||
| for informational purposes only | ||
| and not intended for diagnostic | ||
| use beyond notification. The | ||
| device does not alter the original | ||
| medical image and is not | ||
| intended to be used as a | ||
| diagnostic device. | ||
| The results of BriefCase are | ||
| intended to be used in | presented with notifications for | |
| cases with suspected findings. | ||
| Notifications include compressed | ||
| preview images that are | ||
| meant for informational purposes | ||
| only and not intended for | ||
| diagnostic use | ||
| beyond notification. The device | ||
| does not alter the original | ||
| medical image and is not | ||
| intended to be used as a | ||
| diagnostic device. | ||
| The results of BriefCase are | ||
| intended to be used in | ||
| conjunction with other patient | ||
| information and based on their | ||
| professional judgment, to assist | ||
| with triage/prioritization of | ||
| medical images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | conjunction with other | |
| patient information and based on | ||
| their professional judgment, to | ||
| assist with triage/prioritization of | ||
| medical images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | ||
| User population | Radiologist | Appropriately trained medical |
| specialists | ||
| Anatomical region of interest | Cervical spine | Cervical spine |
| Data acquisition protocol | Non-contrast cervical spine CT | |
| scan | Non-contrast cervical spine CT | |
| scans | ||
| View DICOM data | DICOM Information about the | |
| patient, study and current image | DICOM Information about the | |
| patient, study and current image | ||
| Segmentation of region of | ||
| interest | No; device does not mark, | |
| annotate, or direct users' | ||
| attention to a specific location in | ||
| the original image | No; device does not mark, | |
| annotate, or direct users' | ||
| attention to a specific location in | ||
| the original image | ||
| Algorithm | Artificial intelligence algorithm | |
| with database of images | Artificial intelligence algorithm | |
| with database of images | ||
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small, | |
| compressed, black and white | ||
| preview image that is labeled | ||
| "Not for diagnostic use"; | ||
| The device operates in parallel | ||
| with the standard of care, which | ||
| remains the default option for all | ||
| cases. | Presentation of a small, | |
| compressed, black and white | ||
| preview image that is labeled | ||
| "Not for diagnostic use"; | ||
| The device operates in parallel | ||
| with the standard of care, which | ||
| remains the default option for all | ||
| cases. | ||
| Alteration of original image | No | No |
| Removal of cases from worklist | No | No |
Table 1. Key feature comparison
10
11
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K190896 describes the data that was used to support initial clearance of BriefCase.
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.
12
510(k) Summary
Aidoc Medical, Ltd.'s BriefCase (K203508)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadev St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer aided triage and notification software |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | Aidoc Medical BriefCase (K180647) |
| Reference Device: | Qure.ai Technologies qER (K200921) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved and filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name and accession number. A list of all incoming cases with suspected findings is also displayed. In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the user with notification facilitates earlier triage by allowing one to assess the available images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
13
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.
The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH).
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on professional judgment. to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate devices have identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide notifications and preview head images of potential findings to the user for the purpose of treatment planning and follow up, and are therefore substantially equivalent. The reference qER device is also intended for use by trained medical specialists.
A table comparing the key features of the subject and predicate devices is provided below.
| Subject Device | Predicate Device | |
|---|---|---|
| Aidoc Briefcase (K203508) | Aidoc Briefcase (K180647) | |
| Intended Use / Indications for | ||
| Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software | ||
| indicated for use in the | ||
| analysis of non-enhanced | ||
| head CT images. | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software | ||
| indicated for use in the | ||
| analysis of non-enhanced | ||
| head CT images. | ||
| The device is intended to | ||
| assist hospital networks and | ||
| appropriately trained medical | ||
| specialist in workflow triage | ||
| by flagging and | ||
| communication of suspected | ||
| positive findings of | ||
| pathologies in head CT | ||
| images, namely Intracranial | ||
| Hemorrhage (ICH). | The device is intended to | |
| assist hospital networks and | ||
| trained radiologists in | ||
| workflow triage by flagging | ||
| and communication of | ||
| suspected positive findings | ||
| of pathologies in head CT | ||
| images, namely Intracranial | ||
| Hemorrhage (ICH). | ||
| BriefCase uses an artificial | BriefCase uses an artificial | |
| intelligence algorithm to | ||
| intelligence algorithm to | analyze images and highlight | |
| Subject Device | Predicate Device | |
| Aidoc Briefcase (K203508) | Aidoc Briefcase (K180647) | |
| analyze images and highlight | ||
| cases with detected ICH on a | ||
| standalone desktop | ||
| application in parallel to the | ||
| ongoing standard of care | ||
| image interpretation. The | ||
| user is presented | ||
| with notifications for cases | ||
| with suspected ICH findings. | ||
| Notifications | ||
| include compressed preview | ||
| images that are | ||
| meant for informational | ||
| purposes only and not | ||
| intended for diagnostic use | ||
| beyond notification. The | ||
| device does not alter the | ||
| original medical image and is | ||
| not intended to be used as a | ||
| diagnostic device. | cases with detected ICH on a | |
| standalone desktop | ||
| application in parallel to the | ||
| ongoing standard of care | ||
| image interpretation. The | ||
| user is presented | ||
| with notifications for cases | ||
| with suspected ICH findings. | ||
| Notifications | ||
| include compressed preview | ||
| images that are | ||
| meant for informational | ||
| purposes only and not | ||
| intended for diagnostic use | ||
| beyond notification. The | ||
| device does not alter the | ||
| original medical image and is | ||
| not intended to be used as a | ||
| diagnostic device. | ||
| The results of BriefCase are | ||
| intended to be used in | ||
| conjunction with other | ||
| patient information and | ||
| based on professional | ||
| judgment, to assist with | ||
| triage/prioritization of medical | ||
| images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | The results of BriefCase are | |
| intended to be used in | ||
| conjunction with other | ||
| patient information and | ||
| based on professional | ||
| judgment, to assist with | ||
| triage/prioritization of medical | ||
| images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | ||
| User population | Appropriately trained medical | |
| specialist | Radiologist | |
| Anatomical region of interest | Head | Head |
| Data acquisition protocol | Non contrast CT scan of the | |
| head or neck | Non contrast CT scan of the | |
| head or neck | ||
| View DICOM data | DICOM Information about | |
| the patient, study and current | ||
| image | DICOM Information about | |
| the patient, study and current | ||
| image | ||
| Segmentation of region of | ||
| interest | No; device does not mark, | |
| highlight, or direct users' | ||
| attention to a specific | ||
| location in the original image | No; device does not mark, | |
| highlight, or direct users' | ||
| attention to a specific | ||
| location in the original image | ||
| Algorithm | Artificial intelligence | |
| algorithm with database of | ||
| images | Artificial intelligence | |
| algorithm with database of | ||
| images | ||
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a preview of | |
| the study for initial | ||
| assessment not meant for | ||
| diagnostic purposes | ||
| The device operates in | Presentation of notification | |
| and preview of the study for | ||
| initial assessment not meant | ||
| for diagnostic purposes | ||
| The device operates in | ||
| parallel with the standard of | parallel with the standard of | |
| Subject Device | Predicate Device | |
| Aidoc Briefcase (K203508) | Aidoc Briefcase (K180647) | |
| care, which remains the | ||
| default option for all cases | care, which remains the | |
| default option for all cases | ||
| Alteration of original image | No | No |
| Removal of cases from | ||
| worklist queue | No | No |
Table 1. Key feature comparison
14
15
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K180647 describes the data that was used to support initial clearance of BriefCase.
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.
16
510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadev St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K190072) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., PE). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
17
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate device have identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.
A table comparing the key features of the subject and predicate devices is provided below.
| Predicate Device | Subject Device | |
|---|---|---|
| Aidoc Briefcase (K190072) | Aidoc Briefcase (K203508) | |
| Intended Use / | ||
| Indications for Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated | ||
| for use in the analysis of non- | ||
| enhanced head CT and CTPA | ||
| images. The device is intended | ||
| to assist hospital networks and | ||
| trained radiologists in workflow | ||
| triage by flagging and | ||
| communication of suspected | ||
| positive findings of Intracranial | ||
| Hemorrhage (ICH) and | ||
| Pulmonary Embolism (PE) | ||
| pathologies. For the PE | ||
| pathology, the software is only | ||
| intended to be used on single- | ||
| energy exams. | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated | ||
| for use in the analysis of non- | ||
| enhanced head CT and CTPA | ||
| images. The device is intended | ||
| to assist hospital networks and | ||
| appropriately trained medical | ||
| specialists in workflow triage | ||
| by flagging and communication | ||
| of suspected positive findings of | ||
| Intracranial Hemorrhage (ICH) and | ||
| Pulmonary Embolism (PE) | ||
| pathologies. For the PE | ||
| pathology, the software is only | ||
| intended to be used on single- | ||
| energy exams. | ||
| BriefCase uses an artificial | ||
| intelligence algorithm to | ||
| analyze images and highlight | ||
| cases with detected findings on | BriefCase uses an artificial | |
| intelligence algorithm to | ||
| analyze images and highlight | ||
| cases with detected findings on | ||
| Predicate Device | ||
| Aidoc Briefcase (K190072) | Subject Device | |
| Aidoc Briefcase (K203508) | ||
| a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. | a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. | |
| User population | Radiologist | Appropriately trained medical specialists |
| Anatomical region of interest | Head and chest | Head and chest |
| Data acquisition protocol | Non-contrast head CT scan and CTPA (single energy exams only) | Non-contrast head CT scan and CTPA (single energy exams only) |
| View DICOM data | DICOM Information about the patient, study and current image | DICOM Information about the patient, study and current image |
| Segmentation of region of interest | No; device does not mark, annotate, or direct users' attention to a specific location in the original image | No; device does not mark, annotate, or direct users' attention to a specific location in the original image |
| Algorithm | Artificial intelligence algorithm with database of images | Artificial intelligence algorithm with database of images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small, compressed, black and white preview image that is labeled "Not for diagnostic use"; The device operates in parallel with the standard of care, which remains the default option for all cases. | Presentation of a small, compressed, black and white preview image that is labeled "Not for diagnostic use"; The device operates in parallel with the standard of care, which remains the default option for all cases. |
| Predicate Device | ||
| Aidoc Briefcase (K190072) | Subject Device | |
| Aidoc Briefcase (K203508) | ||
| Alteration of original | ||
| image | No | No |
| Removal of cases from | ||
| worklist queue | No | No |
Table 1. Key feature comparison
18
19
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K190072 describes the data that was used to support initial clearance of BriefCase.
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.
20
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K193298) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. The user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVO) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., IFG). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
21
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected findings of Intra-abdominal Free Gas (IFG) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.
A table comparing the key features of the subject and predicate devices is provided below.
| Table 1. Key feature comparison | ||
|---|---|---|
| Predicate Device | ||
| Aidoc Briefcase (K193298) | Subject Device | |
| Aidoc Briefcase (K203508) | ||
| Intended Use / Indications | ||
| for Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated for | ||
| use in the analysis of abdominal | ||
| CT images. The device is intended | ||
| to assist hospital networks and | ||
| trained radiologists in workflow | ||
| triage by flagging and | ||
| communication of suspected | ||
| positive findings of Intra-abdominal | ||
| Free Gas (IFG) pathologies. |
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a standalone
desktop application in parallel to | BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of
abdominal CT images.
The device is intended to
assist hospital networks and
appropriately trained medical
specialists in workflow triage
by flagging and communication
of suspected positive findings
of Intra-abdominal Free Gas
(IFG) pathologies.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight |
| | Predicate Device
Aidoc Briefcase (K193298) | Subject Device
Aidoc Briefcase (K203508) |
| | the ongoing standard of care
image interpretation. The user is
presented with notifications for
cases with suspected findings.
Notifications include compressed
preview images that are meant for
informational purposes only and
not intended for diagnostic use
beyond notification. The device
does not alter the original medical
image and is not intended to be
used as a diagnostic device.
The results of BriefCase are
intended to be used in conjunction
with other patient information and
based on their professional
judgment, to assist with
triage/prioritization of medical
images. Notified clinicians are
responsible for viewing full images
per the standard of care. | cases with detected findings on
a standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The user
is presented with notifications
for cases with suspected
findings. Notifications
include compressed preview
images that are
meant for informational
purposes only and not intended
for diagnostic use
beyond notification. The device
does not alter the original
medical image and is not
intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and based
on their professional
judgment, to assist with
triage/prioritization of medical
images. Notified clinicians are
responsible for viewing
full images per the standard of
care. |
| User population | Radiologist | Appropriately trained medical
specialists |
| Anatomical region of
interest | Abdomen | Abdomen |
| Data acquisition protocol | Abdominal CT scan | Abdominal CT scan |
| View DICOM data | DICOM Information about the
patient, study and current image | DICOM Information about the
patient, study and current
image |
| Segmentation of region of
interest | No; device does not mark,
annotate, or direct users' attention
to a specific location in the original
image | No; device does not mark,
annotate, or direct users'
attention to a specific location
in the original image |
| Algorithm | Artificial intelligence algorithm with
database of images | Artificial intelligence algorithm
with database of images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small,
compressed, black and white
preview image that is labeled "Not
for diagnostic use";
The device operates in parallel
with the standard of care, which
remains the default option for all
cases. | Presentation of a small,
compressed, black and white
preview image that is labeled
"Not for diagnostic use";
The device operates in parallel
with the standard of care,
which remains the default
option for all cases. |
| Alteration of original image | No | No |
| | Predicate Device
Aidoc Briefcase (K193298) | Subject Device
Aidoc Briefcase (K203508) |
| Removal of cases from
worklist queue | No | No |
22
23
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K193298 describes the data that was used to support initial clearance of BriefCase.
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.
24
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K201020) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Filtration matches metadata fields with keywords. Series are processed chronologically by running the algorithms on each series to detect suspected cases. The software then flags suspect cases by sending notifications to the Worklist desktop application, thereby prompting preemptive triaqe and prioritization by the user . As the BriefCase software platform harbors several triage algorithms, the user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on LVO cases, and a neuro-radiologist would opt to divert PE notifications. Where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new suspected studies when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., iPE). A list of all incoming suspect cases is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
25
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (but not dedicated CTPA protocol). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device is intended to work with GE and Siemens scanners only.
BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists.
Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.
A table comparing the key features of the subject and predicate devices is provided below.
| Table 1. Key feature comparison | ||
|---|---|---|
| Predicate Device | ||
| Aidoc Briefcase (K201020) | Subject Device | |
| Aidoc Briefcase (K203508) | ||
| Intended Use / | ||
| Indications for Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated | ||
| for use in the analysis of | ||
| contrast-enhanced chest CTs | ||
| (but not dedicated CTPA | ||
| protocol). The device is | ||
| intended to assist hospital | ||
| networks and trained | ||
| radiologists in workflow triage | ||
| by flagging and communication | ||
| of suspected positive cases of | ||
| incidental Pulmonary Embolism | ||
| (iPE) pathologies. For the iPE | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated | ||
| for use in the analysis of | ||
| contrast-enhanced chest CTs | ||
| (but not dedicated CTPA | ||
| protocol). The device is | ||
| intended to assist hospital | ||
| networks and appropriately | ||
| trained medical specialists in | ||
| workflow triage by flagging and | ||
| communication of suspected | ||
| positive cases of incidental | ||
| Pulmonary Embolism (iPE) | ||
| Predicate Device | Subject Device | |
| Aidoc Briefcase (K201020) | Aidoc Briefcase (K203508) | |
| pathology, the software is only | ||
| intended to be used on single- | ||
| energy exams. The device is | ||
| intended to work with GE and | ||
| Siemens scanners only. | pathologies. For the iPE | |
| pathology, the software is only | ||
| intended to be used on single- | ||
| energy exams. The device is | ||
| intended to work with GE and | ||
| Siemens scanners only. | ||
| BriefCase uses an artificial | ||
| intelligence algorithm to analyze | ||
| images and flag suspect cases | ||
| on a standalone desktop | ||
| application in parallel to the | ||
| ongoing standard of care image | ||
| interpretation. The user is | ||
| presented with notifications for | ||
| suspect cases. Notifications | ||
| include compressed preview | ||
| images that are meant for | ||
| informational purposes only and | ||
| not intended for diagnostic use | ||
| beyond notification. The device | ||
| does not alter the original | ||
| medical image and is not | ||
| intended to be used as a | ||
| diagnostic device. | ||
| The results of BriefCase are | ||
| intended to be used in | ||
| conjunction with other patient | ||
| information and based on their | ||
| professional judgment, to assist | ||
| with triage/prioritization of | ||
| medical images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | BriefCase uses an artificial | |
| intelligence algorithm to | ||
| analyze images and flag | ||
| suspect cases on a standalone | ||
| desktop application in parallel | ||
| to the ongoing standard of care | ||
| image interpretation. The user is | ||
| presented with notifications | ||
| for suspect cases. Notifications | ||
| include compressed preview | ||
| images that are | ||
| meant for informational | ||
| purposes only and not intended | ||
| for diagnostic use | ||
| beyond notification. The device | ||
| does not alter the original | ||
| medical image and is not | ||
| intended to be used as a | ||
| diagnostic device. | ||
| The results of BriefCase are | ||
| intended to be used in | ||
| conjunction with other | ||
| patient information and based | ||
| on their professional | ||
| judgment, to assist with | ||
| triage/prioritization of medical | ||
| images. Notified clinicians are | ||
| responsible for viewing | ||
| full images per the standard of | ||
| care. | ||
| User population | Radiologist | Appropriately trained medical |
| specialists | ||
| Anatomical region of | ||
| interest | Chest | Chest |
| Inclusion/ | ||
| Exclusion criteria | Inclusion Criteria |
- Contrast-enhanced chest
CTs (but not dedicated
CTPA protocol. - Single energy exams.
- Scans performed with a
64 slice or greater
number of detectors. - Scans performed on
adults/transitional adults ≥
18 years of age. | Inclusion criteria - Contrast-enhanced chest
CTs (but not dedicated
CTPA protocol. - Single energy exams.
- Scans performed with a 64
slice or greater number of
detectors. - Scans performed on
adults/transitional adults ≥
18 years of age. |
| | Predicate Device
Aidoc Briefcase (K201020) | Subject Device
Aidoc Briefcase (K203508) |
| | Slice thickness: 0.5mm –
2.0mm axial. | Slice thickness: 0.5mm –
2.0mm axial. |
| | Exclusion Criteria - All studies that are
technically inadequate,
including studies with motion
artifacts, severe metal
artifacts, or inadequate field
of view. | Exclusion Criteria - All studies that are
technically inadequate,
including studies with motion
artifacts, severe metal
artifacts, or inadequate field
of view. |
| Data acquisition
protocol | Contrast-enhanced chest CTs
(but not dedicated CTPA
protocol) | Contrast-enhanced chest CTs
(but not dedicated CTPA
protocol) |
| View DICOM data | DICOM Information about the
patient, study and current image | DICOM Information about the
patient, study and current image |
| Segmentation of region
of interest | No; device does not mark,
annotate, or direct users'
attention to a specific location in
the original image | No; device does not mark,
annotate, or direct users'
attention to a specific location in
the original image |
| Algorithm | Artificial intelligence algorithm
with database of images | Artificial intelligence algorithm
with database of images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a low-quality,
compressed, grayscale preview
image that is captioned "Not for
diagnostic use". | Presentation of a low-quality,
compressed, grayscale preview
image that is captioned "Not for
diagnostic use". |
| Alteration of original
image | No | No |
| Removal of cases from
worklist queue | No. The device operates in
parallel with the standard of
care, which remains the default
option for all cases. Unflagged
cases are not de-prioritized. | No. The device operates in
parallel with the standard of
care, which remains the default
option for all cases. Unflagged
cases are not de-prioritized. |
| Structure | - AHS module (image
acquisition). - ACS module (image
processing). - Aidoc Worklist application for
workflow integration (worklist
and non-diagnostic basic
Image Viewer). | - AHS module (image
acquisition). - ACS module (image
processing). - Aidoc Worklist application
for workflow integration
(worklist and non-diagnostic
basic Image Viewer). |
Table 1. Kev feature comparison
26
27
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K201020 describes the data that was used to support initial clearance of BriefCase.
28
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.
29
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Primary Predicate Device: | BriefCase (K192383) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.
DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. The user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVO) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., LVO). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
30
Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Substantial Equivalence
The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated low-quality preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.
A table comparing the key features of the subject and predicate devices is provided below.
| Table 1. Key feature comparison | ||
|---|---|---|
| Subject Device | Predicate Device | |
| Aidoc Briefcase (K203508) | Aidoc Briefcase (K192383) | |
| Intended Use / Indications for | ||
| Use | BriefCase is a radiological | |
| computer aided triage and | ||
| notification software indicated | ||
| for use in the analysis of head | ||
| CTA images. The device is | ||
| intended to assist hospital | ||
| networks and appropriately | ||
| trained medical specialists in | ||
| workflow triage by flagging | ||
| and communication of | ||
| suspected positive findings of | ||
| Large Vessel Occlusion (LVO) | ||
| pathologies. | BriefCase is a radiological | |
| computer aided triage and | ||
| notification soft-ware indicated | ||
| for use in the analysis of head | ||
| CTA images. The device is | ||
| intended to assist hospital | ||
| networks and trained medical | ||
| specialists in workflow triage | ||
| by flagging and | ||
| communication of suspected | ||
| positive findings of Large | ||
| Vessel Occlusion (LVO) | ||
| pathologies. | ||
| Subject Device | ||
| Aidoc Briefcase (K203508) | Predicate Device | |
| Aidoc Briefcase (K192383) | ||
| cases with detected findings | ||
| on a standalone desktop | ||
| application in parallel to the | ||
| ongoing standard of care | ||
| image interpretation. The user | ||
| is presented with notifications | ||
| for cases with suspected | ||
| findings. Notifications | ||
| include compressed preview | ||
| images that are | ||
| meant for informational | ||
| purposes only and not | ||
| intended for diagnostic use | ||
| beyond notification. The | ||
| device does not alter the | ||
| original medical image and is | ||
| not intended to be used as a | ||
| diagnostic device. | cases with detected findings | |
| on a standalone desktop | ||
| application in parallel to the | ||
| ongoing standard of care | ||
| image interpretation. The user | ||
| is presented with notifications | ||
| for cases with suspected | ||
| findings. Notifications include | ||
| compressed preview images | ||
| that are meant for | ||
| informational purposes only | ||
| and not intended for | ||
| diagnostic use beyond | ||
| notification. The device does | ||
| not alter the original medical | ||
| image and is not intended to | ||
| be used as a diagnostic | ||
| device. | ||
| The results of BriefCase are | ||
| intended to be used in | ||
| conjunction with other | ||
| patient information and based | ||
| on their professional | ||
| judgment, to assist with | ||
| triage/prioritization of medical | ||
| images. Notified clinicians are | ||
| responsible for viewing | ||
| full images per the standard of | ||
| care. | The results of BriefCase are | |
| intended to be used in | ||
| conjunction with other patient | ||
| information and based on their | ||
| professional judgment, to | ||
| assist with triage/prioritization | ||
| of medical images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | ||
| User population | Appropriately trained medical | |
| specialists | Radiologist | |
| Anatomical region of interest | ||
| Inclusion/ | ||
| Exclusion criteria | Head | |
| Inclusion criteria | ||
| Head CTA protocol with a | ||
| 64-slice scanner or higher;Scans performed on | ||
| adults/transitional adults ≥ | ||
| 18 years of age;Slice thickness 0.5 mm - | ||
| 1.0 mm. | Head | |
| Inclusion Criteria | ||
| Head CTA protocol with a | ||
| 64-slice scanner or higher;Scans performed on | ||
| adults/transitional adults ≥ | ||
| 18 years of age;Slice thickness 0.5 mm - | ||
| 1.0 mm. | ||
| Exclusion Criteria | ||
| All scans that are | ||
| technically inadequate, | ||
| including motion artifacts, | ||
| severe metal artifacts, sub- | ||
| optimal bolus timing or an | ||
| inadequate field of view. | Exclusion Criteria | |
| All scans that are | ||
| technically inadequate, | ||
| including motion artifacts, | ||
| severe metal artifacts, sub- | ||
| optimal bolus timing or an | ||
| inadequate field of view. | ||
| Subject Device | ||
| Aidoc Briefcase (K203508) | Predicate Device | |
| Aidoc Briefcase (K192383) | ||
| View DICOM data | DICOM Information about the | |
| patient, study and current | ||
| image | DICOM Information about the | |
| patient, study and current | ||
| image | ||
| Segmentation of region of | ||
| interest | No; device does not mark, | |
| annotate, or direct users' | ||
| attention to a specific location | ||
| in the original image. | No; device does not mark, | |
| annotate, or direct users' | ||
| attention to a specific location | ||
| in the original image. | ||
| Algorithm | Artificial intelligence algorithm | |
| with database of images. | Artificial intelligence algorithm | |
| with database of images. | ||
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small, | |
| compressed, black and white | ||
| preview image that is labeled | ||
| "Not for diagnostic use"; | ||
| The device operates in | ||
| parallel with the standard of | ||
| care, which remains the | ||
| default option for all cases. | Presentation of a small, | |
| compressed, black and white | ||
| preview image that is labeled | ||
| "Not for diagnostic use"; | ||
| The device operates in | ||
| parallel with the standard of | ||
| care, which remains the | ||
| default option for all cases. | ||
| Alteration of original image | No | No |
| Removal of cases from | ||
| worklist queue | No | No |
| Structure | - AHS module (image acquisition); |
- ACS module (image processing);
- Aidoc Worklist application
for workflow integration
(worklist and Image
Viewer).
Addition of minor changes in
the software platform, e.g.
notification filter, which
neither impacts the order in
which notification come in,
nor affects the safety and
efficacy profile of the device | - AHS module (image acquisition); - ACS module (image processing);
- Aidoc Worklist application
for workflow integration
(worklist and Image
Viewer).
Addition of minor changes in
the software platform, e.g.
notification filter, which
neither impacts the order in
which notification come in,
nor affects the safety and
efficacy profile of the device |
Table 1. Kev feature comparison
31
32
Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K192383 describes the data that was used to support initial clearance of BriefCase.
Conclusions
The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.