BriefCase

K203508 · Aidoc Medical , Ltd. · QAS · Dec 29, 2020 · Radiology

Device Facts

• Record ID: K203508
• Device Name: BriefCase
• Applicant: Aidoc Medical , Ltd.
• Product Code: QAS · Radiology
• Decision Date: Dec 29, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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 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.

Device Story

BriefCase is a radiological computer-aided triage and notification software. It receives DICOM images from hospital PACS, processes them via an AI algorithm on a cloud server to detect specific pathologies (cervical spine fractures, ICH, PE, IFG, LVO), and sends notifications to a desktop Worklist Application. The system operates in parallel to standard-of-care interpretation. When a suspected finding is detected, the clinician receives a pop-up notification with patient details and a compressed, non-diagnostic preview image. The device does not alter original images or perform primary diagnosis. It serves to prioritize the worklist, allowing clinicians to assess high-risk cases earlier than standard workflow. It is intended for use by appropriately trained medical specialists in hospital networks.

Clinical Evidence

No new clinical data was required for this modification. The 510(k) summaries for the predicate devices (K190896, K180647, K190072, K193298, K201020, K192383) contain the clinical evidence supporting the initial clearance of the BriefCase software.

Technological Characteristics

Software-based triage system comprising Aidoc Hospital Server (AHS), Aidoc Cloud Server (ACS), and desktop Worklist Application. Uses AI algorithms to analyze CT images. Operates on Windows Server 2012 64-bit with PostgreSQL and DICOM modules. Connectivity via hospital network to PACS. Non-diagnostic preview images are compressed, grayscale, and unannotated. No hardware components; software-only device.

Indications for Use

Indicated for hospital networks and appropriately trained medical specialists to assist in workflow triage by flagging suspected positive findings of cervical spine fractures (linear lucencies), intracranial hemorrhage (ICH), pulmonary embolism (PE), intra-abdominal free gas (IFG), and large vessel occlusion (LVO) in CT images. For adults/transitional adults ≥18 years.

Regulatory Classification

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.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 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. Standalone 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. 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.

*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.

Predicate Devices

• BriefCase (K190896)
• BriefCase (K180647)
• BriefCase (K190072)
• BriefCase (K193298)
• BriefCase (K201020)
• BriefCase (K192383)

Reference Devices

• qER (K200921)

Submission Summary (Full Text)

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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

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803) 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 ([e-mail]) or phone [phone] 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

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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)

| <div> <span style="font-family: DejaVu Sans, sans-serif;"> ☑ </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-family: DejaVu Sans, sans-serif;"> ☐ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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 [e-mail]

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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 [e-mail]

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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) | |
|------------------------------------------------------------------|-----------------------------------------------------------------|
| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### 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

[e-mail]

"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."

-

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#### 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 [e-mail]

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#### 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 [e-mail]

{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 [e-mail]

{8}------------------------------------------------

#### 510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)

| Submitter: | Aidoc Medical, Ltd.<br>3 Aminadav St.<br>Tel-Aviv, Israel |
|----------------------|---------------------------------------------------------------------------|
| Phone: | [phone] |
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software<br>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.

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#### 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<br>Use | BriefCase is a radiological<br>computer aided triage and<br>notification software indicated for<br>use in the analysis of cervical<br>spine CT images. The device is<br>intended to assist hospital<br>networks and trained radiologists<br>in workflow triage by flagging<br>and communication of suspected<br>positive findings of linear<br>lucencies in the cervical spine<br>bone in patterns compatible with<br>fractures. | BriefCase is a radiological<br>computer aided triage and<br>notification software indicated for<br>use in the analysis of cervical<br>spine CT images. The device is<br>intended to assist hospital<br>networks and appropriately<br>trained medical specialists in<br>workflow triage by flagging and<br>communication of suspected<br>positive findings of linear<br>lucencies in the cervical spine<br>bone in patterns compatible with<br>fractures. |
| | BriefCase uses an artificial<br>intelligence algorithm to analyze<br>images and highlight cases with<br>detected findings on a<br>standalone desktop application<br>in parallel to the ongoing<br>standard of care image<br>interpretation. The user is<br>presented with notifications for | BriefCase uses an artificial<br>intelligence algorithm to analyze<br>images and highlight cases with<br>detected findings on a<br>standalone desktop application<br>in parallel to the ongoing<br>standard of care image<br>interpretation. The user is |
| | Predicate Device | Subject Device |
| | Aidoc Briefcase (K190896) | Aidoc Briefcase (K203508) |
| | cases with suspected findings.<br>Notifications include compressed<br>preview images that are meant<br>for informational purposes only<br>and not intended for diagnostic<br>use beyond notification. The<br>device does not alter the original<br>medical image and is not<br>intended to be used as a<br>diagnostic device.<br>The results of BriefCase are<br>intended to be used in | presented with notifications for<br>cases with suspected findings.<br>Notifications include compressed<br>preview images that are<br>meant for informational purposes<br>only and not intended for<br>diagnostic use<br>beyond notification. The device<br>does not alter the original<br>medical image and is not<br>intended to be used as a<br>diagnostic device.<br>The results of BriefCase are<br>intended to be used in |
| | conjunction with other patient<br>information and based on their<br>professional judgment, to assist<br>with triage/prioritization of<br>medical images. Notified<br>clinicians are responsible for<br>viewing full images per the<br>standard of care. | conjunction with other<br>patient information and based on<br>their professional judgment, to<br>assist with triage/prioritization of<br>medical images. Notified<br>clinicians are responsible for<br>viewing full images per the<br>standard of care. |
| User population | Radiologist | Appropriately trained medical<br>specialists |
| Anatomical region of interest | Cervical spine | Cervical spine |
| Data acquisition protocol | Non-contrast cervical spine CT<br>scan | Non-contrast cervical spine CT<br>scans |
| View DICOM data | DICOM Information about the<br>patient, study and current image | DICOM Information about the<br>patient, study and current image |
| Segmentation of region of<br>interest | No; device does not mark,<br>annotate, or direct users'<br>attention to a specific location in<br>the original image | No; device does not mark,<br>annotate, or direct users'<br>attention to a specific location in<br>the original image |
| Algorithm | Artificial intelligence algorithm<br>with database of images | Artificial intelligence algorithm<br>with database of images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small,<br>compressed, black and white<br>preview image that is labeled<br>"Not for diagnostic use";<br>The device operates in parallel<br>with the standard of care, which<br>remains the default option for all<br>cases. | Presentation of a small,<br>compressed, black and white<br>preview image that is labeled<br>"Not for diagnostic use";<br>The device operates in parallel<br>with the standard of care, which<br>remains the default option for all<br>cases. |
| Alteration of original image | No | No |
| Removal of cases from worklist | No | No |

#### Table 1. Key feature comparison

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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.

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## 510(k) Summary

## Aidoc Medical, Ltd.'s BriefCase (K203508)

#### Submitter:

| Aidoc Medical, Ltd.<br>3 Aminadev St.<br>Tel-Aviv, Israel<br>Phone: | [phone] |
|---------------------------------------------------------------------|--------------------------------------------------------------|
| 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.

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#### 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<br>Use | BriefCase is a radiological<br>computer aided triage and<br>notification software<br>indicated for use in the<br>analysis of non-enhanced<br>head CT images. | BriefCase is a radiological<br>computer aided triage and<br>notification software<br>indicated for use in the<br>analysis of non-enhanced<br>head CT images. |
| | The device is intended to<br>assist hospital networks and<br>appropriately trained medical<br>specialist in workflow triage<br>by flagging and<br>communication of suspected<br>positive findings of<br>pathologies in head CT<br>images, namely Intracranial<br>Hemorrhage (ICH). | The device is intended to<br>assist hospital networks and<br>trained radiologists in<br>workflow triage by flagging<br>and communication of<br>suspected positive findings<br>of pathologies in head CT<br>images, namely Intracranial<br>Hemorrhage (ICH). |
| | BriefCase uses an artificial | BriefCase uses an artificial<br>intelligence algorithm to |
| | intelligence algorithm to | analyze images and highlight |
| | Subject Device | Predicate Device |
| | Aidoc Briefcase (K203508) | Aidoc Briefcase (K180647) |
| | analyze images and highlight<br>cases with detected ICH on a<br>standalone desktop<br>application in parallel to the<br>ongoing standard of care<br>image interpretation. The<br>user is presented<br>with notifications for cases<br>with suspected ICH findings.<br>Notifications<br>include compressed preview<br>images that are<br>meant for informational<br>purposes only and not<br>intended for diagnostic use<br>beyond notification. The<br>device does not alter the<br>original medical image and is<br>not intended to be used as a<br>diagnostic device. | cases with detected ICH on a<br>standalone desktop<br>application in parallel to the<br>ongoing standard of care<br>image interpretation. The<br>user is presented<br>with notifications for cases<br>with suspected ICH findings.<br>Notifications<br>include compressed preview<br>images that are<br>meant for informational<br>purposes only and not<br>intended for diagnostic use<br>beyond notification. The<br>device does not alter the<br>original medical image and is<br>not intended to be used as a<br>diagnostic device. |
| | The results of BriefCase are<br>intended to be used in<br>conjunction with other<br>patient information and<br>based on professional<br>judgment, to assist with<br>triage/prioritization of medical<br>images. Notified<br>clinicians are responsible for<br>viewing full images per the<br>standard of care. | The results of BriefCase are<br>intended to be used in<br>conjunction with other<br>patient information and<br>based on professional<br>judgment, to assist with<br>triage/prioritization of medical<br>images. Notified<br>clinicians are responsible for<br>viewing full images per the<br>standard of care. |
| User population | Appropriately trained medical<br>specialist | Radiologist |
| Anatomical region of interest | Head | Head |
| Data acquisition protocol | Non contrast CT scan of the<br>head or neck | Non contrast CT scan of the<br>head or neck |
| View DICOM data | DICOM Information about<br>the patient, study and current<br>image | DICOM Information about<br>the patient, study and current<br>image |
| Segmentation of region of<br>interest | No; device does not mark,<br>highlight, or direct users'<br>attention to a specific<br>location in the original image | No; device does not mark,<br>highlight, or direct users'<br>attention to a specific<br>location in the original image |
| Algorithm | Artificial intelligence<br>algorithm with database of<br>images | Artificial intelligence<br>algorithm with database of<br>images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a preview of<br>the study for initial<br>assessment not meant for<br>diagnostic purposes<br>The device operates in | Presentation of notification<br>and preview of the study for<br>initial assessment not meant<br>for diagnostic purposes<br>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<br>default option for all cases | care, which remains the<br>default option for all cases |
| Alteration of original image | No | No |
| Removal of cases from<br>worklist queue | No | No |

# Table 1. Key feature comparison

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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.

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#### 510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)

#### Submitter:

| Aidoc Medical, Ltd.<br>3 Aminadev St.<br>Tel-Aviv, Israel<br>Phone: | [phone] |
|---------------------------------------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 17, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software<br>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 ca…