cmTriage

K183285 · Curemetrix, Inc. · QFM · Mar 8, 2019 · Radiology

Device Facts

• Record ID: K183285
• Device Name: cmTriage
• Applicant: Curemetrix, Inc.
• Product Code: QFM · Radiology
• Decision Date: Mar 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

cmTriage is a passive notification-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist. Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care. cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. cmTriage is for prescription use only.

Device Story

cmTriage is a cloud-based software tool for radiologists to prioritize 2D FFDM screening mammograms. It operates in parallel to standard clinical workflows. Input: 2D FFDM DICOM images captured by standard FFDM systems. Process: Local forwarding software de-identifies and transmits images to the CureMetrix cloud; AI algorithm analyzes images for suspicious findings; cloud generates a DICOM Structured Report (SR) with a 'Suspicious' or blank flag. Output: DICOM SR returned to the facility PACS, updating the worklist column for the exam. Usage: Radiologists view flags in the PACS worklist to prioritize reading; the device does not alter original images, provide diagnostic information, or send proactive alerts. Benefit: Enables efficient prioritization of potentially suspicious screening mammograms, potentially improving workflow efficiency. The device is not a diagnostic tool and does not replace standard-of-care review.

Clinical Evidence

Retrospective, blinded, multi-center study using 1,255 mammographic studies (400 biopsy-proven cancer, 855 normal). Primary endpoints: sensitivity and specificity. Results: Mean sensitivity 86.9% (95% CI: 83.6%–90.2%); mean specificity 88.5% (95% CI: 86.4%–90.7%). AUC 0.951 (95% CI: 0.937–0.964). Performance held across breast densities and lesion types (masses/calcifications). Timing performance averaged 3.35 minutes. Population-adjusted mark rate (6.37% at 84.4% sensitivity) compared favorably to radiologist recall rates.

Technological Characteristics

Software-only device. Components: (1) Image Forwarding/Result Receiving software (on-premise), (2) Cloud-based Image Processing/Analysis software, (3) DICOM SR Notification Result File. Connectivity: Networked via secure channel to cloud. Algorithm: AI-based analysis for suspicious regions of interest. Output: DICOM SR file for PACS integration. No hardware components.

Indications for Use

Indicated for use by radiologists to prioritize 2D FFDM screening mammograms within the standard-of-care worklist by flagging exams suggestive of at least one suspicious finding. Prescription use only.

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

• ContaCT (DEN170073)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

CureMetrix, Inc. % Mr. Kevin Harris CEO 9404 Genesee Avenue, Suite 330 LA JOLLA CA 92037

March 8, 2019

Re: K183285

Trade/Device Name: cmTriage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: OFM Dated: February 4, 2019 Received: February 4, 2019

Dear Mr. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183285

Device Name

cm Triage

#### Indications for Use (Describe)

cm Triage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms, cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use on Triage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.

Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care.

cm Triage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis.

cmTriage is for prescription use only.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Submitter | CureMetrix, Inc. |
|---------------------------|-----------------------------------------------------------------|
| Contact Person | Kevin Harris |
| | 9404 Genesee Ave |
| | Suite 330 |
| | La Jolla, CA 92037 |
| | 619-339-9889 |
| | [e-mail] |
| Common Name | Radiological Computer-Assisted Triage and Notification Software |
| Trade Name | cmTriage™ |
| Classification | |
| Name: | Radiological Computer-Assisted Prioritization Software |
| Regulation: | 21 CFR 892.2080 |
| Code: | QFM |
| Class: | Class II |
| Predicate Device | |
| Name: | ContaCT |
| Company: | Viz.AI |
| Code: | QAS |
| 510(k): | DEN170073 |
| 510(k) Submission Number: | K183285 |

## Device Description

CureMetrix's cmTriage is a radiological computer-assisted triage and notification software device. Digital two-dimensional (2D) mammograms are captured by a Full-Field Digital Mammography (FFDM) system and deposited on the PACS. The CureMetrix image forwarding software, acting as a PACS listener, receives a copy of the mammography DICOM image(s), creates a local copy of the image(s), de-identifies the local copy, transmits the local copy, transmits the local copy to the CureMetrix cloud, and then deletes the local copy.

Within the CureMetrix cloud, the cmTriage service receives the DICOM image(s), groups them by study, analyzes the image(s) within the study, and produces a result for each study. The results are produced in the form of DICOM Structured Report (SR) file with a cmTriage result.

The result file is encrypted and transmitted from the CureMetrix cloud back to cmEdge where it is decrypted and reassociated with the original study. The DICOM SR is then routed to the PACS.

Once the PACS receives the DICOM SR, the file is opened, the cmTriage code ("Impression Description") is extracted for the exam, and the worklist column for the exam is updated. The cmTriage code will either indicate "Suspicious" or "" (blank).

Within the PACS worklist the cmTriage code can be displayed in a separate column. Each PACS may have different features and functionality depending on the manufacturer which are outside of the scope and control of CureMetrix and cmTriage. However, in general, at a minimum, the user is able to sort their worklist based on values in columns. This sorting functionality (if present) would allow the radiologist to group Suspicious exams together. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The standard of care for breast cancer screening in the US is quickly becoming one in which both FFDM and digital breast tomosynthesis (DBT) are acquired during the exam. However, cmTriage only operates on 2D images. If a site does not use FFDM and 2D but instead only uses 3D and DBT, they will not be able to use this current device.

In summary, the cmTriage device is intended to provide a passive notification through the PACS to the radiologist indicating the existence of a case that may potentially benefit from that radiologist's prioritization.

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## Intended Use/Indications for Use

cmTriage is a passive notification-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTrificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.

Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care.

cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis.

cmTriage is for prescription use only.

## Technological Characteristics

cmTriage is a software only device that can be segmented into three components: (1) Image Forwarding and Result File Receiving Software, (2) Image Processing and Analysis Software, and (3) Notification Result File.

The Image Forwarding and Result File Receiving Software is configured by the hospital to interact with a healthcare facility's PACS or local DICOM router and is responsible for automatically transmitting a copy of DICOM files from the local router through a secured channel to the Image Processing and Analysis Software based on DICOM metadata.

The Image Processing and Analysis Software component of the device is hosted in the cloud and is reseiving, assembling, processing, and storing DICOM images. This software component includes the software algorithm that is responsible for identifying and quantifying image characteristics that are consistent with a suspicious region of interest in a screening mammogram. When the software algorithm detects imaging characteristics suggestive of a suspicious region of interest, the Image Processing and Analysis Software component sets a flag in the Notification Result File indicating that the exam is "Suspicious" and sends the file back to the Image Forwarding and Result File Receiving Software. While the software algorithm informs the notification process, no other diagnostic information is generated from the algorithm or available to the user beyond the notification.

The Notification Result File is a DICOM SR file that can be used by the PACS or viewing workstation to update the worklist with an indication of that reflects the cmTriage notification of either "Suspicious" or "" (blank).

| Characteristic | Predicate: Viz.AI ContaCT | cmTriage | Similarities or<br>Differences |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | DEN170073 | TBD | |
| Clearance Date | 2/13/18 | TBD | |
| Product Code | QAS | QFR | |
| Class | II | II | Same |
| Regulation | 892.2080 | 892.2080 | Same |
| OTC vs. PUO | PUO | PUO | Same |
| | | | |
| Intended<br>Use.<br>Indications<br>for<br>Use | ContaCT is a notification-only, parallel workflow<br>tool for use by hospital networks and radiologists<br>to identify and communicate images of specific<br>patients to a radiologist, independent of standard<br>of care workflow.<br><br>ContaCT uses an artificial intelligence algorithm to<br>analyze images for findings suggestive of a pre-<br>specified clinical condition and to notify an<br>appropriate medical radiologist of these findings<br>in parallel to standard of care image<br>interpretation. Identification of suspected findings<br>is not for diagnostic use beyond notification.<br><br>Specifically, the device analyzes CT angiogram<br>images of the brain acquired in the acute setting,<br>and sends notifications to neurovascular<br>radiologist that a suspected large vessel occlusion<br>has been identified and recommends review of<br>those images. Images can be previewed through a<br>mobile application.<br><br>Images that are previewed through the mobile<br>application are compressed and are for<br>informational purposes only and not intended for<br>diagnostic use beyond notification. Notified<br>radiologists are responsible for viewing non-<br>compressed images on a diagnostic viewer and<br>engaging in appropriate patient evaluation and<br>relevant discussion with a treating physician<br>before making care-related decisions or requests.<br>ContaCT is limited to analysis of imaging data and<br>should not be used in-lieu of full patient evaluation<br>or relied upon to make or confirm diagnosis. | cmTriage is a passive notification for<br>prioritization-only, parallel-workflow software<br>tool used by radiologists to prioritize specific<br>patients within the standard-of-care image<br>worklist for 2D FFDM screening mammograms.<br>cmTriage uses an artificial intelligence algorithm<br>to analyze 2D FFDM screening mammograms and<br>flags those that are suggestive of the presence of at<br>least one suspicious finding at the exam level.<br>These flags are viewed by the radiologist via their<br>Picture Archiving and Communication System<br>(PACS) worklist. The decision to use cmTriage<br>codes and how to use cmTriage codes is ultimately<br>up to the radiologist. cmTriage does not send a<br>proactive alert directly to the radiologist.<br><br>Radiologists are responsible for reviewing each<br>exam on a diagnostic viewer according to the<br>current standard of care.<br><br>cmTriage is limited to the categorization of exams,<br>does not provide any diagnostic information<br>beyond triage and prioritization, does not remove<br>images from the radiologist's worklist, and should<br>not be used in lieu of full patient evaluation, or<br>relied upon to make or confirm diagnosis.<br><br>cmTriage is for prescription use only. | Similarities<br>• Used by radiologists<br>• Identifies specific<br>patients<br>• Operates in parallel<br>to standard of care<br>workflow<br>• Uses artificial<br>intelligence to<br>analyze images<br>• Looking for findings<br>suggestive of a pre-<br>specified clinical<br>condition<br>• Not intended for<br>diagnostic use<br>• Radiologists are<br>responsible for<br>viewing images on a<br>diagnostic viewer<br>• Limited to analysis<br>of imaging data and<br>should not be used<br>in-lieu of full patient<br>evaluation or relied<br>upon to make or<br>confirm diagnosis<br><br>Noted difference:<br>cmTriage notification<br>is passive vs. proactive<br>and cmTriage codes<br>are accessed by<br>radiologist through<br>PACS worklist and<br>used for prioritization. |
| Technical<br>Method | The device provides triage or notification that is<br>informed by machine learning, artificial<br>intelligence or other image analysis algorithms | The device provides triage or notification that is<br>informed by machine learning, artificial<br>intelligence or other image analysis algorithms | Same |
| Target Area | The device operates on radiological images of the<br>human body. | The device operates on radiological images of the<br>human body. | Same |
| Anatomical Site | Head | Breast | Different anatomic site |
| Where Used | Hospital or Clinic | Hospital or Clinic | Same |
| User Population | Radiologist | Radiologist | Same |
| Software | Device is software only | Device is software only | Same |
| Software Level<br>of Concern | Moderate | Moderate | Same |
| Communication<br>with Patient | Communicates images of patients to a radiologist. | Does not communicate images of patients.<br>cmTriage passively notifies the radiologist via the<br>PACS worklist, whereas ContaCT notifies a pre-<br>identified specialist via direct message. | Noted difference: No<br>images are<br>communicated from<br>cmTriage to<br>radiologist. Only<br>cmTriage codes are<br>returned for viewing<br>within the PACS<br>worklist. |
| Notification/<br>Priority | Yes…