Accipiolx

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MaxQ-Al Ltd. % Joshua Schulman, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs 76 Yigal Alon Street, 5th Floor Tel Aviv, 6706701 ISRAEL October 26, 2018 Re: K182177 Trade/Device Name: Accipiolx Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: II Product Code: OAS Dated: October 4, 2018 Received: October 4, 2018 Dear Dr. Schulman: 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. 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The digital signature also includes the date 2018.10.26 08:54:29 -04'00'. Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K182177 Device Name Accipiolx Indications for Use (Describe) Accipiolx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. Accipiolx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="padding-left: 10px;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> | | <div> <span> <span style="padding-left: 10px;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY #### MaxQ-Al's Accipiolx #### Submitter MaxQ-Al Ltd. 76 Yigal Alon Street, 5th Floor Tel Aviv, Israel 6706701 Tel: +1 -617-765-0333 Contact Person: Joshua Schulman, Ph.D. Date Prepared: October 4, 2018 Name of Device: Accipiolx #### Common or Usual Name/ Classification Name: Radiological Computer Aided Triage and Notification Software Regulatory Class: Class II Regulatory Classification and Product Code: 21 C.F.R. § 892.2080; QAS Predicate Device: ContaCT (Viz.AI), DEN170073 Reference Device: AiDoc Briefcase (K180647) #### Device Description Accipiolx is a software device designed to be installed within healthcare facility radiology networks to identify and prioritize non-contrast head CT (NCCT) scans based on algorithmically-identified findings of acute intracranial hemorrhage (alCH). The device, developed using computer vision and deep learning technologies, facilitates prioritization of CT scans containing findings of alCH. There are two main components of the software device: (1) the Accipiolx Agent and (2) the MaxQ-Al Engine. The Agent serves as an active conduit which receives head CT studies from a PACS and transfers them to the Engine. After successful processing of a case via the MaxQ-Al Engine, the Accipiolx Agent receives the Engine results and returns them to the PACS or workstation for use in worklist prioritization. Accipiolx works in parallel to and in conjunction with the standard care of workflow. After a CT scan has been performed, a copy of the study is automatically retrieved and processed by Accipiolx. The device performs identification and classification of objects consistent with alCH, and provides a case-level indicator which facilitates prioritization of cases with potential acute hemorrhagic findings for urgent review. #### Intended Use / Indications for Use Accipiolx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. Accipiolx analyzes cases using an artificial intelligence algorithm to identify {4}------------------------------------------------ suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. Accipiolx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases. Accipiolx and the predicate device (ContaCT) have the same intended use and substantially similar indications for use. Both devices are assistive software tools for diagnosis, designed to analyze brain CT images for findings suggestive of a pre-specified clinical condition -- specifically, cerebrovascular (CV) events. The subject device (Accipiolx) supports the rapid assessment of acute intracranial hemorrhage (alCH), while the predicate device assesses findings potentially indicative of large vessel occlusion (LVQ). Since alCH and LVQ are aspects of the same differential diagnosis and treatment considerations, the clinical purpose of the two devices is substantially equivalent; thus, both devices have the same intended use. In addition, the AiDoc Briefcase was recently cleared for use in assessment of ICH and thus is a relevant reference device to further demonstrate substantial equivalence of the subject device. ## Summary of Technological Characteristics The technological characteristics and mode of operation of the Accipiolx device are substantially equivalent to the predicate device. Accipiolx and its predicate are DICOM-compliant software devices incorporated into the radiology infrastructure of a clinical center. Both employ algorithms developed through artificial intelligence methodologies to analyze brain CT images received from a CT scanner. Both software devices include an image management component and an image processing and analysis component (in Accipiolx, these are the Agent and the Engine, respectively). Accipiolx was developed using a training CT cases collected from multiple institutions and CT manufacturers. This training process included pilot development, optimization of object and feature identification, algorithmic training and selection/optimization of thresholds above which cases are considered positive. In both the predicate and subject devices, the algorithm identifies applicable CT series' based on image parameters. In both devices, skull stripping and registration steps are performed, the relevant tissues are identified and segmented, and a feature identification process, which includes measures of hyperdensity compared to a pre-defined threshold, is performed. Findings above this threshold cause the software devices to generate a case-level identifier which is used for prioritization of cases based on a suspected cerebrovascular finding. With Accipiolx, the system output itself is the basis for prioritization within radiological workflow and viewing systems. In both cases, the procedure is performed in parallel to and in conjunction with the standard processing of image storage and availability for clinician assessment. {5}------------------------------------------------ A summary table comparing the key features of the subject and predicate devices is provided below. | | Subject Device:<br>MaxQ Al Accipiolx | Predicate Device:<br>Viz.Al ContaCT | |-------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------| | Notification-only, parallel workflow tool | Yes | Yes | | Intended user | Hospital networks and trained clinicians | Hospital networks and trained clinicians | | Setting | Acute care | Acute care | | Identify patients with a pre-specified clinical condition | Yes | Yes | | Clinical condition | Cerebrovascular Event:<br>Intracranial hemorrhage | Cerebrovascular Event: Large vessel occlusion | | Alert to finding | Yes; flagged for review | Yes; flagged for review | | Independent of standard of care workflow | Yes; No cases are removed from worklist | Yes; No cases are removed from worklist | | Modality | Non-Contrast CT | CT Angiogram | | Artificial Intelligence algorithm | Yes | Yes | | Limited to analysis of imaging data | Yes | Yes | | Non-Diagnostic Preview | No | Yes | | Aids prompt identification of cases with indicated findings | Yes | Yes | | Output | Suspected hemorrhage / No suspected hemorrhage | Suspected large vessel occlusion | | Where results are received | PACS / Workstation | PACS / Mobile application | # Performance Testing MaxQ-Al conducted a retrospective study to test the sensitivity and specificity of Accipiolx in processing non-contrast head CT cases with a high or low probability of intracranial hemorrhage (ICH). Device sensitivity and specificity was compared to ground truth established by concurrence of at least two expert neuroradiologist readers. Analysis of 360 cases collected from over 30 US sites demonstrated system sensitivity and specificity of 92% (95% Cl: 87.29-95.68%) and 86% (95% Cl: 80.18-90.81%), respectively. These results exceeded the predefined performance goals for sensitivity and specificity. During performance testing, average per-case processing time was 4.1 minutes (95% Cl: 3.8-4.3 minutes), which is comparable to the processing time reported by the reference BriefCase device. Based on the software testing and clinical performance. Accipiolx has a safety and effectiveness profile that is similar to the predicate device for the proposed indications for use. # Conclusion The Accipiolx device is as safe and effective as the ContaCT device. Accipiolx has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences do not alter the intended prioritization and triage use of the device and do not affect its safety and effectiveness when used as labeled, and also do not raise any new or different questions of safety or effectiveness. Performance data demonstrate that the software functions as intended. Thus, the Accipiolx is substantially equivalent.