(77 days)
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" and was "developed using computer vision and deep learning technologies."
No.
Accipiolx is a diagnostic and workflow prioritization tool that aids in identifying and prioritizing cases potentially indicative of acute intracranial hemorrhage; it does not directly treat or alleviate a medical condition.
No
The device is designed to prioritize cases for clinical assessment, not to provide a definitive diagnosis or to be used for clinical decision-making on a stand-alone basis.
Yes
The device description explicitly states "Accipiolx is a software device designed to be installed within healthcare facility radiology networks". It describes software components (Agent and Engine) and their function within the existing PACS/workstation infrastructure, without mentioning any accompanying hardware.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Accipiolx Function: Accipiolx analyzes medical images (CT scans) that are already acquired from the patient. It does not perform any tests on biological samples. Its function is to process and interpret existing imaging data to aid in workflow prioritization.
Therefore, Accipiolx falls under the category of medical image analysis software or radiology workflow tools, not In Vitro Diagnostics.
No
The document states "Control Plan Authorized (PCCP) and relevant text: Not Found", which indicates the letter does not confirm PCCP authorization.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
OAS
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Non-Contrast CT
Anatomical Site
Head / Brain
Indicated Patient Age Range
Adult
Intended User / Care Setting
Intended user: Hospital networks and trained clinicians
Setting: Acute care
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 92% (95% Cl: 87.29-95.68%)
Specificity: 86% (95% Cl: 80.18-90.81%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name Michael D. O'hara -S in large font on the left side of the image. On the right side of the image is a digital signature with the name Michael D. O'hara -S. 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
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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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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A summary table comparing the key features of the subject and predicate devices is provided below.
| | Subject Device:
MaxQ Al Accipiolx | Predicate Device:
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:
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.