(233 days)
Not Found
Yes
The document explicitly states that the device uses "artificial intelligence algorithms" and "artificial intelligence to detect patterns".
No.
HALO is described as a "notification only cloud-based image processing software" and a "clinical support tool" that identifies suggestive imaging patterns and notifies medical specialists. It explicitly states that "HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist." This indicates it aids in diagnosis rather than directly treating or preventing a condition, which is characteristic of therapeutic devices.
No
Explanation: The device description clearly states that "HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist." It functions as a "notification only, cloud-based clinical support tool" that identifies suggestive imaging patterns and notifies specialists, but does not provide a diagnosis.
Yes
The device is described as "notification only cloud-based image processing software artificial intelligence algorithms" and a "cloud-based clinical support tool". It processes images and sends notifications, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, HALO is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
-
IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
-
HALO's Function: HALO processes and analyzes imaging data (CT angiograms) of the brain. It does not examine biological specimens (blood, tissue, etc.) derived from the human body in vitro.
-
Intended Use: HALO's intended use is to analyze imaging data to identify suggestive patterns and notify medical specialists. It explicitly states that its output should not be used for primary diagnosis or clinical decisions. This further distinguishes it from typical IVDs which provide information directly used for diagnosis or monitoring.
In summary, HALO is a software-based clinical support tool that analyzes medical images, not biological specimens. This places it outside the scope of In Vitro Diagnostic devices.
No
The input text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist.
HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis. HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.
The intended users of HALO are defined as appropriate medical specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. They include physicians such as neurologists, and/or other emergency department physicians.
HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow.
HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation.
A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT angiograms
Anatomical Site
brain vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency departments or other department where stroke patients are administered. They include physicians such as neurologists, radiologists, and/or other emergency department physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
In a multi-center clinical study, the performance of the HALO clinical decision support algorithm for LVO detection was retrospectively evaluated in a consecutive patient cohort admitted to US comprehensive stroke centers.
Three hundred forty-eight CTA scans of the brain were collected. After exclusion, 364 patients were included for further analyses. Ground truth was established by an expert panel consisting of 3 neuro radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In a multi-center clinical study, the performance of the HALO clinical decision support algorithm for LVO detection was retrospectively evaluated in a consecutive patient cohort admitted to US comprehensive stroke centers.
Sample size: 364 patients (348 CTA scans, 364 patients after exclusion)
AUC: 0.97
Standalone performance: For the primary endpoint: calculation of the performance of the HALO algorithm showed a sensitivity and specificity for LVO detection of respectively 91.1% (95% CI, 86.0%-94.8%) and 87.0% (95% CI, 81.2%-91.5%).
Key results: The HALO performance with regard to sensitivity and specificity, and the notification time are both equivalent to that of the selected predicate device: ContaCT of Viz.AI. Therefore, the HALO algorithm fulfills the requirement of a suitable screening tool to support diagnosis of LVOs by flagging these scans as requiring urgent radiologist review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 91.1% (95% CI, 86.0%-94.8%)
Specificity: 87.0% (95% CI, 81.2%-91.5%)
AUC: 0.97
Median notification time for detected LVO cases: 4 minutes 31 seconds.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
November 20, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NiCo-Lab B.V. % Roujuan Zhang Consultant MD Squared B.V. High Tech Campus 29 Eindhoven, 5858AE NETHERLANDS
Re: K200873
Trade/Device Name: HALO Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: October 1, 2020 Received: October 5, 2020
Dear Roujuan Zhang:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200873
Device Name HALO
Indications for Use (Describe)
HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist.
HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis. HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.
The intended users of HALO are defined as appropriate medical specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. They include physicians such as neurologists, and/or other emergency department physicians.
HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K200873
510(k) Summary
| Date Prepared: | March 27, 2020 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer: | NICo-Lab B.V. | ||||||||||||||||
| Paasheuvelweg 25, 1105BP, Amsterdam | |||||||||||||||||
| The Netherlands | |||||||||||||||||
| Contact Person: | Merel Boers | ||||||||||||||||
| CEO | |||||||||||||||||
| Phone: +31202440852 | |||||||||||||||||
| E-mail: mboers@nico-lab.com | |||||||||||||||||
| Device: | |||||||||||||||||
| Trade Name:HALOClassification Name:Radiological Computer-Assissted Triage and | |||||||||||||||||
| Notification SoftwareClassification Regulation:21 CFR 892.2080Classification Panel:RadiologyDevice Class:Class IIPrimary Product Code:QAS | Trade Name: | HALO | Classification Name: | Radiological Computer-Assissted Triage and | |||||||||||||
| Notification Software | Classification Regulation: | 21 CFR 892.2080 | Classification Panel: | Radiology | Device Class: | Class II | Primary Product Code: | QAS | |||||||||
| Trade Name: | HALO | ||||||||||||||||
| Classification Name: | Radiological Computer-Assissted Triage and | ||||||||||||||||
| Notification Software | |||||||||||||||||
| Classification Regulation: | 21 CFR 892.2080 | ||||||||||||||||
| Classification Panel: | Radiology | ||||||||||||||||
| Device Class: | Class II | ||||||||||||||||
| Primary Product Code: | QAS | ||||||||||||||||
| Primary Predicate Device: | |||||||||||||||||
| Trade Name:ContaCTManufacturer:Viz.Al, Inc.DeNovo Clearance:DEN170073Classification Name:Radiological Computer-Assissted Triage and | |||||||||||||||||
| Notification SoftwareClassification Regulation:21 CFR 892.2080Classification Panel:RadiologyDevice Class:Class IIProduct Code:QAS | Trade Name: | ContaCT | Manufacturer: | Viz.Al, Inc. | DeNovo Clearance: | DEN170073 | Classification Name: | Radiological Computer-Assissted Triage and | |||||||||
| Notification Software | Classification Regulation: | 21 CFR 892.2080 | Classification Panel: | Radiology | Device Class: | Class II | Product Code: | QAS | |||||||||
| Trade Name: | ContaCT | ||||||||||||||||
| Manufacturer: | Viz.Al, Inc. | ||||||||||||||||
| DeNovo Clearance: | DEN170073 | ||||||||||||||||
| Classification Name: | Radiological Computer-Assissted Triage and | ||||||||||||||||
| Notification Software | |||||||||||||||||
| Classification Regulation: | 21 CFR 892.2080 | ||||||||||||||||
| Classification Panel: | Radiology | ||||||||||||||||
| Device Class: | Class II | ||||||||||||||||
| Product Code: | QAS |
4
Device description:
HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow.
HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation.
A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.
Indications for Use: HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist.
HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.
The intended users of HALO are defined as medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency departments or other department where stroke patients are administered. They include physicians such as neurologists, radiologists, and/or other emergency department physicians.
HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.
Technological Both HALO and the predicate device ContaCT are intended as a characteristics: notification-only, parallel workflow tool to identify and communicate
5
images of specific patients to a specialist, independent of standard of care workflow. After completion of the data analysis, both devices send a notification if a pattern suggestive for a suspected Large Vessel Occlusion (LVO) has been identified in the dataset.
The technological characteristic of HALO and how it is comparable to the currently marketed and predicate device ContaCT are summarized below.
| Predicate: ContaCT | Subject: HALO | ||
|---|---|---|---|
| Clinical condition | Large vessel | Large vessel | |
| occlusion | occlusion | ||
| Anatomical region of | Head | Head | |
| interest | |||
| Data acquisition | CT angiogram images | CT angiogram images | |
| protocol | of the brain | of the brain | |
| Segmentation of | No; device does not | No; device does not | |
| region of interest | mark, highlight, or | mark, highlight, or | |
| direct users' attention | direct users' attention | ||
| to a specific location | to a specific location | ||
| in the original image. | in the original image. | ||
| Core Algorithm | Artificial intelligence | Artificial intelligence | |
| algorithm with | |||
| database of images | database of images | ||
| Device Output/ | The software sends a | The software sends a | |
| notification to the | notification email to | ||
| Notification | specialist identifying | the specialist | |
| the study of interest. | identifying the study | ||
| Additionally, the | of interest. | ||
| device also provides a | Additionally, the | ||
| DICOM viewing | device provides user | ||
| mobile application | with a link to DICOM | ||
| allow users preview | Web viewer allowing | ||
| the images. | users review the | ||
| images. | |||
| Triage effectiveness | Notification time is | Notification time is | |
| defined as the time | defined as the time | ||
| from CTA to | from CTA to | ||
| notification. | notification. | ||
| Independent of | No cases are removed | No cases are removed | |
| standard of care | from worklist | from worklist | |
| workflow |
Based on the information provided above, non-clinical and clinical performance tests provided in this 510(k) premarket notification demonstrate the proposed HALO is considered substantially equivalent to
6
| Summary of Non-Clinical Performance Data: | Non-Clinical software testing has been performed in accordance with the its predicate device ContaCT in terms of fundamental scientific technology.
"Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005, document number 337) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” (issued October 2, 2014, document number 1825).
All these tests were used to support substantial equivalence of the subject device and demonstrate that the performance of HALO is according to predefined user requirements, system level requirements and the risk control measures. The device meets the acceptance criteria and is adequate for its intended use. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Clinical Performance Data: | In a multi-center clinical study, the performance of the HALO clinical decision support algorithm for LVO detection was retrospectively evaluated in a consecutive patient cohort admitted to US comprehensive stroke centers.
Three hundred forty-eight CTA scans of the brain were collected. After exclusion, 364 patients were included for further analyses. Ground truth was established by an expert panel consisting of 3 neuro radiologists.
For the primary endpoint: calculation of the performance of the HALO algorithm showed a sensitivity and specificity for LVO detection of respectively 91.1% (95% CI, 86.0%-94.8%) and 87.0% (95% CI, 81.2%-91.5%). The area under the curve (AUC) is 0.97.
For the secondary endpoints the median notification time for the detected LVO cases was 4 minutes 31 seconds, with a minimum of 3:47 and maximal 7:12.
The HALO performance with regard to sensitivity and specificity, and the notification time are both equivalent to that of the selected predicate device: ContaCT of Viz.AI.
Therefore, the HALO algorithm fulfills the requirement of a suitable screening tool to support diagnosis of LVOs by flagging these scans as requiring urgent radiologist review. |
7
| Substantial |
|---|
| Equivalence |
| Conclusion: |
The non-clinical and clinical performance tests provided in this 510(k) premarket notification demonstrate HALO is substantially equivalence to the currently marketed predicate device ContaCT (DEN 170073) in terms of indications for use, technological characteristics and safety and effectiveness. The differences between the subject device and predicate device do not alter the triage use of the device and do not affect its safety and effectiveness.