(186 days)
Yes
The predicate device is explicitly named "Neuro.AI Algorithm", indicating the incorporation of AI technology.
No
Explanation: The device is described as an image processing software that provides analysis capabilities for medical images to assist in diagnosis and treatment planning. It does not directly provide therapy or therapeutic intervention to a patient.
Yes
The "Intended Use / Indications for Use" section states: "The TeraRecon Neuro Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions." Additionally, the "Device Description" section states: "The TeraRecon Neuro algorithm outputs can be used by physicians to aid in the diagnosis and for clinical decision support..."
Yes
The device is explicitly described as a "standalone image processing software device" and states it can be deployed on "off-the-shelf hardware" or a "cloud platform," indicating it does not include proprietary hardware.
Based on the provided information, the TeraRecon Neuro Algorithm is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly stated to provide "analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI." It calculates parameters related to "brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps." These analyses are used to "assist the physician in diagnosis" and for "clinical decision support including treatment planning and post treatment evaluation." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. While the input is imaging data, the analysis of this data to provide diagnostic information falls under the scope of IVDs in the context of medical devices.
- Device Description: The device "processes, calculates and outputs brain perfusion analysis results." These results are "used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time." The outputs are "parametric map of measurements" and "2D and 3D visualization of brain tissues and brain blood vessels." These are all analytical outputs derived from patient data (the imaging scans) intended for diagnostic purposes.
- Outputs: The specific outputs like TTP, MTT, CBV, CBF, Tmax, mismatch maps, and hypoperfusion maps are all quantitative or qualitative measurements derived from the imaging data that are used by physicians to assess the physiological state of the brain and aid in diagnosis of conditions like stroke.
- Role in Diagnosis: The document repeatedly states that the results are "designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis" and "aid in the diagnosis and for clinical decision support."
While the device processes imaging data rather than traditional biological specimens like blood or urine, the regulatory definition of an IVD can encompass devices that analyze data derived from the human body to provide diagnostic information. In this case, the imaging data is the "specimen" being analyzed to provide diagnostic insights into brain perfusion.
Therefore, based on its intended use to analyze data derived from the human body (imaging scans) to provide information for diagnosis and clinical decision support, the TeraRecon Neuro Algorithm fits the definition of an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The presence of "Not Found" under "Control Plan Authorized (PCCP) and relevant text" further confirms this.
Intended Use / Indications for Use
The TeraRecon Neuro Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians.
The TeraRecon Neuro Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with, or utilized by other DICOM-compliant systems and results.
The TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.
The results of the TeraRecon Neuro Algorithm can be delivered to the end-user through image viewers such as TeraRecon's Aquarius Intuition system, TeraRecon's Eureka AI Results Explorer, TeraRecon's Eureka Clinical AI Platform, or other image viewing systems like PACS that can support DICOM results generated by the TeraRecon Neuro Algorithm.
The TeraRecon Neuro Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
Product codes
LLZ
Device Description
The TeraRecon Neuro algorithm version 2.0.0 is a modification of the predicate device Neuro.AI Algorithm (K200750), which was a modification of the predicate device, Intuition-TDA, TVA, Parametric Mapping (which was cleared under K131447). The predicate device Intuition -TDA, TVA, Parametric Mapping is an optional module/workflow for the Intuition system (K121916). The TeraRecon Neuro algorithm is an image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device has limited network connectivity or external medical support.
TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
Outputs include parametric map of measurements including time to peak (TTP), take off time (TOT), recirculation time (RT), mean transit time (MTT), blood volume (BV/CBV), blood flow (BF/CBF), time to maximum (Tmax) and penumbra/umbra maps that are derived from combinations of measurement parameters, such as mismatch maps and hypoperfusion maps with volumes and ratios, as well as 2D and 3D visualization of brain tissues and brain blood vessels (Note: Tmax, mismatch and hypoperfusion maps are only available for images of CT modality).
When TeraRecon Neuro results are used in external viewer devices such as TeraRecon's Intuition or Eureka medical devices, all the standard features offered by Intuition or Eureka are employed such as image manipulation tools like drawing the region of interest, manual or automatic segmentation of structures, tools that support creation of a report, transmitting and storing this report in digital form, and tracking historical information about the studies analyzed by the software.
The TeraRecon Neuro algorithm outputs can be used by physicians to aid in the diagnosis and for clinical decision support including treatment planning and post treatment evaluation. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities and limitations. The device is intended to provide supporting analytical tools to a physician, to speed decision-making and to improve communication, but the physician's judgment is paramount, and it is normal practice for physicians to validate theories and treatment decisions multiple ways before proceeding with a risky course of patient management.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The TeraRecon Neuro Algorithm as an "AI Results Explorer" and "AI Platform".
Input Imaging Modality
CT or MRI
Anatomical Site
Brain, Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians, surgeons and medical clinicians.
The device can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of the TeraRecon Neuro algorithm have been verified and validated through software testing, quantitative phantom testing and qualitative clinical user evaluation. Software development and testing were performed in accordance with IEC 62304:2006/AI:2015, Medical Device Software - Software life cycle processes, utilizing a risk-based testing methodology. Risk has been evaluated in accordance with ISO 14971:2007, Medical Devices – Application of Risk Management to Medical Devices. During software testing, all pre-defined acceptance criteria for the Neuro.AI Algorithm were met and all software test cases passed. The same verification and validation methodology, risk assessment and acceptance criterion were used for predicate device.
To execute our clinical user evaluation TeraRecon worked with our evaluator Dr. Robert Falk, MD whom was presented with comparison maps generated by the subject device, the predicate device and two additional reference devices GE Medical Systems FastStroke CT Perfusion 4D (K193289) and ISchemaView RAPID (K182130). The evaluator was asked to confirm through qualitative assessment that the generated maps of TeraRecon Neuro are at least 85% substantially equivalent or better than the predicate and reference devices.
Additionally, we performed a quantitative evaluation of Tmax measurements in comparison to the two reference devices. Considering the ground truth as the average Tmax measurement of the two reference devices for a given ROI, we calculated absolute error and absolute percent error for the subject device compared to ground truth. Acceptance criteria was defined as subject device limit of agreement for both metrics less than or equal than the limit of agreement of each predicate device compared to the ground truth.
The results of the software testing and clinical user evaluation validate that the TeraRecon Neuro device meets its qualified requirements, performs as intended, and is as safe and effective as the predicate device. No new or different questions of safety or efficacy have been raised as a result of the verification and validation process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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 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.
TeraRecon, Inc Michael Sosebee Official Correspondent 4309 Emperor Blvd. Durham, North Carolina 27703
August 12, 2022
Re: K220349
Trade/Device Name: TeraRecon Neuro Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 28, 2022 Received: June 29, 2022
Dear Michael Sosebee:
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/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,
Jessica Lamb, Ph.D.
Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220349
Device Name TeraRecon Neuro
Indications for Use (Describe)
The TeraRecon Neuro Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians.
The TeraRecon Neuro Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with, or utilized by other DICOM-compliant systems and results.
The TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.
The results of the TeraRecon Neuro Algorithm can be delivered to the end-user through image viewers such as TeraRecon's Aquarius Intuition system, TeraRecon's Eureka AI Results Explorer, TeraRecon's Eureka Clinical AI Platform, or other image viewing systems like PACS that can support DICOM results generated by the TeraRecon Neuro Algorithm.
The TeraRecon Neuro Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
| 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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K220349
510(k) Summary 1
TeraRecon Neuro version 2.0.0
[in accordance with 21CFR 807.92]
Submitter 1.1
| 510(k) Sponsor: | TereRecon, Inc. |
|---|---|
| Address: | 4309 Emperor Blvd., |
| Durham, NC 27703, USA | |
| Contact Person: | Michael Sosebee |
| Senior Manager RAQA | |
| Contact Information: | Email: msosebee@terarecon.com |
| Phone: 704-651-6828 | |
| Date Summary Prepared: | 10Feb2022 |
1.2 Subject Device
| Proprietary (Trade) Name of Subject Device | TeraRecon Neuro |
|---|---|
| Model Number | 2.0.0 |
| Device Class | 2 |
| Common / Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| 510(k) Number | K220349 |
1.3 Predicate Device
| 1.3 Predicate Device | |
|---|---|
| Proprietary (Trade) Name of Predicate Device | Neuro.AI Algorithm |
| Model Number | 1.0.0 |
| Device Class | 2 |
| Common / Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| 510(k) Number | K200750 |
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1.4 Device Description
The TeraRecon Neuro algorithm version 2.0.0 is a modification of the predicate device Neuro.AI Algorithm (K200750), which was a modification of the predicate device, Intuition-TDA, TVA, Parametric Mapping (which was cleared under K131447). The predicate device Intuition -TDA, TVA, Parametric Mapping is an optional module/workflow for the Intuition system (K121916). The TeraRecon Neuro algorithm is an image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device has limited network connectivity or external medical support.
TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
Outputs include parametric map of measurements including time to peak (TTP), take off time (TOT), recirculation time (RT), mean transit time (MTT), blood volume (BV/CBV), blood flow (BF/CBF), time to maximum (Tmax) and penumbra/umbra maps that are derived from combinations of measurement parameters, such as mismatch maps and hypoperfusion maps with volumes and ratios, as well as 2D and 3D visualization of brain tissues and brain blood vessels (Note: Tmax, mismatch and hypoperfusion maps are only available for images of CT modality).
When TeraRecon Neuro results are used in external viewer devices such as TeraRecon's Intuition or Eureka medical devices, all the standard features offered by Intuition or Eureka are employed such as image manipulation tools like drawing the region of interest, manual or automatic segmentation of structures, tools that support creation of a report, transmitting and storing this report in digital form, and tracking historical information about the studies analyzed by the software.
The TeraRecon Neuro algorithm outputs can be used by physicians to aid in the diagnosis and for clinical decision support including treatment planning and post treatment evaluation. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities and limitations. The device is intended to provide supporting analytical tools to a physician, to speed decision-making and to improve communication, but the physician's judgment is paramount, and it is normal practice for physicians to validate theories and treatment decisions multiple ways before proceeding with a risky course of patient management.
5
1.5 Indications for Use
The TeraRecon Neuro algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians.
The TeraRecon Neuro algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with, or utilized by other DICOM-compliant systems and results.
The TeraRecon Neuro algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.
The results of the TeraRecon Neuro algorithm can be delivered to the end-user through image viewers such as TeraRecon's Aquarius Intuition system, TeraRecon's Eureka AI Results Explorer, TeraRecon's Eureka Clinical AI Platform, or other image viewing systems like PACS that can support DICOM results generated by the TeraRecon Neuro Algorithm.
The TeraRecon Neuro algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
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1.6 Summary of Technological Characteristics
The TeraRecon Neuro algorithm version 2.0.0 (K220349) is substantially equivalent to the predicate device, Neuro.AI Algorithm (K200750). It has the same basic technological characteristics as the predicate device. The main difference between the subject device and the predicate device is the addition of three perfusions maps Tmax, Hypoperfusion and Mismatch along with improvements made to the quality of existing perfusions maps in version 1.0.0 BV, BF, MTT, TOT, TTP and RT. The subject and predicate devices both allow motion correction and process, calculate and output brain perfusion analysis results for functional, dynamic and derived imaging datasets acquired with CT or MRI. The subject and predicate device results are used for visualization and analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
Outputs include parametric map of measurements including time to peak (TTP), take off time (TOT), recirculation time (RT), mean transit time (MTT), blood volume (BV/CBV), blood flow (BF/CBF), time to maximum (Tmax) and penumbra/umbra maps that are derived from combinations of measurement parameters, such as mismatch maps and hypoperfusion maps with volumes and ratios, as well as 2D and 3D visualization of brain tissues and brain blood vessels.
TeraRecon Neuro can be used by physicians to aid in the diagnosis and for clinical decision support including treatment planning and post treatment evaluation.
Both the subject and predicate devices are interoperable or compatible with CT and MR scanners, 3rd party hospital systems such as PACS, and the TeraRecon Intuition platform. Both devices are standalone software packages, the results of which can be consumed by and viewed by TeraRecon's Eureka AI Results Explorer or by other image viewing systems that can support the results generated by the TeraRecon Neuro algorithm.
The differences in technological characteristics do not raise any new or different questions of safety of effectiveness. Software verification and validation testing validates that the TeraRecon Neuro algorithm is as safe and effective as the predicate device in order to support a determination of substantial equivalence.
See the table below for a description of the technological similarities and differences among the subject and predicate device.
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Table 1: Technological Characteristics Comparison
| | Subject Device | Predicate Device | Reference Device
(Used in Qualitative
Assessment) | Reference Device
(Used in Qualitative
Assessment) |
|---------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Functionality | TeraRecon Neuro version 2.0.0
(TBD) | Neuro.AI Algorithm version
1.0.0
(K200750) | FastStroke, CT Perfusion 4D
(K193289) | iSchemaView RAPID
(K182130) |
| Areas of Use | Same as predicate device | Radiology and could also include
other clinical specialty areas
such as emergency, neurology,
surgery and more | Not specified in K193289's
510(k) summary. | Hospital LAN, inside the
Hospital Firewall
To be used by trained
professionals.
Radiological data network. |
| Modality
Support | Same as predicate device | Vendor-neutral - CT, MR and
other volumetric imaging
modalities. | CT | CT and MRI |
| Body Part | Same as predicate device | Head - entire brain or from
lower edge of the base of nucleus
to upper edge of the ventricles. | Head and Body | Not specified in K182130's
510(k) summary |
| DICOM®
formats | Same as predicate device | NEMA PS 3.1 - 3.20 (2016) | DICOM 3.0 image compatibility | NEMA PS 3.1 - 3.20 (2016) |
8
| Functionality | Subject Device | Predicate Device | Reference Device
(Used in Qualitative Assessment) | Reference Device
(Used in Qualitative Assessment) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TeraRecon Neuro version 2.0.0
(TBD) | Neuro.AI Algorithm version
1.0.0
(K200750) | FastStroke, CT Perfusion 4D
(K193289) | iSchemaView RAPID
(K182130) |
| Operating
System | Same as predicate device | Microsoft Windows® executable
on off the shelf hardware and
CentOS (Interoperability) | Not specified in K193289's
510(k) summary | The software runs on a standard
off-the-shelf computer or a
virtual platform, such as
VMware,
and can be used to perform
image viewing, processing and
analysis of images. Data and
images
are acquired through DICOM
compliant imaging devices.
Linux-based server |
| Functionality | Subject Device
TeraRecon Neuro version 2.0.0
(TBD) | Predicate Device
Neuro.AI Algorithm version
1.0.0
(K200750) | Reference Device
(Used in Qualitative
Assessment)
FastStroke, CT Perfusion 4D
(K193289) | Reference Device
(Used in Qualitative
Assessment)
iSchemaView RAPID
(K182130) |
| Key
Functionality/
Feature and
Region-of-
Interest (ROI)
Markers | Same as predicate device | • Automatic arterial and venous
input function selection
• Ventricle subtraction | CT perfusion 4D is an image
analysis software package, which
allows the user to produce
dynamic image
data and to generate information
with regards to changes in image
intensity over time. It supports
the
analysis of CT Perfusion images
(in the head and body) after the
intravenous injection of contrast,
and
calculation of the various
perfusion-related parameters (i.e.
regional blood flow, regional
blood volume,
mean transit time and capillary
permeability). | The iSchemaView RAPID
provides both viewing and
analysis capabilities for
functional and
dynamic imaging datasets
acquired with CT Perfusion (CT-
P), CT Angiography (CTA), and
MRI including a Diffusion
Weighted MRI (DWI) Module
and a Dynamic Analysis Module
(dynamic contrast-enhanced
imaging data for MRI and CT).
The DWI Module is used to
visualize local water diffusion
properties from the analysis of
diffusion - weighted MRI data.
The Dynamic Analysis Module
is used for visualization and
analysis of dynamic imaging
data, showing properties of
changes in contrast over time.
This functionality includes
calculation of parameters related
to tissue flow (perfusion) and
tissue blood volume. |
| Functionality | Subject Device
TeraRecon Neuro version 2.0.0
(TBD) | Predicate Device
Neuro.AI Algorithm version
1.0.0
(K200750) | Reference Device
(Used in Qualitative
Assessment)
FastStroke, CT Perfusion 4D
(K193289) | Reference Device
(Used in Qualitative
Assessment)
iSchemaView RAPID
(K182130) |
| Perfusion
measurements
and color maps | • Same as predicate device and
• Time to Maximum (Tmax)
• Hypoperfusion maps and
volumes
• Mismatch maps
(penumbra/umbra maps that
are derived from combinations
of measurement parameters)
and related volumes and ratios | • Time to peak (or Time to
Minimum)
• Take off time (or Maximum
Slope of Increase)
• Recirculation time (RT)
• Mean transit time (MTT)
• Blood volume (BV/CBV)
• Blood flow (BF/CBF)
• User configurable settings | • Blood Flow
• Blood Volume
• Mean Transit Time
• Capillary Permeability
• Time to Maximum | • Blood Flow
• Blood Volume
• Mean Transit Time
• Time to Maximum |
| Graph Displays | Same as predicate device | Artery and Vein Fitted and Raw
curves - time/activity | Not specified in K193289's
510(k) summary | Not specified in K182130's
510(k) summary |
| Export
Capability | • Same as predicate device and
• Artery Intensity Profile | DICOM files | Not specified in K193289's
510(k) summary | Not specified in K182130's
510(k) summary |
| Methods for
Mathematical
Modeling | Same as predicate device | SVD | Not specified in K193289's
510(k) summary | Not specified in K182130's
510(k) summary |
| Arterial and
Venous Input
Function
Selection | Same as predicate device | Automatic | Not specified in K193289's
510(k) summary | Arterial input function (AIF) and
Venous output function (VOF) |
| Functionality | Subject Device
TeraRecon Neuro version 2.0.0
(TBD) | Predicate Device
Neuro.AI Algorithm version
1.0.0
(K200750) | Reference Device
(Used in Qualitative
Assessment)
FastStroke, CT Perfusion 4D
(K193289) | Reference Device
(Used in Qualitative
Assessment)
iSchemaView RAPID
(K182130) |
| Containerization
/ dockerization
of algorithm that
enables
interoperability
with 3rd party
results including
viewing such
results | Same as predicate device | • Neuro.AI Algorithm is hosted
on the Eureka platform within
its own docker. The algorithm
is triggered based on input
data and generates result
which will be delivered to
third party system.
• CT and MR Scanners
• 3rd party hospital systems
such as a PACS server, EMR
or other
• TeraRecon Intuition
• Visualization system
• Other image viewing
systems that can support
results generated by the
Neuro.AI Algorithm
• Notification systems | The configuration of
NeuroPackage enables the user
to open a single application,
FastStroke, which provides them
access to both the updated CT
Perfusion 4D
and FastStroke applications.
The capabilities in CT Perfusion
4D
and FastStroke can be offered
independently. | RAPID is available in the
following configurations:
• Standard RAPID, which is
installed directly on a customer's
Linux-based server and
integrated with medical image
processing software such as
commercial PACS.
• Virtual RAPID, wherein the
user accesses RAPID online and
uses it to process DICOM
images otherwise available on
his/her computer. |
| Ventricle
Subtraction | Same as predicate device | Setting allows software to
calculate maps with or without
ventricle included. | Ventricle Segmentation | Not specified in K182130's
510(k) summary |
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1.7 Performance Data
Safety and performance of the TeraRecon Neuro algorithm have been verified and validated through software testing, quantitative phantom testing and qualitative clinical user evaluation. Software development and testing were performed in accordance with IEC 62304:2006/AI:2015, Medical Device Software - Software life cycle processes, utilizing a risk-based testing methodology. Risk has been evaluated in accordance with ISO 14971:2007, Medical Devices – Application of Risk Management to Medical Devices. During software testing, all pre-defined acceptance criteria for the Neuro.AI Algorithm were met and all software test cases passed. The same verification and validation methodology, risk assessment and acceptance criterion were used for predicate device.
To execute our clinical user evaluation TeraRecon worked with our evaluator Dr. Robert Falk, MD whom was presented with comparison maps generated by the subject device, the predicate device and two additional reference devices GE Medical Systems FastStroke CT Perfusion 4D (K193289) and ISchemaView RAPID (K182130). The evaluator was asked to confirm through qualitative assessment that the generated maps of TeraRecon Neuro are at least 85% substantially equivalent or better than the predicate and reference devices.
Additionally, we performed a quantitative evaluation of Tmax measurements in comparison to the two reference devices. Considering the ground truth as the average Tmax measurement of the two reference devices for a given ROI, we calculated absolute error and absolute percent error for the subject device compared to ground truth. Acceptance criteria was defined as subject device limit of agreement for both metrics less than or equal than the limit of agreement of each predicate device compared to the ground truth.
The results of the software testing and clinical user evaluation validate that the TeraRecon Neuro device meets its qualified requirements, performs as intended, and is as safe and effective as the predicate device. No new or different questions of safety or efficacy have been raised as a result of the verification and validation process.
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1.8 Conclusion
The TeraRecon Neuro algorithm is as safe and effective as the predicate device, Neuro.AI Algorithm. The indications for use of the subject device falls within the scope of that for the predicate device. Many of the technological characteristics are the same for the subject and predicate devices. Differences in the technological characteristics between the subject and predicate devices have been addressed through software verification and validation testing and do not raise any new of different questions of safety and effectiveness.
All risk were analyzed, and there are no new risks or modified risks that could result in significant harm which are not effectively mitigated in the predicate device. The analysis above supports a determination of Substantial Equivalence of the TeraRecon Neuro algorithm to the predicate device in terms of safety, efficacy, and performance.