(210 days)
Not Found
No
The document describes image processing techniques like registration, alignment, and segmentation based on a neuroanatomic Atlas, similar to a predicate device. It does not mention AI, ML, or deep learning.
No
Explanation: This device is for automated analysis and quantification of CT images, providing information to trained personnel. It does not directly treat or diagnose a disease. The description explicitly states, "Patient management decisions should not be made based solely on the results of CT CoPilot™ quantitative data," indicating it is an informational tool, not a therapeutic one.
No
This device is intended for automatic labeling, visualization, and volumetric quantification of segmentable structures from CT images of the brain, and to automate post-acquisition quantitative analysis. It provides numerical volumes and annotated images. The description explicitly states, "Patient management decisions should not be made based solely on the results of CT CoPilot™ quantitative data," indicating it is not a standalone diagnostic tool.
Yes
The device is described as proprietary software installed on an off-the-shelf personal computer, with its output intended for PACS display systems. It performs analysis on existing CT images and does not include any hardware components developed or verified by the manufacturer.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of CT CoPilot™ clearly states that it processes CT images of the brain, which are generated from the patient's body, not specimens taken from the body.
- The intended use is for image processing and analysis. The software is designed to automatically label, visualize, and quantify structures within the CT images. This is a form of medical image analysis, not a diagnostic test performed on biological samples.
- The output is numerical volumes and annotated images. The results are presented as quantitative measurements derived from the images and visual overlays on the images, not as results from testing biological specimens.
Therefore, CT CoPilot™ falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CT CoPilot™ is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended to automate the current manual process of identifying, labeling and quantifying structures identified on CT images of the brain and to provide automated registration and reformatting of data.
Product codes
LLZ
Device Description
CT CoPilot™ is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot™ performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific segmental structure. When CT imaging is performed more than once on a patient, the current data is coregistered to the most recent processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot™. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient.
CT CoPilot™ incorporates registration, alignment, and segmentation methods similar to a previous 510(k) cleared device, known as NeuroQuant (K061855), to automatically label and quantify the volume of segmentable structures in MRI images of the head. CT CoPilot™ output is provided in standard DICOM format as additional series of images (with appropriate descriptors) and reports that can be displayed on most third-party commercial DICOM workstations. CT CoPilot™ is intended to provide visualization and quantification data for CT scans of the brain. CT CoPilot™ includes safety procedures and error reporting similar to those adopted by NeuroQuant to identify cases that may not be processed for any reason. CT CoPilot™ is intended to be used by trained personnel in Neuro CT imaging. Patient management decisions should not be made based solely on the results of CT CoPilot™ quantitative data.
In laboratory testing, CT CoPilot™ demonstrates the following registration accuracy based on 100 randomly acquired CT head scans on both normal patients and those with abnormal pathologies: 1) The inter-subject variability of the angle formed by the inter-hemispheric plane and the vertical line, as measured on axial views (yaw), is less than 15 degrees. 2) The intersubject variability of the positioning of the inter-hemispheric plane and the vertical line, as measured on coronal views (roll), is less than 15 degrees. 3) The inter-subject variability of the positioning of the AC/PC plane and the horizontal line, as measured on sagittal views, is less than 15 degrees. Laboratory testing of CT CoPilot™ software on 179 scans from 34 patients with ventriculostomy catheters demonstrates the following correlation coefficients between the automatic software segmentation accuracy of relevant anatomical structures when compared against the same group of medical expert manually segmented subjects: (Lateral Ventricle Volume = 98%, Total CSF Volume = 98%, Intra-Cranial Volume = 99%, Midline Shift Index = 95%). Laboratory testing of CT CoPilot™ segmentation reliability demonstrates equivalent test-retest performance as expert manually segmented subjects. The accuracy testing of CT CoPilot™ registration and segmentation performance was similar to the predicate device (NeuroQuant) without additional safety risk.
CT CoPilot™ consists of proprietary software developed by ZepMed, Inc. installed on an offthe-shelf personal computer. The output of CT CoPilot™ is intended for Picture Archive and Communications System (PACS) display systems. PACS display systems must contain sufficient functionality to display color images (either MR or Secondary Capture), and to display report text and graphics output either in DICOM Structured Report or display of Adobe PDF or JPEG files.
The accuracy of the automatic cross-sectional registration and segmentation in CT CoPilot™ is affected by the subject's deviation from the features embedded in the reference neuroanatomic Atlas. In general, the accuracy of the CT CoPilot™ system software may decrease when the subject's head includes pathologic features not present in the Atlas, lacks features present in the Atlas, or is structurally different than that defined in the preexisting neuroanatomic Atlas. The accuracy of the CT CoPilot™ single image and serial image analysis program may also be degraded by patient motion or by artifacts which are introduced into the patient scanning process, or if patient positioning severely deviates from expectations. Alignment of subject to Atlas space is an important software step in the overall process of registration and segmentation. CT CoPilot™ uses the mechanism for determination of alignment accuracy instantiated in the predicate device (NeuroQuant) for establishing the relationship between image quality and overall alignment accuracy. Specifically, a "measurement index" is determined for each study based on the deviation of each image from the normalized anatomic index embedded in the program. The measurement index is determined by the deviation of the image volumes from normal atlas space. The automatically determined "measurement index" is used to define the limit of anatomic alignment variance which has been determined through laboratory testing of CT CoPilot™ to be accepted by the program. As a safety feature, the CT CoPilot™ software calculates and reports a measurement index number which reflects the adequacy of overall single image and serial image alignment. If the measurement index exceeds specified limits, an error report is generated to inform the user and further processing is terminated.
Factors that may degrade the technical quality and accuracy of CT CoPilot™ registration and segmentation results include:
- a) Patient's motion during scan.
- b) Artifacts affecting overall image quality.
- c) Reconstruction artifacts.
- d) Pathological and or anatomical deviations from the Atlas.
- e) Large initial alignment deviations between the patient and the Atlas.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scanner
Anatomical Site
brain
Indicated Patient Age Range
18 or older
Intended User / Care Setting
trained personnel in Neuro CT imaging
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 laboratory testing, CT CoPilot™ demonstrates the following registration accuracy based on 100 randomly acquired CT head scans on both normal patients and those with abnormal pathologies: 1) The inter-subject variability of the angle formed by the inter-hemispheric plane and the vertical line, as measured on axial views (yaw), is less than 15 degrees. 2) The intersubject variability of the positioning of the inter-hemispheric plane and the vertical line, as measured on coronal views (roll), is less than 15 degrees. 3) The inter-subject variability of the positioning of the AC/PC plane and the horizontal line, as measured on sagittal views, is less than 15 degrees. Laboratory testing of CT CoPilot™ software on 179 scans from 34 patients with ventriculostomy catheters demonstrates the following correlation coefficients between the automatic software segmentation accuracy of relevant anatomical structures when compared against the same group of medical expert manually segmented subjects: (Lateral Ventricle Volume = 98%, Total CSF Volume = 98%, Intra-Cranial Volume = 99%, Midline Shift Index = 95%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Laboratory Testing
Sample Size:
- 100 randomly acquired CT head scans (normal patients and those with abnormal pathologies) for registration accuracy.
- 179 scans from 34 patients with ventriculostomy catheters for segmentation accuracy.
Key Results: - Registration Accuracy:
- The inter-subject variability of the angle formed by the inter-hemispheric plane and the vertical line, as measured on axial views (yaw), is less than 15 degrees.
- The intersubject variability of the positioning of the inter-hemispheric plane and the vertical line, as measured on coronal views (roll), is less than 15 degrees.
- The inter-subject variability of the positioning of the AC/PC plane and the horizontal line, as measured on sagittal views, is less than 15 degrees.
- Segmentation Accuracy (Correlation Coefficients against medical expert manually segmented subjects):
- Lateral Ventricle Volume = 98%
- Total CSF Volume = 98%
- Intra-Cranial Volume = 99%
- Midline Shift Index = 95%
- Segmentation Reliability: demonstrates equivalent test-retest performance as expert manually segmented subjects.
- The accuracy testing of CT CoPilot™ registration and segmentation performance was similar to the predicate device (NeuroQuant) without additional safety risk.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2016
ZepMed, LLC. % Mr. James Monroe CEO Monroe Medical Device Consulting, LLC 319 Shilling Drive SOMERSET NJ 08873
Re: K161322 Trade/Device Name: CT CoPilot™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 11, 2016 Received: November 14, 2016
Dear Mr. Monroe:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CT CoPilot™
Indications for Use (Describe)
CT CoPilot™ is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended to automate the current manual process of identifying, labeling and quantifying structures identified on CT images of the brain and to provide automated registration and reformatting of data.
| 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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FORM FDA 3881 (8/14)
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05 - 510k Summary
CT Co-Pilot
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Dr. Douglas J. Bates, MD ZepMed, LLC. 2465 Avenida de La Playa La Jolla, CA 92037
Phone: (858) 692-0795, Facsimile: (858) 412 - 3711
Contact Person: James W. Monroe; jwmonroe@monroemdc.com, (908) 809-0081
Date Prepared: November 11, 2016
Name of Device and Name/Address of Sponsor
CT CoPilot™
ZepMed, LLC. 2465 Avenida de La Playa La Jolla, CA 92037
Common or Usual Name
Picture Archiving and Communication System
Classification Name
System, Image Processing, Radiological (892.2050)
Classification Panel Radiology
Product Codes LLZ
Device Class II
Predicate Devices NeuroQuant (K061855)
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Image /page/4/Picture/0 description: The image shows the word "ZEPMED" in a bold, sans-serif font. The letters are a dark gray color, with the "Z", "E", and "P" appearing slightly darker than the "M", "E", and "D". The letters are all capitalized and evenly spaced, creating a clean and modern look. The background is plain white.
Intended Use / Indications for Use
CT CoPilot™ is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended to automate the current manual process of identifying, labeling and quantifying structures identified on CT images of the brain and to provide automated registration and reformatting of data.
Device Description
CT CoPilot™ is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot™ performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific segmental structure. When CT imaging is performed more than once on a patient, the current data is coregistered to the most recent processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot™. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient.
CT CoPilot™ incorporates registration, alignment, and segmentation methods similar to a previous 510(k) cleared device, known as NeuroQuant (K061855), to automatically label and quantify the volume of segmentable structures in MRI images of the head. CT CoPilot™ output is provided in standard DICOM format as additional series of images (with appropriate descriptors) and reports that can be displayed on most third-party commercial DICOM workstations. CT CoPilot™ is intended to provide visualization and quantification data for CT scans of the brain. CT CoPilot™ includes safety procedures and error reporting similar to those adopted by NeuroQuant to identify cases that may not be processed for any reason. CT CoPilot™ is intended to be used by trained personnel in Neuro CT imaging. Patient management decisions should not be made based solely on the results of CT CoPilot™ quantitative data.
In laboratory testing, CT CoPilot™ demonstrates the following registration accuracy based on 100 randomly acquired CT head scans on both normal patients and those with abnormal
5
pathologies: 1) The inter-subject variability of the angle formed by the inter-hemispheric plane and the vertical line, as measured on axial views (yaw), is less than 15 degrees. 2) The intersubject variability of the positioning of the inter-hemispheric plane and the vertical line, as measured on coronal views (roll), is less than 15 degrees. 3) The inter-subject variability of the positioning of the AC/PC plane and the horizontal line, as measured on sagittal views, is less than 15 degrees. Laboratory testing of CT CoPilot™ software on 179 scans from 34 patients with ventriculostomy catheters demonstrates the following correlation coefficients between the automatic software segmentation accuracy of relevant anatomical structures when compared against the same group of medical expert manually segmented subjects: (Lateral Ventricle Volume = 98%, Total CSF Volume = 98%, Intra-Cranial Volume = 99%, Midline Shift Index = 95%). Laboratory testing of CT CoPilot™ segmentation reliability demonstrates equivalent test-retest performance as expert manually segmented subjects. The accuracy testing of CT CoPilot™ registration and segmentation performance was similar to the predicate device (NeuroQuant) without additional safety risk.
CT CoPilot™ consists of proprietary software developed by ZepMed, Inc. installed on an offthe-shelf personal computer. The output of CT CoPilot™ is intended for Picture Archive and Communications System (PACS) display systems. PACS display systems must contain sufficient functionality to display color images (either MR or Secondary Capture), and to display report text and graphics output either in DICOM Structured Report or display of Adobe PDF or JPEG files.
The accuracy of the automatic cross-sectional registration and segmentation in CT CoPilot™ is affected by the subject's deviation from the features embedded in the reference neuroanatomic Atlas. In general, the accuracy of the CT CoPilot™ system software may decrease when the subject's head includes pathologic features not present in the Atlas, lacks features present in the Atlas, or is structurally different than that defined in the preexisting neuroanatomic Atlas. The accuracy of the CT CoPilot™ single image and serial image analysis program may also be degraded by patient motion or by artifacts which are introduced into the patient scanning process, or if patient positioning severely deviates from expectations. Alignment of subject to Atlas space is an important software step in the overall process of registration and segmentation. CT CoPilot™ uses the mechanism for
6
determination of alignment accuracy instantiated in the predicate device (NeuroQuant) for establishing the relationship between image quality and overall alignment accuracy. Specifically, a "measurement index" is determined for each study based on the deviation of each image from the normalized anatomic index embedded in the program. The measurement index is determined by the deviation of the image volumes from normal atlas space. The automatically determined "measurement index" is used to define the limit of anatomic alignment variance which has been determined through laboratory testing of CT CoPilot™ to be accepted by the program. As a safety feature, the CT CoPilot™ software calculates and reports a measurement index number which reflects the adequacy of overall single image and serial image alignment. If the measurement index exceeds specified limits, an error report is generated to inform the user and further processing is terminated.
Factors that may degrade the technical quality and accuracy of CT CoPilot™ registration and segmentation results include:
- a) Patient's motion during scan.
- b) Artifacts affecting overall image quality.
- c) Reconstruction artifacts.
- d) Pathological and or anatomical deviations from the Atlas.
- e) Large initial alignment deviations between the patient and the Atlas.
Non-Clinical Testing
- ISO 14971 Second Edition 2007, Medical Devices Application Of Risk Management o To Medical Devices.
- ISO 62304: The Harmonized Standard for Medical Device Software Development .
- . NEMA PS 3.1 - 3.20 (2011), Digital Imaging And Communications In Medicine (Dicom) Set.
Comparison to Predicate Device
ZepMed's CT CoPilot™ , is substantially equivalent to the predicate devices listed below with respect to intended use/indications for use, principles of operation and technological characteristics.
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Substantial Equivalence Table
| Attribute | CT CoPilot™ | NeuroQuant | Equivalence |
|---|---|---|---|
| 510(k) | (Subject Device) | K061855 | |
| Product Code | LLZ | LLZ | Yes |
| Intended Use | CT CoPilot™ is | ||
| intended for automatic | |||
| labeling, visualization | |||
| and volumetric | |||
| quantification of | |||
| segmentable structures | |||
| from sets of CT images | |||
| of the brain. This | |||
| software is intended to | |||
| automate the current | |||
| manual process of | |||
| identifying, labeling | |||
| and quantifying | |||
| structures identified on | |||
| CT images of the brain | |||
| and to provide | |||
| automated registration | |||
| and reformatting of | |||
| data. | NeuroQuant™ is intended | ||
| for automatic labeling, | |||
| visualization and | |||
| volumetric quantification | |||
| of segmentable brain | |||
| structures from sets of MR | |||
| images. This software is | |||
| intended to automate the | |||
| current manual process of | |||
| identifying, labeling and | |||
| quantifying the volume of | |||
| segmental brain structures | |||
| identified on MR images. | Yes | ||
| Data Source | CT Scanner | MRI Scanner | Different |
| Display images | Reformatted, realigned | ||
| axial, coronal, and sagittal | |||
| images. | Reformatted, realigned | ||
| axial, coronal and sagittal | |||
| images. | Yes | ||
| Quantitative | |||
| Metrics | CSF volumes, Intracranial | ||
| volume, Midline shift. | CSF volumes, Intracranial | ||
| volume, Brain structure | |||
| volumes. | Similar | ||
| Physical | |||
| Characteristics | Software package | ||
| • Operates off-the-shelf | |||
| software (multiple | |||
| vendors) | Software package | ||
| • Operates off-the-shelf | |||
| software (multiple | |||
| vendors) | Yes | ||
| Operating | |||
| System | OS:Linux | OS: Linux,Mac,Windows | Yes |
| DICOM | |||
| compatible | Yes | Yes | Yes |
| Performance | |||
| measurement | |||
| Testing | Reproducibility and | ||
| Accuracy testing | Reproducibility and | ||
| Accuracy testing | Yes | ||
| Safety | Measurement data can be | ||
| viewed, accepted or | |||
| rejected by a physician | Measurement data can be | ||
| viewed, accepted or | |||
| rejected by a physician | Yes | ||
| In plane voxel | |||
| Resolution | |||
| (Input Data) | 0.1-1mm | 1mm | Similar |
| Slice | |||
| Thickness | |||
| (Input Data) | 0.2-1mm | 1.2mm | Similar |
| Automatic | |||
| Alignment | Yes | Yes | Yes |
| Registration | |||
| Target Data | Atlas, Prior | Atlas | Similar |
| Skull | |||
| Stripping | Yes | Yes | Yes |
| Automatic | |||
| Segmentation | Yes | Yes | Yes |
| Error | |||
| Detection | Yes | Yes | Yes |
| Output Image | |||
| Data Format | 3D Volumetric, 2D MPR | ||
| -1mm isotropic volume | |||
| -1-5mm thick MPR | 3D Volumetric | ||
| -1mm isotropic volume | Similar | ||
| Color-coded | |||
| Segmentation | |||
| Series | |||
| (Output Data) | Yes | Yes | Yes |
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Substantial Equivalence Discussion:
Both CT CoPilot™ and NeuroQuant (K061855) allow for the visualization and volumetric quantification of brain images. Similarly, both systems incorporate post-acquisition quantitative analysis of acquired images and transform and display the results in DICOM standard formatted images and reports. Both systems perform reproducibility and accuracy testing. The difference between the post processing systems is that CT CoPilot™ is analyzing CT images of the brain
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Image /page/9/Picture/0 description: The image shows the word "ZEPMED" in a bold, sans-serif font. The letters "ZEP" are in a darker shade of gray, while the letters "MED" are in a lighter shade of gray. The letters are all capitalized and have a modern, geometric design. The overall impression is one of a strong, professional brand.
whereas NeuroQuant analyzes MRI images of the brain. Although CT CoPilot™ utilizes CT scans and NeuroQuant utilizes MRI scans, they both perform automated segmentation and quantification of segmental structures within the brain. Post-processing of the images with the Subject device (CT CoPilot™) and predicate device (NeuroQuant) use similar algorithms for segmentation and registration of scans to an Atlas as well as similar safety procedures to assess the quality of segmentation and registration accuracy.
CT CoPilot™ is substantially equivalent in performance, technology, and characteristics. The differences between the two devices do not raise any new questions of safety and effectiveness.