NeuroQuant

K170981 · Cortechs Labs, Inc. · LLZ · Sep 7, 2017 · Radiology

Device Facts

• Record ID: K170981
• Device Name: NeuroQuant
• Applicant: Cortechs Labs, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

NeuroQuant® is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. It is intended to automate the manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.

Device Story

NeuroQuant is an automated MR post-processing software; inputs 3D T1 MRI series and T2 FLAIR MR series. Internal pipeline performs artifact correction, atlas-based segmentation, volume calculation, and report generation. Outputs segmented images with color overlays and morphometric reports in DICOM format. Used in clinical research and routine care by radiologists, neurologists, and neuroradiologists; results displayed on third-party PACS/workstations. Software assists clinicians in assessing structural MRIs by providing quantitative volumetric data compared to reference percentiles; aids in identifying brain abnormalities/lesions. Benefits include standardized, reproducible morphometric measurements, reducing manual segmentation time.

Clinical Evidence

Bench testing only. Segmentation accuracy evaluated against expert manual segmentations using Dice's coefficient: 80-90% for subcortical structures, 75-85% for cortical regions, and >80% for lesions (using T1/T2 FLAIR). Reproducibility assessed via repeated scans: mean absolute volume difference 1-5% for subcortical structures; mean absolute lesion volume difference <0.25cc (<2.5% percentage difference).

Technological Characteristics

Software-based medical image processing; operates on off-the-shelf hardware (Linux, Mac OS X, Windows). Uses dynamic probabilistic neuroanatomical atlas for segmentation. Inputs: 3D T1 MRI and T2 FLAIR series (DICOM). Outputs: DICOM series with color overlays and morphometric reports. Automated quality control includes tissue contrast, atlas alignment, and scan protocol verification.

Indications for Use

Indicated for automatic labeling, visualization, and volumetric quantification of brain structures and lesions from MR images in patients requiring structural MRI assessment. Results are compared to age and gender-matched reference percentile data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• NeuroQuant (K061855)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2017

CorTechs Labs, Inc Kora Marinkovic Director of Quality and Regulatory Affairs 4690 Executive Drive. Suite 250 San Diego, CA 92121

Re: K170981

Trade/Device Name: NeuroOuant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 9, 2017 Received: August 11, 2017

Dear Kora Marinkovic:

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

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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.

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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K170981

Device Name NeuroQuant

Indications for Use (Describe)

Meuro Quant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile 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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# 510(k) Summary: NeuroQuant®

# 1. Submitter

| Name: | CorTechs Labs, Inc | |
|-------------------|--------------------------------------------------------|--|
| Address: | 4690 Executive Drive, Suite 250<br>San Diego, CA 92121 | |
| Contact Person: | Kora Marinkovic | |
| Telephone Number: | [phone] | |
| Fax Number: | [phone] | |
| E-mail: | [e-mail] | |
| Date Prepared: | 8/4/2017 | |

#### 2. Device

| Device Trade Name: | NeuroQuant® |
|-------------------------|---------------------------------------------|
| Common Name: | Medical Image Processing Software |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Description: | Picture archiving and communications system |
| Product Code: | LLZ |
| Classification Panel: | Radiology |

# 3. Predicate Device

| Device: | NeuroQuant™ |
|---------------|--------------------|
| 510(k) Number | K061855 |
| Manufacturer | CorTechs Labs, Inc |
| Product Code: | LLZ |

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| Image: CORTECHS Labs Logo | <b>510(k) Section Number: 5</b> | <b>Document No: 007</b> |
|---------------------------|---------------------------------|--------------------------------------------------------|
| | <b>Title</b> | NeuroQuant 510(k) Premarket Submission: 510(k) Summary |
| | <b>Revision: 01</b> | Pages 2 of 4 Date: 8/4/2017 |

# 4. Device Description

NeuroQuant is a fully automated MR imaging post-processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and lesions from a set of MR images and returns segmented images and morphometric reports. The resulting output is provided in a standard DICOM format as additional MR series with segmented color overlays and morphometric reports that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS). The high throughput capability makes the software suitable for use in both clinical trial research and routine patient care as a support tool for clinicians in assessment of structural MRIs.

NeuroQuant provides morphometric measurements based on 3D T1 MRI series. The output of the software includes volumes that have been annotated with color overlays, with each color representing a particular segmented region, and morphometric reports that provide comparison of measured volumes to age and gender-matched reference percentile data. In addition, the adjunctive use of the T2 FLAIR MR series allows for improved identification of some brain abnormalities such as lesions, which are often associated with T2 FLAIR hyperintensities.

The NeuroQuant processing architecture includes a proprietary automated internal pipeline that performs artifact correction, atlas-based segmentation, volume calculation and report generation.

Additionally, automated safety measures include automated quality control functions, such as tissue contrast check, atlas alignment check and scan protocol verification, which validate that the imaging protocols adhere to system requirements.

From a workflow perspective, NeuroQuant is packaged as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.

### 5. Intended Use

NeuroQuant® is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. It is intended to automate the manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.

# 6. Comparison to Predicate Device

| | CorTechs Labs, Inc | CorTechs Labs, Inc |
|------------------------|-----------------------------------------------|-----------------------------------------------|
| Device Name | NeuroQuantTM V1.0 | NeuroQuant® V2.2 |
| 510(k) No | K061855 | N/A |
| Regulation No | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation Description | "Picture archiving and communications system" | "Picture archiving and communications system" |

Summary Comparison Table for the device and predicate device (K061855):

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| Image: CORTECHS Labs logo | 510(k) Section Number: 5 | Document No: 007 | |
|---------------------------|--------------------------|--------------------------------------------------------|----------------|
| | Title | NeuroQuant 510(k) Premarket Submission: 510(k) Summary | |
| | Revision: 01 | Pages 3 of 4 | Date: 8/4/2017 |

| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Product Code | LLZ | LLZ |
| Indications for Use | Automatic labeling, visualization and volumetric<br>quantification of segmentable brain structures<br>from a set of MR images, intended to automate<br>the current manual process of identifying,<br>labeling and quantifying the volume of<br>segmentable brain structures identified on MR<br>images | Automatic labeling, visualization and volumetric<br>quantification of segmentable brain structures<br>and lesions from a set of MR images. Volumetric<br>data may be compared to reference percentile<br>data |
| Design and<br>Incorporated<br>Technology | • Automated measurement of brain tissue<br>volumes and structures<br>• Automatic segmentation and quantification of<br>brain structures using a probabilistic<br>neuroanatomical atlas based on the MR image<br>intensity | • Automated measurement of brain tissue<br>volumes and structures and lesions<br>• Automatic segmentation and quantification of<br>brain structures using a dynamic probabilistic<br>neuroanatomical atlas, with age and gender<br>specificity, based on the MR image intensity |
| Physical<br>characteristics | • Software package<br>• Operates on off-the-shelf hardware (multiple<br>vendors) | • Software package<br>• Operates on off-the-shelf hardware (multiple<br>vendors) |
| Operating System | Supports Linux and Mac OS X | Supports Linux, Mac OS X and Windows. |
| Processing<br>Architecture | Automated internal pipeline that performs:<br>- artifact correction<br>- segmentation<br>- volume calculation<br>- report generation | Automated internal pipeline that performs:<br>- artifact correction<br>- segmentation<br>- lesion quantification<br>- volume calculation<br>- report generation |
| Data Source | • MRI scanner: 3D T1 MRI scans acquired with<br>specified protocols<br>• NeuroQuant Supports DICOM format as input | • MRI scanner: 3D T1 MRI scans acquired with<br>specified protocols<br>• NeuroQuant Supports DICOM format as input |
| Output | • Provides volumetric measurements of brain<br>structures<br>• Includes segmented color overlays and<br>morphometric reports<br>• Automatically compares results to reference<br>percentile data and to prior scans when available<br>• Supports DICOM format as output of results that<br>can be displayed on DICOM workstations and<br>Picture Archive and Communications Systems | • Provides volumetric measurements of brain<br>structures and lesions<br>• Includes segmented color overlays and<br>morphometric reports<br>• Automatically compares results to reference<br>percentile data and to prior scans when<br>available<br>• Supports DICOM format as output of results that<br>can be displayed on DICOM workstations and<br>Picture Archive and Communications Systems |
| Safety | • Automated quality control functions<br>- Tissue contrast check<br>- Scan protocol verification<br>- Atlas alignment check<br>• Results must be reviewed by a trained physician | • Automated quality control functions<br>- Tissue contrast check<br>- Scan protocol verification<br>- Atlas alignment check<br>• Results must be reviewed by a trained physician |

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| CORTECHS Labs | | 510(k) Section Number: 5 | | Document No: 007 |
|---------------|--------------|--------------------------------------------------------|--------------|------------------|
| | Title | NeuroQuant 510(k) Premarket Submission: 510(k) Summary | | |
| | Revision: 01 | | Pages 4 of 4 | Date: 8/4/2017 |

NeuroQuant is functionally similar and improved from a previous 510(k) market-cleared CorTechs Labs NeuroQuant software device (NeuroQuant K061855).

Both devices have same intended use and basic design and similar operating principle.

Both systems use clinical MR brain scans as input and automatically identify and measure volumes of brain structures. Both systems provide morphometric measurements based on 3D T1 MRI series. The resulting output is provided in a standard DICOM format as additional MR series that can be displayed on third-party DICOM workstations and PACS.

Both systems produce similar reports. The output includes volumes that have been annotated with color overlays, with each color representing a particular segmented reqion, and morphometric reports that provide comparison of measured volumes to reference percentile data.

They utilize the same automated safety measures and have similar processing architecture.

Both devices are DICOM compatible and operate on off-the-shelf hardware.

Both systems are used by medical professionals, such as radiologists, neurologists and neuroradiologists, as well as by clinical researchers, as a support tool in assessment of structural MRIs.

# 7. Performance Testing

NeuroQuant performance was evaluated by comparing segmentation accuracy with expert manual segmentations and by measuring segmentation reproducibility between same subject scans. The system yields reproducible results that are well correlated with computer-aided expert manual segmentations.

NeuroQuant's segmentation accuracy compared to expert manual segmentations of 3D T1 MRI scans was evaluated using Dice's coefficient metric. For major subcortical brain structures Dice's coefficients are in the range of 80-90% and for major cortical regions are in the range of 75-85%. For lesion segmentations evaluated separately using 3D T1 and T2 FLAIR MRI scan pairs of subjects with brain lesions, Dice's coefficient exceeds 80%.

Brain structure segmentation reproducibility of repeated 3D T1 MRI scans for same subjects was evaluated by using the percentage absolute volume differences. The mean percentage absolute volume differences for all major subcortical structures were in the range1-5%. Brain lesion seqmentation reproducibility was evaluated separately using 3D T1 and T2 FLAIR MRI repeated scan pairs of subjects with brain lesions. The mean absolute lesion volume difference was less than 0.25cc, while the mean percentage lesion absolute volume difference was less than 2.5%.

### 8. Conclusions

The performance testing presented above shows that the device is as safe, as effective and performs as well as the predicate device, and as well as gold standard - computer-aided expert manual segmentation.

By virtue of the physical characteristics and intended use, NeuroQuant® is substantially equivalent to its predicate device and its technological improvements do not raise new questions of safety and effectiveness.