DEEP GRAY

K012563 · Cortechs Labs, Inc. · LLZ · Nov 2, 2001 · Radiology

Device Facts

• Record ID: K012563
• Device Name: DEEP GRAY
• Applicant: Cortechs Labs, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Deep Gray is intended to measure the volume of any brain structure and tissue from a set of MR images. It provides visualization tools, basic and advanced regions of interest drawing features and volumetric quantification. Deep Gray is to be used by trained physicians.

Device Story

Deep Gray is a software-based image processing system used by trained physicians to analyze MR brain images. The device imports DICOM 3.0 MR images and provides tools for multi-frame/multi-orientation display. It features manual drawing tools (freehand, polygon) and a semi-automatic labeling tool for brain structures and tissues. The physician performs or oversees the labeling process, which is subject to visual inspection and manual adjustment. The system generates a report quantifying the volumes of labeled structures. By providing these measurements, the device assists clinicians in assessing brain morphology, supporting clinical decision-making regarding brain structure and tissue volume.

Clinical Evidence

Bench testing only. Laboratory performance comparisons were conducted between the device's semi-automatic labeling feature and manual labeling of brain structures to validate the accuracy of the volumetric quantification.

Technological Characteristics

Software-based image processing system. Inputs: DICOM 3.0 MR brain images. Features: Multi-frame/multi-orientation display, manual ROI drawing (freehand, polygon), and semi-automatic labeling of brain structures/tissues. Output: Volumetric report. Operates on standard computing hardware (implied).

Indications for Use

Indicated for the visualization, processing, and analysis of brain images obtained from MR scanners in patients requiring volumetric quantification of brain structures and tissues. For prescription use only.

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

• Vitrea 2, version 2.1 (K002519)
• Advantage Windows Tissue Volume Option (K963345)

Submission Summary (Full Text)

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Document No: DG20 Revision: 1.0 Date: 7/31/2001

Deep Gray Abbreviated 510(k) Submission Page 5 of 26

NOV 0 2 2001

Image /page/0/Picture/5 description: This image shows a black and white illustration of a human brain. The brain is depicted in a side view, showcasing its complex structure with numerous folds and convolutions. The contrast between the black and white areas emphasizes the different regions and textures of the brain, creating a visually striking representation of this vital organ.

CorTechs 6 Thirteenth Street Charlestown, MA 02129

## Abbreviated 510(k) Summary

Submitter: CorTechs

Address: 6 Thirteenth, Charlestown, MA 02129

Phone number: 617 241-9588

Fax number: 617 241-9620

Contact person: Jeffrey M. Anderson, Ph.D.

Date prepared: August 7, 2001

Device Trade name: Deep Gray

Device Common name: The Deep Gray system

Device Classification name: 21 CFR 892.2050 Picture archiving and communications system.

Product Code: LLZ IMAGE PROCESSING SYSTEM

Classification Panel: Radiology

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## Substantially Equivalent To:

Vitrea 2, version 2.1 (K002519) Vital Images, Inc. 3300 Fernbrook Lane North Suite 200 Plymouth, MN 55447

Advantage Windows Tissue Volume Option (K963345) General Electric Medical Systems P.O. Box 414 Milwaukee, WI 53201

Intended use: Deep Gray is intended to measure the volume of any brain structure and tissue from a set of MR images. It provides visualization tools, basic and advanced regions of interest drawing features and volumetric quantification. Deep Gray is to be used by trained physicians.

Device Description: Deep Gray is a software device that provides the following features:

- Import of MR brain images (DICOM 3.0 format). ●
- Multi-frame and multi-orientation image display. ●
- Basic regions of interest drawing tools: free hand drawing, filled polygon . drawing. Labels can be associated with drawn objects.
- Advanced drawing tool: semi-automatic labeling of normal brain structures and . tissues.
- . Generation of a report listing the volumes of labeled structures and tissues.

The operator can choose to manually draw and label brain structures and tissues, or they can chose to perform a semi-automatic labeling, followed by visual inspection and manual adjustment. The Deep Gray system does not have any adverse affects on health. This tool measures and displays the volume of regions of interest. The operator can choose to accept, modify, or reject the volume and/or label suggested by the program.

Software Development: The software was designed, tested and validated These procedures specify individuals within the according to written procedures. organization that are responsible for developing and approving product specifications, coding, testing, validation and maintenance.

Performance Testing: Deep Gray has successfully completed integration testing and verification.

Clinical Evaluation: Laboratory performance comparisons between the semi-automatic labeling feature and manual labeling of brain structures has been successfully completed. See attached clinical performance summary for more information.

510(k) Number: None currently exists.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 022001

Jeffrey M. Anderson, Ph. D. Vice President, Research & Development CorTechs 6 Thirteenth Street CHARLESTOWN MA 02129

Re: K012563 Trade/Device Name: Deep Gray The Deep Gray System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 7, 2001 Received: August 9, 2001

Dear Dr. Anderson:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); 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.

Image /page/2/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire spooline active at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other of Compinance a ( rotification" (21 CFR Part 807.97). Other general information on of receive to promation noneans and be obtained from the Division of Small Manufacturers, Jour responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Deep Gray Abbreviated 510(k) Submission Page 7 of 26

Device Name: Deep Gray

NOV 0222001

## Indications for Use:

Visualization/Processing/Analysis of brain images from MR scanners.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Nancy C. Beagdon
Division Sign-Off

Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K012563