ONCO TRAC MODEL 1, 2, 4

K111642 · Translational Sciences Corporation · LLZ · Nov 18, 2011 · Radiology

Device Facts

• Record ID: K111642
• Device Name: ONCO TRAC MODEL 1, 2, 4
• Applicant: Translational Sciences Corporation
• Product Code: LLZ · Radiology
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI, measurement of lesions identified by trained users, tabulation of measurements. categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. OncoTrac™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncoTrac™ does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function. OncoTrac™ is not intended for use for mammography.

Device Story

OncoTrac™ is a software-based PACS for viewing and analyzing medical images. Input: DICOM-compliant CT and MRI data. Operation: Software runs on Windows-based general-purpose hardware; provides tools for manual lesion measurement, tabulation of measurements, and categorization of tumor response using standard criteria (RECIST, WHO). Output: Structured imaging reports (PDF). Usage: Clinical environment; operated by trained professionals (physicians, technologists, nurses). The device does not perform automated detection or diagnosis; it serves as a tool for trained physicians to interpret images as part of a diagnostic process. Benefits include standardized tumor response assessment and structured reporting to support clinical decision-making.

Clinical Evidence

Bench testing only. The software underwent extensive testing on 64-bit Windows systems by development and quality control teams. A hazard analysis was performed, and the device passed all critical safety tests, demonstrating acceptable performance.

Technological Characteristics

Software-based PACS; runs on native or virtualized 64-bit Microsoft Windows platforms. DICOM compliant. Features include 2D image viewing, manual lesion measurement tools, and structured reporting (PDF). No automated detection or diagnosis algorithms. Moderate level of concern for software safety.

Indications for Use

Indicated for use by trained professionals (physicians, technologists, nurses) for display, visualization, measurement, and analysis of DICOM-compliant CT and MRI images to categorize tumor response. Not indicated for mammography.

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

• AW Server (K081985)

Submission Summary (Full Text)

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OncoTrac™ 510(k)

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NOV 1 8 2011

#### 510(k) Summary 5

Date Prepared:

May 23, 2011

Submitter/Importer/Distributer Name: Submitter's Address:

Submitter's Phone: Submitter's Fax: Contact: Manufacturer:

Proprietary Name: Common Name: Classification:

Substantially Equivalent to:

Translational Sciences Corporation Translational Sciences Corporation. One Mifflin Place, Suite 400 Cambridge, MA 02138 617.297.2577 617.576.9132 Howard Pinsky, Chief Executive Officer Mint Medical Systems, GmbH Im Neuenheimer Feld 582 D-69120 Heidelberg Germany OncoTracTM Software PACS 892.2050 Picture archiving and communications system, Product Code LLZ, (Class II)

Tradename: AW Server Manufacturer: General Electric Medical Systems 510(k) Number: K081985

## Confidential

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OncoTrac™ 510(k)

Translational Sciences Corporation

### Device Description:

OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI.

KIII642

Page 2044

OncoTracTM runs on either a native or virtualized Microsoft Windows platform. Available functions include communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI. measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report. The user controls these functions with a system of interactive menus and tools.

The OncoTrac™ software has been extensively tested on Windows 64 bit systems by members of the development and quality control teams. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance.

### Confidential

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OncoTrac™ 510(k

| | K111642 | | | |
|----|-------------|--|--|--|
| k) | Page 3 of 4 | | | |

| Feature | OncoTracTM | GE AW Server<br>(primary predicate) |
|-------------------------------------------|-----------------------|-------------------------------------|
| 510k number | | K081985 |
| DICOM compliance | yes | yes |
| 2D Imaging | 2D image viewer | Same plus 3D viewer |
| Interactive user controls | yes | yes |
| lesion measurement | yes | yes |
| body region(s) | multiple | multiple |
| modalities | CT, MRI | CT, MRI |
| Quantitative oncology response assessment | RECIST<br>WHO | RECIST<br>WHO |
| Generation of structured report | pdf | same |
| Prescription Use | Yes | same |
| Intended Users | Trained Professionals | same |

# Substantial Equivalence Comparisons to Predicate Devices:

## Confidential

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OncoTrac™ 510(k)

#### Intended Use:

OncoTrac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI, measurement of lesions identified by trained users, tabulation of measurements. categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report.

OncoTrac™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncoTrac™ does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.

OncoTrac™ is not intended for use for mammography.

Confidential

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Image /page/4/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Allen Green, MD, PHD, NJ, LLC Counsel Translational Sciences Corporation One Mifflin Place, Suite 400 CAMBRIDGE MA 02138

NOV 1 8 2011

Re: K111642

Trade/Device Name: OncoTrac Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2011 Received: November 4, 2011

Dear Mr. Green:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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KIII642

Indications for Use

Applicant: Translational Sciences Corporation. One Mifflin Place, Suite 400 Cambridge, MA 02138

510(k) Number (if known): KN1642

Device Name: OncoTrac™

Indications for Use:

Onco Trac™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MRI, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report.

OncoTrac™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncoTrac™ does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.

OncoTracTM is not intended for use for mammography.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard D. O'Shea
(Division Sign Off)

Division of Radialo

10K Klll 642

Confidential

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