QUANTIVA

K061418 · Tomographix IP , Ltd. · LLZ · Jul 21, 2006 · Radiology

Device Facts

• Record ID: K061418
• Device Name: QUANTIVA
• Applicant: Tomographix IP , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Quantiva™ software system coregisters pairs of anatomic (CT) and functional (PET) volumetric image data and displays the fused images to provide additional combined anatomic plus functional image information to the diagnosing radiologist. The Quantiva™ is a software application intended to co-register and display 2D & 3D multimodality (CT & PET) medical images data. The medical practitioner can visualize, process, render, view, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks as distributed locations utilizing standard P.C. hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissue. The software also supports interactive segmentation of the region of interest, automated contouring of multi-slice ROI and labeling of avoidance structures during evaluation. Typical users of Quantiva™ are for trained professionals (including but not limited to: radiologists, clinicians and technicians). When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. The Quantiva™ is indicated for use when it is necessary to acquire, record, review and distribute these images. The Quantiva™ is a prescription device. The labeling, instructions and user operations are designed for trained, licensed medical professionals.

Device Story

Quantiva™ is a software application for co-registering and fusing PET and CT volumetric images. It processes DICOM 3.0 compliant data on standard PC hardware. The system performs rigid and non-rigid image fusion, interactive segmentation, automated contouring of multi-slice regions of interest (ROI), and labeling of avoidance structures. It provides volume and linear measurement tools for tumor evaluation and tissue analysis. Operated by radiologists, clinicians, or technicians in clinical settings, the device enables visualization, rendering, and distribution of multimodal images across networks. The output assists physicians in clinical decision-making by providing combined anatomic and functional information for diagnostic purposes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software application for standard PC hardware. Performs rigid and non-rigid image fusion, interactive segmentation, and automated contouring. Supports DICOM 3.0 connectivity. Developed under Quality Systems.

Indications for Use

Indicated for trained medical professionals (radiologists, clinicians, technicians) to acquire, record, review, and distribute 2D/3D CT and PET medical images for diagnosis. Used for tumor measurement, location/displacement studies, and analysis of hard/soft tissue.

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

• Fusion7D (K033955)

Submission Summary (Full Text)

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# K611418 510(k) Summary

# Quantiva™

JUL 21 2006

| 1 May 2006 | | JUL 21 2006 |
|-----------------------------------------------------------------------------------|--|--------------------------------------------|
| Sponsor | | Consultant |
| Tomographix IP Ltd. | | Mr. Richard Keen |
| 33 Hazelton Avenue, Suite 88 | | Compliance Consultants |
| Toronto, Ontario M5R 2E3 | | 1151 Hope Street |
| Voice 416 638 3103 | | Stamford, CT 06907-1659 |
| Fax [phone] | | 203 329 2700 F 203 329 2345 |
| [e-mail] | | [e-mail] |
| Proprietary Name: | | Quantiva™ |
| Common Name | | Quantiva™ |
| Device Classification Name | | System, Image Processing Radiological |
| Classification Name: | | Picture Archiving and Communication System |
| Product Code | | LLZ |
| Device Classification | | Class II |
| Establishment registration No. | | Not applicable (foreign manufacture) |
| Predicate Device | | Fusion7D, K033955, Mirada Solutions Ltd. |
| Trademark Notice: All Trademarks used other than those of Tomographix IP Ltd. are | | |

registered to their respective owners.

Confidentiality notice: All data contained in this application and all appendixes provided with his appendix or aided trade secrets or proprietary data which the sponsor requests are treated in accordance with law.

## Device Description

The Quantiva™ is a Class II software application intended to co-register anddisplay fused PET plus CT images enabling a qualified radiological technological technologist to visualize 2D & 3D multimodal (CT and PET) medical image data. The qualified user may process, render, view, store, and print DICOM 3.0 compliant medical image data within the system and/or across computer networks utilizing standard P.C. hardware and software.

#### Intended Use

Quantiva™ software system coregisters pairs of anatomic (CT) and functional (PET) volumetric image data and displays the fused images to provide additional combined anatomic plus functional image information to the diagnosing radiologist.

## Technological Characteristics and Substantial Equivalence

This system creates a rigid and non-rigid fusion of two common diagnostic images. This process results in more diagnostic information than is provided by current methods. The QuantivaTM software has benefited from design, development, testing and production procedures that conform to Quality Systems. Tomographix IP Ltd. has determined that the Quantiva™ software has fundamentally the same indications for use as the predicate device.

#### Performance Testing

Information submitted in this premarket notification for the Quantiva™ software includes results of performance testing.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a person embracing or supporting another, with three curved lines above them.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# JUL 2 1 2006

Tomographic IP Ltd. % Mr. Richard Keen Responsible Third Party Official Compliance Consultants 1151 Hope Street STAMFORD CT 06907-1659

Re: K061418

Trade/Device Name: Quantiva™ software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 1, 2006 Received: May 22, 2006

Dear Mr. Keen:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in large bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial". The logo is surrounded by a circular border with text printed around the border.

oting Public -

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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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

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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# 510(K) Number (If known): _ K061418_

# Device Name: Quantiva™ software

The Quantiva™is a software application intended to co-register and display 2D & 3D multimodality (CT & PET) medical images data. The medical practitioner can visualize, process, render, view, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks as distributed locations utilizing standard P.C. hardware.

The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissue. The software also supports interactive segmentation of the region of interest, automated contouring of multi-slice ROI and labeling of avoidance structures during evaluation.

Typical users of Quantiva™ are for trained professionals (including but not limited to: radiologists, clinicians and technicians). When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.

The Quantiva™is indicated for use when it is necessary to acquire, record, review and distribute these images. The Quantiva™ is a prescription device. The labeling, instructions and user operations are designed for trained, licensed medical professionals.

David R. Legnon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number .

Prescription Use _ XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over - The - Counter Use (21 CFR 807 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)