K Number
K061418
Device Name
QUANTIVA
Date Cleared
2006-07-21

(60 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 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.
More Information

Not Found

No
The document describes standard image processing and co-registration techniques without mentioning AI or ML.

No
The device is a software application for co-registering and displaying medical images, intended for diagnosis and evaluation, not for providing therapy.

Yes
The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician, reviewed images may be used as an element for diagnosis." This indicates the device provides information that contributes to a diagnosis.

Yes

The device description explicitly states "The Quantiva™ is a Class II software application". While it mentions utilizing standard P.C. hardware, the device itself is defined as the software.

Based on the provided information, the Quantiva™ software is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens from the human body. The Quantiva™ software processes and displays medical images (CT and PET) taken of the human body, not from the human body.
  • The intended use describes image processing and visualization. The primary functions are co-registration, display, processing, rendering, viewing, storing, printing, and distributing medical images. While it includes measurement and segmentation functions, these are applied to the images themselves, not to biological samples.
  • The device description focuses on image processing and display. It describes the software as a tool for visualizing and manipulating image data.
  • There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.

The Quantiva™ software falls under the category of medical image processing and analysis software, which is distinct from IVDs.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

PET plus CT images

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified radiological technological technologist; diagnosing radiologist; trained professionals (including but not limited to: radiologists, clinicians and technicians); trained physician

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Fusion7D, K033955, Mirada Solutions Ltd.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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).

0

K611418 510(k) Summary

Quantiva™

JUL 21 2006

1 May 2006JUL 21 2006
SponsorConsultant
Tomographix IP Ltd.Mr. Richard Keen
33 Hazelton Avenue, Suite 88Compliance Consultants
Toronto, Ontario M5R 2E31151 Hope Street
Voice 416 638 3103Stamford, CT 06907-1659
Fax 416 924 5884203 329 2700 F 203 329 2345
audrius@tomographix.comrkeen@fda-complianceconsultants.com
Proprietary Name:Quantiva™
Common NameQuantiva™
Device Classification NameSystem, Image Processing Radiological
Classification Name:Picture Archiving and Communication System
Product CodeLLZ
Device ClassificationClass II
Establishment registration No.Not applicable (foreign manufacture)
Predicate DeviceFusion7D, 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 -

2

Page 2 --

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
Other240-276-0100

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 (800) 638-2041 or (240) 276-3150

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

3

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)


Concurrence of CDRH, Office of Device Evaluation (ODE)