MIRAGE

K972886 · Segami Corp., Inc. · LLZ · Oct 1, 1997 · Radiology

Device Facts

• Record ID: K972886
• Device Name: MIRAGE
• Applicant: Segami Corp., Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the Mirage system of image acquisition, processing and analysis is to provide the Nuclear Physician with a tool to acquire, format and store the data acquired by a camera, to display in all the traditional manners, to add three-dimensional renderings to the displays, and to display some kinetic attributes of the imaged organs or systems. The major benefits are the ease of use, the speed of processing, and the variety of display alternatives.

Device Story

Mirage is a software system for nuclear medicine image acquisition, processing, and post-processing. It accepts raw signals from scintigraphy cameras; formats data; performs tomographic reconstruction; and enables visualization/analysis. Used in clinical settings by nuclear physicians to review planar or tomographic, static or dynamic images. Output includes traditional displays, 3D renderings, and kinetic animations. Facilitates clinical decision-making by providing efficient data management and varied display alternatives for organ/system assessment.

Clinical Evidence

Clinical equivalence was evidenced by demonstrating that in clinical applications (using current or archival cases), the clinician's conclusion would not have differed substantially from those of the predicate devices.

Technological Characteristics

PC-based architecture running on Windows NT; software written in Visual C++. Functions include camera-driven acquisition, tomographic reconstruction, and post-processing/visualization. Supports patient data management. No specific hardware materials or sterilization methods listed as it is a software-only system.

Indications for Use

Indicated for the acquisition, formatting, and storage of scintigraphy camera output data. Capable of processing and displaying information in traditional formats, pseudo three-dimensional renderings, and animated sequences showing kinetic attributes of imaged organs. Intended for use by nuclear physicians.

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

• ICON COMPUTER SYSTEM (K914350)
• SOPHY NXT (K913641)

Submission Summary (Full Text)

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# Segami Corporation

# ×972886

## 10. 510K Summary

OCT - 1 1997

## 10.1. Identification

ﻟﻤﺴﺘﻘ

10.1.1 Date of Application:

10.1.2 Manufacturing Facility:

August 4, 1997

Segami Corporation, Inc. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: [phone] fax: [phone]

10.1.3 Contact Person :

Philippe Briandet Ph.D. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: [phone] fax: [phone]

10.1.4 Signature

Philippe Briander

Date 08-04-97

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#### 10. 2. Device Name

ﻴﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ

10.2.1 Classification Name:

10.2.2 Common/Usual Name:

Image Processing System

Nuclear Medicine Planar and SPECT Image Processing Software

10.2.3 Proprietary Name:

MIRAGE

#### 10.3. Substantial Equivalence (Predicate devices)

The predicate devices are the ICON COMPUTER SYSTEM by Siemens Medical Systems, Inc.(Product code JWM, 510K # K914350) and SOPHY NXT by Sopha Medical Systems, Inc.(product code KPS and 501K# K913641).

Substantial equivalence was shown non-clinically by demonstrating that Generic Image Operations, Generic Tomographic post-processing, First Pass Ventriculography and Planar Gated Blood-pool Analysis did not yield substantially different results from those of the predicate devices.

Substantial equivalence was evidenced clinically by demonstrating that in the clinical applications (of current clinical cases or archival cases) the clinician's conclusion would not have differed substantially.

The technological characteristics which differ have no effect on the software's results: The Mirage system is based on the PC architecture (versus Macintosh and proprietary for predicate devices), the operating system is Windows NT (versus Macintosh and Forth), the software language is Visual C++ (versus Pascal and Forth).

The Patient Data Management went through a separate technical test in which the validity and integrity of the data was evaluated.

#### Conclusion:

The Mirage Software package is closely similar in intended use and technical characteristics to the predicate devices. The product raises no new questions regarding safety or effectiveness. Segami Corporation. Inc. concludes that the product is essentially equivalent to devices of the same classification previously approved.

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#### 10.4 Description.

Camera driven acquisition software refers to the formatting of camera signals into spatial distributions, and producing timing signals allowing camera defined acquisition or motion to proceed. The term processing refers to all manners of data manipulation, following the acquisition. including the reconstruction of tomographic volume data from multiple projection acquisitions. The term post-processing refers to image manipulation and analysis which occurs after the image (planar or tomographic, static or dynamic) has been formed. Post-processing specifically includes display methods, which determine how the user can (re)view and interpret the data.

The most crucial component for a post-processing system, which should be able to receive and handle data (images) from different origins (acquisition systems), is the Patient Data Management.

The product (Mirage) is basically a camera driven acquisition, processing and postprocessing (visualization and analysis) software system with a Patient Data Management system, to which minimal processing (e.g. tomographic reconstruction) has been added.

#### 10.5 Statement of Indication for use.

The intended use of the Mirage system of image acquisition, processing and analysis is to provide the Nuclear Physician with a tool to acquire, format and store the data acquired by a camera, to display in all the traditional manners, to add three-dimensional renderings to the displays, and to display some kinetic attributes of the imaged organs or systems. The major benefits are the ease of use, the speed of processing, and the variety of display alternatives.

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Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850

Philippe Briandet, Ph.D. President Segami Corporation 12624 Golden Oak Drive Ellicott City, MD 21042

OCT - I 1997 Re: K972886 Mirage Nuclear Medicine Image Processing System Dated: August 4, 1997 Received: August 5, 1997 Unclassified/Procode: 90 LLZ

Dear Dr. Briandet:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Pracice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.J.Liau Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K972886

Device Name: Mirage

Indications for Use:

The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Thavid A. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)