MIM 4.0 (NEURO

K060816 · Mimvista Corp. · LLZ · May 16, 2006 · Radiology

Device Facts

• Record ID: K060816
• Device Name: MIM 4.0 (NEURO
• Applicant: Mimvista Corp.
• Product Code: LLZ · Radiology
• Decision Date: May 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MIM 4.0 (NEURO) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Region of Interest (ROI) feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to tumors and organs. MIM 4.0 (NEURO) also aids the physician in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections, or within standardized regions of interest.

Device Story

Standalone software for diagnostic imaging; operates on Windows 2000/XP. Inputs: DICOM FET, ECAT PET, SPECT, CT, MRI images. Functions: image registration, fusion, display; cardiac left ventricular function/perfusion analysis (volumes, ejection fraction); ROI contouring; automated quantitative/statistical analysis of PET/SPECT brain scans via nonlinear registration to template space. Used by physicians in clinical settings. Output: processed images, quantitative metrics, statistical comparisons. Assists physician in assessment of brain scans and cardiac function; aids clinical decision-making by providing standardized analysis and reducing time for object definition.

Clinical Evidence

Bench testing only. Performance and functional testing conducted on the software; passed all performance requirements and met specifications.

Technological Characteristics

Standalone software package; Windows 2000/XP platform. Functions: image registration, fusion, ROI contouring, quantitative/statistical analysis. Nonlinear registration algorithm for template space alignment. Supports DICOM, ECAT PET, SPECT, CT, MRI modalities.

Indications for Use

Indicated for physicians to register, fuse, and display multi-modal medical images (SPECT, PET, CT, MRI). Assists in defining structures (tumors, organs, cardiac left ventricular cavity) and assessing PET/SPECT brain scans via quantitative/statistical comparison to templates or other scans.

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

• MIM® 3.5 (K052379)
• NeuroQ™ (K041022)
• Scenium™ (K042863)
• Mirage™ (K010726)

Submission Summary (Full Text)

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Koyo814

# 510(k) Summary of Safety and Effectiveness

(The following information is in conformance with 21 CFR 807.92)

### Submitter:

MIMvista Corp. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122 Phone: [phone] Fax: [phone]

Contact Person: Peter Simmelink

Date Summary Prepared: March 24, 2006

#### Device Name

| Trade Name: | MIM 4.0 (NEURO) |
|----------------------|------------------------------------------|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |

#### Predicate Devices

| K052379 | MIM® 3.5 | MIMvista Corp. |
|---------|----------|--------------------------------|
| K041022 | NeuroQ™ | Syntermed, Inc. |
| K042863 | Scenium™ | Siemens Molecular Imaging Ltd. |
| K010726 | Mirage™ | Segami Corp. |

#### Intended Use

MIM 4.0 (NEURO) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. The Region of Interest (ROI) feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to tumors and organs.

MIM 4.0 (NEURO) also aids the physician in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections, or within standardized regions of interest.

25200 Chagrin Blvd. Suite 200 Cleveland. OH 44122

www.mimvista.com

Tele: 216-896-9798 Fax: [phone]

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K060814

#### Device Description

MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space.

#### Substantial Equivalence

MIM® 4.0 (NEURO) is substantially equivalent to; MIM® 3.5 (CIRCA) software (K052379), NeuroQ™ software (K041022), Scenium™ software (K042863) and Mirage™ (NeuroGam™, NeuroMatch™) Software (K010726).

#### Performance Data

MIMvista has conducted performance and functional testing on the MIM 4.0 (NEURO) software. In all cases, the software passed its' performance requirements and met specifications.

25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122

www.mimvista.com

Tele: 216-896-9798 Fax: [phone]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

MAY 1 6 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Peter Simmelink Chief Operating Officer MIMvista Corportaion 25200 Chagrin Blvd., Suite 200 CLEVELAND OH 44122

Re: K060816

Trade/Device Name: MIM 4.0 (NEURO) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 24, 2006 Received: March 27, 2006

Dear Mr. Simmelink:

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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" around the edge. In the center of the logo is the acronym "FDA" in bold, black letters. Below the acronym are three stars.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat 1 DA's issualice of a successions of the requirements of the Act or any FDA has made a deceminations administered by other Federal agencies. You must comply with all If collars and regulations as numbed to registration and listing (21 CFR Part 807); the Act 3 requirements, merading, out moremants as set forth in the quality labeling (21 CFR Part 801); good manatalating production the electronic product radiation 375cmb (Sections (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) I his letter will anow you to begin manceing your was antial equivalence of your device to a legally premarket nothleation: "The I DA miding of bassamal of in the results 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 If you desire specific advice for your dovies on our working more of the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, please note the regulation entitled, "rhoofamation on your responsibilities under the Act from the CFK 807.97). Tournaly oounly oner generational 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,

Nancy C. Brogdon

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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## INDICATIONS FOR USE

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

Device Name: _MIM

Indications for Use:

The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.

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)

(Posted November 13, 2003)

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