MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE

K051528 · Mevis Technology GmbH & Co. KG · LLZ · Jul 20, 2005 · Radiology

Device Facts

• Record ID: K051528
• Device Name: MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
• Applicant: Mevis Technology GmbH & Co. KG
• Product Code: LLZ · Radiology
• Decision Date: Jul 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The MeVis LiverAnalyzer / LiverViewer Software™ device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safety-margins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches. Medical image data is derived from various sources (i.e. CT scanners, MRI scanners). Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Device Story

PC-based software imports DICOM CT/MRI images; performs organ, tumor, and intrahepatic vessel segmentation; approximates vascular territories. Users interactively define virtual resections and calculate safety margins around lesions to identify affected vascular branches. Output displayed to surgeons for preoperative planning; assists in evaluating surgical strategies. Used in clinical settings by trained professionals (physicians, nurses, technicians). No patient contact; software does not control life-sustaining equipment. Human interpretation required for all displayed information.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

PC-based software application; imports DICOM format CT/MRI images. Performs organ, tumor, and vascular segmentation via voxel-based volume calculation. Standalone software; no patient contact. Hazard analysis level of concern: minor.

Indications for Use

Indicated for preoperative planning in liver surgery. Intended for use by trained professionals (physicians, nurses, technicians) to analyze CT/MRI image data for organ/tumor segmentation, vascular segmentation, and virtual resection planning.

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

• VoxelPlus PACS (K022692)
• Preview Treatment Planning Software (K040852)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string starts with a period followed by the letter 'K'. The string continues with the numbers '051528'. The numbers are written in a clear, legible font.

Image /page/0/Picture/1 description: The image shows a logo for a company called MeVis. The logo is in black and white and features the company name in a stylized font. Below the company name is the text "Centrum fur Medizinische Diagnosesysteme und Visualisierung GmbH". The logo is simple and modern, and it is likely used to represent the company's brand.

## JUL 2 0 2005

### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: June 5, 2005

Submitter's Information: 21 CFR 807.92(a)(1) Dr. Markus Lang MeVis - Center for Medical Diagnostic Systems and Visualization GmbH Universitätsallee 29 D-28359 Bremen, Germany Phone: [phone]

Fax : [phone] E-mail: [e-mail]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) MeVis LiverAnalyser / LiverViewer Software™ Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892 2050 LLZ System, Image Processing Name:

Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological |
|----------------------------|-------------------------------------------|-------------------------------------------|
| Regulation Number | 892.2050 | 892.2050 |
| 510(k) Number | K022692 | K040852 |
| Device Name | VoxelPlus PACS | Preview Treatment<br>Planning Software |
| Applicant | Mevisys Co. Ltd. | Medical Media Systems,<br>Inc. |
| Product Code | LLZ | LLZ |

Device Description: 21 CFR 807 92(a)(4)

MeVis LiverAnalyser / LiverViewer Software™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format. The MeVis-LiverAnalyser is used to analyze data for preoperative planning in liver surgery. The MeVis-LiverAnalyzer contains dedicated methods for organ segmentation, tumor segmentation, and segmentation of intrahepatic vasculature as well as for the approximation of vascular territories. While using the MeVis-LiverAnalyser a number of masks are produced to merge voxels into sets. Each of this set is meant to represent a specific anatomical entity. All volumes calculated by the MeVis-LiverAnalyzer are given directly by the number of voxels in one of these sets multiplied by the voxel volume. No direct measure of anatomical entities is performed.

I

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Image /page/1/Picture/0 description: The image shows a logo for MeVis, which appears to be a company or organization. The logo features the name "MeVis" in a stylized font, with the "Me" part larger and bolder than the "Vis" part. Below the name, there is some smaller text, which is difficult to read due to the image quality. Further down, there is more text that reads "Centrum fur Medizinische Diagnosesysteme und Visualisierung GmbH".

#### Indications for Use: 21 CFR 807 92(a)(5)

The MeVis LiverAnalyzer / LiverViewer Software™ device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ seamentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safety-margins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches.

Medical image data is derived from various sources (i.e. CT scanners, MRI scanners). Typical users of this system are trained professionals, including physicians, nurses, and technicians.

#### Technological Characteristics: 21 CFR 807 92(a)(6)

MeVis LiverAnalyser / LiverViewer Software™ is a software product that assists surgeons when doing preoperative planning and post-operative follow-up. MeVis LiverAnalyser / LiverViewer Software™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format.

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.

#### Conclusion: 21 CFR 807 92(b)(1)

The 510 (k) Pre-Market Notification for MeVis LiverAnalyser / LiverViewer Software™ device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

MeVis LiverAnalyser / LiverViewer Software™ device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with text around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2005

MeVis - Center for Medical Diagnostic Systems and Visualizations GmbH % Mr. Carl Alletto 1600 Manchester Way CORINTH TX 76210

Re: K051528 Trade/Device Name: MeVis LiverAnalyser/ LiverViewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 11, 2005 Received: June 15, 2005

Dear Mr. Alletto:

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.

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.

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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.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 CFR 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/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): 长۵5 1528

Device Name: MeVis LiverAnalyzer / LiverViewer Software™ device

Indications for Use:

The MeVis LiverAnalyzer / LiverViewer Software™ device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safetymargins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches.

Medical image data is derived from various sources (i.e. CT scanners, MRI scanners).

Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Prescription Use
(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)

Nancy C Brogdon