LMS-LIVER

K071241 · Median Technologies · LLZ · Jun 8, 2007 · Radiology

Device Facts

• Record ID: K071241
• Device Name: LMS-LIVER
• Applicant: Median Technologies
• Product Code: LLZ · Radiology
• Decision Date: Jun 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images. LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

Device Story

LMS-Liver is a software application for CT image analysis of the liver. It assists radiologists in lesion evaluation, documentation, and longitudinal follow-up. Input consists of CT images; user identifies lesions via seed point (double-click). Software performs segmentation, computes lesion characteristics (size, volume, intensity), and utilizes 3D registration to match/compare lesions across datasets from different time points. Output includes quantitative measurements and standardized reports. Used in clinical settings by radiologists and qualified clinicians to support oncological workflows. Benefits include standardized assessment of morphological changes and therapy follow-up.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional comparison and hazard analysis.

Technological Characteristics

Software-only application; runs on Windows XP operating system. Features 3D registration techniques, lesion segmentation via seed-point, and automated measurement/reporting tools. Connectivity is implied for standard CT image data ingestion.

Indications for Use

Indicated for adult patients undergoing CT imaging of the liver. Used by radiologists and clinicians to evaluate, document, characterize, and monitor the evolution of hepatic lesions over time.

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

• Syngo TrueD software (K061671)
• Cedara I-Response; Cedara PET/CT (K053301)

Submission Summary (Full Text)

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JUN - 8 2007

# 510(k) Summary

#### Submitter's Information

Submitted by MEDIAN Technologies Le Solaris 120 rue Albert Caquot 06560 Sophia Antipolis France Fax: [phone] Contact: Fredrik Brag, CEO [e-mail] Tel: [phone]

Questions or requests for further information should be addressed to: Michael Auffret, VP Product Management [e-mail] Tel: [phone]

Date summary was prepared: May 14, 2007

### Name of Device

Proprietary name: LMS-Liver Common name: Image visualization and analysis software package Classification Name: Class II 21 CFR 892.2050 LLZ

#### Predicate Devices

| Manufacturer: | SIEMENS | CEDARA |
|-------------------|----------------------------------------------------------|----------------------------------------------------------|
| Common<br>Name: | Accessory to Computed Tomography<br>X-ray System /II/ 90 | Accessory to Computed Tomography<br>X-ray System /II/ 90 |
| Trade Name: | Syngo TrueD software | Cedara I-Response; Cedara PET/CT |
| 510(k)<br>Number: | K061671 | K053301 |

### Device Description

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver can segment hepatic lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity.

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LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.

#### Indication for use

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.

LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.

LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

## Substantial Equivalence Comparison Chart

| Manufacturer | Siemens | Cedara | MEDIAN |
|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------|-----------|
| Product Name | Syngo<br>TrueD<br>software | Cedara I-<br>Response;<br>Cedara<br>PET/CT | LMS-Liver |
| 510(k) | K061671 | K053301 | |
| Software only solution | √ | √ | √ |
| Windows XP operating system | √ | √ | √ |
| CT scans as Input | √ | √ | √ |
| Support the oncological workflow by<br>helping the user assess and document<br>morphological changes in therapy<br>follow-up examinations | √ | √ | √ |
| Compare medical imaging data from<br>different time points | √ | √ | √ |
| Landmark matching and visual<br>alignment | √ | √ | √ |
| Lesion comparison over time | √ | √ | √ |
| Report Generator | √ | √ | √ |

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## Safety

A comprehensive hazard analysis was carried out on MEDIAN Technologies' LMS-Liver software. It concluded that residual risks are acceptable when weighed against the intended benefits of the system.

## Conclusion

LMS-Liver software does not raise new safety risks and is equivalent in function to existing legally marketed devices. LMS-Liver software is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Median Technologies % Mr. Chas Burr President Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890-2920

Re: K071241

Trade/Device Name: LMS-Liver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 30, 2007 Received: May 3, 2007

Dear Mr. Burr:

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/3/Picture/9 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" at the top. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo is circular and contains the letters "FDA" in a stylized design.

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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 yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): _K071241

Device Name: LMS-Liver

Indications for Use:

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.

LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.

LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut lemer no

(Division Sign-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number