LMS-LUNG/TRACK

K070868 · Median Technologies · LLZ · May 15, 2007 · Radiology

Device Facts

• Record ID: K070868
• Device Name: LMS-LUNG/TRACK
• Applicant: Median Technologies
• Product Code: LLZ · Radiology
• Decision Date: May 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports. LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients. LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.

Device Story

LMS-Lung/TRACK is a software package for chest CT image visualization and analysis. Input consists of low or normal dose chest CT datasets. The user identifies pulmonary lesions via seed point selection (double-click); the software then performs automated segmentation to compute lesion characteristics including size, volume, and intensity. Alternatively, users may perform manual 2D measurements. The device matches and compares lesions across longitudinal datasets from the same patient to calculate volume growth and doubling time. Output includes quantitative results and snapshots compiled into an automatic report. Used in clinical settings by radiologists and qualified clinicians to assist in diagnostic thoracic CT examinations. The device aids clinical decision-making by providing standardized measurements of lesion evolution, potentially benefiting patients through improved monitoring of pulmonary nodules.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and functional comparison to legally marketed predicate devices.

Technological Characteristics

Software-based visualization and analysis tool for chest CT images. Features include automated lesion segmentation, 2D/3D measurement algorithms, and longitudinal comparison tools. Operates on standard diagnostic thoracic CT datasets. No specific hardware or material specifications provided.

Indications for Use

Indicated for adult patients undergoing diagnostic thoracic CT examinations. Contraindicated for patients with prior thoracotomy.

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

• CA-1500 (K040028)
• Lung nodule assessment and comparison option (K023785)
• Primelung (K024149)

Submission Summary (Full Text)

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HD70868

## 510(k) Summary

#### Submitter's Information

MAY 1 5 2007

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 9, 2007

## Name of Device

Proprietary name: LMS-Lung/TRACK Common name: Lung nodule visualization and analysis software package Classification Name: Class II, 21 CFR 892.2050, LLZ

## Predicate Devices

| Manufacturer | R2 Technology,<br>inc. | Philips medical<br>systems | Acculmage<br>Diagnostics<br>Corporation |
|------------------|------------------------|-------------------------------------------------------|-----------------------------------------|
| Trade Name | CA-1500 | Lung nodule<br>assessment and<br>comparison<br>option | Primelung |
| 510(k)<br>Number | K040028 | K023785 | K024149 |

## Device Description

LMS-Lung/TRACK provides visualization and analysis tools for chest CT images acquired in low or normal dose.

LMS-Lung/TRACK segments pulmonary lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics

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such as size, volume and intensity. Alternatively, the user can do its own 2D measurements on the lesion.

LMS-Lung/TRACK matches and compares lesions identified by the physician present in two different datasets of the same patient acquired at different dates. It computes the differences of volume and diameters and volume growth.

LMS-Lung/Track provides tool to generate report with snapshots, and results.

## Intended use

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to

- visualize chest CT datasets acquired in low or normal dose: -
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.

f.MS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.

LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.

| Manufacturer | R2Technology | Philips<br>Medical<br>Systems | Acculmage<br>Diagnostics<br>Corporation | MEDIAN<br>Technologies |
|----------------------------------------------------------------------|--------------|-------------------------------------------------|-----------------------------------------|------------------------|
| Product<br>Name | CA-1500 | Lung nodule assessment<br>and comparison option | Primelung | LMS-Lung/TRACK |
| 510(k)<br>Number | K040028 | K023785 | K024149 | |
| CT scans of<br>lungs as Input | √ | √ | √ | √ |
| Interactive 2D<br>and 3D<br>visualizing<br>tools | √ | √ | √ | √ |
| Segmentation<br>of lung lesions<br>(i.e.<br>boundaries<br>detection) | √ | √ | √ | √ |

# Substantial Equivalence Comparison Chart

LMS-Lung/Track software 510(k) K070868

Amendment page 3 of 4

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| Manufacturer | R2 Technology | Philips<br>Medical<br>Systems | Acculmage<br>Diagnostics<br>Corporation | MEDIAN<br>Technologies |
|------------------------------------------------------------------------------|---------------|-------------------------------------------------|-----------------------------------------|------------------------|
| Product<br>Name | CA-1500 | Lung nodule assessment<br>and comparison option | Primelung | LMS-Lung/TRACK |
| Extraction and<br>computation<br>of lesion<br>characteristics<br>(2D and 3D) | ✓ | ✓ | ✓ | ✓ |
| Manual<br>measurement | ✓ | ✓ | ✓ | ✓ |
| Lesion<br>matching over<br>time | ✓ | ✓ | ✓ | ✓ |
| Lesion<br>comparison<br>over time | ✓ | ✓ | ✓ | ✓ |
| Report<br>Generator | ✓ | ✓ | ✓ | ✓ |

## Safety

A comprehensive hazard analysis was carned out on MEDIAN Technologics' LMS-Lung/TRACK software. It concluded that residual risks were acceptable when weighed against the intended benefits of the system.

# Conclusion

LMS-Lung/TRACK software does not raise new safety risks and is equivalent in function to existing legally marketed devices. I MS-Lung/TRACK 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

MAY 1 5 2007

Re: K070868

Trade/Device Name: LMS-Lung/TR ACK Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications syste Regulatory Class: II Product Code: LLZ and JAK Dated: March 26, 2007 Received: March 29, 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 maxi. 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/10 description: The image is a black and white circular logo or seal. The text "1906-2006" is at the top of the circle. The letters "PA" are in the center of the circle in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.

Protecting and Promoting Public Health

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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. B rogdon 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): K070868

Device Name: LMS-Lung/TRACK

Indications for Use:

-

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to

- visualize chest CT datasets acquired in low or normal dose;
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.

LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.

LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(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)

Nancy Croston

Division Sian-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

LMS-Lung/Track software 510(k) K070868

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