LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K033374 · Siemens AG Medical Solutions · OEB · Nov 6, 2003 · Radiology

Device Facts

• Record ID: K033374
• Device Name: LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
• Applicant: Siemens AG Medical Solutions
• Product Code: OEB · Radiology
• Decision Date: Nov 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (eg. nodules) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing). This visualization tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape and position.

Device Story

LungCare CT is a software package for analyzing CT volume datasets. It processes CT images to assist physicians in identifying, evaluating, and tracking lung lesions. The device utilizes digital image processing tools (MIP, MPR, SSD, VRT) and an automated segmentation workflow (Nodule enhanced Viewing) to identify potential lesions. It displays connected voxels above a specific Hounsfield-Unit (HU) threshold to calculate lesion contours. The software provides volumetric analysis and classification tools for lesion size, shape, and position. Used in clinical settings by physicians, the output is presented as a visualization tool to support clinical decision-making regarding lesion growth over time. It facilitates documentation and follow-up of pulmonary nodules.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, software verification, and validation testing.

Technological Characteristics

Software-based image analysis package; operates on syngo platform. Features automated segmentation using Hounsfield-Unit (HU) thresholding to identify connected voxels. Includes tools for MIP, MPR, SSD, and VRT. Designed for use with standard or low-dose spiral CT data.

Indications for Use

Indicated for physicians to confirm presence/absence of lung lesions (nodules) in patients undergoing standard or low-dose spiral CT scanning. Supports evaluation, documentation, and longitudinal follow-up of lesion growth, size, dimensions, shape, and position.

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

• LungCare CT Software (K022013)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The font appears to be a bold sans-serif style. The letters have a slightly rough or distressed texture, giving them a vintage or worn appearance.

NOV - 6 2003

510(k)

Page 1 of 3

# Attachment 9

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## - 510(k) - Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### GENERAL INFORMATION l.

#### Device Name and Classification 1.

| Product Name: | LungCare CT<br>Software Package with extended functionality |
|-----------------------|-------------------------------------------------------------|
| Common Name: | 3D CT Reconstruction Software |
| Classification Name: | Accessory to Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

### Importer/Distributor Establishment: 2. Registration Number: 2240869

Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

#### 3. Manufacturing Facility:

Siemens AG Medical Solutions Henkestrasse 127

D-91052 Erlangen, Germany

#### 4. Contact Person:

Mr. Rüdiger Körner Regulatory Submissions Siemensstr.1; D-91301 Forchheim [phone] Phone: [phone] Fax:

- Date of Preparation of Summary: September 19th 2003 5.

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# SIEMENS

510(k) Page 2 of 2

K033374

### SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL II. EQUIVALENCE DETERMINATION

#### General Safety and Effectiveness Concerns: 6.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

#### 7. Substantial Equivalence:

The LungCare CT software package with extended functionality, adressed in this premarket notification, is substantially equivalent to the following commercially available software package

| Manufacturer | Product | 510(k) | Clearance date |
|--------------|----------------------|---------|----------------|
| 1. Siemens | LungCare CT Software | K022013 | July 16, 2002 |

In summary, Siemens is of the opinion that LungCARE CT software package with extended functionality does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.

#### Device Description and Intended Use: 8.

This premarket notification covers Siemens LungCARE CT software package with extended functionality. It is based on Siemens syngo software platform.

This premarket notification covers Siemens LungCARE CT - Software package with extended functionality. LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools (MIP, MPR SSD, VRT), evaluation tools (volumetric estimation using consistent standardised measurement protocol, comparator tool for lesion matching by synchronisation of two datasets, classification of lesions using configurable descriptors) and reporting tools (targeted presets, saved lesion location) with optimised workflow palette. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing).

This software package is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. lesions) in addition to evaluation, documentation and follow-up of any such lesions using standard or lowdose spiral CT scanning. This visualisation tool allows for volumetric analysis of pulmonary lesion or lesion size over time, helping the Physician to assess the

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# SIEMENS

K033374

510(k

changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

The enhanced part of the LungCARE CT software package provides an extended evaluation of segmentation by displaying all connected voxels above a certain HU ( Hounsfield-Unit ) threshold. The system will now indicate the voxels of equivalent signal level and calculate the contours of the suspicious lesion/lesion.

م 510(k) submission for SIEMENS ' LungCare – Nodule enhanced Viewing Software Package

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, often associated with healthcare organizations.

### Public Health Service

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K033374

> Trade/Device Name: LungCare CT Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: October 16, 2003 Received: October 22, 2003

Dear Mr. Preiss:

This letter corrects our substantially equivalent letter of November 6, 2003.

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 (PMA), 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.

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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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely vours.

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SIEMENS

510(k)

Attachment 2

## Indication for use

510(k) Number (if known):

K 433374

Device Name: functionality

LungCare CT - Software Package with extended

LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (eg. nodules) in addition to evaluation, documentation and follow-up of any such lesions using standard or low-dose spiral CT scanning. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing).

This visualization tool allows for volumetric analysis of pulmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape and position.

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use

er 21 CFR \$801.109)

OR Over-The-Counter Use

Nancy Croasdon
Dir. of Off.

Division Sign-On
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K033374

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