ADVANCED LUNG ANALYSIS II

{0}------------------------------------------------ # Ko42694 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). - Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: July 15, 2004 ## PRODUCT IDENTIFICATION | Name: | Advanced Lung Analysis II | |----------------------|---------------------------------------------------------------------------------------| | Classification Name: | Accessory to Computed Tomography System | | Manufacturer: | General Electric Medical Systems<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE | | Distributor: | General Electric Medical Systems, Buc, France. | Marketed Devices The Advanced Lung Analysis II is substantially equivalent to the devices listed below: | • Model: | Advanced Lung Analysis I | |-----------------|------------------------------------------------| | • Manufacturer: | General Electric Medical Systems, Buc - France | | • 510(k) #: | K013381 | - Model: . LungCarc CT - . Manufacturer: Siemens, Malvern - PA19355 510(k) #: K033374 {1}------------------------------------------------ ### Device Description: K04269y CT Advanced Lung Analysis (ALA 2 / ALA II) is a post processing analysis software package designed to assist radiologists and other clinicians in the evaluation and assessment of nodules and other lesions in the lung. Advanced Lung Analysis II provides an effective solution for providing quick analysis and measurements to help differentiate the radiologist's findings during the primary read. The software assesses and measures all lung nodule types, including measuring volume and their changes over time. Following a C1 scan, the user clicks on a specific nodule and the software automatically calculates and displays a 3-dimensional volume and rendering of the nodule as well as the associated measurements. Advanced Lung Analysis II also offers functionality for quick comparisons between the current and previous patient procedures. The Digital Contrast Agent (DCA) option will further compliment the Radiologist's diagnostic capability by highlighting spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars. and vessels. ALA II and DCA are software options that operate on the GE family of LightSpeed multi-slice CT scanners. Advantage Workstation 4.2 (or higher), and GE PACS systems. #### Indications for Use: Advanced Lung Analysis II is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is dcsigned to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA II optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques. {2}------------------------------------------------ ## Comparison with Predicate: K042694 The functional features of Advanced Lung Analysis II software package are substantially equivalent to that of the following device: | Device Name | FDA Clearance Number | |--------------------------|----------------------| | Advanced Lung Analysis I | K013381 | | LungCare CT | K033374 | #### Adverse Effects on Health: The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by: - · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements. - · Adherence to industry and international standards. #### Conclusions: The Advanced Lung Analysis II docs not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advanced Lung analysis II to be equivalent to those of Advanced Lung Analysis I (K013381) and LungCare CT (K033374). {3}------------------------------------------------ #### 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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. #### Public Health Service MAR 1 1 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 GE Medical Systems % Mr. Daniel W. Lehtonen Staff Engineer Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719 K042694 Re: Trade/Device Name: Advanced Lung Analysis II Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: November 8, 2004 Received: November 9, 2004 #### Dear Mr. Lehtonen: This letter corrects our substantially equivalent letter of November 18, 2004. 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. Isting 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. {4}------------------------------------------------ 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 (OS) 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) | (240) 276-0115 | |----------------|----------------------------------|----------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 | | 21 CFR 892.xxx | (Radiology) | (240) 276-0120 | | Other | | (240) 276-0100 | 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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html. Sincerely yours, Image /page/4/Picture/7 description: The image shows a black and white close-up of a handwritten symbol or character. The symbol consists of a curved line that starts thick and tapers to a point, resembling a stylized letter or abstract design. The stroke appears fluid and calligraphic, suggesting it was created with a brush or pen. Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 042694 510(k) Number (if known): Device Name: #### ADVANCED LUNG ANALYSIS II Indications for Use: Advanced Lung Analysis II is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA II optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR × Over-The-Counter-Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Hanson Division of Reproductive, Abdom and Radiological Device Page ﺮ ﺍﻟﻤ