PRIMELUNG

{0}------------------------------------------------ **Section 1** Ko24149 ## 510(K) Summary (as required by 21 CFR § 807.92) Date: ## A. Submitter's Information: | Name: | Acculmage Diagnostics Corporation | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 400 Grandview Drive<br>South San Francisco, CA 94080 | | Telephone Number: | (650) 875-0192 | | Fax Number: | (650) 875-0194 | | Contact Name: | Oscar Gils Carbó | | Contact Email address: | oscar@accuimage.com | | B. Device Information: | | | Proprietary Name: | PrimeLung | | Common or Usual Name: | Lung nodule visualization and analysis software<br>package. | | Classification: | Class II 21 CFR 892.2050 LLZ | | Substantial Equivalence: | The Acculmage PrimeLung option is Substantially<br>Equivalent to the Siemens Medical Solutions<br>Lungcare CT Software Package, to the GE Medical<br>Systems Advanced Lung Analysis, and to the<br>Acculmage AccuView Workstation with AccuScore<br>software module. | | Device Description: | The Acculmage PrimeLung software module is an<br>additional software option to K990241, AccuView<br>Diagnostics Imaging Workstation with AccuScore,<br>AccuAnalyze, AccuShade, AccuVRT and AccuMIP<br>plug-ins. The AccuShade plug-in is not currently<br>marketed, the AccuMIP plug-in is currently<br>marketed with the name ProjectorPro. The<br>Acculmage PrimeLung plug-in provides<br>visualization and analysis tools for viewing regions<br>of the lung, and generating reports with patient<br>information, images, results and recommendations. | {1}------------------------------------------------ K02-4149 Intended Use: PrimeLunq is a comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the user to analyze lunq nodules and other lung parameters, and to generate an automatic report. #### C. Technological Characteristics of the Device as compared to Predicate Devices: | Manufacturer | Siemens Medical<br>Solutions | GE Medical<br>Systems | Acculmage Diagnostics<br>Corp. | Acculmage<br>Diagnostics Corp. | |-------------------------------------------------------------------|----------------------------------------------------|---------------------------------|---------------------------------------------------------|------------------------------------------------------------| | Product Name | LungCare CT Software | Advanced Lung<br>Analysis | AccuView Workstation with<br>AccuScore, etc. | PrimeLung | | 510(k) Number | K022013 | K013381 | K990241/ K012106 | | | Computer Platform | PC Workstation with<br>Windows Operating<br>System | Sun Workstation | PC Workstation with<br>Windows Operating System | PC Workstation with<br>Windows Operating<br>System | | Type of CT Scanner<br>for which it is<br>applicable | Standard or low-dose<br>spiral CT scanners | At least helical CT<br>scanners | Helical, Multidetector and<br>Electron Beam CT scanners | Helical, Multidetector<br>and Electron Beam CT<br>scanners | | Draw, Edit, Delete<br>ROI (possible<br>nodules | Yes | Yes | Yes | Yes | | Image Processing<br>Tools | MIP, MPR, 3D Volume<br>Rendering | Yes | MIP, MPR, 3D Volume<br>Rendering | MIP, MPR, 3D Volume<br>Rendering | | Segmentation of lung<br>nodule | Yes | Yes | n/a | Yes | | Volume<br>measurements,<br>Comparator tool for<br>nodule matching | Yes | Yes | n/a | Yes | | Report Generator | Yes | Unknown | Yes | Yes | #### Substantial Equivalence Comparison Chart #### D. Brief Discussion of Test Results Submitted: The test plan covers all aspects of the functionality, exercising every user interface button, all menus and submenus, as well as all configurable items, including the measurement tool, segmentation tool and report generator tool. #### E. Conclusions from Test Results: From the Graphic User Interface test results: The Graphic User Interface, its menus and buttons conform as per the PrimeLung functional specification. From a functionality point of view, all functionality works as described in the PrimeLung Functional Specification. From Comparison Tool test results: The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets. From Report Generator Test results: ests results show that the report generator can be created and results can be printed. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 2 1 2003 Mr. Oscar Gils Carbó Vice President Acculmage Diagnostics Corporation 400 Grandview Drive SOUTH SAN FRANCISCO CA 94080 Re: K024149 Trade/Device Name: PrimeLung Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 6, 2002 Received: December 16, 2002 Dear Mr. Carbó: 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 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. Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle. {3}------------------------------------------------ This letter will allow you to begin marketing your device as des 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 the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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 {4}------------------------------------------------ Section 1.1 Ko2449 #### INDICATIONS FOR USE Applicant: Acculmage Diagnostics Corporation 510(k) Number: K024149 PrimeLung Device Name: Indications for Use: Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report. **Prescription Use** **(Per 21 CFR 801.109)** Nancy Hodsdon (Division Sig Division of Re and Radiolog 510(k) Num