CADSTREAM VERSION 5

{0}------------------------------------------------ K092954 # 510(k) Summary 5 # NOV - 6 2009 This 510(k) summary is submitted as part of the PreMarket Notification in accordance with the requirements of SMDA 1990, 21 CFR 807.87(h), and 21 CFR 807.92. | 1. | Date Prepared | September 22, 2009 | |----|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | 2. | 510(k) Submitter | Merge CAD Inc<br>11040 Main Street, Suite 100<br>Bellevue, WA 98004<br>Phone: 425-691-1400<br>Fax: 425-691-1599 | | 3. | 510(k) Contact Person | Brent Lewis, Director Regulatory<br>Affairs and Quality Assurance<br>Email: brentlewis@merge.com<br>Phone: 206-455-5398<br>Fax: 425-691-1599 | | 4. | Device Common Name | Image Processing System | | 5. | Device Trade Name | CADstream Version 5 | | 6. | Classification Regulation | 21 CFR 892.2050 | | 7. | Class | 2 | | 8. | Panel | Radiology Panel | | 9. | Product Code | LLZ | #### 10. Comparison with Legally Marketed Devices CADstream version 5 has been modified to add capability and user interface changes for calculation and presentation of apparent diffusion coefficient (ADC) maps and values, as is common in MRI imaging systems for general MRI studies. This modification is consistent with the previously cleared indications for use and does not alter the fundamental scientific technology of the device. The primary predicate is therefore the previous clearance of CADstream 5 in K081556. Table 1 includes several additional predicate devices cleared with substantially equivalent ADC features to those being implemented for CADstream 5. #### Table 1: Predicate Devices | Manufacturer | Product | Cleared 510(k) | Product Code | Classification | |---------------|-------------|----------------|--------------|----------------| | Merge CAD Inc | CADstream 5 | K081556 | LLZ | 2 | | Cedara | I-Response | K053301 | LLZ | 2 | | Medtronic | StealthViz | K081512 | LLZ | 2 | {1}------------------------------------------------ #### 11. Device Description CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. CADstream receives DICOM magnetic resonance images from a PACS of directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer. Available features support: - . Visualization (standard image viewing tools, MIPs, and reformats) - Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering) - Reporting of user-selected findings and assessment - Interventional planning - Workflow efficiency ■ - 예 Communication and storage (DICOM import/export, query/retrieve, and study storage) The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer. ### 12. Indications for Use CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally. CADstream assists users in planning MRI guided interventional procedures. {2}------------------------------------------------ When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream. CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images. #### 13. Performance Testing The subject device modification has undergone risk analysis to assess the impact of the modification on the device. Based on the risk analysis. verification testing was completed and results demonstrate that the predetermined acceptance criteria were met. #### 14. Conclusion CADstream Version 5 provides features to integrate radiology department workflow by facilitating the visualization, analysis, and reporting of MR images. The potential hazards of adding the ADC map functionality have been studied and controlled as part of the product development process, including risk analysis and design considerations. The successful completion of verification testing has demonstrated conformance to design controls, user needs, and intended use, and that the device is safe and effective. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health and human services. The eagle is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Mr. Brent Lewis Director, Regulatory Affairs and Quality Assurance Merge CAD, Inc. (formerly Confirma, Inc.) 11040 Main Street, Suite 100 BELLEVUE WA 98004 NOV - 6 2009 Re: K092954 Trade/Device Name: CADstream® Version 5 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2009 Received: October 29, 2009 Dear Mr. Lewis: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor to May 28, 1976, the enactment date of the Medical Device Amendments, or to connineroo pror to may 20, 1976, in accordance with the provisions of the Federal Food, Drug, de neces may nat (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110-) the the device, subject to the general controls provisions of the Act. The r ou may, morelore, manos 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 If your device is classified (boo acove) => Existing major regulations affecting your device can be may be subjoct to additions, 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 i toase of devisou has i Drivination that your device complies with other requirements of the Act that I Dri has made a determinations administered by other Federal agencies. You must or any I edelared the Act's requirements, including, but not limited to: registration and listing comply with and rice Frequirements, rt 801); medical device reporting (reporting of medical {4}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sec device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forth in the quality byttering (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dontersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mup://www.lua.gov/rtbound.blogical Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radiological ground to premarket notification" (21CR Part note the regulation entined, "Misorananing of reference events under the MDR regulation (21 CFR Part 803), please go to CHK Part 803), please go to http://www.rada.go/ Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## 4 # Indication(s) for Use Statement (092954 510(k) Number: Device Name: CADstream® Version 5 Indications for Use: CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream. CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Halil Demur (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ Merge CAD Inc CADstream 5 Special 510(k) Page 15