Stroke VCAR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 20, 2016 Ge Medical Systems SCS % Jeme Wallace Regulatory Affairs Director GE Healthcare 540 W Northwest Highway BARRINGTON IL 60010 Re: K152584 Trade/Device Name: Stroke VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 17, 2015 Received: September 18, 2015 Dear Jeme Wallace: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Robert Oolo Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152584 Device Name Stroke VCAR ### Indications for Use (Describe) Stroke VCAR is a CT image analysis software package that provides information to physicians to assist them in the analysis and visualization of Brain CT data derived from DICOM 3.0 compliant CT scans. Stroke VCAR is designed for the purpose of segmenting and assessing intracerebral and intracranial hemorrhages in the brain using semi-automated tools on non-contrast CT exams. Additionally Stroke VCAR provides a set of workflow tools for the segmentation and visualization of aneurysms in the brain from contrast enhanced CT exams. It is intended for use by clinicians to process, review, archive, print and distribute CT studies. This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, giving the logo a classic and recognizable appearance. # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | September 9, 2015 | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems SCS | | | 283, rue de la Minière | | | 78530 Buc, France | | Primary Contact Person: | Peter Uhlir | | | Regulatory Affairs Leader | | | Tel: 00 36 1 4793318 | | | Fax: (847) 277 5240 | | Secondary Contact<br>Person: | Jeme Wallace | | | Regulatory Affairs Director | | | GE Healthcare | | | Tel: (847) 277 4468 | | | Fax: (847) 277 5240 | | Device Trade Name: | Stroke VCAR | | Common/Usual Name: | Stroke VCAR | | Classification Names: | 21CFR 892.1750, Radiology | | Product Code: | JAK | | Predicate Device(s): | K041521 - Volume Viewer Plus | | Device Description /<br>Intended Use: | Stroke VCAR is intended to provide 2D and 3D processing,<br>review and analysis of CT images originally acquired to evaluate<br>the cerebral vascular system and/or intracranial bleeding. The<br>combination of the acquired images, reconstructed images,<br>and measurements performed by the clinician using Stroke<br>VCAR are intended to provide the referring physician clinically<br>relevant information for the purpose of diagnosis, treatment<br>planning and follow-up. | | Indications for Use: | Stroke VCAR is a CT image analysis software package that<br>provides information to physicians to assist them in the analysis<br>and visualization of Brain CT data derived from DICOM 3.0<br>compliant CT scans. Stroke VCAR is designed for the purpose of<br>segmenting and assessing intracerebral and intracranial<br>hemorrhages in the brain using semi-automated tools on non-<br>contrast CT exams. Additionally Stroke VCAR provides a set of<br>workflow tools for the segmentation and visualization of<br>aneurysms in the brain from contrast enhanced CT exams. It is<br>intended for use by clinicians to process, review, archive, print<br>and distribute CT studies.<br>This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation. | | Technology: | The Stroke VCAR software employs the same fundamental<br>scientific technology as its predicate device. | | Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The Stroke VCAR software complies with NEMA PS 3.1 - 3.20<br>(2011) Digital Imaging and Communications in Medicine (DICOM)<br>Set (Radiology) standard.<br>The Stroke VCAR software employs the same fundamental<br>scientific technology as its predicate device (Volume Viewer).<br>Stroke VCAR SW uses the equivalent CT DICOM image data<br>input requirements. It has equivalent display, formatting,<br>archiving and visualization technologies compared to the<br>predicate device. Stroke VCAR utilizes the enhanced<br>segmentation tools (threshold, auto-select) already found in<br>Volume Viewer and optimizes the segmentation algorithms for Hematoma segmentation and Aneurysm segmentation.<br>Thorough testing of these capabilities has not raised any safety or effectiveness issues.<br>The following quality assurance measures were applied to the development of the system:<br>Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Performance testing (Bench testing, validation) Safety testing (Verification) | | | Summary of Clinical tests: | | | A clinical evaluation study using consented clinical images was<br>conducted by three CT technologists in Part 1 and three board<br>certified neuroradiologists in Part 2a and Part 2b who were<br>considered experts. The study was meant to assess the<br>following: | | | ■ Productivity benefits of automated vs. manual hematoma<br>segmentation (Part 1)<br>■ General user Qualitative feedbacks of the Stroke VCAR<br>edition tools (Part 2a and Part 2b) | | | The study results demonstrated that the workflow time to<br>perform automated hematoma segmentation utilizing the<br>Stroke VCAR hematoma edition tool was significantly less than<br>the workflow time to perform hematoma segmentation<br>manually. | | | Additionally study results clearly show that Stroke VCAR adds<br>diagnostic value to the current hematoma and aneurysm<br>clinical workflow and is a useful tool for neuroradiologists to<br>providing comprehensive stroke work-up including automated<br>hematoma and aneurysm processing and analysis,<br>quantification and monitoring. | | | The substantial equivalence determination is based on the<br>software documentation for a MODERATE level of concern<br>device. | | Conclusion: | GE Healthcare considers the Stroke VCAR software application<br>to be as safe, as effective, and performance is substantially<br>equivalent to the predicate device. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are swirling lines around the letters, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.