EV Insite System

{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 seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right features a series of abstract, overlapping human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 24, 2016 PSP Corporation % Ms. Adrienne Lenz Senior Consultant, OA and RA Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 AUSTIN TX 78701 Re: K152716 Trade/Device Name: EV Insite System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 1, 2016 Received: March 3, 2016 Dear Ms. Lenz: 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 Ocko 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) K152716 Device Name EV Insite System #### Indications for Use (Describe) EV Insite System by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> 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 Drug 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}------------------------------------------------ # 510(k) Summary # EV Insite System # K152716 #### 1. Submission Sponsor PSP Corporation Nishi-azabu 28 Moribldg. Nishi-azabu 4-16-13 Minato-ku,Tokyo 106-0031 JAPAN Kenji Ishida Legal Department Phone number: 03-5485-1028 #### 2. Submission Correspondent Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: 262-290-0023 Office Phone: (512) 327.9997 Contact: Adrienne Lenz, Senior Consultant Quality Assurance and Regulatory Affairs Email: project.management@emergogroup.com #### 3. Date Prepared March 1, 2016 #### 4. Device Identification | Trade/Proprietary Name: | EV Insite System | |-------------------------|---------------------------------------------------| | Common/Usual Name: | Picture archiving and communications system (PACS | | Classification Name: | Picture archiving and communications system | {4}------------------------------------------------ | Regulation Number: | 892.2050 | |-----------------------|---------------------------------------------| | Product Code: | LLZ, System, Image Processing, Radiological | | Device Class: | Class II | | Classification Panel: | Radiology | #### 5. Legally Marketed Predicate Device(s) K123174 Centricity PACS-IW with Universal Viewer, manufactured by GE Healthcare #### 6. Device Description The EV Insite System is comprised of two pieces of software: EV Insite R and EXtServer. It is a medical image display and processing software product that provides users with capabilities relating to the storage, communication, digital processing and display within the system or across computer networks of medical images. Images can be searched and displayed in a number of layouts as well as stacked. Image and information processing functions include: paging, magnification, gradation, annotation, PET/CT fusion, multiplaner reconstruction (MPR), Maximum Intensity Projection (MIP), superimposing, measurement, multi-display, flip, rotate, and mirror, cine window level adjustment, and comparison display. The EV Insite system includes features to access and manage medical imaging studies from DICOM 3.0 compliant imaging modalities, and provides information after processing for diagnosis. The EV Insite System software displays image processing results and allows online image search and reading. It does not perform any automatic diagnosis. The system does not produce any original medical images but can be used for primary diagnosis, except for lossy compressed mammographic images which must not be reviewed for primary image interpretations unless using an FDA cleared display. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. All images located on the EV Insite system have been received from DICOM compliant modalities and/or image acquisition systems. The EV Insite system allows trained professionals to display and manipulate images stored in DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants. The EV Insite system is designed to be deployed over conventional networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems. {5}------------------------------------------------ # 7. Indication for Use Statement EV Insite system by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. # 8. Substantial Equivalence Discussion The following table compares the EV Insite System to the predicate device with respect to indications for use, principles of operation, and technological characteristics. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | Manufacturer | PSP Corporation | GE Healthcare | Significant Differences | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | EV Insite System | Centricity PACS-IW | | | 510(k) Number | This submission | K123174 | None | | Product Code | LLZ | LLZ | None | | Regulation Number | 892.2050 | 892.2050 | None | | Indications for Use | EV Insite system by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks.<br>Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.<br>Lossy compressed | Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for | None | | Manufacturer | PSP Corporation | GE Healthcare | Significant<br>Differences | | Trade Name | EV Insite System | Centricity PACS-IW | | | Indications for<br>Use, continued | mammographic images must<br>not be reviewed for primary<br>image interpretations.<br>Mammographic images may<br>only be interpreted using an<br>FDA cleared display that meets<br>technical specifications<br>reviewed and accepted by FDA. | primary image interpretations.<br>Mammographic images<br>may only be interpreted using<br>an FDA approved<br>monitor that offers at least 5<br>Megapixel resolution and meet<br>other technical specifications<br>reviewed and accepted by the<br>FDA.<br>Typical users of this system are<br>trained professionals, including<br>but not limited to radiologists,<br>physicians,<br>nurses, medical technicians,<br>and assistants. | | | Mechanism of<br>Action | Software that runs on<br>commercially available off-the-<br>shelf computer hardware<br>platforms. | Software that runs on<br>commercially available off-the-<br>shelf computer hardware<br>platforms. | None | | Technology<br>Overview | Medical image display and<br>interpretation software<br>product that is part of a picture<br>archiving and communications<br>system. It provides users with<br>capabilities relating to the<br>acceptance, transfer, display,<br>storage, and digital processing<br>of medical images (including<br>digital mammograms). The<br>software is run on<br>commercially available<br>hardware specified in the<br>labeling. | Medical image display and<br>interpretation software<br>product that is part of a picture<br>archiving and communications<br>system. It provides users with<br>capabilities relating to the<br>acceptance, transfer, display,<br>storage, and digital processing<br>of medical images (including<br>digital mammograms). The<br>software is run on<br>commercially available<br>hardware specified in the<br>labeling. | None | | Manufacturer | PSP Corporation | GE Healthcare | Significant | | Trade Name | EV Insite System | Centricity PACS-IW | Differences | | Compatible<br>Imaging<br>Modalities | Computed Tomography (CT),<br>Magnetic Resonance (MR),<br>Ultrasound (US), Nuclear<br>medicine (NM), Computerized<br>radiography (CR), Digital<br>mammography (MG), Digital x-<br>ray (DX), Positron Emission<br>Tomography (PET/PT), X-Ray<br>Angiography (XA), Digital Intra-<br>oral X-Ray (IO),<br>Radiotluoroscopic X-ray (RF),<br>Secondary Capture Images (SC),<br>Visible Light (VL) Endoscopic,<br>Microscopic and Photographic<br>ImageStorage and other<br>DICOM imaging modalities. | Computed Tomography (CT),<br>Magnetic<br>Resonance (MR), Ultrasound<br>(US), Nuclear medicine (NM),<br>Computerized radiography<br>(CR), Digital mammography<br>(MG), Digital x-ray (DX),<br>Positron Emission Tomography<br>(PET/PT), X-Ray Angiography<br>(XA),Digital Intra-oral X-Ray<br>(IO), Radiotluoroscopic X-ray<br>(RF), Secondary Capture Images<br>(SC), Visible Light (VL)<br>Endoscopic, Microscopic and<br>Photographic Image<br>Storage, Slide Coordinates<br>Microscopic Image Storage,<br>Presentation States (PS), Key<br>image Notes (KIN) and other<br>DICOM imaging modalities. | EV Insite System<br>has fewer<br>compatible<br>imaging<br>modalities. Both<br>systems are<br>compatible with<br>the most widely<br>used imaging<br>modalities. | | Image Sources | DICOM, JPEG Baseline (Process<br>1), JPEG Extended (Process 2 &<br>4),<br>JPEG Lossless, Non-<br>Hierarchical, First-Order<br>Prediction (Process 14<br>[Selection Value 1]), RLE<br>Lossless | DICOM, JPEG and JPEG 2000 | EV Insite System<br>does not support<br>Jpeg2000. | | Image and<br>Information<br>Processing<br>Functions | Image Search/list<br>Image Display (number of<br>layouts)<br>Image stack<br>Paging,<br>Magnification<br>Demagnification, | Image Search/list<br>Image Display (number of<br>layouts)<br>Image stack<br>Mammography Viewer<br>Paging,<br>Slab Scroll<br>Magnification | Centricity has<br>more processing<br>functions,<br>including special<br>processing for<br>mammograms, 3-<br>D Rendering,<br>Ultrasound<br>Measurements,<br>Spine Labeling, | | Manufacturer | PSP Corporation | GE Healthcare | Significant | | Trade Name | EV Insite System | Centricity PACS-IW | Differences | | Image and<br>Information | Windowing (Window level<br>adjustment), | Demagnification,<br>Sharpen | ortho images,<br>vessel analysis, | | Processing<br>Functions<br>continued | Annotation,<br>PET-MR/CT Fusion,<br>Multiplaner reconstruction<br>(MPR),<br>Maximum Intensity Projection<br>(MIP),<br>Image overlay,<br>Measurement,<br>Multi-display,<br>Flip, Rotate, and Mirror<br>Cine<br>Comparison display<br>Convolution. | Annotation,<br>Image overlay,<br>PET/CT Fusion<br>Multiplaner reconstruction<br>(MPR),<br>Maximum Intensity Projection<br>(MIP),<br>3-D Rendering<br>Measurement,<br>Multi-display,<br>Flip, Rotate, and Mirror<br>Cine<br>Window level adjustment, and<br>Comparison display<br>Ultrasound Measurements<br>Spine Labeling<br>Ortho tools<br>Vessel Analysis<br>Advanced PET/CT | advanced PET/CT<br>and digital<br>subtraction<br>angiography. EV<br>Insite System's<br>fusion function<br>includes PET/MR<br>in addition to<br>PET/CT like<br>Centricity. | # Table 5A – Comparison of Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of EV Insite System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, PSP Corporation completed non-clinical performance tests. The EV Insite System meets all the requirements for overall design results confirming that the design output meets the design inputs and specifications for the device. The EV Insite System passed all the testing in accordance with internal requirements shown below to support substantial equivalence of the subject device: - . Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or a latent design flaw in the software device could lead to an erroneous diagnosis that would lead to a minor injury. Verification {9}------------------------------------------------ and validation of the EV Insite System Software consists of unit testing, software testing and system verification and validation. - The EV Insite System software was developed and tested following processes in compliance with IEC 62304: 2006 Medical Device Software - Software Life Cycle. # 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. # 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s). The EV Insite System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).