EXA

{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 a stylized caduceus symbol, which features three human profiles facing right, with a staff and serpent intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 16, 2014 Viztek LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K142919 Trade/Device Name: EXATM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2014 Received: November 19, 2014 Dear Mr. Kamm: 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 A. Ochs Robert A. Ochs. Ph.D. Acting 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) K142919 Device Name EXATM #### Indications for Use (Describe) EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians. ## Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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, 510(k) Number K142919 Viztek, LLC. 6950 Philips Hwy Jacksonville, FL 32216 Phone: 800.366.5343, Fax: 904.448.9936 Date Prepared: November 3, 2014 Contact: Josip Cermin, President - 1. Identification of the Device: Proprietary-Trade Name: EXA™ Classification Name: Picture Archiving and Communications System Product Code LLZ Regulation 892.2250 Common/Usual Name: PACS System - 2. Equivalent legally marketed device: Viztek OPAL-RAD™ (K063337). - 3. Indications for Use (intended use). EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians. - 4. Description of the Device: EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ RAD suite. - 5. Safety and Effectiveness, comparison to predicate device. The results of software validation and comparison to our predicate device indicates that the new device is as safe and effective as our predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate. - 6. Substantial Equivalence Chart Follows {4}------------------------------------------------ | Characteristic | Viztek OPAL-RAD™ (K063337). | EXA™ K142919 (This submission) | |----------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Opal-RAD™ is a software device that | EXA™ is a software device that receives | | | receives digital images and data from | digital images and data from various sources | | (Unchanged) | various sources (i.e. CT scanners, MR | (i.e. CT scanners, MR scanners, ultrasound | | The indications statement | scanners, ultrasound systems, R/F Units, | systems, R/F Units, computed & direct | | is unchanged from our | computed & direct radiographic devices, | radiographic devices, secondary capture | | predicate. | secondary capture devices, scanners, | devices, scanners, imaging gateways or other | | | imaging gateways other or imaging | imaging sources). Images and data can be | | | sources). Images and data can be stored, | stored, communicated, processed and | | | communicated, processed and displayed | displayed within the system and or across | | | within the system and or across computer | computer networks at distributed locations. | | | networks at distributed locations. Lossy | Lossy compressed mammographic images are | | | compressed mammographic images are | not intended for diagnostic review. | | | not intended for diagnostic review. | Mammographic images should only be | | | Mammographic images should only be | viewed with a monitor cleared by FDA for | | | viewed with a monitor approved by FDA | viewing mammographic images. For primary | | | for viewing mammographic images. For | diagnosis, post process DICOM "for | | | primary diagnosis, post process DICOM | presentation" images must be used. Typical | | | "for presentation" images must be used. | users of this system are trained professionals, | | | Typical users of this system are trained | nurses, and technicians. (SAME) | | | professionals, nurses, and technicians. | | | Configuration | This submission is Software only | SAME | | Film Digitizer | Part of the system | NO | | DICOM | Yes | Yes | | Compression | Wavelet/JPEG2000 | SAME | | Improvements to perform | NO | YES,<br>• The ability to rotate of MIP in MPR mode was the added function.<br>• Verify Multiplanar reconstruction | | Imaging work | | | | Expanded GUI interface to | NO | YES, Expanded GUI Interface for users-<br>changes to allow client EXA to function with Web | | integrate more effectively | | | | with the WEB | | | | Language Capability | NO | YES, Ability to use multilingual interface to<br>client's operating system (i.e foreign country multi-language translation from English).<br>Allows interpretation of Spanish and<br>Portuguese | | | | | | | | | | Worklist Expansion | NO | YES, Web Work list- includes most of the | | - WEB Worklist | | advanced study list features and the entire | | - Client Worklist | | Image Viewing features, but cannot create | | | | Patient CDs or Import images and scanned | | | | documents. Verify Client Worklist- Includes | | | | all the advanced Study List and Image | | | | Viewing features mentioned above. Available | | | | modules in the client worklist provide the | | | | following: Sending and Receiving images | | | | over phone line, local area networks and the | | | | Internet. Included in this includes DICOM | | | | transmission/receive. | | Verify PACS Backend - | NO | YES, Ability to add clarity to DICOM images | | DICOM Improvements | | has been allowed | | Improvements to Panel | NO | YES | | Guide PACS – UAI | | | | Multifunctional Interface | | | | Characteristic | Viztek OPAL-RAD™ (K063337). | EXA™ K142919 (This submission) | | Module Updates | NO | YES,<br>Peer Review-Allows a radiologist to review a report from a second radiologist Exam Report Module functions per specification | | Computer | PC | SAME | | Power source | AC Line (PC Required) | AC Line (PC Required) | {5}------------------------------------------------ - 7. Summary of Bench Testing Conducted: Software Verification and Validation was performed.. Risk Analysis was conducted. The testing showed that the device meets its predetermined Software Requirements Specifications. - 8. Summary of Clinical Testing: Not applicable. The software acquires images via a DICOM network connection from FDA cleared imaging devices. - 9. Conclusion: After analyzing software validation and risk analysis, it is the conclusion of Viztek Inc that the EXA™ is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.