CONI

{0}------------------------------------------------ K130624 Page 1 of 5 # 510(k) Summary GlobalMedia Group, LLC. CONi™ MAY 0 7 2013 Date Prepared: January 8, 2013 Submitter's Information: GlobalMedia Group, LLC 15020 N. 74th St. Scottsdale, AZ 85260 | Contact: | Nicholas Campbell | |----------|-------------------| | Phone: | (480) 398-7430 | | Fax: | (480) 922-1090 | #### Trade Name, Common Name and Classification: Trade Name: CONi® Device Classification Regulation: 892.2050 ~ Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological #### Predicate Device: Trade Name: ALZ Web PACS (Version 1.0) Device Classification Regulation: 892.2050 – Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological Applicant: ALZ, Inc. 510(k) Number: K081304 Device Description: CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving medical images. The CONi software system is comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView). CONi supports imaging studies from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection. Studies can be shared with a specialist at another facility quickly with a study-specific passcode. This facilitates remote consultation and expedites the study transfer process in emergency situations when a patient is being transported. No physical media such as CDs are needed because collaboration occurs entirely over an internet connection. Secondary over-triage can even be avoided. {1}------------------------------------------------ #### Intended Use: CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection. CONi is not intended for use in mammography. #### Technological Characteristics and Substantial Equivalence The proposed and predicate devices provide a web-based system for the archiving and viewing of medical images. The proposed and predicate devices are to be used with general purpose computing hardware to acquire, transmit, or view the stored medical images. Equivalent with the predicate device, CONi consists of a software application that is installed in a hosted server environment that will communicate with the client's PCs via an internet connection. Communication between the CONi application and client's PCs utilizes DICOM protocols and encrypted browser communications. Both the proposed and predicate devices are hosted by HIPAA compliant facilities. File acquisition, sending functions, and image view and manipulation are included in the proposed and predicate devices. | | GlobalMedia Group | ALZ | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CONI | Web PACS (Version 1) | | Device<br>Description | CONI (Capture Over Network Interface) is<br>a secure cloud-based application for<br>viewing and archiving medical images. The<br>CONI software system is comprised of a<br>Picture Archiving and Communication<br>System (CONIPACS) and an image viewer<br>(CONIView). Images and information can<br>be viewed and stored via a secure<br>Internet connection. | The ALZ Web PACS (Version 1.0) is<br>designed for management, viewing, and<br>processing of DICOM images. The ALZ Web<br>PACS consists of the ALZ Web PACS<br>software application installed on a server<br>and the ALZ Web PACS viewer running on<br>client computers connecting to the server<br>via HTTPS protocol. | | Regulation<br>Number | 892.2050 | 892.2050 | | Product Code | LLZ | LLZ | | Intended Use | CONI provides for the archiving and<br>viewing of medical images from the<br>following DICOM modalities: Computed<br>Tomography (CT), Magnetic Resonance<br>(MR), X-ray (CR), Ultrasound (US), and<br>Visible Light (External Camera (XC) and<br>Other (OT)). Images and information can<br>be viewed and stored via a secure<br>Internet connection.<br><br>CONI is not intended for use in | The ALZ Web PACS (Version 1.0) is an<br>imaging software system intended to be<br>used by trained healthcare professionals.<br>ALZ Web PACS is used with general<br>purpose computing hardware to acquire,<br>transmit, store, view, and process DICOM<br>images.<br><br>The device is not intended for<br>mammography. | | | GlobalMedia Group<br>CONI<br>mammography. | ALZ<br>Web PACS (Version 1) | | Technological<br>Characteristics<br>(Server) | Reliable hardware platform, preconfigured<br>and pretested<br>Multiple simultaneous DICOM associations<br>Multi-modality, multi-vendor functionality<br>and compatibility<br>RIS incorporated<br>Server monitored by GlobalMed and<br>hosting site (FireHost)<br>Shared archive<br>Studies are marked as reviewed after a<br>report is written | Reliable hardware platform, preconfigured<br>and pretested<br>Multiple simultaneous DICOM associations<br>Multi-modality, multi-vendor functionality<br>and compatibility<br>RIS incorporated<br>Server instance monitoring<br>Shared archive<br>Studies are marked as read after a DICOM<br>query (this feature is set if client requests) | | Technological<br>Characteristics<br>(Communication) | Not a feature<br>DICOM Worklist Client<br>Automatic study routing based on<br>administrative routing rules<br>Compiles with DICOM standards<br>Email notification upon arrival of new<br>study or finished report | DICOM query/retrieve<br>DICOM Print client and DICOM Worklist<br>client<br>Auto forward of data sets<br>Complies with all HL7 and DICOM,<br>standards<br>Email notification upon arrival of new study | | | Not a feature | Emailing images as JPEG | | Technological<br>Characteristics<br>(Licensing) | Supports all modalities except<br>mammography | Available for all DICOM modalities | | | Unlimited number of web users | Unlimited number of web users | | Technological<br>Characteristics<br>(Web) | User-friendly web interface layout<br>Coherent overview of studies with search<br>and filter possibilities<br>Automatic browser logout<br>Unlimited number of users and concurrent<br>users<br>Display of all color/grayscale images<br>PDF reports<br>Transfer of images via web to DICOM<br>destinations | User-friendly web interface layout<br>Coherent overview of studies with search<br>and filter possibilities<br>Automatic browser logout<br>Unlimited number of users and concurrent<br>users<br>Display of all color/grayscale images<br>Display of structured reports<br>Transfer of images via web to DICOM<br>destinations | | | Not a Feature | File attachments to images or studies | | Technological<br>Characteristics<br>(Import) | Not a Feature<br>Not a Feature | Import of any DICOMDIR media<br>Directory registration of DICOM data | | Technological<br>Characteristics<br>(Export) | Not a Feature | DICOM export function by burning the<br>DICOM images to a CD or by using a USB | | Technological<br>Characteristics | Automatic synchronization with remote<br>servers | Automatic synchronization with remote<br>servers | | | GlobalMedia Group<br>CONI | ALZ<br>Web PACS (Version 1) | | (Database) | Not a Feature | Configurable overflow management (high<br>water/low water, study date, custom<br>settings) if setting is requested by client | | Technological<br>Characteristics<br>(Data Access) | Admin user<br>Predefined privileges for physicians,<br>nurses, and technicians<br>User access control | Admin user<br>Privilege settings for each user/group are<br>customizable<br>User access control | | Technological<br>Characteristics<br>(Service) | No client software updates required | Software updates/upgrades optional | | Technological<br>Characteristics<br>(Languages) | English, Spanish, and Portuguese | English | | Technological<br>Characteristics<br>(Web Viewer) | Available to an unlimited number of<br>viewers and concurrent viewers<br>Viewing of any kind of images and PDF<br>reports<br>Center/window | Available to an unlimited number of<br>viewers and concurrent viewers<br>Viewing of any kind of images and<br>structured reports<br>Center/window | | | Not a feature | Comparison of multiple studies | | | Stack mode/cine mode | Stack mode/cine mode | | | Not a Feature | Measurements (distance, ROI, angle) | | | Thumbnail preview | Thumbnail preview | | | Background preload | Background preload | | | Supports DICOM compressions. Server<br>does not compress DICOM files. | JPEG DICOM compressions vary per<br>modality | | Typical User | Trained professionals, physicians, nurses,<br>clinicians and technicians. | Healthcare professionals | | Software Level<br>of Concern | Moderate | Moderate | #### Substantial Equivalence Table: {2}------------------------------------------------ {3}------------------------------------------------ ### Summary of Non-Clinical Tests The following quality assurance measures were applied to the development of the CONI system: - . Establishment of Requirements - Risk Analysis (software and system) . - . DICOM Standard Conformance Statement - . HIPAA Compliance Statement - . Software Unit Testing - . Software Integration Testing - . Software System Testing - Software Hazard Testing . #### Safety and Effectiveness Summary The CONi software application provides a safe and secure location for the archiving and {4}------------------------------------------------ viewing of medical images. CONi does not diagnosis any medical condition and is intended to be used by trained individuals. The software utilizes DICOM communication protocols and has been designed and tested to meet HIPAA requirements. CONi does not control the function of any other medical device. GlobalMedia Group considers the CONi software application to be as safe and effective for use as the previous cleared predicate device. #### Conclusion The GlobalMedia Group CONi software application has similar functionality, intended use, technological characteristics, and typical users as the predicate device. As a result, the CapSure software application will fall under the same FDA classification number and product code as the predicate device. The GlobalMedia Group CONi software introduces no new issues or concerns of safety and effectiveness, and is substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 7, 2013 Globalmedia Group LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K130624 Trade/Device Name: CONi™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 23, 2013 Received: April 24, 2013 Dear Mr. Job: 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 {6}------------------------------------------------ Page 2 - Mr. Job 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small 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/ResourcesforYou/Industry/default.htm. Sincerely yours. Smh7) Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health for Enclosure {7}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known): K130624 Device Name: CONi® Indications for Use: CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT). Magnetic Resonance (MR), X-ray (CR); Ultrasound (US), and Single Frame Visible Light Photography (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection. CONi is not intended for use in mammography. CONi is not intended for diagnostic use on mobile devices Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Smh. 7). (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Page 1 of 1