Epiphany Cardio Server Mobile

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July 30, 2018 Epiphany Healthcare, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 Re: K181720 Trade/Device Name: Epiphany Cardio Server Mobile Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: June 28, 2018 Received: June 29, 2018 Dear Mark 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, M.A. Wilhelmsen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181720 Device Name Epiphany Cardio Server Mobile #### Indications for Use (Describe) Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following: · View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or historical patient information originally stored, analyzed or received by the Cardio Server ECG Management System. · View the ECG lead traces using different display settings. · Compare the results of current ECG tests with the patient's previous ECG test results stored on the Cardio Server ECG Management System. · Perform manual ECG-related measurements using the electronic caliper tool. · Communicate information with the Cardio Server ECG Management System such as login credentials and user settings. Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. Epiphany Cardio Server Mobile is not intended for real time monitoring. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------|--------------------------------------------------------------------------| | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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 Epiphany Cardio Server Mobile Epiphany Healthcare, LLC 3000 E. Boundary Terrace, Suite 2 Midlothian, VA 23112 Contact Person: Pat White Phone: 336-617-7923 Fax: 703-991-2501 Date Prepared: July 27,2018 | Name of the device: | Epiphany Cardio Server Mobile | |-----------------------------|-----------------------------------------------| | Common Name: | Cardio Server Mobile | | Classification Name: | Programmable Diagnostic Computer/ 870.1425 | | Classification Regulation: | 21 CFR 870.1425 | | Product code: | DQK | | Device Class: | Class II | | Primary Predicate Device: | McKesson Cardiology ECG Mobile (K133534) | | Reference Predicate Device: | Cardio Server ECG Management System (K052883) | ### Intended Use / Indications for Use Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following: - . View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or historical patient information originally stored, analyzed or received by the Cardio Server ECG Management System. - View the ECG lead traces using different display settings. . - Compare the results of current ECG tests with the patient's previous ECG . test results stored on the Cardio Server ECG Management System. - . Perform manual ECG-related measurements using the electronic caliper tool. {4}------------------------------------------------ - . Communicate information with the Cardio Server ECG Management System such as login credentials and user settings. The Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. The Epiphany Cardio Server Mobile application is not intended for real-time monitoring. # Technological Characteristics The Epiphany Cardio Server Mobile provides secure access to ECG records and related information contained on the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software functions as an accessory to the Cardio Server ECG Management System, and requires a WIFI or cellular connection to a pre-installed and properly configured Cardio Server ECG Management System. Through providing remote access to the ECG data stored on the Cardio Server ECG Management System, the user is able to review current and previous ECG tests, results, and perform measurements on the ECG waveforms. Cardio Server Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile application is not intended to replace the functionalities provided by the Cardio Server ECG Management System desktop client but to extend those to make selected functionalities described above available via mobile devices. The Epiphany Cardio Server Mobile functions as a non-real time system and is not intended for real time monitoring. The Epiphany Cardio Server Mobile can be used both inside and outside of medical facilities except in areas where cellular phone or wireless device use is prohibited. The Epiphany Cardio Server Mobile is intended to operate on Apple iPad and iPhone running iOS mobile operating system from Apple Inc. # Comparison of Technological Characteristics with the Predicate Device (See table below.) {5}------------------------------------------------ | Comparison of Technological Characteristics with the Predicate Device | | | | | | | | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------|----|----|----|----| | Number | Description | Epiphany Cardio<br>Server Mobile | McKesson Cardiology ECG<br>Mobile (K133534) | | | | | | 1 | Intended Use/Indications for Use<br>View ECG test results from a mobile<br>device, including waveforms,<br>measurements, and diagnosis statements. | Yes | Yes | | | | | | 1.2 | View current or historical patient<br>information originally stored, analyzed, or<br>received by the device to which this device<br>is an accessory. | Yes | Yes | | | | | | 1.3 | View ECG lead traces using optional<br>display settings. | Yes | Yes | | | | | | 1.4 | Compare the results of current ECG tests<br>with any previous ECG test results stored<br>on the device to which this device is an<br>accessory. | Yes | Yes | | | | | | 1.5 | Perform ECG related measurements using<br>electronic calipers. | Yes | Yes | | | | | | 1.6 | Communicate information with the device<br>to which this device is an accessory, such<br>as login credentials and user settings. | Yes | Yes | | | | | | 1.7 | Does not store patient information or test<br>results on the mobile device. | Yes | Yes | | | | | | 1.8 | Does not provide real-time monitoring. | Yes | Yes | | | | | | 2 | Target Population | | | | | | | | 2.1 | To be used under direct supervision of a<br>licensed healthcare practitioner and by<br>trained operators. | Yes | Yes | | | | | | 3 | Performance | | | | | | | | 3.1 | Non-clinical testing included software<br>verification, validation, and security<br>testing. | Yes | Yes | | | | | | 4 | Materials | | | | | | | | 4.1 | Software only. | Yes | Yes | | | | | | 5 | Compatibility with the environment and other devices | | | | | | | | 5.1 | Requires WIFI or cellular connection to<br>access data. | Yes | Yes | | | | | | 5.2 | Compatible with Apple iPhone and iPad. | Yes | Yes | | | | | | 5.3 | Compatible with iOS 10 and later. | Yes | Yes | | | | | | 5.4 | Compatible with iOS 7.x, 8.x, 9.x versions. | No | Yes | | | | | | 6 | Where Used | | | | | | | | 6.1 | To be used in hospital or any remote<br>location that allows mobile device use, cell<br>phone use, or WIFI use. | Yes | Yes | | | | | | 6.2 | To be used under the direct supervision of<br>a licensed healthcare practioner and by<br>trained operators. | Yes | Yes | | | | | | 7 | Not applicable to the above devices | | | | | | | | 7.1 | Thermal Safety | No | No | | | | | | 7.2 | Mechanical Safety | No | No | | | | | | 7.3 | Sterility | No | No | | | | | | 7.4 | Biocompatibility | No | No | | | | | | 7.5 | Electrical Safety | No | No | | | | | | 7.6 | Chemical Safety | No | No | | | | | | 7.7 | Radiation Safety | No | No | | | | | | 7.8 | 7.9 | Anatomical Site | Energy Used and/or Delivered | No | No | No | No | | | Epiphany Cardio Server Mobile 510(k) Summary | | | | | | | {6}------------------------------------------------ # Performance Data Non-clinical testing performed included software verification, validation, and security testing to ensure that the Cardio Server Mobile met all design specifications and requirements. Unit and system level testing included assurance of operability with the predicate McKesson Cardiology ECG Mobile application and user accuracy qualification of ECG waveform and related information representation in a simulated user test environment. Bench testing performed verified the Cardio Server Mobile display and measurements capabilities using sample cases based on technical characteristics and relevancy to the intended function of the Epiphany Cardio Server Mobile application. The testing considered different display manipulations (e.g., full-screen display, zoom, navigating between screens, device orientation), display quality, and display accuracy when compared to the original data as presented by Cardio Server ECG Management System. In particular, the testing was performed to ensure adequate user readability and imaqe quality on a small screen. In all instances, the Epiphany Cardio Server Mobile functioned as intended by the design requirements and the observed results demonstrated substantial equivalence with the predicate device. ## Substantial Equivalence The Epiphany Cardio Server Mobile has the same intended use, similar indications, technological characteristics and principles of operation as the predicate device. Both devices display ECG tracings and procedure data, and allow for manual waveform measurements. Any differences between the predicate device and Epiphany Cardio Server Mobile do not raise any new questions related to safety and effectiveness. Based on the performance test results, the Epiphany Cardio Server Mobile is substantially equivalent to the McKesson Cardiology ECG Mobile (K133534).