K Number

Device Name

Epiphany Cardio Server Mobile

Manufacturer

Epiphany Healthcare, LLC

Date Cleared

2018-07-30

(31 days)

Product Code

DQK DOK

Regulation Number

870.1425

Intended 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. · 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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133534

Reference Devices

K052883

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that it "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," which are common applications of AI/ML in ECG analysis.

Therapeutic

No.
The device is a software application for viewing and analyzing ECG data, not for providing therapy or treatment.

Diagnostic

This device is described as a software application for accessing and displaying previously stored and analyzed ECG data. It allows viewing, comparing, and manual measurement of ECGs but explicitly states it "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 diagnostic process itself is performed by the Cardio Server ECG Management System, and this mobile application acts as an accessory for viewing that pre-existing information.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software application" that runs on mobile devices (Apple iPad and iPhone) and functions as an accessory to a separate ECG Management System. It does not include or require any specific hardware components beyond the standard mobile device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The Epiphany Cardio Server Mobile is a software application that accesses and displays previously acquired ECG data. It does not perform any tests on biological samples. Its function is to provide a mobile interface for reviewing and interacting with existing ECG data and related patient information.
No analysis of biological samples: The description explicitly states that the device does not directly communicate with acquisition devices and does not use automatic data processing to derive measurements or provide diagnostic statements from the ECG data. It relies on data already processed and stored by the Cardio Server ECG Management System.

Therefore, the Epiphany Cardio Server Mobile falls under the category of a medical device software that provides access and viewing capabilities for existing diagnostic data, rather than performing an in vitro diagnostic test itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.
· 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.

Product codes (comma separated list FDA assigned to the subject device)

DQK

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators.
To be used in hospital or any remote location that allows mobile device use, cell phone use, or WIFI use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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 image quality on a small screen.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

McKesson Cardiology ECG Mobile (K133534)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Cardio Server ECG Management System (K052883)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.

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. 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 of medical device-related adverse events) (21 CFR 803) for

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

Indications for Use

510(k) Number (if known) K181720

Device Name Epiphany Cardio Server Mobile

Indications for Use (Describe)

· 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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)