The Epicardia Anywhere is indicated as a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

Device Description

The Epicardia Anywhere System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail and clinicallysignificant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

AI/ML Overview

This document is a 510(k) summary for the Epicardia Anywhere device, primarily comparing it to a predicate device, the Epicardia 5000. It focuses on demonstrating substantial equivalence based on technological characteristics and indications for use, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets those criteria (e.g., sample size for test sets, number of experts, MRMC studies, ground truth establishment) is not detailed in this submission. The submission explicitly states "CLINICAL TESTING: Not Applicable."

However, I can extract the relevant information provided and frame it within the context of required testing for substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with explicit performance-based acceptance criteria related to clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) and corresponding reported performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the technological characteristics and indications for use of the subject device (Epicardia Anywhere) are the same or substantially equivalent to the predicate device (Epicardia 5000) and that applicable non-clinical standards were met.

The comparison table provided in the document serves as the basis for demonstrating equivalence in technological characteristics.

Feature	PREDICATE DEVICE Epicardia 5000 (K090834)	SUBJECT DEVICE Epicardia Anywhere	Substantially Equivalent (SE) Determination	Implied Acceptance Criterion	Reported Device Performance (vs. Predicate)
ECG Analysis	Yes (Diogenes)	Yes (Diogenes)	Identical/SE	ECG analysis algorithm (Diogenes) must be capable of processing and classifying ECG events similarly to the predicate.	Same Diogenes version as predicate.
User Interface	Personal Computer (Windows)	Personal Computer (Windows)	Identical/SE	User interaction and display of information should be consistent with predicate.	Same Windows-based PC interface.
PC Interface	TCP/IP, Trans Telephonic, Cellular, Direct, USB, File	TCP/IP, Trans Telephonic, Cellular, Direct, USB, File	Identical/SE	Device must support the same methods for data transfer and communication as the predicate.	Uses the same interface options.
Operating System	Microsoft Windows	Microsoft Windows	Identical/SE	Must operate within a standard, consistent software environment.	Same Microsoft Windows based application.
Location of Server	Desktop	Azure-cloud based	Different/SE	Cloud-based server must not introduce new safety/effectiveness issues and maintain functionality.	Functionality retained; no new safety/effectiveness issues introduced. Hazard analysis confirmed SE.
EC38 Type	Type 3	Not Applicable	Different/SE	(Not applicable for software-only system, demonstrating it doesn't need this spec if it's solely software.)	Solely a software system, so EC38 is not applicable.
Unique Patient ID	Limited	Unlimited	Different/SE	Expanded patient ID capability should not negatively impact device function or data integrity.	Expanded from limited to unlimited.
Processor	16 BIT	64 BIT	SE	Processor upgrade should improve performance without negatively impacting existing functionalities or safety.	Server side software changed from 16 bit to 64 bit.
Consecutive ECG (Workflow)	24-Hours to 30-Day	24-Hours to 30-Day	Identical/SE	Must support the same monitoring durations and workflow as the predicate.	Presents consecutive ECG of 24 hours to 30 days in workflow, same as predicate.
Indications for Use	"Indications for Use" (implied, predicate features)	"Indications for Use" (explicitly stated)	Same (with minor additions)	Indications for Use must be the same or very similar, demonstrating the same purpose and clinical application.	Same, with exception of adding required age designation and prescription notation.

Implied Acceptance Criteria for Non-Clinical Testing:
The document lists national and international standards utilized for testing, implying that compliance with these standards serves as "acceptance criteria" for safety and effectiveness:

ANSI/AAMI EC57:1998/(R)2008 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
AAMI / ANSI / ISO 14971:2007/(R)2010 Medical devices - Application of risk management to medical devices
AAMI / ANSI / IEC 62366:2007/(R)2013 Medical Devices - Application of Usability Engineering to Medical Devices

Reported Performance (in relation to these standards):
"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Epicardia Anywhere testing met all relevant requirements of the aforementioned tests and therefore, the subject device does not introduce any new issue of safety or effectiveness and is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified, as clinical testing was "Not Applicable." The document refers to "testing" against standards (e.g., ANSI/AAMI EC57 for algorithms), which typically involves well-defined datasets (e.g., standard ECG databases like MIT-BIH Arrhythmia Database). However, the specific size or characteristics of the datasets used for general "testing" are not detailed in this 510(k) summary.
Data Provenance: Not specified. Again, clinical data was not used. For "testing" against standards, common practice would be to use publicly available and well-characterized ECG databases.
Retrospective/Prospective: Not applicable, as no clinical testing was performed or reported.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical test set requiring expert ground truth for performance evaluation was involved. The 510(k) relies on the substantial equivalence to a predicate, utilizing the same core algorithm (Diogenes) which would have been validated previously.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "CLINICAL TESTING: Not Applicable." The rationale is that "No new issues of safety or effectiveness are introduced by using this device" (due to primarily being a cloud-based server change and retaining core functionality).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document implies that the core ECG analysis algorithm, "Diogenes," was part of the testing implicitly. It states "The ECG analysis, Diogenes, remains the same. The version of Diogenes in the subject device is the same version of Diogenes in the predicate, Epicardia 5000."
Furthermore, ANSI/AAMI EC57:1998/(R)2008 is listed as a standard used for testing. This standard is specifically "Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms," which implies an assessment of the algorithm's performance in a standalone manner. However, the results of this testing (e.g., specific performance metrics) are not provided in the summary, only the statement that the testing "met all relevant requirements."

7. The Type of Ground Truth Used

For the non-clinical testing of the Diogenes algorithm (implied by the use of ANSI/AAMI EC57), the ground truth for such algorithms is typically established from standardized ECG databases (e.g., MIT-BIH Arrhythmia Database) where expert annotations have already designated arrhythmias and other cardiac events. The submission does not specify which databases were used.

8. The Sample Size for the Training Set

Not specified. The document focuses on demonstrating equivalence to an existing device rather than a de novo development of a new algorithm where training set details would be critical. The "Diogenes" algorithm is pre-existing; its training set details would have been established during its original development and validation.

9. How the Ground Truth for the Training Set was Established

Not specified. This relates to the development of the "Diogenes" algorithm itself, which is a component of both the predicate and subject devices. Ground truth for arrhythmia detection algorithms is typically established by expert cardiovascular specialists (e.g., cardiologists, electrophysiologists) manually annotating ECG waveforms. These annotations are then used to train and validate the algorithm.

In summary: This 510(k) summary for Epicardia Anywhere is a "software modification" submission, where the primary justification for substantial equivalence is that the device uses the same core algorithm ("Diogenes") and maintains the same indications for use as a previously cleared predicate device. The changes are primarily in the deployment environment (cloud vs. desktop server) and underlying infrastructure (64-bit processor, unlimited patient IDs). Due to this nature, the FDA's review relies on non-clinical testing demonstrating that these changes do not introduce new safety or effectiveness issues, rather than requiring a new clinical performance study with human readers or specific statistical acceptance criteria for accuracy metrics.

Summary

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Image /page/0/Picture/0 description: The image shows 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 then the word "ADMINISTRATION" in a smaller font below.

January 10, 2018

Medicomp, Inc. % Susan Goldstein-Falk mdi Consultants 55 Northern Blvd Great Neck, New York 11021

Re: K173170

Trade/Device Name: Epicardia Anywhere Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: December 7, 2017 Received: December 11, 2017

Dear Susan Goldstein-Falk:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

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& Hillel

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173170

Device Name Epicardia Anywhere

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Medicomp. The logo features a blue and red intertwined heart symbol on the left, followed by the company name "MEDICOMP" in blue, bold letters. A red line is underneath the company name, and the tagline "Advancing diagnostic cardiology since 1981" is below the red line in a smaller font.

510(k) SUMMARY

The assigned 510(k) number is: K173170

1. SUBMITTER'S INFORMATION

Company Name: Medicomp, Inc. Company Address: 600 Atlantis Rd. Melbourne Florida, 32904, USA Date Summary Prepared: January 9, 2018 Contact: Mr. Sean Marcus

Medicomp, Inc. 600 Atlantis Road Melbourne, FL 32904 TEL: 321-676-0010 x2150 E-MAIL: smarcus@medicompinc.com

2. SUBJECT DEVICE IDENTIFICATION

Trade Name: Epicardia Anywhere Common Name or Classification Name: Arrhythmia Detector and Alarm CFR Part 870.1025 Product Code: DSI Device Class: II (two)

3. PREDICATE DEVICE IDENTIFICATION

Trade Name: Epicardia 5000 Common Name or Classification Name: Arrhythmia Detector and Alarm CFR Part 870.1025 Product Code: DSI Device Class: II (two) K090834

4. DEVICE DESCRIPTION

The Epicardia Anywhere System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the

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Image /page/4/Picture/0 description: The image shows the Medicomp logo. The logo features a stylized heart shape in red and blue, with an arrow incorporated into the design. To the right of the heart is the word "MEDICOMP" in blue, with a red line underneath. Below the line, the text "Advancing diagnostic cardiology since 1981" is written in a smaller font.

patient's ECG, and provides various summary reports that detail and clinicallysignificant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

5. INDICATIONS FOR USE

6. COMPARISON OF SUBJECT DEVICE TO PREDICATE DEVICE

The operating system in both the predicate and subject devices remain the same, using a Microsoft Windows based application. The main technological difference between the two devices is the environment in which the server is located.

The predicate device, Epicardia 5000, uses a desktop-based application. The subject device, Epicardia Anywhere, uses the Azure-cloud based server with a core processor. The predicate device, Epicardia 5000, can be client installed on the windows based PC that communicates with a server on the back end. The subject device, Epicardia Anywhere is a web based application that connects to the server on the back end from the PC. Both the subject and predicate devices have a back-end server with a core processor.

Epicardia Anywhere is accessible from across the Internet using popular web browsers. The subject device will retain all major functionality of the predicate device. No new issues of safety or effectiveness are introduced by using this device. This modification remains substantially equivalent and is accounted for in the Device Hazard Analysis.

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Below is a comparison chart outlining the similarities and differences between the subject and predicate devices:

	PREDICATE DEVICEEpicardia 5000K090834	SUBJECT DEVICEEpicardia Anywhere	SUBSTANTIALLY EQUIVELENT
ECG Analysis	Yes (Diogenes)	Yes (Diogenes)	Identical/SE
User Interface	Personal Computer(Windows)	Personal Computer(Windows)	Identical/SE
PC interface	TCP/IPTrans TelephonicCellularDirectUSBFile	TCP/IPTrans TelephonicCellularDirectUSBFile	Identical/SE
OperatingSystem	Microsoft Windows	Microsoft Windows	Identical/SE
Location ofServer	Desktop	Azure-cloud based	Different/SE
EC38 Type	Type 3	Not Applicable	Different/SE
Unique PatientID	Limited	Unlimited	Different/SE
Processor	16 BIT	64 BIT	SE
ConsecutiveECG(Workflow)	24-Hours to 30-Day	24-Hours to 30-Day	Identical/SE

Comparisons Summary

A. Indications for Use

The Indications for Use is the same, with exception of adding required age designation and prescription notation.

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Image /page/6/Picture/0 description: The image shows the logo for Medicomp. The logo consists of a blue and red intertwined heart shape on the left, followed by the word "MEDICOMP" in blue, bold letters. Underneath the word, there is a red line, and below that, the text "Advancing diagnostic cardiology since 1981" is written in a smaller, lighter blue font.

B. Technological Characteristics

The ECG analysis, Diogenes, remains the same. The version of Diogenes in the subject device is the same version of Diogenes in the predicate, Epicardia 5000.

The user interface is the same, the predicate and the subject device applications run on a personal computer. Both the predicate and the subject device are a Microsoft Windows based interface. The predicate device, Epicardia 5000 presents patient data from a workflow perspective, as does the subject device, Epicardia Anywhere.

Both the predicate and the subject device use the same interface options: TCP/IP, Trans-telephonic, Cellular, Direct, USB and file based interfaces.

The operating system in both the predicate and subject device remains the same, using a Microsoft Windows based application. The main technological difference between the two devices is the environment in which the server is located. The predicate device, Epicardia 5000, uses a desktop-based application. The subject device, Epicardia Anywhere, uses the Azure-cloud based server with a core processor.

The EC38 Type is not applicable for Epicardia Anywhere because it is solely a software system. The unique patient ID is changed from limited to unlimited. The server side software is changed from 16 bit to 64 bit. The predicate and subject devices both present consecutive ECG of 24 hours to 30 days in workflow.

The Technological Characteristics are substantially equivalent to the predicate device.

C. Comparison between Subject and Predicate Device

This device is similar in design and construction, and has the same indications for use and performance characteristics to the predicate device. Epicardia Anywhere will be cloud hosted and accessible from across the Internet using popular web browsers. It will retain all the major functionality of Epicardia 5000. No new issues of safety or effectiveness are introduced by using this device.

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Image /page/7/Picture/0 description: The image shows the logo for Medicomp. The logo consists of a blue and red intertwined heart symbol on the left, followed by the company name "MEDICOMP" in large, blue, sans-serif font. Below the name is a red line, and underneath that, the text "Advancing diagnostic cardiology since 1981" is written in a smaller, blue font.

D. Argument for Substantial Equivalence to Predicate Device

The indications for use and the technological characteristics of Epicardia Anywhere remain the same as predicate device and therefore we believe it is Substantially Equivalent to the predicate device.

7. NON-CLINICAL TESTS PERFORMED FOR DETERMINATION OF SUBSTANTAIL EQUIVALENCE

Testing information demonstrating safety and effectiveness of Epicardia Anywhere in the intended environment of use is supported by testing that was conducted in accordance with National and International Standards.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices:

The following National and International Standards were utilized for testing the subject device:

ANSI/AAMI EC57:1998/(R)2008 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
AAMI / ANSI / ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices - Application of risk management to medical devices
AAMI / ANSI / IEC 62366:2007/(R)2013 Medical Devices - Application of Usability Engineering to Medical Devices

Relevant Guidances:

1. Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (2003)
1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
1. Premarket Assessment of Pediatric Medical Devices (2015)

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Image /page/8/Picture/0 description: The image shows the logo for Medicomp. The logo consists of a red and blue intertwined heart symbol on the left, followed by the word "MEDICOMP" in large, blue, sans-serif letters. A red line is underneath the word "MEDICOMP", and the text "Advancing diagnostic cardiology since 1981" is below the red line in a smaller font.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Epicardia Anywhere testing met all relevant requirements of the aforementioned tests and therefore, the subject device does not introduce any new issue of safety or effectiveness and is substantially equivalent to the predicate device.

8. CLINICAL TESTING

Not Applicable

9. SOFTWARE

Epicardia Anywhere is similar in design and construction, and has the same indications for use and performance characteristics to the predicate device. It utilizes functionality that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.

10. CONCLUSION

The subject device, Epicardia Anywhere, has identical indications for use as the predicate device, Epicardia 5000. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. Therefore, Epicardia Anywhere is substantially equivalent to the predicate device, Epicardia 5000, K090834.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.