The eCordum™ Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

Device Description

The eCordum™ Cardiac Monitor (eCordum™ CM) is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use.

The eCordum™ CM device is powered by a replaceable battery and has two interchangeable attachable covers with respective ECG electrodes for long-term ECG recording. The Wearable Unit for long-term recording is used with two standard disposable Off-The-Shelf (OTS) ECG electrodes. For long term recording ECG data is obtained by attaching the device to user's chest using OTS ECG electrodes. Long-term recordings provide a single channel ECG signal. During recording the device collects and encrypts ECG data in the storage media for unidirectional transmission to a Bluetooth enabled device.

AI/ML Overview

The provided text describes the eCordum Cardiac Monitor (eCordum CM) and its substantial equivalence to a predicate device, the BodyGuardian System. However, it does not include detailed acceptance criteria or the specific study results that quantitatively prove the device meets these criteria in the format requested.

The document states that the device "passed all testing" and "met all the requirements," but it doesn't provide the actual performance metrics or the specific studies demonstrating these. It's focused on regulatory compliance and substantial equivalence rather than a detailed performance study with acceptance criteria and results.

Given the information provided, I can only extract what is implied to be the acceptance criteria (compliance with standards) and the general statement that the device met these.

Here's an attempt to answer based on the available information, with significant limitations due to the nature of the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are primarily compliance with relevant medical device standards. The performance is generally stated as "met all requirements" or "passed all testing."

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 10993-1:2009 (Biocompatibility)	All biocompatibility testing passed.
Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Software)	Software verification and validation testing conducted; product works as designed.
Compliance with ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Electrical Safety)	Assessed for conformity and found to comply.
Compliance with IEC 60601-1-2:2014 (Fourth Edition) (EMC)	Assessed for conformity and found to comply.
Compliance with ANSI/AAMI/IEC 60601-2-47:2012 (60601-2-47) (ECG Performance)	Met all the requirements for overall design, confirming design output meets design inputs and specifications.
Firmware meets requirements and specifications	Firmware testing showed that eCordum CM device meet all requirements and specifications.
Cybersecurity protection	Cybersecurity protection is supported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets related to performance evaluation (e.g., number of ECG recordings, number of subjects). It also does not mention the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily bench/laboratory testing based on standards, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes compliance with technical standards and software validation, not a study requiring expert-established ground truth for a test set of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no mention of a test set requiring adjudication of medical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The eCordum Cardiac Monitor is described as a device that "records, transfers and stores single-channel electrocardiogram (ECG) data." It explicitly states, "The ECG data is intended to supplement other patient data and is not intended for automated analysis." Therefore, it does not involve AI for interpretation or assistance to human readers, and no MRMC study was conducted.

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

Not applicable. The device does not perform automated analysis or have an algorithm for interpreting ECG data. It is a data acquisition and transfer device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the tests described is the specifications and requirements of the relevant medical device standards (e.g., IEC 60601-2-47 for ECG performance, ISO 10993-1 for biocompatibility). The "truth" is whether the device's measured performance meets the predefined thresholds and parameters outlined in those standards.

8. The sample size for the training set

Not applicable. The eCordum CM does not use AI/machine learning, so there is no training set mentioned or implied.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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October 30, 2020

eCordum, Inc. % Becky Ditty Consultant Biologics Consulting 1555 King St. Suite 300 Alexandria, Virginia 22314

Re: K193296

Trade/Device Name: eCordum Cardiac Monitor (eCordum CM) Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH Dated: November 26, 2019 Received: November 27, 2019

Dear Becky Ditty:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193296

Device Name eCordum™ Cardiac Monitor (eCordum™ CM)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K193296 510(k) Summary

1. Submission Sponsor

eCordum, Inc. 419 1st Street East Northport, NY 11731 USA Vladislav Bukhman President Email: vlad.bukhman@ecordum.com Tel number: 631.223.6447

2. Submission Correspondent

Biologics Consulting 1555 King Street, Suite 300 Alexandria, VA 22314 USA Becky Ditty Consultant Email: bditty@biologicsconsulting.com Tel number: 269.888.2516

3. Date Prepared

November 26, 2019

4. Device Identification

Trade/Proprietary Name:	eCordum™ Cardiac Monitor (eCordum™ CM)
Common/Usual Name:	Transmitters and receivers, electrocardiograph, telephone
Regulation Name:	Telephone electrocardiograph transmitter and receiver
Classification Regulation:	21 CFR§870.2920
Product Codes:	DXH
Device Class:	II
Classification Panel:	Cardiovascular

5. Legally Marketed Predicate Device(s)

K121197 BodyGuardian System manufactured by Preventice Solutions

6. Device Description

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7. Indication for Use Statement

8. Substantial Equivalence Discussion

Comparison of Indications

Table 1 compares the indications for use of the subject device with the indications for use of the two predicate devices.

eCordum CM(K193296)	Preventice(K121197)
The eCordum™ Cardiac Monitor isintended to record, transfer andstore single-channelelectrocardiogram (ECG) data viaBluetooth transmission to Bluetoothenabled devices. The monitor isintended for use by healthcareprofessionals, patients with knownor suspected heart conditions andhealth conscious individuals. TheECG data is intended to supplementother patient data and is notintended for automated analysis.The device has not been tested and itis not intended for pediatric use.	The BodyGuardian System detects andmonitors non-lethal cardiacarrhythmias in ambulatory patients,when prescribed by a physician orother qualified healthcare professional.The BodyGuardian Systemcontinuously records, stores andperiodically transmits the followingphysiological data to a remotecomputer server for up to 30 days at atime:• ECG• Heart rate (including HR variabilityand HR reliability)• Respiration rate• Activity

eCordum CM(K193296)

Preventice(K121197)

The eCordum™ Cardiac Monitor isintended to record, transfer andstore single-channelelectrocardiogram (ECG) data viaBluetooth transmission to Bluetoothenabled devices. The monitor isintended for use by healthcareprofessionals, patients with knownor suspected heart conditions andhealth conscious individuals. TheECG data is intended to supplementother patient data and is notintended for automated analysis.The device has not been tested and itis not intended for pediatric use.

The BodyGuardian System detects andmonitors non-lethal cardiacarrhythmias in ambulatory patients,when prescribed by a physician orother qualified healthcare professional.The BodyGuardian Systemcontinuously records, stores andperiodically transmits the followingphysiological data to a remotecomputer server for up to 30 days at atime:• ECG• Heart rate (including HR variabilityand HR reliability)• Respiration rate• Activity

Comparison of Indications for Use Table 1:

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The subject device and the predicate devices have tundamental intended use, namely to record, store and transfer ECGs. The subject eCordum device does NOT perform any arrhythmia detection, and does not detect heart rate, respiration rate nor activity.

In regard to the eCordum wearable, the subject device and the predicate Preventice device are both intended for prescription use only.

These differences do not raise different questions of safety and effectiveness, and thus do not constitute a new intended use.

Comparison of Technological Comparison

Table 2 provides a detailed comparison between the subject device and the predicate devices.

	Proposed eCordum CM Device	Predicate Preventice WearableECG Monitor
510(k) Number	K193296	K121197
Applicant	eCordum, Inc.	Preventice
Device Name	eCordum™ CM	Preventice BodyGuardian Device
ClassificationRegulation	21 CFR§870.2920	21 CFR§870.1025
Product Code	DXH	DSI
Rx or OTC	RX for wearable option	RX
Intended Use	Ambulatory	Ambulatory
Alarm	No	No
Adult/Pediatric	Adult	Adult
Electrodes	Attachable standardambulatory OTS electrodeswith conductive gel.	Attachable standard ambulatoryOTS electrodes with conductivegel.

Table 2: Device Comparison Table

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	Proposed eCordum CM Device	Predicate Preventice WearableECG Monitor
SingleUse/Reusable	Disposable ambulatory OTSelectrodes.	Disposable ambulatory OTSelectrodes.
ECG and EventsStorage	Transmit ECG data to aBluetooth enabled device.	Stores and periodically transmitsevents and ECG data to remoteserver via a mobile device wheninternet is available.
Real time ECGView	No	No
ArrhythmiaDetection	No	Yes
Sampling Rate	250 Hz	250 Hz
Application/Wear	Chest for ambulatory OTSelectrodes.	Chest for ambulatory OTSelectrodes.
User Interface	Automatic turn on upon skincontactMobile app	Same
Connection	Class II Bluetooth	Class II Bluetooth
Power Supply	Replaceable battery	Single use rechargeable battery

The eCordum™ CM has a same intended use and similar technological characteristics performance as the predicate devices. The subject device has been tested and shown to comply with IEC 60601-2-47. The results of firmware testing showed that eCordum CM device meet all requirements and specifications as described in the Software Validation and Verification protocol and reports.

9. Performance Data

The eCordum™ Cardiac Monitor meets all the requirements for overall design, biocompatibility, electrical, EMC safety and cybersecurity protection. The eCordum™ Cardiac Monitor passed all testing and supports the claims of substantial equivalence and safe operation.

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Biocompatibility

A biocompatibility assessment for patient contacting materials was performed in accordance with ISO 10993-1:2009. All biocompatibility testing passed.

Software Documentation

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Verification of the eCordum™ Cardiac Monitor was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.

EMC and Electrical Safety

The eCordum™ CM was assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012
IEC 60601-1-2:2014 (Fourth Edition)

Bench Testing

Bench testing was done to support device performance and substantial equivalence. Testing demonstrating that the eCordum™ Cardiac Monitor complies with ANSI/AAMI/IEC 60601-2-47:2012 (60601-2-47): Medical electrical equipment – Part 2-47. The eCordum™ Cardiac Monitor met all the requirements for overall design confirming that design output meets design inputs and specifications.

10. Statement of Substantial Equivalence

The eCordum™ Cardiac Monitor is substantially equivalent to predicate device. The eCordum™ Cardiac Monitor has the same intended use and the same technological characteristics as the previously cleared predicate device, BodyGuardian monitor by Preventice. The new device (eCordum™ Cardiac Monitor) does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).