The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms.

The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.

Device Description

The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers.

The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.

AI/ML Overview

The LIVMOR Halo AF Detection System's acceptance criteria and the study proving it meets these criteria are detailed as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implicit from Predicate/Study Results)	Reported Device Performance (LIVMOR Halo AF Detection System)
Per Subject (n=92)
Sensitivity	Comparable to or better than FibriCheck (95.6%)	100.0%
Specificity	Comparable to FibriCheck (96.55%)	93.0%
Positive Predictive Value	Not explicitly stated as acceptance, but reported	89.7%
Negative Predictive Value	Not explicitly stated as acceptance, but reported	100.0%
Accuracy	Not explicitly stated as acceptance, but reported	95.7%
Per Measurement (n=1834)
Sensitivity	Not explicitly stated as acceptance, but reported for predicate	93.3%
Specificity	Not explicitly stated as acceptance, but reported for predicate	99.1%

Note: The document implicitly sets the predicate device's performance as a benchmark for substantial equivalence. While direct acceptance criteria are not explicitly listed in a "criteria" column, the demonstrated performance statistics are presented as meeting "performance goals."

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

Sample Size for Test Set:
- Per Subject Analysis: 92 subjects.
- Per Measurement Analysis: 1834 measurements (derived from these subjects).
Data Provenance: The document does not specify the country of origin. It indicates the data was collected through a "clinical study" involving "simultaneously collected ECG data with a Holter monitor," suggesting it was prospective in nature for the purpose of this validation study.

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

The document states that the ground truth was "established by physician review of simultaneously collected ECG data with a Holter monitor." It does not specify:

The exact number of physicians (experts) involved.
Their specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1 consensus). It only mentions "physician review."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes a study to validate the standalone performance of the LIVMOR Halo AF Detection System against a ground truth established by physician-reviewed Holter ECGs. It does not mention a comparative effectiveness study involving human readers with and without AI assistance (i.e., an MRMC study to show human reader improvement).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes. The study described is a standalone performance study. The device's algorithm generated results (AF detection), which were then compared directly against the ground truth established by physician review of Holter ECGs. The performance metrics (sensitivity, specificity, etc.) are reported for the device itself.

7. Type of Ground Truth Used

The ground truth used was "expert consensus" in the form of "physician review of simultaneously collected ECG data with a Holter monitor." This implies that the Holter ECGs provided the definitive physiological data, and physicians interpreted this data to determine the presence or absence of AF, serving as the gold standard for comparison.

8. Sample Size for the Training Set

The document does not provide information about the sample size of the training set used for the development of the LIVMOR Halo AF Detection System's algorithm. The provided data relates specifically to the validation/test set.

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

Since the document does not mention the training set size, it also does not elaborate on how the ground truth for any potential training set was established. The clinical performance data provided solely pertains to the evaluation of the finished device on a test set.

Summary

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September 23, 2020

Ken Persen Chief Executive Officer LIVMOR, Inc. 16470 Bake Pkwv.. Ste. 200 Irvine, California 92618

Re: K201208

Trade/Device Name: LIVMOR HALO AF Detection System™ Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: August 21, 2020 Received: August 24, 2020

Dear Ken Persen:

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 medical devices and radiation-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 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) K201208

Device Name LIVMOR Halo AF Detection SystemTM

Indications for Use (Describe)

The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.

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

SUBMITTER

Submitter Name:	LIVMOR, Inc.
Submitter Address:	16470 Bake Parkway, Suite 200Irvine, CA 92618
Phone Number:	(612) 747-9595
Contact Person:	Ken Persen, CEO
Date Prepared:	May 2, 2020
DEVICE
Device Trade Name:	LIVMOR Halo AF Detection System™
Common Name:	Irregular Heart Rhythm Monitor
Classification Name:	Telephone electrocardiograph transmitter and receiver
Number:	21 CFR 870.2920
Product Code:	DXH
Class:	II
Classification Panel:	Cardiovascular

PREDICATE DEVICE

Primary Predicate:	FibriCheck (K173872)
Intended Use:	FibriCheck is indicated for self-testing by patients who have been diagnosed with, or aresusceptible to developing, atrial fibrillation and who would like to monitor and record theirpulse rhythms on an intermittent basis.

The primary predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The LIVMOR Halo AF Detection System™ is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted of detected irregular heart rhythms.

The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring System™, and is not validated for use with other pulse monitoring systems.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The LIVMOR Halo AF Detection System has the same intended use, technological characteristics, and principles of operation as its predicate device. FibriCheck. The minor differences between the LIVMOR device and its predicate device do not raise new questions of safety or effectiveness.

The LIVMOR Halo AF Detection was evaluated for sensitivity and specificity in the intended use subjects.

The primary differences between the LIVMOR Halo AF Detection System and predicate are:

Duration of recording LIVMOR Halo AF Detection System analyses data recorded for a duration of hours o automatically each night, and for periods of 10 minutes on patient initiation, with patient at rest, whilst Predicate records for 1 minute on patient initiation with patient at rest.
. Delivery of result - The LIVMOR AF Detection System results are delivered to the overseeing physician through the LIVMOR HeartView Physician Web Portal, whilst the Predicate delivers AF detection results direct to the patient

Device Name	LIVMOR Halo AF Detection System	FibriCheck
510(k) Number	K201208	K173872
Manufacturer	LIVMOR	Qompium
Regulation	870.2920	870.2920
Device Classification Name	Telephone electrocardiographtransmitter and receiver	Telephone electrocardiographtransmitter and receiver
Product Code	DXH	DXH
IndicationStatement	The LIVMOR Halo AF Detection SystemTM isindicated for use by patients who have beendiagnosed with or are susceptible to developingatrial fibrillation and who would like to monitorand record their pulse rhythms on anintermittent basis so that their physician can be alerted of detected irregular heart rhythms.The LIVMOR Halo AF Detection System isintended for use in conjunction with theLIVMOR Halo+ Home Monitoring SystemTM,and is not validated for use with other pulsemonitoring systems.	FibriCheck is indicated for self-testing bypatients who have been diagnosed with, orare susceptible to developing, atrialfibrillation and who would like to monitorand record their heart rhythms on anintermittent basis.
Intended User	Adult	Adult
Prescription device forhome use	Yes	Yes
Single patient use	Yes	Yes
Monitors regularity ofheartbeat	Yes	Yes

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Device Name	LIVMOR Halo AF Detection System	FibriCheck
Alerts user to irregularrhythm	Physician would consult with the patient ifAF is suggested.	User is notified when AF is detectedand prompted to follow up with aphysician.
Device design	LIVMOR Halo AF Detection System obtainsPPG waveform via a smart watch andtransmits to HeartView portal when connectedto Wifi	FibriCheck obtains PPG waveform viamobile phone camera and displays signalin real time on the mobile phone with anarrhythmia index.
User Interface	Web portal	Web portal
AF Detection Functionality &Performance	Per Subject (n=92)Sensitivity: 100%Specificity: 93.0%Per Measurement (n=1834)Sensitivity: 93.3%Specificity: 99.1%	Per Subject (n=223)Sensitivity: 95.6%Specificity: 96.6%Per Measurement (n=547)Sensitivity: 95.3%Specificity: 96.2%

PERFORMANCE DATA

Non-Clinical Testing Validation and Verification Testing carried out on the Halo AF Detection System indicates that it meets its predefined product's requirements and requirements from the following product standards:

· AAMI/ANSI/IEC 62304:2006, Medical Device Software Software Life Cycle Processes
Clinical Performance Testing

The company performed a clinical study demonstrating sensitivity and specificity of the device in detecting atrial fibrillation when compared to ground truth as established by physician review of simultaneously collected ECG data with a Holter monitor. Mean values are presented below and are statistically significant. Device confirmed to meet performance goals.

	LIVMOR (n=92)	FibriCheck (n=223)
Sensitivity	100.0%	95.6%
Specificity	93.0%	96.55%
Positive Predictive Value	89.7%	95.60%
Negative Predictive Value	100.0%	96.55%
Accuracy	95.7%	96.14%

Software V&V Testing

Validation testing involved algorithm testing which validated the accuracy of Halo AF Detection System. The product was deemed fit for clinical use. Usability validation is part of the Clinical Performance data and Halo AF Detection System was tested and meets the requirements of the following standard:

. IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices.
Applying Human Factors and Usability Engineering to Medical ● Devices, Guidance for Industry and Food and Drug Administration

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Staff; FEBRUARY 2016

Halo AF Detection System was designed and developed as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device". Halo AF Detection System was considered to represent "moderate" level of concern as it is not intended to provide recommendations for treatment. According to AAMI/ANSI/IEC 62304 Standard, Halo AF Detection System safety classification has been set toClass B.

Conclusion

The information discussed above and provided in the 510(k) submission demonstrate that the LIVMOR Halo AF Detection System (a SaMD device) is substantially equivalent to the predicate.

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).