The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

Device Description

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only.

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

. Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter).

The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

AI/ML Overview

The provided text addresses the clinical study, but lacks specific details on the acceptance criteria and the comprehensive study data. Based on the information available, here's a breakdown of what can be inferred and what is missing:

The HeartBeam AIMIGo™ System Clinical Study Summary

The HeartBeam AIMIGo™ System underwent two clinical studies to support its 510(k) submission, confirming its substantial equivalence to the predicate device (AliveCor KardiaMobile 6L) and a reference device (VectraCor Universal Smart ECG).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. It indicates that "All study endpoints were met" for both clinical studies, implying that the device's performance reached the predefined success criteria. However, the specific metrics and targets are not detailed.

Inferred Performance Goals (based on study objectives):

Pivotal Study: To demonstrate clinical equivalence of ECG waveforms between AIMIGo 3-L VECG and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias. This implies high level of agreement or correlation in ECG waveform morphology and characteristics relevant for arrhythmia detection.
Device Positioning Validation Study: To validate that within a predetermined range of distance, direction, and orientation from the recommended position, the AIMIGo 3L VECG output signal characteristics remain unaffected when compared to a simultaneously recorded standard 12L ECG signal, for interpretation of non-life-threatening arrhythmias. This suggests performance robustness under varied positioning.

Observed Device Performance:

"All study endpoints were met" for both the Pivotal Study and the Device Positioning Validation Study. This is the only reported device performance.

Table Structure (Hypothetical, as specific criteria are not provided):

Acceptance Criteria Category	Specific Metric/Endpoint (Hypothetical)	Target (Hypothetical)	Reported Device Performance
Pivotal Study	ECG Waveform Equivalence for Arrhythmia Interpretation	e.g., >90% Agreement with 12L ECG	All endpoints met
	Specificity for Non-life-threatening Arrhythmias	e.g., >X%	All endpoints met
	Sensitivity for Non-life-threatening Arrhythmias	e.g., >Y%	All endpoints met
Positioning Study	Signal Quality Robustness Across Positioning	e.g., <Z% degradation in signal-to-noise ratio or accuracy	All endpoints met
	Equivalent Interpretation in Varied Positions	e.g., Equivalent interpretation of arrhythmias compared to ideal positioning	All endpoints met

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the exact sample size for the test set used in either clinical study. It only refers to a "Pivotal Study" and a "Device Positioning Validation Study."
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It states that the Device Positioning Validation Study was "prospective." The nature of the "Pivotal Study" (retrospective or prospective) is not explicitly mentioned, though "clinical equivalence" studies usually involve prospective data collection.

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions that the device is "intended to be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional." This implies that qualified medical professionals were involved in the interpretation, but the details of their roles in establishing the ground truth for the study are absent.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The HeartBeam AIMIGo™ System explicitly states, "The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional." This means it acts as a data recorder and viewer, not an AI-powered diagnostic tool assisting human readers. Therefore, an MRMC study on AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

The document states, "The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems." This confirms that no standalone (algorithm only) performance was conducted, as the device's function is solely to record, store, and transfer ECG data for manual interpretation.

7. Type of Ground Truth Used

The ground truth in these studies would implicitly be established by the manual interpretation of the reference standard 12-lead ECG by qualified medical professionals. The pivotal study aimed to show "clinical equivalence of ECG waveforms between AIMIGo 3-L VECG (investigational device) recordings and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias." This indicates that the 12-L ECG interpretation served as the ground truth against which the AIMIGo's output was compared.

8. Sample Size for the Training Set

The HeartBeam AIMIGo™ System is presented as a medical device that records and transmits ECG signals for manual interpretation, not a device that employs a machine learning algorithm requiring a separate "training set." Therefore, a training set in the AI/ML context is not applicable.

9. How Ground Truth for Training Set was Established

Since a training set (for an AI/ML algorithm) is not applicable, the method for establishing its ground truth is also not applicable.

Summary

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December 13, 2024

HeartBeam, Inc. % Deborah Castillo VP of Regulatory Affairs Veranex, Inc. 224 Airport Parkway Suite 250 San Jose. California 95110

Re: K231424

Trade/Device Name: HeartBeam AIMIGo(TM) System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, MWJ, DXH Dated: December 11, 2024 Received: December 12, 2024

Dear Deborah Castillo:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Jennifer W. Shih -S

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) K231424

Device Name

HEARTBEAM AIMIGO™ SYSTEM

Indications for Use (Describe)

The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (EG) acqured from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arthythmias by a physician or healthcare professional.

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) Notification K231424

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

HeartBeam, Inc. 2118 Walsh Road, Suite 210 Santa Clara, CA, 95050 USA Phone: 408-899-4443

Contact Person:

Deborah Castillo VP of Regulatory Affairs 2118 Walsh Road, Suite 210 Santa Clara, CA, 95050 USA Phone: 408-899-4443

Date Prepared: November 20, 2024

DEVICE INFORMATION [807.92(a)(2)]

Trade Name: HeartBeam AIMIGo™ System

Generic/Common Name:

Electrocardiograph

Classification:

Class II

Regulation:

21 CFR§870.2340

Product Codes:

DPS Primary: Secondary: MWJ, DXH

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PREDICATE DEVICE(S) [807.92(a)(3)]

Primary Predicate: AliveCor, Inc., KardiaMobile 6L (K210753)

Reference Device: VectraCor Inc., Universal Smart ECG, VectraPlex ECG (K173952)

DEVICE DESCRIPTION [807.92(a)(4)]

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

. Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

INDICATIONS FOR USE [807.92(a)(5)]

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SUBSTANTIAL EQUIVALENCE

The HeartBeam AIMIGo™ System Has the same intended use and similar physical characteristics and technological characteristics as the predicate device, the KardiaMobile 6L (K210753). The difference between the two devices is in the 3-lead signal data, which is similar to the reference device, the Universal Smart ECG/VectraPlex ECG from VectraCor, Inc (K173952). The differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the HeartBeam AIMIGo™ System is substantially equivalent to the Predicate Device.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

Table 1 below shows the comparison of technological characteristics with the predicate devices.

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Device Name	HeartBeam AIMIGO™ System(Subject Device)	AliveCor KardiaMobile 6L(Primary Predicate Device)	Universal Smart ECG – VectraPlex ECG(Reference Device)	Rationale for SubstantialEquivalence/ Comments
510(k) Number	K231424	K210753	K173952	-
Company	HeartBeam, Inc.	AliveCor, Inc	VectraCor, Inc	-
Regulation	21 CFR§870.2340	21 CFR§870.2340	21 CFR§870.2340	Same
Product Code	DPS, DXH, MWJ	DPS, DXH, QDA	DPS, MLD	Same
Class	II	II	II	Same
Intended Use /Indications for Use	The HeartBeam AIMIGO™System is a portable non-invasive recorder intended torecord, store, and transfer apatient's 3-Lead (in threedirections) electrocardiogram(ECG) acquired from 5electrodes. The device isintended to be used by adultpatients in either a clinicalsetting or at home.The device does not conductcardiac analysis and can beused with an ECG Viewersoftware system for manualinterpretation of non-life-threatening arrhythmias by aphysician or healthcareprofessional.	KardiaMobile 6L is intended to record,store and transfer one- and two-channel electrocardiogram (ECG)rhythms.In single channel mode, KardiaMobile6L can record Lead-I.In two channel mode, KardiaMobile 6Lcan record Lead-I and Lead-IIsimultaneously and derive Lead-III andunipolar limb leads aVR, aVF and aVL.KardiaMobile 6L also displays ECGrhythms and output of ECG analysisfrom AliveCor's KardiaAl platformincluding detecting the presence ofnormal sinus rhythm, atrial fibrillation,bradycardia, tachycardia, and others.KardiaMobile 6L is intended for use byhealthcare professionals, patients withknown or suspected heart conditionsand health-conscious individuals.The device has not been tested andis not intended for pediatric use.	The System is intended to derive,display and print a derived 12 lead ECGas well as the X, Y, Z leads from theacquisition of just 3 leads (5electrodes). The System also has thecapability to acquire the standard 12lead ECG using the standard 10electrodes andconvert the ECG signal into a digitalformat.• The 12 lead interpretive software isa windows-based programintended to interpretelectrocardiograms. The softwarereceives, displays and stores asingle, three or standard 12 leadsimultaneous ECG recording, whichis transmitted either locally ortrans-telephonically from an ECGmonitor using a proprietary digitaldata transmission protocol+. Thedevice contains proprietarysoftware algorithms to receive,store, analyze and interpret the 12lead ECG signal only.• In 5 electrode mode, the Systemanalyzes data from 3 leads (5electrodes) and produces visualand audible alarms for ECG changesthat may be consistent with 12-	Similar
Device Name	HeartBeam AIMIGo™ System(Subject Device)	AliveCor KardiaMobile 6L(Primary Predicate Device)	Universal Smart ECG - VectraPlex ECG(Reference Device)	Rationale for SubstantialEquivalence/ Comments
			lead ECG signs of Acute MyocardialIschemic Injury, including AcuteMyocardial Infarction. This mode isnot intended to be a sole means ofdiagnosis, but prompts the user toacquire a standard 12 lead ECG(using 10 electrodes) forinterpretation by a physician whenthe Cardiac Electrical Biomarker(CEB®) is 95 or greater. Monitoringpatients with a CEB® is onlyindicated for patients presentingwith chest pain or other presumedanginal equivalents.• The interpretation software is onlyavailable for the standard 12 leadECG utilizing the standard 10electrodes.• The System is intended to be usedby healthcare professionals, ortrained personnel where ECGmonitoring /acquisition is indicatedfor hospitals and/or clinics.• The System can be used withinelectro-surgical environments.• Device is for Adult use.
Patient Population	Adults Only	Adults Only	Adults Only	Same
Use Environment	Clinical or Home Setting	Clinical or Home Setting	Clinical Setting Only	Same
Channel	3 channels.	1 or 2 Channels	3 or 12 channels.	Similar
Device Name	HeartBeam AIMIGO™ System(Subject Device)	AliveCor KardiaMobile 6L(Primary Predicate Device)	Universal Smart ECG - VectraPlex ECG(Reference Device)	Rationale for SubstantialEquivalence/ Comments
Number ofElectrodes	5 dry-electrodes	3 dry-electrodes	5 or 10 gel-electrodes	Similar
Recording Duration	30 seconds	Minimum of 30 seconds	Minimum of 10 seconds	Same
Data AcquisitionFrequencyResponse	0.5 Hz to 40 Hz	0.5 Hz to 40 Hz	0.05 to 175Hz ± 3dB	Same
Single Use	No	No	No	Same
Prescription Use/Over the Counter	Prescription Use	Prescription Use and OTC use	Prescription Use	Same
Power Source	Battery, 1 Lithium-ionrechargeable.	Battery, 1 Lithium Manganese DioxideCoin Cells (CR2016)	Powered by a PC USB or PS/2 port	Similar

Table 1: Comparison of Technological Characteristics with the Predicate Device

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PERFORMANCE DATA [807.92(b)]:

All necessary bench testing was conducted on the HeartBeam AIMIGo™ System to support a determination of substantial equivalence to the Predicate Device.

Nonclinical Testing Summary [807.92(b)(1)]:

The nonclinical bench testing included:

Software verification and validation per the requirements of EC 62304:2006 (Medical . device software - Software life cycle processes).
. ECG acquisition and transmission performance were verified with applicable clauses of IEC 60601-2-47:2012.
. A biocompatibility evaluation of the HeartBeam AIMIGo™ hardware materials was conducted per the requirements of ISO 10993-1:2018 and in consideration of the FDA Guidance Document titled, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" (September 4, 2020).
Electromagnetic Compatibility and Electrical Safety testing were performed to verify that ● the AIMIGo™ hardware complied with the requirements of:
- IEC 60601-1:2012 and ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and O A2:2010/(R)2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance),
- IEC 60601-1-2:2014 (Medical electrical equipment -Part 1-2: General o requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests),
- IEC 60601-2-47:2012 (Medical electrical equipment Part 2-47: Particular o requirements for the basic safety and essential performance of ambulatory electrocardiographic systems), and
- IEC 60601-1-11:2015 (Medical electrical equipment Part 1-11: General o requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
Human Factors and Usability testing in accordance with IEC 62366-1 (Medical devices . Part 1: Application of usability engineering to medical devices).
. General hardware and system-level verifications were conducted to demonstrate that the subject device performs in accordance with its design specifications.

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the HeartBeam AIMIGo™ System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the HeartBeam AIMIGo™ System does not raise different questions

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of safety or effectiveness for recording a patient's vector electrocardiogram when compared to the Predicate Device.

Clinical Testing Summary [807.92(b)(2)]:

Clinical testing was conducted to support device performance in this 510(k) submission:

Pivotal Study: The objective of this study was to demonstrate the clinical equivalence of ECG waveforms between AIMIGo 3-L VECG (investigational device) recordings and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias . All study endpoints were met, and the information provided supports that device performance is substantially equivalent to the predicate.
Device Positioning Validation Study: This was a prospective single-arm clinical trial to validate that within a predetermined range of distance, direction and orientation with respect to the recommended position per labeling, the output signal characteristics of the AIMIGo 3L VECG remain unaffected when compared to a standard 12L ECG signal recorded simultaneously, for interpretation of non-life-threatening arrhythmias. All study endpoints were met, and the information provided supports that device performance is substantially equivalent to the predicate.

CONCLUSIONS [807.92(b)(3)]:

Based on the results from the tests performed in support of the HeartBeam AIMIGo™ System, it is concluded that the Proposed Device is substantially equivalent to the legally marketed Predicate Device.

SUMMARY

The HeartBeam AIMIGo™ System is substantially equivalent to the Predicate Device.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).