(576 days)
No
The summary explicitly states the device does not conduct cardiac analysis and is not intended to be used with automated ECG analysis systems. It focuses on recording and transmitting ECG data for manual interpretation.
No
The device is intended to record, store, and transfer ECG data for manual interpretation by a physician. It does not provide analysis, diagnosis, or treatment, and therefore is not a therapeutic device.
Yes
The device is intended to record, store, and transfer a patient's ECG for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. While it does not conduct cardiac analysis or provide a clinical diagnosis itself, the recorded data is explicitly used to aid in the diagnostic process by a qualified medical professional.
No
The device description explicitly mentions a "recording device" and "hardware platform," and the performance studies include extensive testing of hardware components (biocompatibility, electromagnetic compatibility, electrical safety, general hardware and system-level verifications). This indicates the system includes physical hardware beyond just software.
Based on the provided information, the HeartBeam AIMIGo™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This typically involves testing substances like blood, urine, or tissue.
- HeartBeam AIMIGo™ Function: The HeartBeam AIMIGo™ System records, stores, and transfers a patient's electrocardiogram (ECG). An ECG is a recording of the electrical activity of the heart, which is a physiological signal measured directly from the body's surface. It does not involve the analysis of specimens derived from the body.
- Intended Use: The intended use is to record and transfer ECG data for manual interpretation by a healthcare professional. It explicitly states that the device does not conduct cardiac analysis and is not intended for use with automated ECG analysis systems.
- Device Description: The description reinforces that it records and transmits the ECG signal for display as rhythm strips for manual interpretation.
Therefore, the HeartBeam AIMIGo™ System falls under the category of a medical device that measures a physiological signal directly from the patient, rather than an IVD device that analyzes specimens.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPS, MWJ, DXH
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.
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
Adults Only
Intended User / Care Setting
Used by adult patients in either a clinical setting or at home by a physician or healthcare professional for manual interpretation.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing Summary: 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 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 of safety or effectiveness for recording a patient's vector electrocardiogram when compared to the Predicate Device.
Clinical Testing Summary:
- 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.
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.
AliveCor, Inc., KardiaMobile 6L (K210753)
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.
VectraCor Inc., Universal Smart ECG, VectraPlex ECG (K173952)
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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
3
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
5
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 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.
INDICATIONS FOR USE [807.92(a)(5)]
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.
6
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.
7
| Device Name | HeartBeam AIMIGO™ System
(Subject Device) | AliveCor KardiaMobile 6L
(Primary Predicate Device) | Universal Smart ECG – VectraPlex ECG
(Reference Device) | Rationale for Substantial
Equivalence/ 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 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. | KardiaMobile 6L is intended to record,
store and transfer one- and two-
channel electrocardiogram (ECG)
rhythms.
In single channel mode, KardiaMobile
6L can record Lead-I.
In two channel mode, KardiaMobile 6L
can record Lead-I and Lead-II
simultaneously and derive Lead-III and
unipolar limb leads aVR, aVF and aVL.
KardiaMobile 6L also displays ECG
rhythms and output of ECG analysis
from AliveCor's KardiaAl platform
including detecting the presence of
normal sinus rhythm, atrial fibrillation,
bradycardia, tachycardia, and others.
KardiaMobile 6L 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
is not intended for pediatric use. | The System is intended to derive,
display and print a derived 12 lead ECG
as well as the X, Y, Z leads from the
acquisition of just 3 leads (5
electrodes). The System also has the
capability to acquire the standard 12
lead ECG using the standard 10
electrodes and
convert the ECG signal into a digital
format.
• The 12 lead interpretive software is
a windows-based program
intended to interpret
electrocardiograms. The software
receives, displays and stores a
single, three or standard 12 lead
simultaneous ECG recording, which
is transmitted either locally or
trans-telephonically from an ECG
monitor using a proprietary digital
data transmission protocol+. The
device contains proprietary
software algorithms to receive,
store, analyze and interpret the 12
lead ECG signal only.
• In 5 electrode mode, the System
analyzes data from 3 leads (5
electrodes) and produces visual
and audible alarms for ECG changes
that 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 Substantial
Equivalence/ Comments |
| | | | lead ECG signs of Acute Myocardial
Ischemic Injury, including Acute
Myocardial Infarction. This mode is
not intended to be a sole means of
diagnosis, but prompts the user to
acquire a standard 12 lead ECG
(using 10 electrodes) for
interpretation by a physician when
the Cardiac Electrical Biomarker
(CEB®) is 95 or greater. Monitoring
patients with a CEB® is only
indicated for patients presenting
with chest pain or other presumed
anginal equivalents.
• The interpretation software is only
available for the standard 12 lead
ECG utilizing the standard 10
electrodes.
• The System is intended to be used
by healthcare professionals, or
trained personnel where ECG
monitoring /acquisition is indicated
for hospitals and/or clinics.
• The System can be used within
electro-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 Substantial
Equivalence/ Comments |
| Number of
Electrodes | 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 Acquisition
Frequency
Response | 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-ion
rechargeable. | Battery, 1 Lithium Manganese Dioxide
Coin Cells (CR2016) | Powered by a PC USB or PS/2 port | Similar |
Table 1: Comparison of Technological Characteristics with the Predicate Device
8
9
10
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
11
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.