(231 days)
Standard 12-lead ECG
No
The document mentions a "proprietary algorithm" and "HeartKey ECG algorithm" for ECG rhythm analysis, but there is no mention of AI, ML, DNN, or any description of training or test sets that would typically be associated with AI/ML development. The performance studies focus on comparing the device's algorithm to a standard 12-lead ECG and a predicate device, not on evaluating the performance of an AI/ML model.
No
The device is an ambulatory monitoring device intended to record, store, and transfer ECG data for evaluation and analysis, not to provide therapy.
Yes
The device records, stores, transfers, displays, and analyzes ECG rhythms to detect conditions like atrial fibrillation, bradycardia, and tachycardia, and the reported information is for review by a physician to render a diagnosis.
No
The device description explicitly states that the Frontier X Plus includes hardware components: "The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware". This indicates it is not a software-only device.
Based on the provided information, the Frontier X Plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Frontier X Plus Function: The Frontier X Plus device directly measures and analyzes electrical signals from the heart (ECG) on the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as an "ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation." This aligns with in-vivo monitoring, not in-vitro analysis of specimens.
- Input Modality: The input modality is "ECG (electrocardiogram) rhythms," which are electrical signals from the body, not a biological specimen.
Therefore, the Frontier X Plus falls under the category of a medical device for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
Product codes
MLO, DXH, DPS
Device Description
The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On or below chest
Indicated Patient Age Range
adult patients, The device has not been tested for pediatric use.
Intended User / Care Setting
healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
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
The Clinical Investigation Study was conducted in a population consistent with the subject device's indications for use. The study's objectives included a comparative evaluation of the clinical equivalence of ECG waveforms recorded by the subject device to simultaneously captured ECG waveforms from a reference device (Standard 12-lead ECG). The study further evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device. ECGs from the subject and reference devices were collected and analyzed at various time points representative of normal subject and reference device use. Various quantitative and qualitative metrics including relevant ECG waveform characteristics were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device. The collective results of the performance testing demonstrate that the Frontier X Plus meets the established specifications and complies with the aforementioned standards.
A total of 832 users were included in the Study population. This included approximately 30% data from Females, 70% from Males, and approximately 66% from White/Caucasians, 5% Hispanic/Latino, 19% Asian, 5% Black and 4% other ethnic groups. As far as Age distribution is concerned, approximately 22% of Users were aged between 18-44, 56% were between 45-65 and 22% were 65 yrs and over. Of the total set of users that were part of the study population, 32% of users, i.e., 264 users had recorded episodes of Atrial Fibrillation. In terms of BMI, approximately 10% of users were below a BMI of 21, 40% had a BMI between 21 and 25, and 50% had a BMI greater than 25.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Investigation Study.
Sample size: A total of 832 users.
Key results: The data provided demonstrated the substantial equivalence with the predicate device. The collective results of the performance testing demonstrate that the Frontier X Plus meets the established specifications and complies with the aforementioned standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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November 8, 2024
Fourth Frontier Technologies Pvt Ltd Manav Bhushan CEO 2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL, 2nd Stage, Indiranagar Bengaluru, Karnataka 560038 India
Re: K240794
Trade/Device Name: Frontier X Plus Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO. DXH. DPS Dated: November 7, 2024 Received: November 7, 2024
Dear Manav Bhushan:
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.
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"
1
(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 OS 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 Rue"). 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-devices/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 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).
2
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) K240794
Device Name Frontier X Plus
Indications for Use (Describe)
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Notification K240794
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Fourth Frontier Technologies Private Limited 2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL 2ndStage Indiranagar, Bengaluru, 560038 Karnataka, India Phone: +1- 512-8817266
Applicant Contact Person:
Manav Bhushan CEO Fourth Frontier Technologies Private Limited
Email: manav@fourthfrontier.com
Date Prepared: November 4, 2024
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Frontier X Plus
Generic/Common Name:
Medical Magnetic Tape Recorder
Classification:
21 CFR§870.2800, Medical Magnetic Tape Recorder, Class II
Product Code:
MLO
Subsequent Product Code(s): DXH , DPS
PREDICATE DEVICE(S) [807.92(a)(3)]
K201644 - QardioCore ECG Monitor (primary predicate device) Product code: DSH
K182396 – AliveCor Heart Monitor (predicate device, currently marketed as "KardiaMobile") Product code: DXH, DPS
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DEVICE DESCRIPTION [807.92(a)(4)]
The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.
INDICATIONS FOR USE [807.92(a)(5)]
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician, who will render a diagnosis based on clinical judgment and experience.
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Image /page/6/Picture/1 description: The image shows a logo and some text. The logo is a stylized letter 'f' in red. The text reads "510(k) Summary" in bold, and "K240794" in the upper right corner of the image. The text is black.
Comparison of Technological Characteristics with the predicate DEVICE[807.92(a)(6)]
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,
KardiaStation System |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K240794 | K201644 | K182396 |
| Regulation
Number(s) | 21 CFR 870.2800 | 21 CFR 870.2800 | 21 CFR 870.2920
21 CFR 870.2340 |
| Regulation
Name | ● Medical Magnetic
Tape Recorder | ● Medical Magnetic
Tape Recorder | ● Transmitters And
Receivers,
Electrocardiograph,
Telephone
Electrocardiograph |
| Regulatory
Class | Class II | Class II | Class II |
| Classification
Product Code | MLO | DSH | DXH |
| Subsequent
Product
Code(s) | DXH, DPS | N/A | DPS |
| The
Over
Counter | No | No | Yes |
| Indications
for
use | The Frontier X Plus
device is an ambulatory
monitoring device
intended to record,
store, and transfer
single-channel (ECG)
rhythms for monitoring
and evaluation. The
Frontier X Plus system
also displays ECG
waveforms and ECG
rhythm analysis;
detecting the presence
of normal sinus rhythm | The QardioCore ECG
ambulatory monitoring
device is intended to
capture, store, transmit,
and display ECG
information for recording
periods of up to 24-hours
in a single session. It is
indicated for use on adult
patients who may be
asymptomatic or who
meet clinical indications
to perform an ECG-Holter
monitor exam. The
QardioCore ECG monitor
is a prescription only | The KardiaMobile System is
intended to record, store
and transfer single-channel
electrocardiogram (ECG)
rhythms. The KardiaMobile
system also displays ECG
rhythms and output of ECG
analysis from AliveCor's
KardiaAI platform including
detecting the presence of
normal sinus rhythm, atrial
fibrillation, bradycardia,
tachycardia, and others
when prescribed or used
under the care of a
healthcare professional. |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,
KardiaStation System |
| | atrial fibrillation,
bradycardia,
tachycardia,
inconclusive and
unreadable rhythm. The
Frontier X Plus is
intended for use by
healthcare
professionals, patients
with known or
suspected heart
conditions and
health-conscious
individuals. It is
indicated for use on
adult patients who may
be asymptomatic or
who may suffer from
transient symptoms
requiring cardiac
monitoring. The device
has not been tested for
pediatric use. The
Frontier X Plus is a
prescription-only
device, and the reported
information is provided
for review by a
physician who will
render a diagnosis
based on clinical
judgment and
experience. | device, and the reported
information is provided
for review by a physician
who will render a
diagnosis based on clinical
judgment and experience. | The KardiaMobile System 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. |
| Mechanism of
Action | User completes circuit
with skin contact and
hardware transmits | User completes circuit
with skin contact and | User completes circuit with
skin contact and hardware
transmits signal to |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,
KardiaStation System |
| | signal to
Frontier X Plus firmware
to convert and display
ECG waveform | hardware transmits signal
to
Frontier X Plus firmware
to convert and display
ECG waveform | Frontier X Plus firmware to
convert and display ECG
waveform |
| Where used
(intended use) | Mobile/active users at
rest (ambulatory) | Mobile/active users at
rest (ambulatory) | Mobile/active users at rest
(ambulatory) |
| Anatomical
sites | On or below chest | On or below chest | Left hand fingers to right
hand fingers
Left leg to right hand
fingers On or below chest |
| Available
Algorithms | Atrial Fibrillation
Unreadable
Normal Sinus Rhythm
Tachycardia
Bradycardia
Inconclusive | None | Atrial Fibrillation
Noise Algorithm
(Unreadable/Inconclusive)
Normal Sinus Rhythm
Tachycardia
Bradycardia |
| Data
Acquisition:
Frequency
Response | 0.05 Hz to 40 Hz | 0.5 to 40 Hz | 0.5 Hz to 40 Hz |
| ECG electrodes | Dry electrodes (Chest
strap - single use) | Dry electrodes | Dry electrodes |
| ECG channels | Single Channel | Single Channel | Single Channel |
| Resolution | 16 bits | 18 bits | 16 bits |
| Sample Rate | 500 samples / second
(500 Hz) | 125 samples / second
(125Hz) | 300 samples/second |
| Number of ECG
Leads | Single lead, 2 electrodes | Single lead, 2 electrodes | Single lead, 2 electrodes |
| Power Supply:
Battery | 3.7V Li-Polymer Battery
(rechargeable) | 3.7V Li-Polymer Battery
(rechargeable) | 3.7V Li-Polymer Battery
(rechargeable) |
| Battery
Life
(typical) | 3 years (500 full charges) | 2 years | 2 years (100 hours) |
| User Interface:
Primary Lead
Data
acquisition
Hardware
Software
interface | Chest Strap to Apple
iOS-based or Google
Android-based software
via Bluetooth and via
embedded Frontier X
Plus software | Chest Strap to Apple
iOS-based or Google
Android-based software
via Bluetooth | Lead I, Left to Right
Ultrasonic acoustics
Two-electrode sensor
Apple iOS-based or Google
Android-based software |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,
KardiaStation System |
| Physical Specs:
Dimensions
Weight | 74mm x 26mm x 14mm
23g (without strap) | 185mm x 87mm x 9mm
130g (including strap) | 82mm x 32mm x 4mm
15g |
| Prescribed: | Prescription | Prescription | Prescription and OTC |
| Communication
s | Bluetooth | Bluetooth | Ultrasonic Acoustics
acquired by phone |
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SUBSTANTIAL EQUIVALENCE
The Frontier X Plus subject device has the same intended use and similar technological characteristics as the QardioCore ECG Monitor predicate device. The differences in technological characteristics have been analyzed and addressed through performance testing. The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness.
PERFORMANCE DATA [807.92(b)]
All necessary performance testing was conducted on the Frontier X Plus to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Nonclinical Testing Summary:
All necessary performance testing was conducted on the Frontier X Plus to support a determination of substantial equivalence to the predicate device. This testing included the following:
- -Cybersecurity Testing
- -Verification against the device's specifications
- Software verification and validation -
- -Signal integrity testing to evaluate impact of cleaning and aging
- -Frontier X Plus validation using real-world data, supplementary clinical investigation data and human factors data
- -Evaluation to the following standards:
- O ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 0 ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- International Standard ISO 10993 Fourth edition: 2021-11, Biological Evaluation of Medical 0 Devices Part 10: "Tests for Skin Sensitization". Reference Number: ISO 10993 -10:2021 (E).
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Image /page/10/Picture/1 description: The image shows a logo and the text "510(k) Summary". The logo is a stylized letter 'f' in red. The text is located below the logo and is written in a bold font. The text indicates that the document is a summary related to a 510(k) submission, which is a type of premarket submission to the FDA for medical devices.
- International Standard ISO 10993 First edition: 2021-01, Biological Evaluation of Medical 0 Devices Part 23: "Tests for Irritation". Reference Number: ISO 10993 -23:2021 (E).
- O IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance,
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of O Wireless Coexistence.
- FDA Guidance: Cybersecurity in Medical Devices: Quality System O Considerations and Content of Premarket Submissions
- IEC 60601-1-2:2014+AMD1: 2020 CSV, Medical Electrical Equipment Part 1-2: O General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests,
- IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General 0 requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and
- IEC 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular 0 Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
- ANSI/AAMI EC57: 2012, Testing and Reporting Performance Results of Cardiac O Rhythm and ST Segment Measurement Algorithms (K200884)
[807.92(b)(1)] Clinical Testing Summary:
The Clinical Investigation Study was conducted in a population consistent with the subject device's indications for use. The study's objectives included a comparative evaluation of the clinical equivalence of ECG waveforms recorded by the subject device to simultaneously captured ECG waveforms from a reference device (Standard 12-lead ECG). The study further evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device. ECGs from the subject and reference devices were collected and analyzed at various time points representative of normal subject and reference device use. Various quantitative and qualitative metrics including relevant ECG waveform characteristics were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device. The collective results of the performance testing demonstrate that the Frontier X Plus meets the established specifications and complies with the aforementioned standards.
A total of 832 users were included in the Study population. This included approximately 30% data
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Image /page/11/Picture/1 description: The image shows a logo and the text "510(k) Summary". The logo is a stylized letter 'f' in red. The text is in a larger, bold font and is located below the logo. The background is white.
from Females, 70% from Males, and approximately 66% from White/Caucasians, 5% Hispanic/Latino, 19% Asian, 5% Black and 4% other ethnic groups. As far as Age distribution is concerned, approximately 22% of Users were aged between 18-44, 56% were between 45-65 and 22% were 65 yrs and over. Of the total set of users that were part of the study population, 32% of users, i.e., 264 users had recorded episodes of Atrial Fibrillation. In terms of BMI, approximately 10% of users were below a BMI of 21, 40% had a BMI between 21 and 25, and 50% had a BMI greater than 25.
SUMMARY
The Frontier X Plus subject device has the same intended use and similar technological characteristics as the QardioCore ECG Monitor predicate device. The differences in technological characteristics have been analyzed and addressed through performance testing. The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness. The Frontier X Plus is substantially equivalent to the predicate device.