Frontier X Plus

K240794 · Fourth Frontier Technologies Pvt, Ltd. · MLO · Nov 8, 2024 · Cardiovascular

Device Facts

• Record ID: K240794
• Device Name: Frontier X Plus
• Applicant: Fourth Frontier Technologies Pvt, Ltd.
• Product Code: MLO · Cardiovascular
• Decision Date: Nov 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

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.

Device Story

Frontier X Plus is an ambulatory single-channel ECG event recorder; utilizes dry electrode array in chest strap to capture cardiac signals; transmits data via Bluetooth to mobile software (iOS/Android) for processing by embedded firmware and HeartKey ECG algorithm; displays ECG waveforms and rhythm analysis (AFib, normal sinus, bradycardia, tachycardia, inconclusive/unreadable) to users; intended for use by healthcare professionals, patients, and health-conscious individuals; physician reviews output for diagnosis; enables remote cardiac monitoring; benefits include early detection of transient heart conditions.

Clinical Evidence

Clinical study of 832 adult users (30% female, 70% male; age 18-44: 22%, 45-65: 56%, 65+: 22%; 32% with AFib history). Compared Frontier X Plus ECG waveforms and rhythm analysis (AFib, NSR, Tachycardia, Bradycardia, Inconclusive/Unreadable) against simultaneous 12-lead ECG reference. Data demonstrated substantial equivalence in waveform quality and classification accuracy.

Technological Characteristics

Single-channel ECG; dry electrode chest strap; 16-bit resolution; 500 Hz sampling rate; 0.05-40 Hz frequency response; 3.7V Li-Polymer battery; Bluetooth connectivity; dimensions 74x26x14mm; weight 23g. Complies with ISO 10993-1/5/10/23, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, and ANSI/AAMI EC57.

Indications for Use

Indicated for adult patients, asymptomatic or symptomatic, requiring cardiac monitoring for known or suspected heart conditions. Not for pediatric use.

Regulatory Classification

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.

Predicate Devices

• QardioCore ECG Monitor (K201644)
• AliveCor Heart Monitor (KardiaMobile) (K182396)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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 ([e-mail]) or phone [phone] 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)

#### 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}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the alphanumeric string "K240794" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, making the string easily readable. The background is plain white.

Image /page/4/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.

# 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: [phone]

#### Applicant Contact Person:

Manav Bhushan CEO Fourth Frontier Technologies Private Limited

Email: [e-mail]

#### 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

{5}------------------------------------------------

Image /page/5/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 black and is located below the logo. The text is bolded and centered.

# 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.

{6}------------------------------------------------

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,<br>KardiaStation System |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K240794 | K201644 | K182396 |
| Regulation<br>Number(s) | 21 CFR 870.2800 | 21 CFR 870.2800 | 21 CFR 870.2920<br>21 CFR 870.2340 |
| Regulation<br>Name | ● Medical Magnetic<br>Tape Recorder | ● Medical Magnetic<br>Tape Recorder | ● Transmitters And<br>Receivers,<br>Electrocardiograph,<br>Telephone<br>Electrocardiograph |
| Regulatory<br>Class | Class II | Class II | Class II |
| Classification<br>Product Code | MLO | DSH | DXH |
| Subsequent<br>Product<br>Code(s) | DXH, DPS | N/A | DPS |
| The<br>Over<br>Counter | No | No | Yes |
| Indications<br>for<br>use | The Frontier X Plus<br>device is an ambulatory<br>monitoring device<br>intended to record,<br>store, and transfer<br>single-channel (ECG)<br>rhythms for monitoring<br>and evaluation. The<br>Frontier X Plus system<br>also displays ECG<br>waveforms and ECG<br>rhythm analysis;<br>detecting the presence<br>of normal sinus rhythm | The QardioCore ECG<br>ambulatory monitoring<br>device is intended to<br>capture, store, transmit,<br>and display ECG<br>information for recording<br>periods of up to 24-hours<br>in a single session. It is<br>indicated for use on adult<br>patients who may be<br>asymptomatic or who<br>meet clinical indications<br>to perform an ECG-Holter<br>monitor exam. The<br>QardioCore ECG monitor<br>is a prescription only | The KardiaMobile System is<br>intended to record, store<br>and transfer single-channel<br>electrocardiogram (ECG)<br>rhythms. The KardiaMobile<br>system also displays ECG<br>rhythms and output of ECG<br>analysis from AliveCor's<br>KardiaAI platform including<br>detecting the presence of<br>normal sinus rhythm, atrial<br>fibrillation, bradycardia,<br>tachycardia, and others<br>when prescribed or used<br>under the care of a<br>healthcare professional. |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,<br>KardiaStation System |
| | atrial fibrillation,<br>bradycardia,<br>tachycardia,<br>inconclusive and<br>unreadable rhythm. The<br>Frontier X Plus is<br>intended for use by<br>healthcare<br>professionals, patients<br>with known or<br>suspected heart<br>conditions and<br>health-conscious<br>individuals. It is<br>indicated for use on<br>adult patients who may<br>be asymptomatic or<br>who may suffer from<br>transient symptoms<br>requiring cardiac<br>monitoring. The device<br>has not been tested for<br>pediatric use. The<br>Frontier X Plus is a<br>prescription-only<br>device, and the reported<br>information is provided<br>for review by a<br>physician who will<br>render a diagnosis<br>based on clinical<br>judgment and<br>experience. | device, and the reported<br>information is provided<br>for review by a physician<br>who will render a<br>diagnosis based on clinical<br>judgment and experience. | The KardiaMobile System is<br>intended for use by<br>healthcare professionals,<br>patients with known or<br>suspected heart conditions<br>and health-conscious<br>individuals. The device has<br>not been tested and is not<br>intended for pediatric use. |
| Mechanism of<br>Action | User completes circuit<br>with skin contact and<br>hardware transmits | User completes circuit<br>with skin contact and | User completes circuit with<br>skin contact and hardware<br>transmits signal to |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,<br>KardiaStation System |
| | signal to<br>Frontier X Plus firmware<br>to convert and display<br>ECG waveform | hardware transmits signal<br>to<br>Frontier X Plus firmware<br>to convert and display<br>ECG waveform | Frontier X Plus firmware to<br>convert and display ECG<br>waveform |
| Where used<br>(intended use) | Mobile/active users at<br>rest (ambulatory) | Mobile/active users at<br>rest (ambulatory) | Mobile/active users at rest<br>(ambulatory) |
| Anatomical<br>sites | On or below chest | On or below chest | Left hand fingers to right<br>hand fingers<br>Left leg to right hand<br>fingers On or below chest |
| Available<br>Algorithms | Atrial Fibrillation<br>Unreadable<br>Normal Sinus Rhythm<br>Tachycardia<br>Bradycardia<br>Inconclusive | None | Atrial Fibrillation<br>Noise Algorithm<br>(Unreadable/Inconclusive)<br>Normal Sinus Rhythm<br>Tachycardia<br>Bradycardia |
| Data<br>Acquisition:<br>Frequency<br>Response | 0.05 Hz to 40 Hz | 0.5 to 40 Hz | 0.5 Hz to 40 Hz |
| ECG electrodes | Dry electrodes (Chest<br>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<br>(500 Hz) | 125 samples / second<br>(125Hz) | 300 samples/second |
| Number of ECG<br>Leads | Single lead, 2 electrodes | Single lead, 2 electrodes | Single lead, 2 electrodes |
| Power Supply:<br>Battery | 3.7V Li-Polymer Battery<br>(rechargeable) | 3.7V Li-Polymer Battery<br>(rechargeable) | 3.7V Li-Polymer Battery<br>(rechargeable) |
| Battery<br>Life<br>(typical) | 3 years (500 full charges) | 2 years | 2 years (100 hours) |
| User Interface:<br>Primary Lead<br>Data<br>acquisition<br>Hardware<br>Software<br>interface | Chest Strap to Apple<br>iOS-based or Google<br>Android-based software<br>via Bluetooth and via<br>embedded Frontier X<br>Plus software | Chest Strap to Apple<br>iOS-based or Google<br>Android-based software<br>via Bluetooth | Lead I, Left to Right<br>Ultrasonic acoustics<br>Two-electrode sensor<br>Apple iOS-based or Google<br>Android-based software |
| Feature | Frontier X Plus | QardioCore ECG Monitor | KardiaMobile,<br>KardiaStation System |
| Physical Specs:<br>Dimensions<br>Weight | 74mm x 26mm x 14mm<br>23g (without strap) | 185mm x 87mm x 9mm<br>130g (including strap) | 82mm x 32mm x 4mm<br>15g |
| Prescribed: | Prescription | Prescription | Prescription and OTC |
| Communication<br>s | Bluetooth | Bluetooth | Ultrasonic Acoustics<br>acquired by phone |

{7}------------------------------------------------

Image /page/7/Picture/0 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 underlined.

{8}------------------------------------------------

Image /page/8/Picture/0 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 black and is located below the logo. There is a horizontal line under the text.

{9}------------------------------------------------

Image /page/9/Picture/0 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 black and is located below the logo. The text is bolded and appears to be the title of a document.

# 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).

{10}------------------------------------------------

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

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the alphanumeric string "K240794" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, creating a clear and legible presentation.

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.