AT-Patch ECG Analysis System

K203638 · Atsens Co., Ltd. · DSH · Oct 12, 2022 · Cardiovascular

Device Facts

• Record ID: K203638
• Device Name: AT-Patch ECG Analysis System
• Applicant: Atsens Co., Ltd.
• Product Code: DSH · Cardiovascular
• Decision Date: Oct 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

Device Story

AT-Patch is a wearable, ambulatory ECG recorder; acquires and stores 1-channel ECG data for up to 14 days. Device attaches to skin surface; uses coin battery (CR2032). System includes AT-Patch device, ATN-C130 mobile app, and ATR-C130 PC software. App allows patient to document symptoms and view ECG in real-time solely for signal quality assessment; no clinical/diagnostic use for real-time display. Data downloaded via cable or BLE dongle to PC software for manual clinician review. Device lacks automated ECG analysis. Benefits include long-term cardiac rhythm data collection for ambulatory patients to aid physician diagnosis of transient symptoms.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, 60601-2-47), EMC (IEC 60601-1-2), biocompatibility (ISO 10993 series), cybersecurity, patch adhesion (ANSI/AAMI EC12), and usability (IEC 62366-1).

Technological Characteristics

1-channel ECG recorder; ARM Cortex-M4 CPU; 250 Hz sampling; 10-bit ADC; 10MΩ input impedance; 0.05-40Hz frequency response. Connectivity: 2.4GHz BLE 4.2. Power: 3V CR2032 coin battery. Dimensions: 31x39x8.3mm; weight <13g. Non-sterile. Software: Android/iOS app and Windows PC software. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for patients 18 years or older, asymptomatic or suffering from transient symptoms (palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety), requiring long-term (up to 14 days) ambulatory ECG recording.

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

• Zio SkyRunner(SR) ECG Monitoring service (K143513)

Submission Summary (Full Text)

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October 12, 2022

ATsens Co., Ltd % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South

Re: K203638

Trade/Device Name: AT-Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: September 13, 2022 Received: October 7, 2022

Dear Do Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203638

Device Name AT-Patch

#### Indications for Use (Describe)

The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

Preparation Date: October 7, 2022

# 1. Applicant / Submitter

Applicant/Submitter: ATsens Co.,Ltd/KeonHoon Lee Address: Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13637 Korea Tel: [phone] Fax: [phone] Email: [e-mail]

### 2. Submission Contact Person

Contact Person: Do Hyun Kim, BT Solutions, Inc. Address: 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Tel: [phone] Fax: [phone] Email: [e-mail]

### 3. Device Information

| Trade Name | AT-Patch |
|---------------------------|--------------------------------|
| Common Name | AT-Patch |
| Classification Name | Medical magnetic Tape Recorder |
| Classification Regulation | 21CFR870.2800 |
| Device Class | 2 |
| Product Code | DSH |

### 4. Predicate Device

| Manufacturer | iRhythm technologies, Inc. |
|---------------|------------------------------------------|
| Device Name | Zio SkyRunner(SR) ECG Monitoring service |
| 510(k) number | K143513 |

### 5. Description

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AT-Patch consists of 1) AT-Patch device, 2) Software for ECG viewing (ATR-C130), 3) App (ATN-C130) that communicates with the device and allows the patient to view the ECG waveform for visual assessment of the recording quality, and included parts (Dedicated Cable, BLE Dongle and USB memory).

AT-Patch an ambulatory ECG recorder, designed to continuously acquire and store patient's ECG for up to 14 days. The AT-Patch can connect to the device applicaitn (ATN-C130) torecord symptoms with the App during operation and to check the ECG recording. The device is not intended for real-time monitoring.

| ATP-<br>C130 | | |
|--------------|----------------------------|----------------------|
| | Item | Description |
| ECG | Type | BF type |
| | Sampling Rate | 250 sample/sec |
| | Input Offset Dynamic Range | $\pm$ 300mV |
| | Channel | 1 channel |
| | ADC Resolution | 10 bits |
| | Input Impedance | $\geq$ 10MΩ |
| | Frequency Response | 0.05Hz to 40Hz |
| Electrode | AC impedance | Less than 3KΩ (10Hz) |
| RF | RF communication | 2.4GHz BLE 4.2 |
| | Effective Radiated Power | <1mW |
| | RF Frequency Band of TX | 2.4GHz |
| | Bandwidth of the Receiver | 2400 ~ 2480MHz |

### 6. Technological Characteristic

| | CPU | ARM Cortex-M4 |
|-------------------|--------------------------|------------------------------------------------|
| S/W | Supported App | Android 8.1 or<br>higher iOS 12.0 or<br>higher |
| | Supported PC S/W Version | Window 10 (64bit) |
| Power Requirement | Power Supply | DC 3V, Coin Battery (CR2032) |
| | Intended use period | Up to 14 days |

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| | Total Size (L x W x H: mm) | 95 x 52.6 x 8.3 |
|-----------------------------|-----------------------------------|------------------------------------------------------------------|
| Physical<br>Characteristics | Main Body Size (L x W x H:<br>mm) | 31 x 39 x 8.3 |
| | Weight (g) | Main Body: Below 13g |
| | Lifetime | 12 months |
| QoS | Latency | ATN-C130: less than<br>130msec ATR-C130: less<br>than 150msec |
| | Throughput | ATN-C130: more than<br>12,000bps ATR-C130: more<br>than 4,500bps |
| | Distance | Maximum 7 (m) |

#### 7. Intended Use / Indication for use

The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in realtime solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

#### 8. Device Components

- 1) AT-Patch Device (ATP-C130): The device that acquires and stores the patient's ECG signal for up to 14 days.
2) App (ATN-C130): App to check that the device is operating normally and allows the patient and caregiver to manually record symptoms. The app has the following features.

2-1). Check if the device is operating normally (View ECG data - not intended for clinical or diagnostic uses)

2-2). Symptom note recording (allows to manually note that a patient feels an abnormality while wearing it)

2-3). Log-in function (user ID, password)

2-4). Operation connection for start the

device record 2-5). Software lock function

- Live on view 60 minutes limit function per days

- 30 minutes access limit in case of 5 consecutive login failures

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- Login execution function when not in use for a long time (30 minutes)

- 3) AT-Report Software for ECG viewing (ATR-C130): Software that downloads the patient's ECG data saved in the device's memory and the symptom note record recorded by the patient from the App (ATN-C130) through a specific cable provided. The software also allows to visualize the ECG signal for manual interpretation. The software does not include automated ECG analysis. This software also provides the main functions of ATN-130 App via a BlueTooth dongle, allowing the use of the device by patients not having a mobile phone compatible with ATN-130 App.
### Accessories:

- Cable
- BlueTooth Low Energy dongle

### 9. Substantial Equivalence Discussion

AT-Patch is substantially equivalent to the predicate device, Zio SR ECG Monitoring service (K143513). The following comparison table is presented to demonstrate substantial equivalence.

- A. Comparison with predicate device

| Descriptive<br>Information | Subject Device | Predicate Device |
|----------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------|
| Manufacturer | ATsens Co.,Ltd | iRhythm technologies, Inc. |
| Device Name | AT-Patch | Zio SkyRunner (SR)<br>Electrocardiogram<br>(ECG) Monitoring<br>Service |
| 510(k) number | K203638 | K143513 |
| Classification<br>Product Code /<br>Regulatory<br>Number | DSH (21CFR §870.2800) | DSH<br>(21CFR §870.2800)<br>DQK<br>(21CFR § 870.1425)<br>DXH<br>(21CFR § 870.2920) |
| Regulatory Class | 2 | 2 |
| Patient<br>environment | Ambulatory | Ambulatory |
| Patient population | Non-pediatric,<br>Non-critical care patients | Non-pediatric,<br>Non-critical care patients |

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| Indications for<br>Use | The device is intended to<br>measure, save, and view<br>continuous electrocardiogram<br>(ECG) information for long-<br>term recording (up to 14 days)<br>from ambulatory patients by<br>attaching to the skin surface.<br>ECG records are stored in the<br>the device for review after the<br>recording period (up to 14<br>days) is completed, and are not<br>intended for for real-time<br>monitoring. The device does<br>not include automated ECG<br>analysis functions, and the<br>recorded ECGs are not<br>intended for automated<br>analysis. The device allows<br>patient and clinicians to view<br>the ECG signal recorded in<br>real-time solely for the purpose<br>of visual assessment of the<br>recording quality; the ECG<br>signal displayed in real time is<br>not intended for any clinical or<br>diagnostic use. It is indicated<br>for use on patients 18 years or<br>older who may be<br>asymptomatic or who may<br>suffer from transient symptoms<br>such as palpitations, shortness<br>of breath, dizziness, light-<br>headedness, fatigue, or anxiety. | The ZIO SR ECG Monitoring<br>Service is intended to capture,<br>analyze, and report<br>symptomatic and/or<br>continuous electrocardiogram<br>(ECG) information for long-<br>term monitoring (up to 14<br>days).<br>It is indicated for use on adult<br>patients 18 years or older who<br>may be asymptomatic or who<br>may suffer from transient<br>symptoms such as palpitations,<br>shortness of breath, dizziness,<br>light-headedness, pre-<br>syncope, syncope, fatigue, or<br>anxiety. The reported ECG<br>metrics include single-lead<br>analysis on a beat by beat<br>basis, heart rate measurement<br>and rhythm analysis. The<br>report does not contain<br>diagnostic interpretation; the<br>reported analysis is provided<br>for review by the intended user<br>to render a diagnosis based on<br>clinical judgment and<br>experience. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription or<br>OTC | Prescription | Prescription |
| Technological characteristics | | |
| Key system<br>components | 1) AT-Patch<br>2) App<br>3) AT-Report | 1) Zio SR Patch Recorder<br>with Bluetooth technology<br>2) Zio SR Wireless Gateway<br>3) ZIO ECG Utilization<br>Service System |
| Wear period | Up to 14 days | Up to 14 days |
| ECG channel | 1 channel | 1 channel |
| Recording Format | Continuous | Continuous |
| Input Impedance | ≥ 10MΩ | ≥ 10MΩ |
| RF<br>Communication | 2.4 GHz Bluetooth | 2.4 GHz Bluetooth |
| Frequency of band | 2400 ~ 2480 MHz | 2400 ~ 2480 MHz |
| Power supply | DC 3V, Coin battery (CR2032) | DC 3V, Coin battery (CR2032)<br>(2ea) |
| ECG analysis | View ECG | Rhythm<br>types Beat<br>Heart<br>rates<br>Runs |
| Operational<br>temperature | 41 to 104° F | 41 to 104° F |
| Operational<br>humidity | 10% to 95% (non-condensing) | 10% to 95% (non-condensing) |
| App function | 1. Check whether the device<br>is working normally<br>2. Document symptom events | 1. Document symptom events |
| LOC of software | Major | Moderate |

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### 1. The same between Subject device and Predicate Device.

### 1) Product Code

The proposed product code of the subject device is DSH. This is the same product code of the predicate device in K143513.

### 2) Regulatory number and classification

The proposed regulatory number of the subject device is 878.2800 and the classification is 2. Compared to the predicate device, it does not contain 870.1425 and 870.2920. It is the same regulatory number and classification as the predicate device in K143513.

### 3) Indications for Use

The subject device is indicated for use to measure, save, and view electrocardiogram (ECG) information for long-term recording (up to 14 days) by attaching to the skin surface. The predicate device is indicated for use to capture, analyze, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. It is similar as the predicate device in K143513.

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#### 4) Prescription Use

The subject device is a prescription use device. It is the same as the predicate devices in K143513.

#### 5) Patients environment

The subject device is a wearable device. So, the patient can use this device while moving in daily life. It is the same as the predicate devices in K143513.

#### 6) Technical characteristic

The key functions of the subject device are similar in most functions except in some components and App functions compared to the predicate device. The technological characteristics are similar compared to the predicate devices in K143513.

| Performance test standard | Subject device | Predicate device |
|----------------------------------------|----------------|------------------|
| IEC 60601-1 | 0 | 0 |
| IEC 60601-1-2 | 0 | 0 |
| IEC 60601-1-6 | 0 | 0 |
| IEC 60601-1-11 | 0 | 0 |
| IEC 62304 | 0 | 0 |
| IEC 62366 | 0 | 0 |
| IEC 60601-2-47 | 0 | 0 |
| ANSI/AAMI EC12 | 0 | 0 |
| Cybersecurity test | 0 | 0 |
| Battery using time performance<br>test | 0 | 0 |
| ISO 10993-1 | 0 | 0 |
| ISO 10993-5 | 0 | 0 |
| ISO 10993-10 | 0 | 0 |
| ISO 10993-12 | 0 | 0 |
| ISO 10993-23 | 0 | - |

### 1.2 Difference between Subject device and Predicate Device

### 1) Key system components

The subject device has different system components (AT-Patch, AT-Report and App). The subject device does not have wireless gateway. The wireless gateway of the predicate device role is a transmitter that sends a real-time recording such as ECG waveforms recorded in the app when the device is operated in iRhythm's monitoring

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center for reporting. The subject device shows the electrocardiogram record in real time as an App solely for visual signal quality assessment, but does not have the function of sending it to a diagnostic center such as a hospital, therefore a wireless gateway is not needed for the subject device. ECG signals recorded by the subject device are not intended for automated analysis, and the subject device does not include automated analysis functions.

| | Subject device | Predicate device |
|------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Same<br>Component | 1. AT-Patch<br>2. AT REPORT (ATR-C130)<br>3. App (ATN-C130) | 1. Zio SR Patch recorder<br>2. Zio SR wireless Gateway<br>3. Zio ECG Utilization Service system |
| Different<br>Component | - | Zio SR gateway |

The presence or absence of a gateway does not affect the measurement, recording and analysis of data after use for 14 days, so subject device and predicate devices are not different due to this difference.

## 2) App function

: The subject device has a function to check whether the device is working normally through ECG waveform on the App compared to the predicated device. The subject device is a recorder, whereas the predicate device is a monitoring device. The predicate device can view the patient ECG waveform in the monitoring center for report of iRhythm technologies, Inc. The difference between the subject device and the predicate device is whether the corresponding function is implemented in the App or the monitoring center for reporting. The function of App allows the patient to check whether the device they are wearing is operating normally.

| | Subject device | Predicate device |
|-----------------------|-------------------------------------------------------|----------------------------|
| Same function | 1. Document symptom events | 1. Document symptom events |
| Different<br>function | 1. To check whether the device is<br>working normally | - |

※ The patient's waveform through the App is simply a means to check whether the device is working normally. The record is not saved. It is impossible to analyze any symptoms such as arrhythmia through this. Therefore, whether the waveform is viewed by the patient or at the center. it is a difference in convenience and not in function that has any influence on the purpose of use of the product. Therefore, the difference in App function does not affect the equivalence with the predicate device.

## 3) Indication for use

: The subject device is indicated for use to measure, save, and view electrocardiogram (ECG) information for long-term recording (up to 14 days) by attaching to the skin

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surface. The predicate device is indicated for use to capture, analyze, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring.

| | Subject device | Predicate device |
|-------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Same part | continuously measure, save and<br>view patient's ECG | continuously measure, save and<br>view patient's ECG |
| Different<br>part | View ECG information for<br>long- term recording (up to 14<br>days) by attaching to the skin<br>surface. | analyze, and report symptomatic<br>and asymptomatic cardiac events<br>and continuous<br>electrocardiogram<br>information for long-term<br>monitoring |

### 4) ECG Analysis software

The subject device does not have ECG analysis functions. By receiving the patient's data stored in the device, you can manage information including the patient's ECG data and view the patient's ECG. On the other hand, the predicate device can analyze, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information in their ECG Analysis Software.

| | Subject device | Predicate device |
|-----------------------|----------------------------------------------------------------------|----------------------------------------------------------------|
| Same<br>functio<br>n | 1. Patient<br>information<br>management<br>2. View patients ECG data | 1. Patient information management<br>2. View patients ECG data |
| Different<br>function | - | Analyze, and report patients ECG<br>data |

The subject device has been tested about electrical safety, EMC, biocompatibility, and performance. The results show that these differences do not raise any problems in the safety and effectiveness

### 10. Electrical Testing and EMC Testing

The subject device is an electrical medical device. Electrical hazard, mechanical hazard and high temperature hazard are included within the device.

The electrical and EMC tests were performed in accordance with the FDA recognized standards.

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- IEC 60601-1:2005/2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-47:2012, Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic system.
- -IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- -IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

The test results met the electrical safety and EMC requirements.

### 11. Performance Testing - Nonclinical

#### 1) Biocompatibility

The biocompatibility tests were performed in accordance with the FDA recognized standards:

- ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- -ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
- -ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
- -ISO 10993-23:2021(E) Biological evaluation of medical devices - Part 23: Tests for irritation

#### 2) Sterilization and Shelf life test

This device is not sterile.

The shelf life of device was verified in accordance with the internal criteria.

As a result of testing according to the internal criteria, it has been verified that this device can be use for up 14 days and satisfies the warranty period of 1 year.

3) ATP-C130 intended using time test

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As a result of testing according to the internal criteria, it has been verified that this device can be used for up 14 days.

4) Patch adhesion persistence test

Patch adhesion persistence test was performed in accordance with FDA Standard

- ANSI/AAMI EC12:2000 (R2015) Disposable ECG Electrodes

5) ECG Electrodes performance test

ECG Electrode was performed according to FDA Standard

- ANSI/AAMI EC12:2000 (R2015) Disposable ECG Electrodes

6) Cybersecurity test

Cybersecurity tests were performed in accordance the FDA recognized guidance.

- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued in 2018.

7) Extractable Substance Test

The extractable substance tests were performed about PH, Potassium permanganatereducible substances, Residue on evaporation, UV spectrum and Heavy metals.

8) ECG Electrodes test

ECG Electrodes tests were performed in accordance 'ANSI/AAMI EC12:2000(R2015)'.

9) Software

Software validation was evaluated according to IEC62304:2015.

### 10) Energy reduction

Energy reduction tests were performed using alternative method of IEC 60601-1 Clause 8.5.5.2. The device was demonstrated to be safe in case of defibrillation, however the device is not defibrillation-proof.

11) QoS

Qos test are performed according to ANSI TIR 69:2017

12) Usability

Usability formative & summative test were performed according to IEC 62366-1:2015 and FDA guidance.

The Test results met the performance requirements.

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#### 12. Conclusion

In comparison between the subject device and the predicate device, there are the similar indications for use, principle of operation, and technological characteristics. Although there are some differences (e.g., App function, system components, medical process and ECG Analysis function), they do not raise new or different questions of safety and effectiveness as compared to the predicate device. Results of the tests performed support the claims of substantial equivalence.

In this regard, we conclude that the subject device is substantially equivalent to the predicate device.