EZYPRO ECG Recorder (Model: UG02)

K213233 · Sigknow Biomedical Co., Ltd. · DRG · Jun 23, 2022 · Cardiovascular

Device Facts

• Record ID: K213233
• Device Name: EZYPRO ECG Recorder (Model: UG02)
• Applicant: Sigknow Biomedical Co., Ltd.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection. During wearing, EZYPRO ECG recorder (model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation. UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.

Device Story

EZYPRO ECG Recorder (Model: UG02) is a wearable, single-lead cardiac rhythm recorder; records ECG data for up to 14 days. Patient wears device at home or workplace; marks symptomatic episodes via button press. Device transmits data via Bluetooth to EZY iSee mobile app for signal spot checks; app provides no diagnostic interpretation. Data downloaded to PC via USB for physician review. Physician performs manual interpretation of ECG and heart rate. Device benefits patients by enabling long-term ambulatory cardiac monitoring without interfering with daily routines.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Single-lead ECG recorder; 18-bit resolution, 256 Hz sampling rate. Powered by 360 mAh rechargeable lithium battery. Dimensions: 47x32x12 mm; weight: 20g. Connectivity: Bluetooth (to mobile app), USB (to PC). Materials: biocompatible adhesive electrodes. Software: firmware, EZY iSee mobile app, Windows-based setting tool. Sterilization: not specified.

Indications for Use

Indicated for patients older than 21 years requiring continuous single-lead cardiac rhythm recording for up to 14 days. Not intended for critical care patients.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Rooti Rx System ECG Event Recorder, Rooti Link APP Software (K163694)

Reference Devices

• ZIO® Patch (K121319)

Submission Summary (Full Text)

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June 23, 2022

Sigknow Biomedical Co.,Ltd. Hsiao-Fan Liu Regulatory Affairs 6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, Taipei City, 105412 Taiwan

Re: K213233

Trade/Device Name: EZYPRO ECG Recorder (Model: UG02) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: May 16, 2022 Received: May 26, 2022

Dear Hsiao-Fan Liu:

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.

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

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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 (OS) 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 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).

Sincerely,

Jennifer Shih 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

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## Indications for Use

510(k) Number (if known) K213233

Device Name EZYPRO ECG Recorder (Model: UG02)

EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.

During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.

UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.

| 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) SUMMARY

| 5.1 | Type of Submission | Traditional |
|-----|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 | Date of Summary | 06/17/2022 |
| 5.3 | Submitter | Sigknow Biomedical Co., Ltd.<br>Address: 6F., No.760, Sec. 4, Bade Rd., Songshan Dist.,<br>Taipei City 105, Taiwan (R.O.C.)<br>Phone: [phone]<br>Contact: Hsiao-Fan Liu<br>[e-mail] |

#### 5.4 Identification of the Device

| Proprietary/Trade Name: | EZYPRO ECG Recorder (Model:<br>UG02) |
|-------------------------|------------------------------------------------------------------|
| Model Number: | UG02 |
| Regulation Description: | Radiofrequency physiological signal<br>transmitter and receiver. |
| Review Panel: | Cardiovascular |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |

#### રત્ત Identification of the Predicate Device

| Predicate Device Name: | Rooti Rx System ECG Event<br>Recorder, Rooti Link APP Software |
|------------------------|----------------------------------------------------------------|
| Model Number: | — |
| 510(k) Number: | K163694 |
| Manufacturer: | Rooti Labs Ltd. |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |

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#### 5.6 Identification of the Reference Device

| Reference Device Name: | ZIO® Patch |
|------------------------|----------------------------|
| Model Number: | — |
| 510(k) Number: | K121319 |
| Manufacturer: | iRhythm Technologies, Inc. |
| Regulation Number: | 870.2800 |
| Product Code: | DSH |
| Device Class: | II |

#### Intended Use/Indications for Use of the Device 5.7

EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection.

During wearing, EZYPRO ECG recorder (model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.

UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.

#### 5.8 Device Description

EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.

The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.

Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the

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diagnosis.

EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.

#### 5.9 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, EZYPRO ECG Recorder (Model: UG02).

- . Reliability Test
- Reliability Test (ME)
- Reliability Evaluation (500 cycles reusable) -
- Shelf Life Test .
- . Biocompatibility
- Biological evaluation of medical device ।
- In Vitro Cytotoxicity Test (Agar Diffusion)
- Intracutaneous Irritation Study in Rabbits
- Skin Sensitization Study in Guinea Pigs (Maximization Test) ।
- . Software
- Recorder Firmware Validation ।
- EZY iSee Software Validation
- UG02 Setting Tool Software Validation
- Cybersecurity Cybersecurity Management
- Electromagnetic compatibility and electrical safety test ●
- IEC 60601-1 Test
- EMC Test
- Radio Spectrum Test ।
- SAR Evaluation ।
- Safety Requirements for Portable Sealed Secondary Cells ।
- Lithium Polymer Battery Safety Test
- IEC 60601-1-11 Test
- Energy Reduction Test ।
- Performance test .

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- IEC 60601-2-47 Test
- Product Function Test (EE)
- Disposable ECG electrodes Test
- QRS and Heart Rate Accuracy
- HFE/UE .
- . MR Unsafe Evaluation
- RF Wireless Evaluation

All the test results demonstrate EZYPRO ECG Recorder (Model: UG02) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

## 5.10 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

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# 5.11 Substantial Equivalence Determination

EZYPRO ECG Recorder (Model: UG02) submitted in this 510(k) file is substantially equivalent in intended use, safety and performance to the cleared Rooti Rx System (K163694). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K213233 | K163694 | N/A |
| Proprietary<br>Name | EZYPRO ECG Recorder (Model: UG02) | Rooti Rx System ECG Event<br>Recorder, Rooti Link APP Software | N/A |
| Manufacturer | Sigknow Biomedical Co., Ltd. | Rooti Labs Limited | N/A |
| Regulation<br>Number | 21 CFR 870.2910 | 21 CFR 870.2910 | Same |
| Classification | Class II | Class II | Same |
| Product Code | DRG | DRG | Same |
| Intended Use | EZYPRO ECG Recorder (Model: UG02)<br>is a prescription-only, single-patient-use,<br>continuously recording single-lead cardiac<br>rhythm recorder that can be worn up to 14<br>days each time through recharge. It is | The intended use of the Rooti Rx<br>System is to allow a patient at home<br>or in the workplace to record<br>single-lead electrocardiography<br>(ECG) data for post-analysis by | Similar<br>The subject device is to record<br>single-lead cardiac rhythm from<br>patients who are older than 21<br>years old; its medical indication is |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| | indicated for use on patients who are older<br>than 21 years old. At the end of the<br>recording, the recorded ECG data can be<br>transferred in an available file on PC via<br>the USB connection.<br>During wearing, EZYPRO ECG recorder<br>(model: UG02) can digitally transmit ECG<br>data to the mobile device with the APP<br>(EZY iSee) embedded through Bluetooth<br>technology, supporting spot checks on<br>signals. EZY iSee does not contain<br>diagnostic interpretation.<br>UG02 setting tool is a program executed<br>on the Windows OS platform and to<br>provide an interface for setting up<br>operational parameters of EZYPRO ECG<br>Recorder (Model: UG02) and downloading<br>the recorded ECG data. | medical professionals. The Rooti Rx<br>device stores the ECG data, and the<br>recorded data is transmitted to a<br>medical professional's iOS device<br>via Wi-Fi at a later time.<br>The device is not intended to be used<br>on critical care patients.<br>The Rooti Rx System is indicated for<br>use on general care patients and on<br>patients who are 21 years of age or<br>older. | same as the predicate device.<br>The recorded data could be<br>transmitted wireless to a medical<br>professional's equipment.<br>The subject device has additional<br>component, UG02 setting tool that<br>can set up the operational<br>parameters and download the data. |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Data Storage<br>Capacity | 14 days | 7 days | Different<br>The subject device has more<br>capacity. And the software<br>validation and performance tests<br>could demonstrate that it would not<br>affect the safety and effectiveness. |
| Method of<br>Application | Designed adhesive electrode | Off the shelf adhesive electrode | Different<br>The subject device has exclusive<br>electrode, and the function of<br>exclusive electrode has been tested.<br>It could demonstrate the substantial<br>equivalence of devices. |
| ECG channel | Channel 1, Single lead | Channel 1, Single lead | Same |
| Electrode<br>Position | Left Sternum, inclined<br>(Self-defined position called<br>"ECG Channel A") | Left Sternum, horizontal | Different<br>A reference device (ZIO Patch,<br>K121319) which are applied to the<br>similar position as the subject<br>device was used to support the |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| | | | technological characteristic. The<br>relevant evaluation and tests<br>could demonstrate the subject<br>device is substantially equivalent<br>to the predicate. |
| ECG resolution | 18 bits, ±5mV | 24 bits, 6mVp-v, offset ±300mV | Different<br>The subject device has lower ECG<br>resolution.<br>Performance tests shown that it<br>meets the requirements and the<br>device is substantially equivalent<br>to the predicate. |
| ECG sampling<br>rate (Hz) | 256 | 500 | Different<br>Both are more than double the<br>highest useful frequency<br>component (40Hz).<br>Performance tests shown that it<br>meets the requirements and the |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| | | | device is substantially equivalent to<br>the predicate. |
| Water resistant | Yes | Yes | Same |
| Data<br>transmission | Bluetooth | Wifi | Different<br>Although they are different in data<br>transmission, it doesn't affect the<br>device function.<br>Software validation demonstrated<br>that it meets the requirements. |
| Power source | 360 mAh lithium battery<br>(Rechargeable battery) | 240 mAh lithium battery<br>(Rechargeable battery) | Similar<br>The subject device has more<br>quantity of electricity.<br>The relevant electric safety tests<br>shown that it meets the<br>requirements. |
| Weight (g) | 20 | 14 | Similar<br>Although the subject device is<br>heavier due to the battery, it |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| | | | doesn't affect the device function. |
| Dimensions<br>(mm) | 47 (L) x 32 (W) x 12 (H) mm | 62 x 22.5 x 8.45 mm | <b>Similar</b><br>Although the subject device is<br>larger due to the battery, it doesn't<br>affect the device function. |

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## 5.12 Similarity and Difference

In terms of the intended use, the subject device and the predicate device are much similar.

The subject device can be worn up to 14 days to record ECG data. During wearing, it can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals just for making sure the device are working normally. At the end of the recording, the recorded ECG data can be downloaded from recorder for post-analysis by medical professionals.

The predicate device can be worn up to 7 days to record ECG data. During wearing, the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time for post-analysis.

Both of them are used on general care patients and on patients who are 21 years of age or older. They are both used at home or in the workplace, and the recorded data is finally received to medical professionals.

Therefore, the intended use and the indication for use for the subject device are substantially equivalent to the predicate device.

In the terms of electrode position, the subject device adopts a specific position named "ECG Channel A", which is different from the predicate. Therefore, a reference device (ZIO Patch, K121319) applied to a similar position was added to support the technological characteristic.

In terms of the specification, because of the larger battery, the subject device has bigger data storage capacity, power source, weight and dimension so that it can record ECG data up to 14 days.

On the other hand, although there are some differences on data transmission technology, ECG resolution, and ECG sampling rate, they do not affect the safety and performance of the subject device based on the provided test reports.

In terms of the ECG patch, the subject device has exclusive electrode, and the

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function of exclusive electrode has been tested to demonstrate substantial equivalence

#### 5.13 Conclusion

In conclusion, according to the substantial equivalence discussion, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device in all respects. The intended use for the EZYPRO ECG Recorder (Model: UG02) are substantially equivalent to the predicate device. The performance testing results demonstrate that any differences in the technological characteristics between the devices are incidental and not significant which do not raise any new issues of safety or efficacy as compared to the predicate. Therefore, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device.