Rooti Rx ECG Event Recorder, Rooti Link APP Software

K163694 · Rooti Labs , Ltd. · DRG · Nov 7, 2017 · Cardiovascular

Device Facts

• Record ID: K163694
• Device Name: Rooti Rx ECG Event Recorder, Rooti Link APP Software
• Applicant: Rooti Labs , Ltd.
• Product Code: DRG · Cardiovascular
• Decision Date: Nov 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time. The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Device Story

Wearable single-lead ECG recording system; includes Rooti Rx device, patch, charging dock, and Rooti Link app. Captures electrical heart signals via standard off-the-shelf adhesive electrodes; stores data locally for up to 7 days. Patient-operated in home or workplace settings. Data transmitted via Wi-Fi to medical professional's iOS device for post-analysis. Enables remote monitoring of cardiac activity; assists clinicians in diagnostic decision-making; provides patient convenience by allowing ambulatory recording outside clinical settings.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with recognized consensus standards including AAMI ANSI ISO 10993-1 (biocompatibility), IEC 60601-1-11 (home healthcare safety), AAMI ANSI ES60601-1 (general safety), AAMI ANSI IEC 60601-1-2 (EMC), and AAMI ANSI IEC 60601-2-47 (ambulatory ECG systems).

Technological Characteristics

Wearable single-lead ECG recorder. Dimensions: 62x22.5x8.45 mm; Weight: 14g. Power: Rechargeable battery. Connectivity: Wi-Fi to iOS device. Sampling rate: 500 Hz. Resolution: 24-bit. Water-resistant. Uses standard off-the-shelf adhesive electrodes. Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-47, and ISO 10993-1.

Indications for Use

Indicated for general care patients 21 years of age or older for recording single-lead ECG data at home or in the workplace. Not for use on 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

• Zephyr Technology, BIOMODULE 3-M1 (K123658)

Submission Summary (Full Text)

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November 7, 2017

Rooti Labs Ltd. Ms. Sue Chuang Chief Operating Officer 5f-1, No.17, Zhouzi St., Neihu Dist. Taipei. 11493 TW

Re: K163694

Trade/Device Name: Rooti Rx System ECG Event Recorder, Rooti Link APP Software Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: December 9, 2016 Received: December 28, 2016

Dear Ms. Sue Chuang:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hilleman

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known) K163694

#### Device Name

Rooti Rx System ECG Event Recorder, Rooti Link APP Software

### Indications for Use (Describe)

- The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.

- The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

- 1. Company Identification Rooti Labs Ltd. 5F-1, No.71, Zhouzi St., Neihu Dist., Taipei, Taiwan Tel: [phone]
- 2. Submitter's Name and Address Sue Chuang Email: [e-mail] Tel: [phone]

3. Device Trade Name: Rooti Rx System ECG Event Recorder, Rooti Link APP Software Product name: Rooti Rx System Model/Type name: Rooti Rx System ECG Event Recorder Regulation Number: 21 CFR 870.2910 Product Code: DRG Device Class: II

- 4. Predicate Device
Zephyr Technology, BIOMODULE 3-M1, 510(k) number K123658.

# 5. Intended Use

- The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded

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data is transmitted to a medical professional's iOS device via Wi-Fi at a later time. - The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

- 6. Device Desciption
Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.

- 7. Compliance of Recognized Consensus Standard

| USA Standard | | | | |
|--------------|-----------------------|----------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NO. | Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number And Date | Title of Standard |
| 1 | 2-156 | AAMI ANSI ISO | 10993-1:2009/(R)2013 | Biological Evaluation Of Medical<br>Devices - Part 1: Evaluation And Testing<br>Within A Risk Management Process |
| 2 | 19-6 | IEC | 60601-1-11 Edition 1.0<br>2010-04 | Medical Electrical Equipment - Part 1-11<br>General Requirements For Basic Safety<br>And Essential Performance - Collateral<br>Standard: Requirements For Medical<br>Electrical Equipment And Medical<br>Electrical Systems Used In The Home<br>Healthcare Environment [Including: |
| 3 | 19-4 | AAMI ANSI | ES60601-1:2005/(R)2012<br>And A1:2012, | Technical Corrigendum 1 (2011)]<br>C1:2009/(R)2012 And A2:2010/(R)2012<br>(Consolidated Text) Medical Electrical<br>Equipment - Part 1: General<br>Requirements For Basic Safety And<br>Essential Performance (IEC<br>60601-1:2005, MOD) |
| 4 | 19-2 | AAMI ANSI IEC | 60601-1-2:2007/(R)2012 | Medical Electrical Equipment - Part 1-2:<br>General Requirements For Basic Safety<br>And Essential Performance - Collateral<br>Standard: Electromagnetic Compatibility<br>Requirements And Tests (Edition 3) |
| 5 | 3-127 | AAMI ANSI IEC | 60601-2-47:2012 | Medical Electrical Equipment -- Part<br>2-47: Particular Requirements For The<br>Basic Safety And Essential Performance<br>Of Ambulatory Electrocardiographic<br>Systems |

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# 8. Safety and Effectiveness Substantial Equivalence Comparison

| Device Name | BIOMODULE 3-M1 | Rooti Rx System | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Applicant | Zephyr Technology | Rooti Labs Limited | - |
| 510(K) Number | K123658 | | |
| Regulation<br>Number | 870.2360 | 870.2910 | |
| Classification | Class II | Class II | - |
| Product Code | DRX | DRG | - |
| Intended Use | The intended use of the BioModule<br>3-M1 is to provide a General Ward<br>Monitoring facility for detecting,<br>storing and transmitting physiological<br>data to a qualified receiving station.<br>The scientific concept on which this<br>device is based on the principle that<br>low level electrical pulses from the<br>heart are measurable of the surface of<br>the skin. This device functions by<br>capturing these electrical pulses via<br>electrodes and delivering these<br>signals to sophisticated electronics for<br>processing. The calibration is<br>established by the factory and yields<br>accurate and calibrated signals that<br>can maintain calibration over its<br>useful life. | The intended use of the Rooti<br>Rx System is to allow a patient at<br>home or in the workplace to record<br>single-lead electrocardiography<br>(ECG) data for post-analysis by<br>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<br>Wi-Fi at a later time.<br>- The device is not intended to be<br>used 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. | Similar |
| Indication For<br>Use | The BioModule 3-M1 is a<br>physiological monitoring telemetry<br>device intended for monitoring<br>ambulatory patients in alternate care<br>settings. The device consists of<br>adhesive electrodes and an electronics<br>module. The device stores and<br>transmits vital sign data including<br>ECG, heart rate, respiration rate, body<br>orientation and activity. The<br>BioModule 3-M2 provides a facility<br>to detect and transmit single lead<br>ECG signals to be received by<br>qualified instruments.<br>The BioModule 3-M1 collects and<br>transmits measurements captured in<br>alternate care settings as prescribed<br>by the health care professional.<br>Breathing rate values are accurately<br>transmitted only during sedentary<br>periods.<br>The BioModule 3-M1 is indicated for | The intended use of the Rooti Rx<br>System is to allow a patient at home or<br>in the workplace to record single-lead<br>electrocardiography (ECG) data for<br>post-analysis by medical professionals.<br>The Rooti Rx device stores the ECG<br>data,<br>and the recorded data is<br>transmitted to a medical<br>professional's iOS device via<br>Wi-Fi at a later time.<br>- The device is not intended to be<br>used 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. | Similar |
| | use as a general patient monitor to provide physiological information as part of general ward monitoring system. | | |
| Data Storage Capacity | 140 hrs | 7 days | Rooti Rx Systemhas more capacity |
| Method Of Application | Off the shelf adhesive electrode | Off the shelf adhesive electrode | Same |
| Number of ECG | 1 | 1 | Same |
| ECG resolution | 12 | 24 | Rooti Rx |
| ECG sampling rate (Hz) | 1000 | 500 | Both are more than double the highest useful frequency component (40Hz). |
| Water resistant | Yes | Yes | Same |
| Data transmission | wireless | wireless | Same |
| Power source | Rechargeable battery | Rechargeable battery | Same |
| Weight (g) | 33 | 14 | Rooti Rx System is lighter |
| Dimensions (mm) | 88 x 48 x 8 | 62x22.5x8.45 | Rooti Rx System is smaller |

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# 9. Conclusion

Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, Patch, Charging dock and Rooti Link. The intended use of the Rooti Rx System is

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to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.

According to the substantial equivalence discussion, the Rooti Rx System is substantially equivalent to the predicate devices in all respects. The intended use and the indication for use for the Rooti Rx System are substantially equivalent to the intended use and the indication for use for 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. Therefore, the Rooti Rx System is substantially equivalent to the predicate device