Guardian Angel GA1000 Digital Vital Sign Monitoring System

K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · DQA · Mar 3, 2017 · Cardiovascular

Device Facts

• Record ID: K162580
• Device Name: Guardian Angel GA1000 Digital Vital Sign Monitoring System
• Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Guardian Angel GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.

Device Story

The Guardian Angel GA1000 is a digital vital sign monitor consisting of a wrist-worn sensor module and a portable, table-top wireless display unit. It uses red and infrared LED transmittance technology to measure functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Data is transmitted via Bluetooth v4.0 from the sensor to the display unit. The display unit features an LCD panel and speakers to provide visual and audio alarms for SpO2, pulse rate, low battery, and sensor disconnection/faults. The device is intended for use by clinicians in hospital settings. By providing real-time monitoring and alerts, the system assists healthcare providers in identifying abnormal vital signs, potentially enabling timely clinical intervention and improving patient safety.

Clinical Evidence

Clinical performance was verified in a study of healthy adult subjects under controlled induced hypoxia (70%-100% SpO2 range) per ISO 80601-2-61:2011. Over 200 data points were collected per sensor. The Arms (accuracy root-mean-square difference) for each sensor was below 3%, meeting FDA guidance requirements for pulse oximeters.

Technological Characteristics

Transmittance-based pulse oximetry using red (660 nm) and infrared (905 nm) LEDs. Components: wrist-worn sensor module, wireless display unit. Connectivity: Bluetooth v4.0. Power: 3.7V Lithium battery (sensor), Lithium battery/AC (display). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-5/10 (biocompatibility), ISO 80601-2-61 (pulse oximetry), IEC 60601-1-8 (alarms), IEC 62304 (software).

Indications for Use

Indicated for adult and pediatric patients for spot-checking or continuous monitoring of functional SpO2 and pulse rate in hospital environments during non-motion and well-perfused conditions.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Avant Digital Pulse Oximetry System, Model 4000, 4100, Nonin Medical, Inc. (K052669)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2017

Taiwan Aulisa Medical Devices Technologies, Inc. % Don Mizota Consultant 725 Morninghome Rd Danville, California 94526

Re: K162580

Trade/Device Name: Guardian Angel GA1000 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 26, 2017 Received: January 30, 2017

Dear Don Mizota:

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Lori A. Wiggins -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K162580

Device Name

Guardian Angel GA1000 Digital Vital Sign Monitoring System

Indications for Use (Describe)

The Guardian Angel GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.

| Type of Use (Select one or both, as applicable) | <span> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" stroke-width="1" width="12"></rect> <line stroke="black" stroke-width="1" x1="0" x2="12" y1="0" y2="12"></line> <line stroke="black" stroke-width="1" x1="0" x2="12" y1="12" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" stroke-width="1" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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### Section 5: 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92

#### 5.1. General Information

| | Date Summary Prepared: September 13th, 2016 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Taiwan Aulisa Medical Devices Technologies, Inc.<br>Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,<br>Nangang Dist., Taipei City 115 TW<br>Phone: [phone]<br>FAX: [phone] |
| Contact Person: | Jenny Lai<br>RA<br>Taiwan Aulisa Medical Devices Technologies, Inc.<br>Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., |

Nangang Dist.,Taipei City 115 TW Phone: [phone] FAX: [phone] Email: [e-mail]

#### 5.2. Name of Device

| Trade Name: | Guardian Angel GA1000 Digital Vital Sign Monitoring<br>System |
|-----------------|---------------------------------------------------------------|
| Common Name: | Pulse Oximeter |
| Classification: | Oximeter CFR §870.2700 |
| Class: | Class II |
| Product Code: | DQA |

#### 5.3. Legally Marketed Predicate Devices for Claimed Equivalence

K052669, Avant Digital Pulse Oximetry System, Model 4000, 4100, Nonin Medical, Inc.

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#### 5.4. Device Description

Aulisa's GA1000 is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation level. The system includes a self-contained wrist-worn Sensor Module and a portable, table-top wireless Display Unit. The Guardian Angel GA1000 Digital Vital Sign Monitoring System is also equipped with an alarm system that alerts the caregiver when a patient's pulse rate is too low or too high and when the patient's SpO2 is too low or too high.

Guardian Angel GA1000 Digital Vital Sign Monitoring System contains the following components.

- Sensor Module ●
- Display Unit ●
- Finger Sensor ●
- Sensor Module wristband ●
- Sensor Module Charging Adaptor ●
- Display Unit Charging Adaptor ●
- . Display Unit Stand

The GA1000 measures SpO2 and pulse rate based on transmittance technology, measuring the absorbance of red and infrared light passed through the tissue.

The GA1000 uses Bluetooth v4.0 to transmit data between the wrist-worn Sensor Module and the wireless Display Unit. Both the Sensor Module and the Display Unit is Bluetooth® 4.0 compatible.

The GA1000 uses non-invasive red and infrared LED sensors to measure the functional blood oxygen saturation and pulse rate. The measurements are wirelessly transmitted to the Display Unit, which displays the measurements using a Liquid-Crystal-Display (LCD) panel. The system provides adjustable visual and audio oxygen saturation, and pulse rate alarms through the LCD panel and speakers. Additional alarms are featured, including low battery on the Sensor Module, Sensor Cable disconnection, Sensor Module disconnection, Sensor Cable Probe fault, Sensor Probe detached from patient, Display Unit battery low.

#### 5.5. Intended Use

The Guardian Angel GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of

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patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.

#### Technological Characteristics 5.6.

The comparison table of technological characteristics for Guardian Angel GA1000 Digital Vital Sign Monitoring System and Nonin Avant Digital Pulse Oximetry System is shown as follows:

## Table 5.1 - Comparison Table to Predicate Device

| | Subject Device | Predicate Device | | |
|-------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------|
| Product code | DQA | DQA | | |
| Classification | Class II | Class II | | |
| Principles of<br>Operation | Red and Infra-red<br>transmittance technology | Red and Infra-red<br>transmittance technology | | |
| System<br>Components | Sensor Module and<br>Display Unit | Patient Module and<br>Display Unit | | |
| Wireless<br>technology/<br>Data<br>Transmission | Bluetooth v4.0 | Bluetooth 1.1 | | |
| Software level<br>of concern | Medium | Medium | | |
| SpO2<br>Specifications<br>(No Motion) | Displayed<br>Range: | 1-100% | Displayed<br>Range: | 0-100% |
| | Declared<br>Range: | 70-100% | Declared<br>Range: | 70-100% |
| | Accuracy:<br>(Pediatrics :<br>SC100M,<br>ENSC100M;<br>Adults:<br>SC100L,<br>ENSC100L) | Adults/<br>Pediatrics:<br>3 digits | Accuracy:<br>(Finger Clip<br>Flexi,<br>Flexifoam,<br>8000R,<br>8000Q) | Adults/<br>Pediatrics:<br>2 digits<br>3 digits<br>4 digits |
| | Range: | 30-290 bpm | Range: | 18-300 bpm |
| Pulse Rate<br>Specifications<br>(No motion) | Accuracy:<br>( SC100M,<br>SC100L,<br>ENSC100M,<br>ENSC100L) | Adults/<br>Pediatrics:<br>±3 % | Accuracy:<br>(Finger Clip<br>Flexi,<br>Flexifoam,<br>8000R,<br>8000Q) | Adults/<br>Pediatrics:<br>±3% |

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| Measurement<br>Wavelengths<br>and Output<br>Power | Red 660 nm @ 1.8 mw<br>nominal<br>Infrared 905 nm @ 2 mw<br>nominal | Red 660 nm @ 3 mw nominal<br>Infrared 910 nm @ 3 mw<br>nominal |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System<br>Components | Sensor Module and<br>Display Unit | Patient Module and<br>Display Unit |
| Power Supply | Sensor Module: 3.7V<br>Lithium battery<br>Display Unit: Lithium<br>battery, AC adaptor | Patient Module: AA battery<br>Display Unit: NiMH battery,<br>AC adaptor |
| Sensor Form | Soft Finger Sensor | Clip and Wrap Sensor |
| Alarms | Audible and visual pulse<br>rate and oxygen saturation<br>alarms.<br>Low battery and critical<br>battery, disconnection<br>alarms. | Audible and visual pulse rate,<br>oxygen saturation, and<br>perfusion alarms.<br>Low battery and<br>disconnection alarms. |
| Indications For<br>Use | The Guardian Angel<br>GA1000 Digital Vital Sign<br>Monitoring System is<br>indicated for use in<br>measuring and displaying<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate of adult and<br>pediatric patients. It is<br>indicated for spot-checking<br>and / or continuous<br>monitoring of patients<br>during non-motion and<br>under well-perfused<br>conditions. The intended<br>environment of use is<br>hospital. This system is a<br>reusable device. | The NONIN® Avant®<br>4000 Digital Pulse Oximetry<br>System is indicated for<br>measuring and displaying<br>functional oxygen saturation<br>of arterial hemoglobin (SpO2)<br>and pulse rate of adult,<br>pediatric, and infant patients.<br>It is indicated for spot<br>checking and/or continuous<br>monitoring of patients during<br>both motion and no motion<br>conditions, and for patients<br>who are well or poorly<br>perfused. |

#### Substantial Equivalence 5.7.

The Guardian Angel GA1000 Digital Vital Sign Monitoring System uses technology which is equivalent to the legally marketed predicate device cleared under K052669. The subject device is indicated for monitoring adults and pediatric patients whereas the predicate is indicated for use for monitoring adults, pediatric, and infant patients. In addition, the subject

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device is indicated to monitor during non-motion conditions and in poorly perfused patients. These differences are not critical to the intended diagnostic use of the device. The indications of the subject device encompass a smaller patient population and less conditions of use; thus, the differences do not affect the safety and effectiveness of the device when used as labeled.

#### 5.8. Summary of Performance Testing

Accuracy of pulse oximeter, electrical, mechanical, electromagnetic compatibility, software and biocompatibility testing have been performed on the GA1000.

The results of the testing demonstrate that the Taiwan Aulisa Medical Technologies Guardian Angel GA1000 Digital Vital Sign Monitoring System is as safe and effective, as the legally marketed predicate device.

#### 5.8.1. Non-clinical Testing

The following non-clinical testing has been conducted for the GA1000 Digital Vital Sign Monitoring System, performed according to GA1000 product requirement specification and quality system to illustrate substantial equivalence.

| Performance Testing | ISO 80601-2-61:2011 |
|-------------------------------------------------|----------------------------------------------------------------------------------------|
| Electrical Safety<br>testing | IEC 60601-1:2005 |
| Biocompatibility<br>Testing | ISO 10993-10: 2010, ISO 10993-5:2009 |
| Electrical Safety<br>Testing and EMC<br>Testing | IEC 60601-1-2:2007 |
| Alarm System | IEC 60601-1-8:2006 |
| Wireless Coexistence | FDA Guidance Radio Frequency Wireless<br>Technology in Medical Devices (2013) |
| Software Verification | IEC 62304:2006<br>FDA Guidance Off-The-Shelf Software Use<br>in Medical Devices (1999) |
| Pulse Oximetry<br>Testing | ISO 80601-2-61:2011<br>FDA Pulse Oximeters Guidance (2013) |

## Table 5.2 - Utilization of Standards table

The tests performed on the GA1000 include:

- · Functional Test

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- Push, Impact and Drop Test ●
- Particulate and Water Ingress Test .
- . Temperature and Humidity Test
- Battery Life Test ●
- Radio Frequency Compatibility ●
- Emissions and Immunity Tests ●
- Biocompatibility Test .
- Alarm System Test ●

The subject device underwent bench tests following standards listed above. Software Validation and Verification was also performed following IEC 62304:2006. Biocompatibilities of patient contact materials have been tested, showing the materials to be biocompatible. The tests show compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-8, IEC 62304, ISO 10993-5, ISO 10993-10, and ISO 80601-2-61.

#### 5.8.2. Clinical Testing

Clinical data were collected to verify the performance accuracy of GA1000 on healthy adult subjects over the range of 70%-100% SpO through controlled induced hypoxia. The data was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Standard.

Over 200 data points were collected for each sensor. The Arms of each sensor is below 3%, compliant with FDA quidance on Pulse Oximeter -Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4t0, 2013.

#### Conclusion 5.9.

Based on the clinical data and non-clinical testing summarized in 510(k) submission, the result demonstrates Guardian Angel GA1000 Digital Vital Sign Monitoring System is in compliance with design specifications. applicable standards, and the intended use. Performance test data demonstrate substantial equivalence to the predicate device.