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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Guardian Angel GA1000 Digital Vital Sign Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Guidance)	Reported Device Performance (Guardian Angel GA1000)
SpO2 Accuracy (Declared Range: 70-100%, No Motion)	Adults/Pediatrics: 3 digits (Specific sensor types: SC100M, ENSC100M; Adults: SC100L, ENSC100L)
Pulse Rate Accuracy (No Motion)	Adults/Pediatrics: ±3% (Specific sensor types: SC100M, SC100L, ENSC100M, ENSC100L)
SpO2 Accuracy in induced hypoxia (70-100% SpO2)	Arms of each sensor is below 3% (compliant with FDA guidance on Pulse Oximeter - Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4th, 2013)
Electrical Safety (IEC 60601-1:2005)	Compliant with IEC 60601-1
Biocompatibility (ISO 10993-10: 2010, ISO 10993-5:2009)	Biocompatible for patient contact materials; compliant with ISO 10993-5 and ISO 10993-10
Electrical Safety & EMC (IEC 60601-1-2:2007)	Compliant with IEC 60601-1-2
Alarm System (IEC 60601-1-8:2006)	Compliant with IEC 60601-1-8
Wireless Coexistence (FDA Guidance Radio Frequency Wireless Technology in Medical Devices (2013))	Tested for Radio Frequency Compatibility and Emissions/Immunity Tests
Software Verification (IEC 62304:2006, FDA Guidance Off-The-Shelf Software Use in Medical Devices (1999))	Compliant with IEC 62304 and FDA Guidance Off-The-Shelf Software Use in Medical Devices (1999)
Pulse Oximetry Testing (ISO 80601-2-61:2011, FDA Pulse Oximeters Guidance (2013))	Compliant with ISO 80601-2-61 and FDA Pulse Oximeters Guidance (2013)
Functional Test	Performed
Push, Impact, and Drop Test	Performed
Particulate and Water Ingress Test	Performed
Temperature and Humidity Test	Performed
Battery Life Test	Performed

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for SpO2 Accuracy (Clinical Testing): "Over 200 data points were collected for each sensor." This implies the sample size refers to the number of data points, not necessarily individual subjects.
Data Provenance: The study was conducted on "healthy adult subjects." The document does not specify the country of origin of the data, but the submitting company is based in Taiwan. The study was prospective in nature, involving induced hypoxia.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical test set. For pulse oximetry, the ground truth for SpO2 is typically established using a co-oximeter on arterial blood samples, which is a laboratory measurement rather than an expert consensus process.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the clinical test set. For pulse oximetry accuracy during induced hypoxia, the comparison is typically made between the device reading and the gold standard co-oximetry reading, rather than relying on expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The Guardian Angel GA1000 is a vital sign monitoring device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The clinical testing described for SpO2 accuracy (induced hypoxia study) and the various non-clinical tests (electrical safety, EMC, software, etc.) evaluate the device's performance in isolation, without human intervention in the core measurement and algorithm functionality.

7. Type of Ground Truth Used

For the clinical testing of SpO2 accuracy, the ground truth was established through controlled induced hypoxia conditions, implying comparison against a reference method such as co-oximetry from arterial blood samples (though co-oximetry is not explicitly named, it's the standard for this type of testing).

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As this device appears to be primarily an embedded system for measuring vital signs, it may not rely on a "training set" in the same way a machine learning-based AI diagnostic tool would. If there is any internal algorithm tuning or calibration, the details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since no training set information is provided, the method for establishing its ground truth is also not specified.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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

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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.Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,Nangang Dist., Taipei City 115 TWPhone: 886-2-2655-7297FAX: 886-2-2655-7260
Contact Person:	Jenny LaiRATaiwan Aulisa Medical Devices Technologies, Inc.Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,

Nangang Dist.,Taipei City 115 TW Phone: 886-2-2655-7297 FAX: 886-2-2655-7260 Email: jenny.lai@aulisa.com

5.2. Name of Device

Trade Name:	Guardian Angel GA1000 Digital Vital Sign MonitoringSystem
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

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.

5.5. Intended Use

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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 ofOperation	Red and Infra-redtransmittance technology	Red and Infra-redtransmittance technology
SystemComponents	Sensor Module andDisplay Unit	Patient Module andDisplay Unit
Wirelesstechnology/DataTransmission	Bluetooth v4.0	Bluetooth 1.1
Software levelof concern	Medium	Medium
SpO2Specifications(No Motion)	DisplayedRange:	1-100%	DisplayedRange:	0-100%
	DeclaredRange:	70-100%	DeclaredRange:	70-100%
	Accuracy:(Pediatrics :SC100M,ENSC100M;Adults:SC100L,ENSC100L)	Adults/Pediatrics:3 digits	Accuracy:(Finger ClipFlexi,Flexifoam,8000R,8000Q)	Adults/Pediatrics:2 digits3 digits4 digits
	Range:	30-290 bpm	Range:	18-300 bpm
Pulse RateSpecifications(No motion)	Accuracy:( SC100M,SC100L,ENSC100M,ENSC100L)	Adults/Pediatrics:±3 %	Accuracy:(Finger ClipFlexi,Flexifoam,8000R,8000Q)	Adults/Pediatrics:±3%

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MeasurementWavelengthsand OutputPower	Red 660 nm @ 1.8 mwnominalInfrared 905 nm @ 2 mwnominal	Red 660 nm @ 3 mw nominalInfrared 910 nm @ 3 mwnominal
SystemComponents	Sensor Module andDisplay Unit	Patient Module andDisplay Unit
Power Supply	Sensor Module: 3.7VLithium batteryDisplay Unit: Lithiumbattery, AC adaptor	Patient Module: AA batteryDisplay Unit: NiMH battery,AC adaptor
Sensor Form	Soft Finger Sensor	Clip and Wrap Sensor
Alarms	Audible and visual pulserate and oxygen saturationalarms.Low battery and criticalbattery, disconnectionalarms.	Audible and visual pulse rate,oxygen saturation, andperfusion alarms.Low battery anddisconnection alarms.
Indications ForUse	The Guardian AngelGA1000 Digital Vital SignMonitoring System isindicated for use inmeasuring and displayingfunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate of adult andpediatric patients. It isindicated for spot-checkingand / or continuousmonitoring of patientsduring non-motion andunder well-perfusedconditions. The intendedenvironment of use ishospital. This system is areusable device.	The NONIN® Avant®4000 Digital Pulse OximetrySystem is indicated formeasuring and displayingfunctional oxygen saturationof arterial hemoglobin (SpO2)and pulse rate of adult,pediatric, and infant patients.It is indicated for spotchecking and/or continuousmonitoring of patients duringboth motion and no motionconditions, and for patientswho are well or poorlyperfused.

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 Safetytesting	IEC 60601-1:2005
BiocompatibilityTesting	ISO 10993-10: 2010, ISO 10993-5:2009
Electrical SafetyTesting and EMCTesting	IEC 60601-1-2:2007
Alarm System	IEC 60601-1-8:2006
Wireless Coexistence	FDA Guidance Radio Frequency WirelessTechnology in Medical Devices (2013)
Software Verification	IEC 62304:2006FDA Guidance Off-The-Shelf Software Usein Medical Devices (1999)
Pulse OximetryTesting	ISO 80601-2-61:2011FDA 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.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).