The Guardian Angel Rx GA2000 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 environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

Device Description

The subject device is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation (SpO₂). It is also equipped with an audio/video camera to monitor the patient in real time. In addition, the subject device provides visual and auditory alarms that alert the caregiver when a patient's pulse rate and/or SpO2 falls outside of preset limits or when a technical error is detected. During a physiological alarm event, the pulse rate and SpO2 data along with the audio/video data are recorded automatically by the subject device. The careqiver can review the historical data whenever needed.

The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU).

It uses non-invasive red and infrared technology to measure the pulse rate and SpO2. The measurements are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, which measures functional oxygen saturation (SpO2) and pulse rate.

Here's an organized breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device's accuracy was verified through a clinical study. The acceptance criterion for SpO2 accuracy is explicitly mentioned in relation to the FDA guidance.

Parameter	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Ams (Accuracy root-mean-square) less than 3 digits (70%-100% SpO2 range) as per FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)]	Ams is less than 3 digits, compliant with FDA guidance on Pulse Oximeters.
Pulse Rate	Not explicitly stated as an acceptance criterion in the provided text, but measured.	Pulse rate measurements were taken. (Specific accuracy value not provided within the criteria section in this document excerpt).

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

Sample Size for Test Set: "healthy adult subjects" (number not specified, but stated "Over 200 data points were collected").
Data Provenance: The study involved "healthy adult subjects" and used "controlled induced hypoxia." The country of origin for the data is not specified within the provided text. It is a prospective study as it involved collecting new data on subjects under controlled conditions.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in this context. For pulse oximetry accuracy studies, the "ground truth" (reference measurement of arterial oxygen saturation, SaO2) is typically established through co-oximetry of arterial blood samples, not expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth for pulse oximetry accuracy is derived from direct physiological measurements (co-oximetry), not subjective expert judgment that would require adjudication.

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

A MRMC comparative effectiveness study was not conducted. This device is a vital sign monitor, and its performance is evaluated based on the accuracy of its physiological measurements against a reference standard, not human interpretation of images or other data. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this type of device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, the clinical study directly assesses the standalone performance of the device (the oximeter) in measuring SpO2 and pulse rate against a reference standard, without human interpretation of the device's output to determine diagnosis. The Ams value reported represents the algorithm's performance.

7. Type of Ground Truth Used:

The ground truth used was established via physiological measurements during controlled induced hypoxia. While not explicitly detailed in this excerpt, for pulse oximeters, the gold standard for SpO2 "ground truth" is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples.

8. Sample Size for the Training Set:

The provided text does not specify a training set size. This type of device (an oximeter) typically relies on established physiological principles and signal processing algorithms derived from extensive research and development in pulse oximetry, rather than a "training set" in the machine learning sense for a new AI algorithm. While there's internal algorithm development, the document refers to a clinical study for verification of accuracy, not for training a model.

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

As no explicit training set is mentioned in the context of a machine learning model, this question is not fully applicable based on the provided text. The device's underlying technology and ground truth for its development would be based on the established physiological relationship between light absorption and oxygen saturation, validated through extensive physiological studies over decades of pulse oximetry development.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

Re: K183067

Trade/Device Name: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DRG Dated: January 28, 2019 Received: February 1, 2019

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Todd D. Courtney -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K183067

Device Name

Guardian Angel Rx GA2000 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 of Preparation: February 1, 2019
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:	Paul LiuRegulatory Affairs SupervisorTaiwan 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: 886-2-2655-7260Email: paul.liu@aulisa.com

5.2. Trade/Device Name

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

5.3. Regulatory Information

Regulation Number	Regulation Name	Regulation Class	Product Code
21 CFR 870.2700	Oximeter	Class II	DQA
21 CFR 870.2910	RadiofrequencyPhysiological SignalTransmitter and Receiver	Class II	DRG

5.4. Predicate Devices

Primary predicate

K040589, Avant 9600 Digital Pulse Oximeter, Nonin Medical, Inc.

{4}------------------------------------------------

Reference devices

K150361, ViSi Mobile Monitoring System, Sotera Wireless, Inc.

K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.

5.5. Device Description

The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera and a portable, table-top wireless Display Unit (DU).

5.6. Intended Use

The Guardian Angel Rx GA2000 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 environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

5.7. Comparison with Predicates

The subject device has similar intended use and technology characteristics to the primary predicate, K040589, Avant 9600 Digital Pulse Oximeter, except that the subject device is indicated for a narrower range of patient population and environment of use than the primary predicate. Further, the subject device wirelessly transmits data to a remote display whereas the primary predicate does not.

The subject device uses the same Sensor Module (SM) and a similar Display Unit (DU) as currently configured on our reference device, K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System (cleared under), and uses the same Bluetooth technology for data transmission. The subject device has a Receiver/Transponder (RT) included to transmit the data from the Sensor Module to the Display Unit using the 802.11 radio frequency band which

{5}------------------------------------------------

extends the data transmission range of the system. A camera and microphone is incorporated in the RT, which transmits audio/video data via the same 802.11 band. The 802.11-based telemetry technology is equivalent to that used in the Secondary Predicate: ViSi Mobile Monitoring System (cleared under K150361).

The comparison table for the subject device versus the primary predicate, Avant 9600 (K040589), and the secondary predicate ViSi Mobile Monitoring System (K150361), is shown in Table 5.1.

	Subject Device	Primary Predicate	Reference Device	Reference Device
Item	The Guardian AngelRx GA2000 DigitalVital Sign MonitoringSystem	Avant 9600 DigitalPulse Oximeter(K040589) withReusable Flexsensors	ViSi Mobile MonitoringSystem (K150361)	Guardian AngelGA1000 Digital VitalSign MonitoringSystem (K162580)
Indication for use	The Guardian AngelRx GA2000 DigitalVital Sign MonitoringSystem is indicatedfor use in measuring,recording, anddisplaying functionaloxygen saturation ofarterial hemoglobin(SpO2), pulse rate,and audio videosignals of adult andpediatric patients. It isindicated for spot-checking and/orcontinuousmonitoring of patientsduring non-motionand under well-perfused conditions.The intendedenvironments of useare hospitals, medicalfacilities, home care,and subacuteenvironments. Thissystem is a reusabledevice.	The Nonin Avant9600 Digital PulseOximeter is aportable, tabletopdevice indicated foruse in simultaneouslymeasuring,displaying, andrecording functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rateof adult, pediatric,infant, and neonatalpatients in hospitals,medical facilities,home care, andsubacuteenvironments. It mayalso be used inpatient transport,sleep laboratories,and EMSenvironments. TheAvant 9600 isintended forcontinuous monitoringand / or spot-checking of patientsduring both no motionand motionconditions, forpatients who are wellor poorly perfused.	The ViSi MobileMonitoring System isintended for use byclinicians and medicallyqualified personnel forsingle or multi-parameter vital signsmonitoring of adultpatients (18 years orolder). It is indicated forECG (3 or 5 lead-wire), respiration rate(RESP), heart rate(HR), noninvasiveblood pressure (NIBP),continuous noninvasiveblood pressure(cNIBP), noninvasivemonitoring of functionaloxygen saturation ofarterial hemoglobin(SpO2), pulse rate(PR), and skintemperature (TEMP) inhospital-basedfacilities; including,general medical-surgical floors,intermediate carefloors, and emergencydepartments. The ViSiMobile MonitoringSystem may be usedas standalone devicesor networked to ViSiMobile RemoteViewers throughwireless 802.11communication.	The Guardian AngelGA1000 Digital VitalSign MonitoringSystem is indicatedfor use in measuringand displayingfunctional oxygensaturation of arterialhemoglobin (SpO2)and pulse rate ofadult and pediatricpatients. It isindicated for spot-checking and / orcontinuousmonitoring of patientsduring non-motionand under well-perfused conditions.The intendedenvironment of use ishospital. This systemis a reusable device.
Patientpopulation	Adult and pediatric	Adult and pediatric,infant, and neonatalpatients	Adult	Adults and pediatrics
Item	Subject Device	Primary Predicate	Reference Device	Reference Device
Environment of use	The Guardian AngelRx GA2000 DigitalVital Sign MonitoringSystem	Avant 9600 DigitalPulse Oximeter(K040589) withReusable Flexsensors	ViSi Mobile MonitoringSystem (K150361)	Guardian AngelGA1000 Digital VitalSign MonitoringSystem (K162580)
Out-of-hospitaltransport	Hospitals, medicalfacilities, home care,and subacuteenvironments	Hospitals, medicalfacilities, home care,and subacuteenvironments	Hospital-based facilities	Hospitals, medicalfacilities, home care,and subacuteenvironments
Motion	No	Yes	Not specified	No
Motion	Non-motion	Non-motionMotion	Not specified	Non-motion
Perfusion	Well-perfused	Well-perfusedPoorly-perfused	Not specified	Well-perfused
Single-use orreusable	Reusable	Reusable	Reusable	Reusable
Measurement	Pulse rate and SpO2	Pulse rate and SpO2	Pulse rate, SpO2,ECG, blood pressure,respiration rate andskin temperature	Pulse rate and SpO2
Technology ofpulse oximetry	Red and Infraredtechnology	Red and Infraredtechnology	Red and Infraredtechnology	Red and Infraredtechnology
LEDwavelengths &output power ofpulse oximetry	Red: 660 nm @ 1.8mw nominalInfrared: 905 nm @ 2mw nominal	Red: 660 nm @ 0.8mw max. avg.Infrared: 910 nm @1.2 mw max. avg.	Red: 660 nm @ 6.5 mwmax.Infrared: 905 nm @ 5.2mw max.	Red: 660 nm @ 1.8mw nominalInfrared: 905 nm @ 2mw nominal
Accuracy(No motion)	SpO2Pulse Rate	$SpO2 ± 3 digits (70-100%)$$Pulse Rate ± 3% (30-290 bpm)$	$SpO2 ± 2 digits (70-100%)$$Pulse Rate ± 3 digits (30-240 bpm)$	$SpO2 ± 3 digits (70-100%)$$Pulse Rate ± 3% (30-290 bpm)$
Displayed range	$SpO2 1-100%$$Pulse Rate 30-290 bpm$	$SpO2 0-100%$$Pulse Rate 18-300 bpm$	$SpO2 0-100%$$Pulse Rate 0-240 bpm$	$SpO2 1-100%$$Pulse Rate 30-290 bpm$
Display	10.1" LCD	LED	OLED	7" LCD
Alarms	Visual and auditoryalarms	Visual and auditoryalarms	Visual and auditoryalarms	Visual and auditoryalarms
Power Supply	Lithium battery, ACadaptor	NiMH battery, ACadaptor	Lithium battery, ACadaptor	Lithium battery, ACadaptor
Wirelesstechnology /Datatransmission	Bluetooth802.11	None	802.11	Bluetooth
Biocompatibility	Skin (surface) contactProlonged contact	Skin (surface) contactProlonged contact	Skin (surface) contactProlonged contact	Skin (surface) contactProlonged contact

Table 5.1 - Comparison with Predicate

{6}------------------------------------------------

{7}------------------------------------------------

5.8. Summary of Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation ●

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device. The device complies with the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8 and ISO 80601-2-61 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Clinical Study

Clinical data were collected, according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Standard, to verify the accuracy of the subject device on healthy adult subjects over the range of 70%-100% SpO2 through controlled induced hypoxia. Over 200 data points were collected. The Ams is less than 3 digits, compliant with FDA guidance on Pulse Oximeters -Premarket notification submissions [510(k)].

5.9. Substantially Equivalent Conclusion

Based on the non-clinical testing and clinical data summarized in this 510(k) submission, the results demonstrate that the subject device is substantially equivalent to the predicate. The differences do not raise different questions of safety or effectiveness when compared to the predicate.

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).