The Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants 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 caregiver can review the historical data whenever needed.

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

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

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states acceptance criteria for SpO2 and Pulse Rate accuracy.

Metric	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy (no motion, 70-100%)	± 3 digits	Arms below 3%
Pulse Rate Accuracy (18-300 bpm)	± 3 digits	Not explicitly stated with a performance metric, but the device is stated to meet the ± 3 digits (18-300 bpm) accuracy as per the comparison table and the clinical study confirms SpO2 accuracy, implying overall accuracy.

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

Sample Size (Test Set): "Over 200 data points were collected." The clinical study focused on collecting data points for SpO2 accuracy.
Data Provenance: The study was conducted on "healthy subjects" and involved "controlled induced hypoxia." The country of origin for the study is not explicitly stated within the provided text. It is a prospective study as data was "collected" to verify accuracy.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. This is common in pulse oximetry studies where ground truth for SpO2 is typically established using a co-oximeter connected to an arterial blood gas sample, which is a direct measurement, not an expert visual interpretation.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for the test set. Given the nature of pulse oximetry accuracy studies, where ground truth is typically derived from direct physiological measurements (co-oximetry) rather than subjective interpretation, an adjudication process involving multiple experts is generally not applicable or necessary for the primary accuracy endpoint.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. The study described is a clinical accuracy study for a device measuring physiological parameters, not an interpretive task that would typically involve multiple readers (like radiologists reviewing images). Therefore, there is no effect size of human readers improving with or without AI assistance reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the clinical study described is a standalone performance study. It directly assessed the accuracy of the device's SpO2 measurements against a reference standard without human interpretation being part of the primary measurement endpoint.

7. The Type of Ground Truth Used:

The ground truth for SpO2 accuracy was established through controlled induced hypoxia in healthy subjects. This typically involves simultaneously measuring arterial oxygen saturation using a laboratory co-oximeter (considered the gold standard) from arterial blood samples while comparing it to the device's readings. While "co-oximetry" isn't explicitly named, "controlled induced hypoxia" is the standard method for generating a wide range of accurately known SpO2 values.

8. The Sample Size for the Training Set:

The document does not provide information regarding a "training set" or its sample size. This device appears to be a hardware-based physiological monitoring system, not an AI/ML-driven solution that would typically involve a distinct training set for an algorithm. The clinical data mentioned is for performance verification.

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

As no training set is mentioned for an AI/ML model, the establishment of ground truth for a training set is not applicable here. The "clinical study" described serves as the validation/test set for the device's accuracy.

Summary

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June 25, 2019

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

Re: K191207

Trade/Device Name: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA, DRG Dated: May 23, 2019 Received: May 28, 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

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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) 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 (QS)

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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191207

Device Name

Guardian Angel Rx GA2001 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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Section 7: 510(k) Summary K191207

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

7.1 General Information

Date of Preparation: April 30, 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

7.2 Trade/Device Name

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

7.3 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

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7.4 Predicate

Predicate device

K182822, Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.

Reference device

K183067, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.

7.5 Device Description

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

7.6 Intended Use

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7.7 Comparison of Indications and Technological Characteristics

Fundamental scientific technology and intended use of the subject device are the same as the predicate device, K182822. The subject device was modified to (1) add Wi-Fi capability to extend the data transmission range, and to (2) include a real-time audio/video monitoring feature. The new characteristics added to the subject device are the same as reference device, K183067; and they were verified and validated according to the same procedures cleared under K183067.

A comparison table for the subject device versus the predicate device, K182822, and the reference device, K183067, is shown in Table 7.1.

Item	Subject Device	Predicate Device	Reference Device
	Guardian Angel Rx GA2001Digital Vital Sign MonitoringSystem	Guardian Angel Rx GA1001Digital Vital Sign MonitoringSystem (K182822)	The Guardian Angel Rx GA2000Digital Vital Sign MonitoringSystem (K183067)
Indication for use	The Guardian Angel RxGA2001 Digital Vital SignMonitoring System isindicated for use inmeasuring and displayingfunctional oxygen saturationof arterial hemoglobin(SpO2) and pulse rate. It isindicated for spot-checkingand/or continuous monitoringof pediatrics and infantsduring non-motion and underwell-perfused conditions.The intended environmentsof use are hospitals, medicalfacilities, home care, andsubacute environments. Thissystem is a reusable device.	The Guardian Angel RxGA1001 Digital Vital SignMonitoring System isindicated for use inmeasuring and displayingfunctional oxygen saturationof arterial hemoglobin(SpO2) and pulse rate. It isindicated for spot-checkingand/or continuous monitoringof pediatrics and infantsduring non-motion and underwell-perfused conditions.The intended environmentsof use are hospitals, medicalfacilities, home care, andsubacute environments. Thissystem is a reusable device.	The Guardian Angel Rx GA2000Digital Vital Sign MonitoringSystem is indicated for use inmeasuring, recording, anddisplaying functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate, and audiovideo signals of adult andpediatric patients. It is indicatedfor spot-checking and/orcontinuous monitoring ofpatients during non-motion andunder well-perfused conditions.The intended environments ofuse are hospitals, medicalfacilities, home care, andsubacute environments. Thissystem is a reusable device.
Patient population	Pediatrics and infants	Pediatrics and infants	Adult and pediatric
Application site	Foot	Foot	Finger
Environment ofuse	Hospitals, medical facilities,home care, and subacuteenvironments	Hospitals, medical facilities,home care, and subacuteenvironments	Hospitals, medical facilities,home care, and subacuteenvironments
Out-of-hospitaltransport	No	No	No
Motion	Non-motion	Non-motion	Non-motion

Table 7.1 - Comparison with Predicate and Reference

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Item	Subject Device		Predicate Device		Reference Device
	Guardian Angel Rx GA2001Digital Vital Sign MonitoringSystem		Guardian Angel Rx GA1001Digital Vital Sign MonitoringSystem (K182822)		The Guardian Angel Rx GA2000Digital Vital Sign MonitoringSystem (K183067)
Perfusion	Well-perfused		Well-perfused		Well-perfused
Single-use orreusable	Reusable		Reusable		Reusable
Measurement	Pulse rate and SpO2		Pulse rate and SpO2		Pulse rate and SpO2
Technology ofpulse oximetry	Red and Infrared technology		Red and Infrared technology		Red and Infrared technology
LED wavelengths& output power ofpulse oximetry	Red: 660 nm @ 9.8 mwInfrared: 880 nm @ 6.5 mw		Red: 660 nm @ 9.8 mwInfrared: 880 nm @ 6.5 mw		Red: 660 nm @ 1.8 mwInfrared: 905 nm @ 2 mw
Accuracy(No motion)	SpO2	± 3 digits(70-100%)	SpO2	± 3 digits(70-100%)	SpO2	± 3 digits(70-100%)
	PulseRate	± 3 digits(18-300 bpm)	PulseRate	± 3 digits(18-300 bpm)	PulseRate	± 3%(30-290 bpm)
Displayed range	SpO2	0-100%	SpO2	0-100%	SpO2	1-100%
	PulseRate	18-300 bpm	PulseRate	18-300 bpm	PulseRate	30-290 bpm
Display	10.1" LCD		10.1" LCD		10.1" LCD
Alarms	Visual and auditory alarms		Visual and auditory alarms		Visual and auditory alarms
Power Supply	Lithium battery, AC adaptor		Lithium battery, AC adaptor		Lithium battery, AC adaptor
Real-timeaudio/video	Yes		No		Yes
Wirelesstechnology/Datatransmission	Bluetooth802.11		Bluetooth		Bluetooth802.11
Biocompatibility	Skin (surface) contactProlonged contact		Skin (surface) contactProlonged contact		Skin (surface) contactProlonged contact

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7.8 Summary of Performance Testing

The performance data are summarized below 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 subjects over the range of 70%-100% SpO2 through controlled induced hypoxia. Over 200 data points were collected. The Arms is below 3%, compliant with FDA quidance on Pulse Oximeters - Premarket notification submissions [510(k)].

7.9 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).