The Guardian Angel Rx GA1001 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). The subject device consists of a selfcontained foot-worn sensor module (SM) 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 taken by the SM are wirelessly transmitted to the DU for display using Bluetooth technology. The subject device also 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System
Purpose: Measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Primarily for pediatrics and infants during non-motion and well-perfused conditions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance
Pulse Oximetry Accuracy (SpO2): Accuracy (Arms) below 3% over the range of 70%-100% SpO2	Arms is below 3%, compliant with FDA guidance on Pulse Oximeters - Premarket notification submissions [510(k)].
Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8	Device complies with these standards.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2	Device complies with this standard.
Biocompatibility: Meet requirements of ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Biocompatibility evaluation conducted, including Cytotoxicity, Sensitization, and Irritation tests. (Implicitly passed as it supports substantial equivalence).
Software Verification & Validation: Documentation provided as recommended by FDA guidance.	Software verification and validation testing conducted and documentation provided. (Implicitly passed).

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

Sample Size for Test Set (Clinical Study): "Over 200 data points were collected."
Data Provenance:
- Country of Origin: Not explicitly stated, but the applicant is "Taiwan Aulisa Medical Devices Technologies, Inc." This suggests the clinical study could have been conducted in Taiwan or another location consistent with the applicant's operations.
- Retrospective or Prospective: "Clinical data were collected... to verify the accuracy of the subject device on healthy subjects over the range of 70%-100% SpO2 through controlled induced hypoxia." This indicates a prospective clinical study.

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

This device is an oximeter, not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for SpO2 accuracy is established through controlled induced hypoxia measurements against a reference standard (likely arterial blood gas measurements, though not explicitly stated, this is the standard for pulse oximetry accuracy). Therefore, the concept of "experts establishing ground truth" in the context of interpretation (like radiologists for imaging) does not apply here. The expertise required would be in conducting the induced hypoxia study and accurate blood gas analysis.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for pulse oximetry accuracy is derived from physiological measurements (e.g., arterial blood gas analysis under controlled hypoxia), not subjective expert judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI assistance (e.g., radiologists reading medical images). The Guardian Angel Rx GA1001 is a vital sign monitoring system, not an AI-powered diagnostic imaging tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

The clinical study described (measuring SpO2 accuracy through controlled induced hypoxia) is a standalone performance evaluation of the device. It assesses the device's ability to accurately measure SpO2 directly, without human interpretation as part of the primary measurement function. The performance metric "Arms is below 3%" directly reflects the algorithm's (and hardware's) accuracy compared to the reference standard.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was established through controlled induced hypoxia on healthy subjects. In the context of pulse oximetry, this typically involves comparing the device's SpO2 readings to simultaneously measured arterial oxygen saturation (SaO2) values obtained from arterial blood gas (ABG) analysis. The sO2 (and corresponding SaO2) values from the ABG are considered the "ground truth."

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. For hardware devices with embedded algorithms like pulse oximeters, the "training" (calibration and refinement of algorithms) typically happens during development and might use internal data or general physiological models. The provided study describes the validation/test set used for regulatory submission.

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

As no information is provided about a distinct "training set" in the context of machine learning, the method for establishing its ground truth is not detailed. For traditional medical device algorithms, the "ground truth" for development and calibration would be established through established scientific principles, extensive physiological data, and potentially iterative testing against reference methods (like ABG) during the R&D phase.

Summary

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

Re: K182822

Trade/Device Name: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA 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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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

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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Indications for Use

510(k) Number (if known) K182822

Device Name

Guardian Angel Rx GA1001 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 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 GA1001 Digital Vital Sign Monitoring System

5.3. Regulatory Information

Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulation Class: Class II
DQA Product Code:

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5.4. Predicate

Predicate device

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

Reference device

K162580. Guardian Angel GA1000 Digital Vital Sign Monitoring System

5.5. Device Description

5.6. Intended Use

5.7. Comparison of Indications and Technological Characteristics

The subject device has similar intended use and technology characteristics to the predicate device. 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 predicate, and that the subject device wirelessly transmits data for remote display but the predicate does not.

The subject device uses a similar display unit as our reference device, K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System, which uses a liquidcrystal display (LCD) for display and Bluetooth technology for data transmission, except that the size of the display panel is enlarged.

The comparison table for the subject device versus the predicate device. K040589, and the reference device, K162580, is shown in Table 5.1.

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Item	Subject Device	Predicate Device	Reference Device
Item	Guardian Angel RxGA1001 Digital VitalSign Monitoring System	Avant 9600 Digital PulseOximeter (K040589) withReusable Flex Sensors	Guardian Angel GA1000Digital Vital SignMonitoring System(K162580)
Indication foruse	The Guardian Angel RxGA1001 Digital VitalSign Monitoring Systemis indicated for use inmeasuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate. Itis indicated for spot-checking and/orcontinuous monitoring ofpediatrics and infantsduring non-motion andunder well-perfusedconditions. The intendedenvironments of use arehospitals, medicalfacilities, home care,and subacuteenvironments. Thissystem is a reusabledevice.	The Nonin Avant 9600Digital Pulse Oximeter is aportable, tabletop deviceindicated for use insimultaneously measuring,displaying, and recordingfunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate of adult,pediatric, infant, andneonatal patients inhospitals, medical facilities,home care, and subacuteenvironments. It may alsobe used in patienttransport, sleeplaboratories, and EMSenvironments. The Avant9600 is intended forcontinuous monitoringand/or spot-checking ofpatients during both nomotion and motionconditions, for patients whoare well or poorly perfused.	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-checking and / orcontinuous monitoring ofpatients during non-motion and under well-perfused conditions. Theintended environment ofuse is hospital. Thissystem is a reusabledevice.
Patientpopulation	Pediatrics and infants	Adult and pediatric, infant,and neonatal patients	Adults and pediatrics
Application site	Foot	Finger, toe or foot	Finger
Environment ofuse	Hospitals, medicalfacilities, home care,and subacuteenvironments	Hospitals, medical facilities,home care, transport andsubacute environments	Hospitals
Out-of-hospitaltransport	No	Yes	No
Motion	Non-motion	Non-motionMotion	Non-motion
Perfusion	Well-perfused	Well-perfusedPoorly-perfused	Well-perfused
Single-use orreusable	Reusable	Reusable	Reusable
Measurement	Pulse rate and SpO2	Pulse rate and SpO2	Pulse rate and SpO2

Table 5.1 – Comparison with Predicate

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Item	Subject Device	Predicate Device	Reference Device
Guardian Angel RxGA1001 Digital VitalSign Monitoring System	Avant 9600 Digital PulseOximeter (K040589) withReusable Flex Sensors	Guardian Angel GA1000Digital Vital SignMonitoring System(K162580)
Technology ofpulse oximetry	Red and Infraredtechnology	Red and Infraredtechnology	Red and Infraredtechnology
LEDwavelengths &output power ofpulse oximetry	Red: 660 nm @ 9.8 mwInfrared: 880 nm @ 6.5mw	Red: 660 nm @ 0.8 mwmax. avg.Infrared: 910 nm @ 1.2 mwmax. avg	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(30-300 bpm)	PulseRate	± 3 digits(18-300 bpm)	PulseRate	± 3%(30-290 bpm)
Displayed range	SpO2	1-100%	SpO2	0-100%	SpO2	1-100%
	PulseRate	30-300 bpm	PulseRate	18-300 bpm	PulseRate	30-290 bpm
Display	10.1" LCD	LED	7" LCD
Alarms	Visual and auditoryalarms	Visual and auditory alarms	Visual and auditoryalarms
Power Supply	Sensor Module: LithiumbatteryDisplay Unit: Lithiumbattery, AC adaptor	Monitor: NiMH battery, ACadaptor	Sensor Module: LithiumbatteryDisplay Unit: Lithiumbattery, AC adaptor
Wirelesstechnology/Datatransmission	Bluetooth	None	Bluetooth
Biocompatibility	Skin (surface) contactProlonged contact	Skin (surface) contactProlonged contact	Skin (surface) contactProlonged contact

Summary of Performance Testing 5.8.

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:

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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)].

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).