Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard pulse oximeter using established non-invasive red and infrared technology and Bluetooth transmission. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or key metrics.

Therapeutic

No
The device is a monitoring system that measures and displays vital signs (SpO2 and pulse rate); it does not provide any therapy or treatment.

Diagnostic

No

The device is described as a "Digital Vital Sign Monitoring System" that measures and displays functional oxygen saturation (SpO2) and pulse rate. While it provides data, it does not explicitly state that it diagnoses a condition or disease, but rather monitors vital signs.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "selfcontained foot-worn sensor module (SM)" and a "portable, table-top wireless display unit (DU)," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Guardian Angel Rx GA1001 measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These measurements are taken non-invasively using a foot-worn sensor and red/infrared technology. It does not analyze samples taken from the body.
Intended Use: The intended use is for monitoring vital signs in patients, not for analyzing biological samples.

Therefore, the device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Foot

Indicated Patient Age Range

Pediatrics and infants

Intended User / Care Setting

hospitals, medical facilities, home care, and subacute environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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)].

Key Metrics

Accuracy (No motion) SpO2: ± 3 digits (70-100%)
Pulse Rate: ± 3 digits (30-300 bpm)

Predicate Device(s)

K040589

Reference Device(s)

K162580

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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)

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.

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 TW
Phone: 886-2-2655-7297
FAX: 886-2-2655-7260
Contact Person:	Paul Liu
Regulatory Affairs Supervisor
Taiwan 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: 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

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.

5.6. Intended Use

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.

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 Rx
GA1001 Digital Vital
Sign Monitoring System	Avant 9600 Digital Pulse
Oximeter (K040589) with
Reusable Flex Sensors	Guardian Angel GA1000
Digital Vital Sign
Monitoring System
(K162580)
Indication for
use	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.	The Nonin Avant 9600
Digital Pulse Oximeter is a
portable, tabletop device
indicated for use in
simultaneously measuring,
displaying, and recording
functional oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate of adult,
pediatric, infant, and
neonatal patients in
hospitals, medical facilities,
home care, and subacute
environments. It may also
be used in patient
transport, sleep
laboratories, and EMS
environments. The Avant
9600 is intended for
continuous monitoring
and/or spot-checking of
patients during both no
motion and motion
conditions, for patients who
are well or poorly perfused.	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.
Patient
population	Pediatrics and infants	Adult and pediatric, infant,
and neonatal patients	Adults and pediatrics
Application site	Foot	Finger, toe or foot	Finger
Environment of
use	Hospitals, medical
facilities, home care,
and subacute
environments	Hospitals, medical facilities,
home care, transport and
subacute environments	Hospitals
Out-of-hospital
transport	No	Yes	No
Motion	Non-motion	Non-motion
Motion	Non-motion
Perfusion	Well-perfused	Well-perfused
Poorly-perfused	Well-perfused
Single-use or
reusable	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 Rx
GA1001 Digital Vital
Sign Monitoring System	Avant 9600 Digital Pulse
Oximeter (K040589) with
Reusable Flex Sensors	Guardian Angel GA1000
Digital Vital Sign
Monitoring System
(K162580)
Technology of
pulse oximetry	Red and Infrared
technology	Red and Infrared
technology	Red and Infrared
technology
LED
wavelengths &
output power of
pulse oximetry	Red: 660 nm @ 9.8 mw
Infrared: 880 nm @ 6.5
mw	Red: 660 nm @ 0.8 mw
max. avg.
Infrared: 910 nm @ 1.2 mw
max. avg	Red: 660 nm @ 1.8 mw
Infrared: 905 nm @ 2 mw
Accuracy
(No motion)	SpO2

                                                                      | ± 3 digits

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.