Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

K203208 · Taiwan Aulisa Medical Devices Technologies, Inc. · DQA · Jun 12, 2022 · Cardiovascular

Device Facts

• Record ID: K203208
• Device Name: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
• Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

Device Story

Digital vital sign monitoring system; measures SpO2, pulse rate, and body temperature; includes audio/video camera for real-time patient monitoring. Sensor modules (oximeter/thermometer) transmit data via Bluetooth to a Receiver/Transponder; Receiver/Transponder transmits physiological and A/V data via Wi-Fi to an Aulisa-supplied tablet (Display Unit). System provides visual/auditory alarms for out-of-limit vital signs or technical errors; automatically records data during alarm events for caregiver review. Used in hospitals, medical facilities, home care, and subacute environments by clinicians or caregivers. Enables remote monitoring and historical data review; facilitates timely clinical intervention through alarm notifications.

Clinical Evidence

SpO2 accuracy validated per ISO 80601-2-61 on healthy male/female subjects with varying skin tones. Results showed A-rms < 3 digits for 70-100% range under steady-state conditions. Temperature measurement derived directly from input signal; no clinical validation performed.

Technological Characteristics

System uses Red/Infrared oximetry (660nm/905nm or 880nm) and electronic thermometry. Connectivity via Bluetooth 4.0 and Wi-Fi. Powered by lithium battery/AC adapter. Reusable and disposable sensor options. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61, ASTM E1112, and ISO 10993-5/10.

Indications for Use

Indicated for measuring, recording, and displaying SpO2, pulse rate, and body temperature in hospitals, medical facilities, home care, and subacute environments. Oximetry indicated for adults, pediatrics, and infants (model-dependent) during non-motion, well-perfused conditions. Thermometry indicated for continuous armpit monitoring of adults, pediatrics, and infants.

Regulatory Classification

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.

Predicate Devices

• Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067)
• Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (K191207)
• Fever Scout™ Continuous Monitoring Thermometer (K181013)

Submission Summary (Full Text)

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June 12, 2022

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

Re: K203208

Trade/Device Name: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL, DRG Dated: June 7, 2022 Received: June 9, 2022

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

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requirements, including, but not limited to: registration and listing (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 mediation-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/cdrl-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of 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) K203208

### Device Name

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

## Indications for Use (Describe)

### GA2000

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.

### GA2001

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.

### GA2002

The Guardian Angel Rx GA2000 Series Digital Vital Sigm Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

## GA2100

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

## GA2101

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying function of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

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Type of Use (Select one or both, as applicable)

X 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.

Assigned 510(k) number: K203208

#### 5.1 General Information

| Date of Preparation | June 10, 2022 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Identification | Taiwan Aulisa Medical Devices Technologies, Inc.<br>Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,<br>Nangang Dist., Taipei City 115 TW<br>TEL.: [phone]<br>FAX: [phone] |
| Contact Person | Paul Liu<br>Regulatory Affairs Manager<br>Email: [e-mail] |

#### 5.2 Trade/Device Name

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

#### 5.3 Regulatory Information

| Regulation Number | Product<br>Code | Classification Name | Device<br>Class |
|-------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2700 | DQA | Oximeter | Class II |
| 880.2910 | FLL | Clinical electronic thermometer | Class II |
| 870.2910 | DRG | Radiofrequency Physiological<br>Signal Transmitter and Receiver | Class II |

#### 5.4 Predicate Device(s)

## Primary predicate

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

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Secondary predicate

- . K191207. Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System. Taiwan Aulisa Medical Devices Technologies, Inc.
- K181013, Fever Scout™ Continuous Monitoring Thermometer, VivaLnk Inc. ●

#### ર. ર Device Description

The subject device is a digital vital sign monitoring system that measures and displays a patient's vital signs, i.e. pulse rate, oxygen saturation (SpO2) and body temperature. 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 vital signs fall outside of pre-set limits or when a technical error is detected. During a physiological alarm event, the vital sign data along with the audio/video data are recorded automatically by the subject device. The caregiver can review the historical data whenever needed.

The sensor module(s) of the subject device detects vital signs and sends out the data to the Receiver/Transponder using Bluetooth technology. The Receiver/Transponder then transmits, via a customer Wi-Fi network, the physiological data along with audio/video signals obtained by an embedded camera to an Aulisa-supplied tablet (i.e. the Display Unit).

The subject device contains a total of three Aulisa sensor modules, Adult/Pediatric Oximeter Module, Infant Oximeter Module, and Thermometer Module. The three Aulisa sensor modules connect to the Receiver/Transponder either independently or simultaneously, resulting in five system configurations and system model names as listed below.

| System Model | Aulisa Sensor<br>Module(s) | Population | Parameters |
|--------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------|
| GA2000 | Adult/Pediatric<br>Oximeter Module | • Adult (> 40 kg / 88 lbs)<br>• Pediatric (10 kg - 40 kg / 22 lbs - 88 lbs) | • SpO2<br>• Pulse Rate |
| GA2001 | Infant Oximeter<br>Module | • Pediatric & Infant (< 10 kg / 22 lbs) | • SpO2<br>• Pulse Rate |
| GA2002 | Thermometer Module | • Adult<br>• Pediatric<br>• Infant | Body Temperature |
| GA2100 | • Adult/Pediatric<br>Oximeter Module<br>• Thermometer<br>Module | • Adult<br>• Pediatric | • SpO2<br>• Pulse Rate<br>• Body Temperature |
| GA2101 | • Infant Oximeter<br>Module<br>• Thermometer<br>Module | • Pediatric & Infant | • SpO2<br>• Pulse Rate<br>• Body Temperature |

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#### 5.6 Intended Use

## GA2000

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.

## GA2001

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.

## GA2002

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

## GA2100

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

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# GA2101

The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.

The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

#### 5.7 Comparison with Predicate Device

Among the system components of the subject device. the Display Unit. Receiver/Transponder, Adult/Pediatric Oximeter Module with reusable sensors, and Infant Oximeter Module have been cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067) and Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (K191207), which are the predicates in this submission.

Built upon the existing configuration, a few modifications have been made 1) to include a new sensor module, the Thermometer Module, adding the body temperature feature to the subject device, and 2) to provide an alternative sensor, a disposable sensor, to the existing reusable sensors for Adult/Pediatric Oximeter Module.

Table 5.7.1 lists the similarities and differences between the subject device, by model, and primary predicate, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067), and between the subject device and secondary predicates (K191207 and K181013).

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# Table 5.7.1

| | Subject Device | | | | | Primary<br>Predicate | Secondary<br>Predicate | Secondary<br>Predicate |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | | | |
| Device name | | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | | | | Guardian Angel<br>Rx GA2000<br>Digital Vital<br>Sign<br>Monitoring<br>System | Guardian Angel<br>Rx GA2001<br>Digital Vital<br>Sign<br>Monitoring<br>System | Fever Scout™<br>Continuous<br>Monitoring<br>Thermometer |
| K number | | | | | | K183067 | K191207 | K181013 |
| Model number | GA2000 | GA2001 | GA2002 | GA2100 | GA2101 | GA2000 | GA2001 | |
| Indications for<br>use | The Guardian<br>Angel Rx<br>GA2000 Series<br>Digital Vital Sign<br>Monitoring<br>System (Model<br>GA2000) is<br>indicated for use<br>in measuring,<br>recording, and<br>displaying<br>functional oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2) and pulse<br>rate (PR). The<br>intended<br>environments of<br>use are hospitals,<br>medical facilities | The Guardian<br>Angel Rx<br>GA2000 Series<br>Digital Vital Sign<br>Monitoring<br>System (Model<br>GA2001) is<br>indicated for use<br>in measuring,<br>recording, and<br>displaying<br>functional oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2) and pulse<br>rate (PR). The<br>intended<br>environments of<br>use are hospitals,<br>medical facilities | The Guardian<br>Angel Rx<br>GA2000 Series<br>Digital Vital Sign<br>Monitoring<br>System (Model<br>GA2002) is<br>indicated for use<br>in measuring,<br>recording, and<br>displaying body<br>temperature. The<br>intended<br>environments of<br>use are hospitals,<br>medical facilities,<br>home care, and<br>subacute<br>environments.<br>This system is a<br>reusable device | The Guardian<br>Angel Rx<br>GA2000 Series<br>Digital Vital Sign<br>Monitoring<br>System (Model<br>GA2100) is<br>indicated for use<br>in measuring,<br>recording, and<br>displaying<br>functional oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2) and pulse<br>rate (PR) and<br>body temperature.<br>The intended<br>environments of<br>use are hospitals | The Guardian<br>Angel Rx<br>GA2000 Series<br>Digital Vital Sign<br>Monitoring<br>System (Model<br>GA2101) is<br>indicated for use<br>in measuring,<br>recording, and<br>displaying<br>functional oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2) and pulse<br>rate (PR) and<br>body temperature.<br>The intended<br>environments of<br>use are hospitals | The Guardian<br>Angel Rx<br>GA2000 Digital<br>Vital Sign<br>Monitoring<br>System is<br>indicated for<br>use in<br>measuring,<br>recording, and<br>displaying<br>functional<br>oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2), pulse<br>rate, and audio<br>video signals of<br>adult and | The Guardian<br>Angel Rx<br>GA2001 Digital<br>Vital Sign<br>Monitoring<br>System is<br>indicated for<br>use in<br>measuring and<br>displaying<br>functional<br>oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2) and<br>pulse rate.<br>It is indicated<br>for spot-<br>checking and/or | The wireless<br>Fever Scout™<br>Continuous<br>Monitoring<br>thermometer is<br>a non-invasive<br>and re-usable<br>electronic<br>device for<br>home use and a<br>non-invasive<br>and single<br>patientuse in<br>the hospital.<br>This product is<br>intended for<br>non-urgent<br>ambulatory<br>continuous<br>armpit body<br>temperature |

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Section 5

| | Subject Device | | | | Primary<br>Predicate | Secondary<br>Predicate | Secondary<br>Predicate | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Patient<br>population | home care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>The Oximeter<br>Module(s) is<br>indicated for spot-<br>checking and/or<br>continuous<br>monitoring of<br>SpO2 and PR of<br>adults and<br>pediatrics during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>adult, pediatric | home care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>The Oximeter<br>Module(s) is<br>indicated for spot-<br>checking and/or<br>continuous<br>monitoring of<br>SpO2 and PR of<br>pediatrics and<br>infants during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>pediatric, infant | The Thermometer<br>Module is<br>indicated for<br>continuous ampit<br>body temperature<br>monitoring of<br>adults, pediatrics,<br>and infants.<br>adult, pediatric,<br>infant | medical facilities,<br>home care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>The Oximeter<br>Module(s) is<br>indicated for spot-<br>checking and/or<br>continuous<br>monitoring of<br>SpO2 and PR of<br>adults and<br>pediatrics during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>The Thermometer<br>Module is<br>indicated for<br>continuous ampit<br>body temperature<br>monitoring of<br>adults, pediatrics,<br>and infants.<br>adult, pediatric,<br>infant | medical facilities,<br>home care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>The Oximeter<br>Module(s) is<br>indicated for spot-<br>checking and/or<br>continuous<br>monitoring of<br>SpO2 and PR of<br>pediatrics and<br>infants during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>The Thermometer<br>Module is<br>indicated for<br>continuous ampit<br>body temperature<br>monitoring of<br>adults, pediatrics,<br>and infants.<br>adult, pediatric,<br>infant | pediatric<br>patients.<br>It is indicated<br>for spot-<br>checking and/or<br>continuous<br>monitoring of<br>patients during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>The intended<br>environments<br>of use are<br>hospitals,<br>medical<br>facilities, home<br>care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>adult, pediatric | continuous<br>monitoring of<br>pediatrics and<br>infants during<br>non-motion and<br>under well-<br>perfused<br>conditions.<br>The intended<br>environments<br>of use are<br>hospitals,<br>medical<br>facilities, home<br>care, and<br>subacute<br>environments.<br>This system is a<br>reusable device.<br>pediatric, infant | monitoring<br>from ages 29<br>days and older<br>ages 29 days<br>and older |

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| | Subject Device | | | | | Primary<br>Predicate | Secondary<br>Predicate | Secondary<br>Predicate |
|------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Use<br>environment | hospitals, medical<br>facilities, home<br>care, subacute<br>environments | hospitals, medical<br>facilities, home<br>care, subacute<br>environments | hospitals, medical<br>facilities, home<br>care, subacute<br>environments | hospitals, medical<br>facilities, home<br>care, subacute<br>environments | hospitals, medical<br>facilities, home<br>care, subacute<br>environments | hospitals,<br>medical<br>facilities, home<br>care, subacute<br>environments | hospitals,<br>medical<br>facilities, home<br>care, subacute<br>environments | home, hospital |
| Measurement | Pulse rate, SpO2 | Pulse rate, SpO2 | body temperature | Pulse rate, SpO2,<br>body temperature | Pulse rate, SpO2,<br>body temperature | Pulse rate,<br>SpO2 | Pulse rate,<br>SpO2 | body<br>temperature |
| Disposable or<br>reusable | reusable/<br>disposable | reusable/<br>disposable | reusable/<br>disposable | reusable/<br>disposable | reusable/<br>disposable | reusable | reusable | reusable/<br>disposable |
| Wireless<br>communication | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | Bluetooth 4.0<br>Wi-Fi | • Bluetooth BLE<br>• Wireless (Wi-Fi) 2.4G |
| Operating<br>platform | Aulisa Display<br>Unit | Aulisa Display<br>Unit | Aulisa Display<br>Unit | Aulisa Display<br>Unit | Aulisa Display<br>Unit | Aulisa Display<br>Unit | Aulisa Display<br>Unit | • iPhone 5S+or<br>later & iOS<br>8.0 or later<br>• Android 4.3<br>or later |
| Alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | Visualand<br>auditory<br>alarms | na |
| Real-time<br>audio/video | Yes | Yes | Yes | Yes | Yes | Yes | Yes | na |
| Pulse Oximetry | | | | | | | | |
| Measuring site | Finger | Foot | na | Finger | Foot | Finger | Finger | na |
| Out-of-hospital<br>transport | No | No | na | No | No | No | No | na |
| Motion | Non-motion | Non-motion | na | Non-motion | Non-motion | Non-motion | Non-motion | na |
| Perfusion | Well-perfused | Well-perfused | na | Well-perfused | Well-perfused | Well-perfused | Well-perfused | na |

{11}------------------------------------------------

| | | | | | | Primary | Secondary | Secondary |
|----------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | | | Predicate | Predicate | Predicate | | |
| Technology | Red and Infrared<br>technology | Red and Infrared<br>technology | na | Red and Infrared<br>technology | Red and Infrared<br>technology | Red and<br>Infrared<br>technology | Red and<br>Infrared<br>technology | na |
| Wavelengths &<br>output power | Red:<br>660 nm @ 1.8<br>mw | Red:<br>660 nm @ 9.8<br>mw | na | Red:<br>660 nm @ 1.8<br>mw | Red:<br>660 nm @ 9.8<br>mw | Red:<br>660 nm @ 1.8<br>mw | Red:<br>660 nm @ 9.8<br>mw | na |
| | Infrared:<br>905 nm @ 2 mw | Infrared:<br>880 nm @ 6.5<br>mw | | Infrared:<br>905 nm @ 2 mw | Infrared:<br>880 nm @ 6.5<br>mw | Infrared:<br>905 nm @ 2<br>mw | Infrared:<br>880 nm @ 6.5<br>mw | na |
| Measurement<br>accuracy (No<br>motion) | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3% (30-290<br>bpm) | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3 digits (18-300<br>bpm) | na | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3% (30-290<br>bpm) | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3 digits (18-300<br>bpm) | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3% (30-290<br>bpm) | SpO2:<br>$\pm$ 3 digits (70-<br>100%)<br>PR:<br>$\pm$ 3 digits (18-<br>300 bpm) | na |
| Displayed<br>range | SpO2: 1-100%<br>PR: 30-290bpm | SpO2: 0-100%<br>PR: 18-300bpm | na | SpO2: 1-100%<br>PR: 30-290bpm | SpO2: 0-100%<br>PR: 18-300bpm | SpO2: 1-100%<br>PR: 30-290<br>bpm | SpO2: 0-100%<br>PR: 18-300<br>bpm | na |
| Power supply | Lithium battery<br>AC adaptor | Lithium battery<br>AC adaptor | na | Lithium battery<br>AC adaptor | Lithium battery<br>AC adaptor | Lithium battery<br>AC adaptor | Lithium battery<br>AC adaptor | na |
| Body Temperature | | | | | | | | |
| Measurement<br>accuracy | na | na | 89.6°F-107.6°F:<br>$\pm$ 0.2°F<br>(32°C-42°C:<br>$\pm$ 0.1°C) | 89.6°F-107.6°F:<br>$\pm$ 0.2°F<br>(32°C-42°C:<br>$\pm$ 0.1°C) | 89.6°F-107.6°F:<br>$\pm$ 0.2°F<br>(32°C-42°C:<br>$\pm$ 0.1°C) | na | na | 98.6°F-<br>102.2°F:<br>$\pm$ 0.2°F<br>(37°C-39°C:<br>$\pm$ 0.1°C)<br><br>95°F-98.6°F:<br>$\pm$ 0.4°F<br>(35°C-37°C:<br>$\pm$ 0.2°C) |

{12}------------------------------------------------

K203208

| | Subject Device | | | Primary<br>Predicate | Secondary<br>Predicate | Secondary<br>Predicate | | |
|----------------------------------------|----------------|----|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----|--------------------------------------------|
| | | | | | | 102.2°F-<br>107.6°F:<br>$\pm$ 0.4°F<br>(39°C-42°C:<br>$\pm$ 0.2°C) | | |
| Display range | na | na | 89.6°F-107.6°F<br>(32°C-42°C)<br><89.6°F (32.0°C)<br>displays "Lo"<br>>107.6°F<br>(42.0°C) displays<br>"Hi" | 89.6°F-107.6°F<br>(32°C-42°C)<br><89.6°F (32.0°C)<br>displays "Lo"<br>>107.6°F<br>(42.0°C) displays<br>"Hi" | 89.6°F-107.6°F<br>(32°C-42°C)<br><89.6°F (32.0°C)<br>displays "Lo"<br>>107.6°F<br>(42.0°C) displays<br>"Hi" | na | na | 95°F-107.6°F<br>(35°C-42°C) |
| Operation<br>mode | na | na | Continuous | Continuous | Continuous | na | na | Continuous |
| Measuring site | na | na | Axillary (armpit) | Axillary (armpit) | Axillary (armpit) | na | na | Axillary<br>(armpit) |
| Power supply | na | na | CR2025 | CR2025 | CR2025 | na | na | MS Lithium<br>rechargeable<br>battery 3.0V |
| Duration of<br>continuous<br>patch use | na | na | up to 24 hours | up to 24 hours | up to 24 hours | na | na | 7 days |

{13}------------------------------------------------

#### 5.8 Summary of Non-clinical Testing

The results of the testing demonstrate equivalence with the predicate device(s) and compliance with recognized standards. Below table summarizes test results for the subject device, which met the relevant requirements of the applicable recognized standards or claimed specifications.

| Item | Reference | Result |
|----------------------------------------|-------------------------------------------------------------------|--------|
| Electrical Safety | IEC 60601-1<br>IEC 60601-1-11 | Pass |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Defibrillation Protection | IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61<br>ASTM E1112<br>IEC 60601-1-8<br>IEC 60086 series | Pass |
| Mechanical Durability | IEC 60601-1<br>IEC 60601-1-11 | Pass |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10 | Pass |
| Software V&V | FDA Guidance | Pass |
| Bench testing for Accuracy | Manufacturer's specifications | Pass |
| Security Testing | - | Pass |
| Wireless Coexistence Testing | ANSI C63.27 | Pass |
| Durability and Performance testing | Manufacturer's specifications | Pass |
| CR2025 Battery Life Testing | Manufacturer's specifications | Pass |

#### 5.9 Summary of Clinical Testing

The functional oxygen saturation (SpO2) measurements of the subject device were validated in accordance with ISO 80601-2-61. The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects. The SpO2 accuracy data were calculated using the root-mean-square (A-ms) and the results which indicated that the subject device had an Ams less than 3 digits during steady-state conditions over the range of 70-100% were in compliance with the specified performance claimed by the manufacturer.

The output temperature of the subject device is derived directly from input signal without any adjustment, and therefore no clinical validation is needed.

{14}------------------------------------------------

# 5.10 Conclusion

The data provided as part of this submission for the subject device supports the substantial equivalence determination.