Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

K191207 · Taiwan Aulisa Medical Devices Technologies, Inc. · DQA · Jun 25, 2019 · Cardiovascular

Device Facts

• Record ID: K191207
• Device Name: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
• Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 25, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Digital vital sign monitoring system; measures SpO2 and pulse rate via non-invasive red/infrared sensor module worn on foot. System includes sensor module, receiver/transponder with integrated audio/video camera, and portable wireless display unit. Sensor transmits data to receiver via Bluetooth; receiver transmits data and A/V signals to display via Wi-Fi (802.11). Device provides visual/auditory alarms for out-of-limit vital signs or technical errors. During alarm events, system automatically records pulse rate, SpO2, and A/V data for caregiver review. Used in hospitals, medical facilities, home care, and subacute settings by clinicians or caregivers. Output allows real-time patient monitoring and historical data review to support clinical decision-making and patient safety.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61:2011 (Clause 201.12.1.101.2 and Annex EE.2) on healthy subjects using controlled induced hypoxia. Over 200 data points collected across 70%-100% SpO2 range. Results showed Arms < 3%, meeting FDA guidance requirements for pulse oximeters.

Technological Characteristics

Non-invasive pulse oximetry using red (660 nm) and infrared (880 nm) LEDs. Components: foot-worn sensor, receiver/transponder, 10.1" LCD display. Connectivity: Bluetooth (sensor to receiver), Wi-Fi 802.11 (receiver to display). Power: Lithium battery/AC adapter. Biocompatibility: ISO 10993-1 compliant (cytotoxicity, sensitization, irritation). Safety/EMC: IEC 60601-1, 60601-1-11, 60601-1-8, ISO 80601-2-61, IEC 60601-1-2.

Indications for Use

Indicated for pediatrics and infants for spot-checking and/or continuous monitoring of functional SpO2 and pulse rate during non-motion and well-perfused conditions in hospitals, medical facilities, home care, and subacute environments.

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 GA1001 Digital Vital Sign Monitoring System (K182822)

Reference Devices

• Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <span style="font-family:Wingdings;"> <input checked="true" type="checkbox"/></span> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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.<br>Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,<br>Nangang Dist.,Taipei City 115 TW<br>Phone: [phone]<br>FAX: [phone] |
| Contact Person: | Paul Liu<br>Regulatory Affairs Supervisor<br>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>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 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 | Radiofrequency<br>Physiological Signal<br>Transmitter 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 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.

## 7.6 Intended Use

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.

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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 GA2001<br>Digital Vital Sign Monitoring<br>System | Guardian Angel Rx GA1001<br>Digital Vital Sign Monitoring<br>System (K182822) | The Guardian Angel Rx GA2000<br>Digital Vital Sign Monitoring<br>System (K183067) |
| Indication for use | The Guardian Angel Rx<br>GA2001 Digital Vital Sign<br>Monitoring System is<br>indicated for use in<br>measuring and displaying<br>functional oxygen saturation<br>of arterial hemoglobin<br>(SpO2) and pulse rate. It is<br>indicated for spot-checking<br>and/or continuous monitoring<br>of pediatrics and infants<br>during non-motion and under<br>well-perfused conditions.<br>The intended environments<br>of use are hospitals, medical<br>facilities, home care, and<br>subacute environments. This<br>system is a reusable device. | The Guardian Angel Rx<br>GA1001 Digital Vital Sign<br>Monitoring System is<br>indicated for use in<br>measuring and displaying<br>functional oxygen saturation<br>of arterial hemoglobin<br>(SpO2) and pulse rate. It is<br>indicated for spot-checking<br>and/or continuous monitoring<br>of pediatrics and infants<br>during non-motion and under<br>well-perfused conditions.<br>The intended environments<br>of use are hospitals, medical<br>facilities, home care, and<br>subacute environments. This<br>system is a reusable device. | The Guardian Angel Rx GA2000<br>Digital Vital Sign Monitoring<br>System is indicated for use in<br>measuring, recording, and<br>displaying functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2), pulse rate, and audio<br>video signals of adult and<br>pediatric patients. It is indicated<br>for spot-checking and/or<br>continuous monitoring of<br>patients during non-motion and<br>under well-perfused conditions.<br>The intended environments of<br>use are hospitals, medical<br>facilities, home care, and<br>subacute environments. This<br>system is a reusable device. |
| Patient population | Pediatrics and infants | Pediatrics and infants | Adult and pediatric |
| Application site | Foot | Foot | Finger |
| Environment of<br>use | Hospitals, medical facilities,<br>home care, and subacute<br>environments | Hospitals, medical facilities,<br>home care, and subacute<br>environments | Hospitals, medical facilities,<br>home care, and subacute<br>environments |
| Out-of-hospital<br>transport | 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 GA2001<br>Digital Vital Sign Monitoring<br>System | | Guardian Angel Rx GA1001<br>Digital Vital Sign Monitoring<br>System (K182822) | | The Guardian Angel Rx GA2000<br>Digital Vital Sign Monitoring<br>System (K183067) | |
| Perfusion | Well-perfused | | Well-perfused | | Well-perfused | |
| Single-use or<br>reusable | Reusable | | Reusable | | Reusable | |
| Measurement | Pulse rate and SpO2 | | Pulse rate and SpO2 | | Pulse rate and SpO2 | |
| Technology of<br>pulse oximetry | Red and Infrared technology | | Red and Infrared technology | | Red and Infrared technology | |
| LED wavelengths<br>& output power of<br>pulse oximetry | Red: 660 nm @ 9.8 mw<br>Infrared: 880 nm @ 6.5 mw | | Red: 660 nm @ 9.8 mw<br>Infrared: 880 nm @ 6.5 mw | | Red: 660 nm @ 1.8 mw<br>Infrared: 905 nm @ 2 mw | |
| Accuracy<br>(No motion) | SpO2 | ± 3 digits<br>(70-100%) | SpO2 | ± 3 digits<br>(70-100%) | SpO2 | ± 3 digits<br>(70-100%) |
| | Pulse<br>Rate | ± 3 digits<br>(18-300 bpm) | Pulse<br>Rate | ± 3 digits<br>(18-300 bpm) | Pulse<br>Rate | ± 3%<br>(30-290 bpm) |
| Displayed range | SpO2 | 0-100% | SpO2 | 0-100% | SpO2 | 1-100% |
| | Pulse<br>Rate | 18-300 bpm | Pulse<br>Rate | 18-300 bpm | Pulse<br>Rate | 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-time<br>audio/video | Yes | | No | | Yes | |
| Wireless<br>technology/Data<br>transmission | Bluetooth<br>802.11 | | Bluetooth | | Bluetooth<br>802.11 | |
| Biocompatibility | Skin (surface) contact<br>Prolonged contact | | Skin (surface) contact<br>Prolonged contact | | Skin (surface) contact<br>Prolonged 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.