Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System

K182822 · Taiwan Aulisa Medical Devices Technologies, Inc. · DQA · Mar 1, 2019 · Cardiovascular

Device Facts

• Record ID: K182822
• Device Name: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
• Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Digital vital sign monitoring system; measures SpO2 and pulse rate via non-invasive red/infrared sensor module (SM) worn on foot; wirelessly transmits data via Bluetooth to portable, table-top display unit (DU). Used in hospitals, medical facilities, home care, and subacute environments by clinicians or caregivers. Provides visual/auditory alarms for out-of-limit vital signs or technical errors. Enables remote monitoring of pediatric/infant patients; assists caregivers in clinical decision-making through real-time display and alerts.

Clinical Evidence

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

Technological Characteristics

Reusable system; foot-worn sensor module and table-top display unit. Red (660 nm) and Infrared (880 nm) LEDs. Bluetooth wireless connectivity. Powered by lithium batteries (SM/DU) and AC adaptor (DU). 10.1" LCD display. Complies with ISO 10993-1 (biocompatibility), IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-61 (safety), and IEC 60601-1-2 (EMC).

Indications for Use

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

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

• Avant 9600 Digital Pulse Oximeter (K040589)

Reference Devices

• Guardian Angel GA1000 Digital Vital Sign Monitoring System (K162580)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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.<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] |

#### 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<br>GA1001 Digital Vital<br>Sign Monitoring System | Avant 9600 Digital Pulse<br>Oximeter (K040589) with<br>Reusable Flex Sensors | Guardian Angel GA1000<br>Digital Vital Sign<br>Monitoring System<br>(K162580) |
| Indication for<br>use | The Guardian Angel Rx<br>GA1001 Digital Vital<br>Sign Monitoring System<br>is indicated for use in<br>measuring and<br>displaying functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2) and pulse rate. It<br>is indicated for spot-<br>checking and/or<br>continuous monitoring of<br>pediatrics and infants<br>during non-motion and<br>under well-perfused<br>conditions. The intended<br>environments of use are<br>hospitals, medical<br>facilities, home care,<br>and subacute<br>environments. This<br>system is a reusable<br>device. | The Nonin Avant 9600<br>Digital Pulse Oximeter is a<br>portable, tabletop device<br>indicated for use in<br>simultaneously measuring,<br>displaying, and recording<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate of adult,<br>pediatric, infant, and<br>neonatal patients in<br>hospitals, medical facilities,<br>home care, and subacute<br>environments. It may also<br>be used in patient<br>transport, sleep<br>laboratories, and EMS<br>environments. The Avant<br>9600 is intended for<br>continuous monitoring<br>and/or spot-checking of<br>patients during both no<br>motion and motion<br>conditions, for patients who<br>are well or poorly perfused. | The Guardian Angel<br>GA1000 Digital Vital Sign<br>Monitoring System is<br>indicated for use in<br>measuring and displaying<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate of adult and<br>pediatric patients. It is<br>indicated for spot-<br>checking and / or<br>continuous monitoring of<br>patients during non-<br>motion and under well-<br>perfused conditions. The<br>intended environment of<br>use is hospital. This<br>system is a reusable<br>device. |
| Patient<br>population | Pediatrics and infants | Adult and pediatric, infant,<br>and neonatal patients | Adults and pediatrics |
| Application site | Foot | Finger, toe or foot | Finger |
| Environment of<br>use | Hospitals, medical<br>facilities, home care,<br>and subacute<br>environments | Hospitals, medical facilities,<br>home care, transport and<br>subacute environments | Hospitals |
| Out-of-hospital<br>transport | No | Yes | No |
| Motion | Non-motion | Non-motion<br>Motion | Non-motion |
| Perfusion | Well-perfused | Well-perfused<br>Poorly-perfused | Well-perfused |
| Single-use or<br>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<br>GA1001 Digital Vital<br>Sign Monitoring System | Avant 9600 Digital Pulse<br>Oximeter (K040589) with<br>Reusable Flex Sensors | Guardian Angel GA1000<br>Digital Vital Sign<br>Monitoring System<br>(K162580) | | | | |
| Technology of<br>pulse oximetry | Red and Infrared<br>technology | Red and Infrared<br>technology | Red and Infrared<br>technology | | | |
| LED<br>wavelengths &<br>output power of<br>pulse oximetry | Red: 660 nm @ 9.8 mw<br>Infrared: 880 nm @ 6.5<br>mw | Red: 660 nm @ 0.8 mw<br>max. avg.<br>Infrared: 910 nm @ 1.2 mw<br>max. avg | Red: 660 nm @ 1.8 mw<br>Infrared: 905 nm @ 2 mw | | | |
| Accuracy<br>(No motion) | SpO2<br> | ± 3 digits<br>(70-100%) | SpO2 | ± 3 digits<br>(70-100%) | SpO2 | ± 3 digits<br>(70-100%) |
| | Pulse<br>Rate | ± 3 digits<br>(30-300 bpm) | Pulse<br>Rate | ± 3 digits<br>(18-300 bpm) | Pulse<br>Rate | ± 3%<br>(30-290 bpm) |
| Displayed range | SpO2 | 1-100% | SpO2 | 0-100% | SpO2 | 1-100% |
| | Pulse<br>Rate | 30-300 bpm | Pulse<br>Rate | 18-300 bpm | Pulse<br>Rate | 30-290 bpm |
| Display | 10.1" LCD | LED | 7" LCD | | | |
| Alarms | Visual and auditory<br>alarms | Visual and auditory alarms | Visual and auditory<br>alarms | | | |
| Power Supply | Sensor Module: Lithium<br>battery<br>Display Unit: Lithium<br>battery, AC adaptor | Monitor: NiMH battery, AC<br>adaptor | Sensor Module: Lithium<br>battery<br>Display Unit: Lithium<br>battery, AC adaptor | | | |
| Wireless<br>technology/Data<br>transmission | Bluetooth | None | Bluetooth | | | |
| Biocompatibility | Skin (surface) contact<br>Prolonged contact | Skin (surface) contact<br>Prolonged contact | Skin (surface) contact<br>Prolonged 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.