(590 days)
Not Found
No
The summary describes a standard vital sign monitoring system with sensors, data transmission, display, and alarms. There is no mention of AI or ML in the intended use, device description, or performance studies. The audio/video camera is for real-time monitoring and recording, not for analysis using AI/ML.
No.
The device is indicated for measuring, recording, and displaying vital signs (SpO2, pulse rate, body temperature) and providing a monitoring system with alarms, but it does not perform any therapeutic function. It is a diagnostic/monitoring device.
Yes
The device measures, records, and displays various vital signs (SpO2, pulse rate, body temperature) and provides alarms when these fall outside pre-set limits, which are all activities associated with monitoring a patient's physiological state to identify potential medical issues.
No
The device description explicitly mentions "sensor module(s)", "Receiver/Transponder", and an "embedded camera", indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System measures physiological parameters directly from the patient's body (SpO2, pulse rate, body temperature) and uses an external camera for monitoring. It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring vital signs and patient presence, not for analyzing biological specimens.
Therefore, this device falls under the category of a vital sign monitor, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, FLL, DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger, Foot, Axillary (armpit)
Indicated Patient Age Range
Adult, Pediatric, Infant
Intended User / Care Setting
Hospitals, Medical facilities, Home care, Subacute environments. The indications for use specify "caregiver" regarding the user.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The results of the testing demonstrate equivalence with the predicate device(s) and compliance with recognized standards. Studies include: Electrical Safety, Temperature and Humidity, Atmospheric Pressure (Altitude), Defibrillation Protection, Electromagnetic Immunity and Emissions, Performance, Mechanical Durability, Biocompatibility, Software V&V, Bench testing for Accuracy, Security Testing, Wireless Coexistence Testing, Durability and Performance testing, CR2025 Battery Life Testing. All tests passed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: A-ms less than 3 digits (70-100%)
SpO2: +/- 3 digits (70-100%)
PR: +/- 3% (30-290 bpm)
PR: +/- 3 digits (18-300 bpm)
Body Temperature (GA2002, GA2100, GA2101): +/- 0.2°F (32°C-42°C: +/- 0.1°C) for 89.6°F-107.6°F
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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 USA 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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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. |
| Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., | |
| Nangang Dist., Taipei City 115 TW | |
| TEL.: +886-2-2655-7297 | |
| FAX: +886-2-2655-7260 | |
| Contact Person | Paul Liu |
| Regulatory Affairs Manager | |
| Email: paul.liu@aulisa.com |
5.2 Trade/Device Name
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
5.3 Regulatory Information
| Regulation Number | Product
Code | Classification Name | Device
Class |
|-------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2700 | DQA | Oximeter | Class II |
| 880.2910 | FLL | Clinical electronic thermometer | Class II |
| 870.2910 | DRG | Radiofrequency Physiological
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
Module(s) | Population | Parameters |
|--------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------|
| GA2000 | Adult/Pediatric
Oximeter Module | • Adult (> 40 kg / 88 lbs)
• Pediatric (10 kg - 40 kg / 22 lbs - 88 lbs) | • SpO2
• Pulse Rate |
| GA2001 | Infant Oximeter
Module | • Pediatric & Infant (107.6°F
(42.0°C) displays
"Hi" | 89.6°F-107.6°F
(32°C-42°C)
107.6°F
(42.0°C) displays
"Hi" | 89.6°F-107.6°F
(32°C-42°C)
107.6°F
(42.0°C) displays
"Hi" | na | na | 95°F-107.6°F
(35°C-42°C) |
| Operation
mode | na | na | Continuous | Continuous | Continuous | na | na | Continuous |
| Measuring site | na | na | Axillary (armpit) | Axillary (armpit) | Axillary (armpit) | na | na | Axillary
(armpit) |
| Power supply | na | na | CR2025 | CR2025 | CR2025 | na | na | MS Lithium
rechargeable
battery 3.0V |
| Duration of
continuous
patch use | na | na | up to 24 hours | up to 24 hours | up to 24 hours | na | na | 7 days |
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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 | |
| 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 | |
| ASTM E1112 | ||
| IEC 60601-1-8 | ||
| IEC 60086 series | Pass | |
| Mechanical Durability | IEC 60601-1 | |
| IEC 60601-1-11 | Pass | |
| Biocompatibility | ISO 10993-5 | |
| 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.