(590 days)
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 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.
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.
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.
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.
The provided document describes the Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents acceptance criteria primarily for the functional oxygen saturation (SpO2), pulse rate (PR), and body temperature measurements.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Oximetry (SpO2) | Accuracy (No Motion): $\pm$ 3 digits (70-100%) | SpO2 accuracy calculated using root-mean-square (A-rms) was less than 3 digits during steady-state conditions over the range of 70-100%. |
| Pulse Rate (PR) - GA2000/GA2100 | Accuracy (No Motion): $\pm$ 3% (30-290 bpm) | The document states SpO2 accuracy was compliant with specified performance; PR accuracy is implicitly covered by consistency with predicate. (Explicit PR accuracy result for the subject device is not separately stated beyond the criteria). |
| Pulse Rate (PR) - GA2001/GA2101 | Accuracy (No Motion): $\pm$ 3 digits (18-300 bpm) | The document states SpO2 accuracy was compliant with specified performance; PR accuracy is implicitly covered by consistency with predicate. (Explicit PR accuracy result for the subject device is not separately stated beyond the criteria). |
| Body Temperature (GA2002/GA2100/GA2101) | Accuracy: 89.6°F-107.6°F: $\pm$ 0.2°F (32°C-42°C: $\pm$ 0.1°C) | The output temperature is derived directly from the input signal without adjustment, implying it meets this specification. |
| 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 |
2. Sample Size and Data Provenance for Test Set
The "clinical evaluation for SpO2 accuracy" was conducted on a test set of "healthy male and female, light to dark skinned subjects."
The document does not specify the exact sample size used for this SpO2 clinical test set.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts and Qualifications for Ground Truth
For the SpO2 clinical evaluation, there is no mention of experts establishing ground truth. Instead, the "functional oxygen saturation (SpO2) measurements of the subject device were validated in accordance with ISO 80601-2-61." This standard typically involves comparison against an invasive co-oximeter reference measurement, which is considered the ground truth. There are no experts involved in establishing this physiological ground truth for SpO2.
For body temperature, "the output temperature of the subject device is derived directly from input signal without any adjustment," implying that the ground truth for temperature measurement would be based on a calibrated reference thermometer, also not requiring experts for ground truth establishment.
4. Adjudication Method
The document does not mention an adjudication method for the test set. Given the nature of physiological measurements (SpO2 and temperature), adjudication by multiple experts is typically not part of the validation process, as the ground truth is established through direct physiological measurement by a gold-standard device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the document. This type of study is more common for diagnostic imaging AI devices where human interpretation needs to be evaluated with and without AI assistance. The Guardian Angel Rx GA2000 Series is a vital sign monitoring system, not an imaging interpretation aid.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (device-only performance).
The clinical evaluation for SpO2 accuracy was conducted to determine the device's accuracy in measuring SpO2 (A-rms less than 3 digits from 70-100%).
Similarly, the body temperature measurement accuracy and various other technical tests (electrical safety, EMC, mechanical durability, etc.) represent standalone performance evaluations of the device.
7. Type of Ground Truth Used
- For SpO2: The ground truth for SpO2 accuracy was established through comparison with a reference standard as specified by ISO 80601-2-61. This standard typically mandates the use of an invasive co-oximeter for arterial blood gas analysis as the reference ground truth.
- For Body Temperature: The ground truth for body temperature measurement would be a highly accurate and calibrated reference thermometer, as the device's output is derived directly from input signal without any adjustment.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. This device functions as a sensor and measurement system, rather than an AI/ML model that would require a separate "training set" in the conventional sense. Its performance is validated against physiological standards and predicate devices.
9. How Ground Truth for Training Set was Established
As no training set is mentioned or implied for an AI/ML model, the establishment of its ground truth is not applicable in this context. The validation for this vital sign monitor relies on direct comparison to established physiological measurement standards in a test setting.
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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 (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
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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.Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St.,Nangang Dist., Taipei City 115 TWTEL.: +886-2-2655-7297FAX: +886-2-2655-7260 |
| Contact Person | Paul LiuRegulatory Affairs ManagerEmail: 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 | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|
| 870.2700 | DQA | Oximeter | Class II |
| 880.2910 | FLL | Clinical electronic thermometer | Class II |
| 870.2910 | DRG | Radiofrequency PhysiologicalSignal 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 SensorModule(s) | Population | Parameters |
|---|---|---|---|
| GA2000 | Adult/PediatricOximeter Module | • Adult (> 40 kg / 88 lbs)• Pediatric (10 kg - 40 kg / 22 lbs - 88 lbs) | • SpO2• Pulse Rate |
| GA2001 | Infant OximeterModule | • Pediatric & Infant (< 10 kg / 22 lbs) | • SpO2• Pulse Rate |
| GA2002 | Thermometer Module | • Adult• Pediatric• Infant | Body Temperature |
| GA2100 | • Adult/PediatricOximeter Module• ThermometerModule | • Adult• Pediatric | • SpO2• Pulse Rate• Body Temperature |
| GA2101 | • Infant OximeterModule• ThermometerModule | • Pediatric & Infant | • SpO2• Pulse Rate• 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 | PrimaryPredicate | SecondaryPredicate | SecondaryPredicate | |||||
|---|---|---|---|---|---|---|---|---|
| Device name | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Guardian AngelRx GA2000Digital VitalSignMonitoringSystem | Guardian AngelRx GA2001Digital VitalSignMonitoringSystem | Fever Scout™ContinuousMonitoringThermometer | ||||
| K number | K183067 | K191207 | K181013 | |||||
| Model number | GA2000 | GA2001 | GA2002 | GA2100 | GA2101 | GA2000 | GA2001 | |
| Indications foruse | The GuardianAngel RxGA2000 SeriesDigital Vital SignMonitoringSystem (ModelGA2000) isindicated for usein measuring,recording, anddisplayingfunctional oxygensaturation ofarterialhemoglobin(SpO2) and pulserate (PR). Theintendedenvironments ofuse are hospitals,medical facilities | The GuardianAngel RxGA2000 SeriesDigital Vital SignMonitoringSystem (ModelGA2001) isindicated for usein measuring,recording, anddisplayingfunctional oxygensaturation ofarterialhemoglobin(SpO2) and pulserate (PR). Theintendedenvironments ofuse are hospitals,medical facilities | The GuardianAngel RxGA2000 SeriesDigital Vital SignMonitoringSystem (ModelGA2002) isindicated for usein measuring,recording, anddisplaying bodytemperature. Theintendedenvironments ofuse are hospitals,medical facilities,home care, andsubacuteenvironments.This system is areusable device | The GuardianAngel RxGA2000 SeriesDigital Vital SignMonitoringSystem (ModelGA2100) isindicated for usein measuring,recording, anddisplayingfunctional oxygensaturation ofarterialhemoglobin(SpO2) and pulserate (PR) andbody temperature.The intendedenvironments ofuse are hospitals | The GuardianAngel RxGA2000 SeriesDigital Vital SignMonitoringSystem (ModelGA2101) isindicated for usein measuring,recording, anddisplayingfunctional oxygensaturation ofarterialhemoglobin(SpO2) and pulserate (PR) andbody temperature.The intendedenvironments ofuse are hospitals | The GuardianAngel RxGA2000 DigitalVital SignMonitoringSystem isindicated foruse inmeasuring,recording, anddisplayingfunctionaloxygensaturation ofarterialhemoglobin(SpO2), pulserate, and audiovideo signals ofadult and | The GuardianAngel RxGA2001 DigitalVital SignMonitoringSystem isindicated foruse inmeasuring anddisplayingfunctionaloxygensaturation ofarterialhemoglobin(SpO2) andpulse rate.It is indicatedfor spot-checking and/or | The wirelessFever Scout™ContinuousMonitoringthermometer isa non-invasiveand re-usableelectronicdevice forhome use and anon-invasiveand singlepatientuse inthe hospital.This product isintended fornon-urgentambulatorycontinuousarmpit bodytemperature |
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Section 5
| Subject Device | PrimaryPredicate | SecondaryPredicate | SecondaryPredicate | |||||
|---|---|---|---|---|---|---|---|---|
| Patientpopulation | home care, andsubacuteenvironments.This system is areusable device.The OximeterModule(s) isindicated for spot-checking and/orcontinuousmonitoring ofSpO2 and PR ofadults andpediatrics duringnon-motion andunder well-perfusedconditions.adult, pediatric | home care, andsubacuteenvironments.This system is areusable device.The OximeterModule(s) isindicated for spot-checking and/orcontinuousmonitoring ofSpO2 and PR ofpediatrics andinfants duringnon-motion andunder well-perfusedconditions.pediatric, infant | The ThermometerModule isindicated forcontinuous ampitbody temperaturemonitoring ofadults, pediatrics,and infants.adult, pediatric,infant | medical facilities,home care, andsubacuteenvironments.This system is areusable device.The OximeterModule(s) isindicated for spot-checking and/orcontinuousmonitoring ofSpO2 and PR ofadults andpediatrics duringnon-motion andunder well-perfusedconditions.The ThermometerModule isindicated forcontinuous ampitbody temperaturemonitoring ofadults, pediatrics,and infants.adult, pediatric,infant | medical facilities,home care, andsubacuteenvironments.This system is areusable device.The OximeterModule(s) isindicated for spot-checking and/orcontinuousmonitoring ofSpO2 and PR ofpediatrics andinfants duringnon-motion andunder well-perfusedconditions.The ThermometerModule isindicated forcontinuous ampitbody temperaturemonitoring ofadults, pediatrics,and infants.adult, pediatric,infant | pediatricpatients.It is indicatedfor spot-checking and/orcontinuousmonitoring ofpatients duringnon-motion andunder well-perfusedconditions.The intendedenvironmentsof use arehospitals,medicalfacilities, homecare, andsubacuteenvironments.This system is areusable device.adult, pediatric | continuousmonitoring ofpediatrics andinfants duringnon-motion andunder well-perfusedconditions.The intendedenvironmentsof use arehospitals,medicalfacilities, homecare, andsubacuteenvironments.This system is areusable device.pediatric, infant | monitoringfrom ages 29days and olderages 29 daysand older |
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| Subject Device | PrimaryPredicate | SecondaryPredicate | SecondaryPredicate | |||||
|---|---|---|---|---|---|---|---|---|
| Useenvironment | hospitals, medicalfacilities, homecare, subacuteenvironments | hospitals, medicalfacilities, homecare, subacuteenvironments | hospitals, medicalfacilities, homecare, subacuteenvironments | hospitals, medicalfacilities, homecare, subacuteenvironments | hospitals, medicalfacilities, homecare, subacuteenvironments | hospitals,medicalfacilities, homecare, subacuteenvironments | hospitals,medicalfacilities, homecare, subacuteenvironments | home, hospital |
| Measurement | Pulse rate, SpO2 | Pulse rate, SpO2 | body temperature | Pulse rate, SpO2,body temperature | Pulse rate, SpO2,body temperature | Pulse rate,SpO2 | Pulse rate,SpO2 | bodytemperature |
| Disposable orreusable | reusable/disposable | reusable/disposable | reusable/disposable | reusable/disposable | reusable/disposable | reusable | reusable | reusable/disposable |
| Wirelesscommunication | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | Bluetooth 4.0Wi-Fi | • Bluetooth BLE• Wireless (Wi-Fi) 2.4G |
| Operatingplatform | Aulisa DisplayUnit | Aulisa DisplayUnit | Aulisa DisplayUnit | Aulisa DisplayUnit | Aulisa DisplayUnit | Aulisa DisplayUnit | Aulisa DisplayUnit | • iPhone 5S+orlater & iOS8.0 or later• Android 4.3or later |
| Alarms | Visualandauditoryalarms | Visualandauditoryalarms | Visualandauditoryalarms | Visualandauditoryalarms | Visualandauditoryalarms | Visualandauditoryalarms | Visualandauditoryalarms | na |
| Real-timeaudio/video | Yes | Yes | Yes | Yes | Yes | Yes | Yes | na |
| Pulse Oximetry | ||||||||
| Measuring site | Finger | Foot | na | Finger | Foot | Finger | Finger | na |
| Out-of-hospitaltransport | 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 |
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| Primary | Secondary | Secondary | ||||||
|---|---|---|---|---|---|---|---|---|
| Subject Device | Predicate | Predicate | Predicate | |||||
| Technology | Red and Infraredtechnology | Red and Infraredtechnology | na | Red and Infraredtechnology | Red and Infraredtechnology | Red andInfraredtechnology | Red andInfraredtechnology | na |
| Wavelengths &output power | Red:660 nm @ 1.8mw | Red:660 nm @ 9.8mw | na | Red:660 nm @ 1.8mw | Red:660 nm @ 9.8mw | Red:660 nm @ 1.8mw | Red:660 nm @ 9.8mw | na |
| Infrared:905 nm @ 2 mw | Infrared:880 nm @ 6.5mw | Infrared:905 nm @ 2 mw | Infrared:880 nm @ 6.5mw | Infrared:905 nm @ 2mw | Infrared:880 nm @ 6.5mw | na | ||
| Measurementaccuracy (Nomotion) | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3% (30-290bpm) | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3 digits (18-300bpm) | na | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3% (30-290bpm) | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3 digits (18-300bpm) | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3% (30-290bpm) | SpO2:$\pm$ 3 digits (70-100%)PR:$\pm$ 3 digits (18-300 bpm) | na |
| Displayedrange | SpO2: 1-100%PR: 30-290bpm | SpO2: 0-100%PR: 18-300bpm | na | SpO2: 1-100%PR: 30-290bpm | SpO2: 0-100%PR: 18-300bpm | SpO2: 1-100%PR: 30-290bpm | SpO2: 0-100%PR: 18-300bpm | na |
| Power supply | Lithium batteryAC adaptor | Lithium batteryAC adaptor | na | Lithium batteryAC adaptor | Lithium batteryAC adaptor | Lithium batteryAC adaptor | Lithium batteryAC adaptor | na |
| Body Temperature | ||||||||
| Measurementaccuracy | na | na | 89.6°F-107.6°F:$\pm$ 0.2°F(32°C-42°C:$\pm$ 0.1°C) | 89.6°F-107.6°F:$\pm$ 0.2°F(32°C-42°C:$\pm$ 0.1°C) | 89.6°F-107.6°F:$\pm$ 0.2°F(32°C-42°C:$\pm$ 0.1°C) | na | na | 98.6°F-102.2°F:$\pm$ 0.2°F(37°C-39°C:$\pm$ 0.1°C)95°F-98.6°F:$\pm$ 0.4°F(35°C-37°C:$\pm$ 0.2°C) |
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| Subject Device | PrimaryPredicate | SecondaryPredicate | SecondaryPredicate | |||||
|---|---|---|---|---|---|---|---|---|
| 102.2°F-107.6°F:$\pm$ 0.4°F(39°C-42°C:$\pm$ 0.2°C) | ||||||||
| Display range | na | na | 89.6°F-107.6°F(32°C-42°C)<89.6°F (32.0°C)displays "Lo">107.6°F(42.0°C) displays"Hi" | 89.6°F-107.6°F(32°C-42°C)<89.6°F (32.0°C)displays "Lo">107.6°F(42.0°C) displays"Hi" | 89.6°F-107.6°F(32°C-42°C)<89.6°F (32.0°C)displays "Lo">107.6°F(42.0°C) displays"Hi" | na | na | 95°F-107.6°F(35°C-42°C) |
| Operationmode | 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 Lithiumrechargeablebattery 3.0V |
| Duration ofcontinuouspatch 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 60601-1IEC 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 80601-2-61ASTM E1112IEC 60601-1-8IEC 60086 series | Pass |
| Mechanical Durability | IEC 60601-1IEC 60601-1-11 | Pass |
| Biocompatibility | ISO 10993-5ISO 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.
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5.10 Conclusion
The data provided as part of this submission for the subject device supports the substantial equivalence determination.
§ 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).