(116 days)
No
The summary describes a standard vital sign monitoring system using established technologies (pulse oximetry, audio/video, wireless communication) and does not mention any AI or ML components or capabilities.
No.
The device is a vital sign monitoring system that measures and displays SpO2 and pulse rate. It is used for monitoring and alerting caregivers, not for treating any condition.
Yes
The device measures and displays functional oxygen saturation (SpO2) and pulse rate, provides visual and auditory alarms for out-of-limit values, and records data, which are all activities associated with diagnosing a patient's physiological state.
No
The device description explicitly states the system consists of hardware components: a wrist-worn Sensor Module, a Receiver/Transponder with an embedded audio/video camera, and a portable, table-top wireless Display Unit.
Based on the provided information, the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids outside of the body to obtain information about a person's health.
- The Guardian Angel Rx GA2000 is a non-invasive monitoring system. It measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using a wrist-worn sensor. It does not involve the collection or analysis of bodily specimens.
- The intended use and device description clearly state its function is to monitor vital signs and provide audio/video surveillance. This aligns with the definition of a patient monitoring device, not an IVD.
Therefore, the Guardian Angel Rx GA2000 falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients 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.
Product codes
DQA, DRG
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 careqiver can review the historical data whenever needed.
The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera 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 are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
hospitals, medical facilities, home care, and subacute environments.
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
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 adult subjects over the range of 70%-100% SpO2 through controlled induced hypoxia. Over 200 data points were collected. The Ams is less than 3 digits, compliant with FDA guidance on Pulse Oximeters -Premarket notification submissions [510(k)].
Key Metrics
Accuracy (No motion):
SpO2 ± 3 digits (70-100%)
Pulse Rate ± 3% (30-290 bpm)
Predicate Device(s)
K040589, Avant 9600 Digital Pulse Oximeter, Nonin Medical, Inc.
Reference Device(s)
K150361, ViSi Mobile Monitoring System, Sotera Wireless, Inc., K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Taiwan Aulisa Medical Devices Technologies, Inc. % Don Mizota Consultant 725 Morninghome Road Danville, California 94526
Re: K183067
Trade/Device Name: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DRG 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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.htm); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Todd D. Courtney -S
for 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
2
Indications for Use
510(k) Number (if known) K183067
Device Name
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
Indications for Use (Describe)
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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. |
| Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., | |
| Nangang Dist.,Taipei City 115 TW | |
| Phone: 886-2-2655-7297 | |
| FAX: 886-2-2655-7260 | |
| Contact Person: | Paul Liu |
| Regulatory Affairs Supervisor | |
| Taiwan Aulisa Medical Devices Technologies, Inc. | |
| Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., | |
| Nangang Dist.,Taipei City 115 TW | |
| Phone: 886-2-2655-7297 | |
| FAX: 886-2-2655-7260 | |
| Email: paul.liu@aulisa.com |
5.2. Trade/Device Name
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
5.3. Regulatory Information
| Regulation Number | Regulation Name | Regulation Class | Product Code |
|---|---|---|---|
| 21 CFR 870.2700 | Oximeter | Class II | DQA |
| 21 CFR 870.2910 | Radiofrequency | ||
| Physiological Signal | |||
| Transmitter and Receiver | Class II | DRG |
5.4. Predicate Devices
Primary predicate
K040589, Avant 9600 Digital Pulse Oximeter, Nonin Medical, Inc.
4
Reference devices
K150361, ViSi Mobile Monitoring System, Sotera Wireless, Inc.
K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.
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). 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 careqiver can review the historical data whenever needed.
The system consists of a self-contained wrist-worn Sensor Module (SM), a Receiver/ Transponder (RT) with an embedded audio/video camera 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 are taken by the SM and are transmitted to the RT which delivers the measurements along with audio/video signals to the DU for display, wherein Bluetooth technology is used to transmit data between the SM and the RT, and data is transmitted from the RT to the DU via the Wi-Fi 802.11 band.
5.6. Intended Use
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and/or continuous monitoring of patients 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 with Predicates
The subject device has similar intended use and technology characteristics to the primary predicate, 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 primary predicate. Further, the subject device wirelessly transmits data to a remote display whereas the primary predicate does not.
The subject device uses the same Sensor Module (SM) and a similar Display Unit (DU) as currently configured on our reference device, K162580, Guardian Angel GA1000 Digital Vital Sign Monitoring System (cleared under), and uses the same Bluetooth technology for data transmission. The subject device has a Receiver/Transponder (RT) included to transmit the data from the Sensor Module to the Display Unit using the 802.11 radio frequency band which
5
extends the data transmission range of the system. A camera and microphone is incorporated in the RT, which transmits audio/video data via the same 802.11 band. The 802.11-based telemetry technology is equivalent to that used in the Secondary Predicate: ViSi Mobile Monitoring System (cleared under K150361).
The comparison table for the subject device versus the primary predicate, Avant 9600 (K040589), and the secondary predicate ViSi Mobile Monitoring System (K150361), is shown in Table 5.1.
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Item | The Guardian Angel | |||
| Rx GA2000 Digital | ||||
| Vital Sign Monitoring | ||||
| System | Avant 9600 Digital | |||
| Pulse Oximeter | ||||
| (K040589) with | ||||
| Reusable Flex | ||||
| sensors | ViSi Mobile Monitoring | |||
| System (K150361) | Guardian Angel | |||
| GA1000 Digital Vital | ||||
| Sign Monitoring | ||||
| System (K162580) | ||||
| Indication for use | The Guardian Angel | |||
| Rx GA2000 Digital | ||||
| Vital Sign Monitoring | ||||
| System is indicated | ||||
| for use in measuring, | ||||
| recording, and | ||||
| displaying functional | ||||
| oxygen saturation of | ||||
| arterial hemoglobin | ||||
| (SpO2), pulse rate, | ||||
| and audio video | ||||
| signals of adult and | ||||
| pediatric patients. It is | ||||
| indicated for spot- | ||||
| checking and/or | ||||
| continuous | ||||
| monitoring of patients | ||||
| 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. | The Nonin Avant | |||
| 9600 Digital Pulse | ||||
| Oximeter is a | ||||
| portable, tabletop | ||||
| device indicated for | ||||
| use in simultaneously | ||||
| measuring, | ||||
| displaying, and | ||||
| recording functional | ||||
| oxygen saturation of | ||||
| arterial hemoglobin | ||||
| (SpO2) and pulse rate | ||||
| of adult, pediatric, | ||||
| infant, and neonatal | ||||
| patients in hospitals, | ||||
| medical facilities, | ||||
| home care, and | ||||
| subacute | ||||
| environments. It may | ||||
| also be used in | ||||
| patient transport, | ||||
| sleep laboratories, | ||||
| and EMS | ||||
| environments. The | ||||
| Avant 9600 is | ||||
| intended for | ||||
| continuous monitoring | ||||
| and / or spot- | ||||
| checking of patients | ||||
| during both no motion | ||||
| and motion | ||||
| conditions, for | ||||
| patients who are well | ||||
| or poorly perfused. | The ViSi Mobile | |||
| Monitoring System is | ||||
| intended for use by | ||||
| clinicians and medically | ||||
| qualified personnel for | ||||
| single or multi- | ||||
| parameter vital signs | ||||
| monitoring of adult | ||||
| patients (18 years or | ||||
| older). It is indicated for | ||||
| ECG (3 or 5 lead- | ||||
| wire), respiration rate | ||||
| (RESP), heart rate | ||||
| (HR), noninvasive | ||||
| blood pressure (NIBP), | ||||
| continuous noninvasive | ||||
| blood pressure | ||||
| (cNIBP), noninvasive | ||||
| monitoring of functional | ||||
| oxygen saturation of | ||||
| arterial hemoglobin | ||||
| (SpO2), pulse rate | ||||
| (PR), and skin | ||||
| temperature (TEMP) in | ||||
| hospital-based | ||||
| facilities; including, | ||||
| general medical- | ||||
| surgical floors, | ||||
| intermediate care | ||||
| floors, and emergency | ||||
| departments. The ViSi | ||||
| Mobile Monitoring | ||||
| System may be used | ||||
| as standalone devices | ||||
| or networked to ViSi | ||||
| Mobile Remote | ||||
| Viewers through | ||||
| wireless 802.11 | ||||
| communication. | The Guardian Angel | |||
| GA1000 Digital Vital | ||||
| Sign Monitoring | ||||
| System is indicated | ||||
| for use in measuring | ||||
| and displaying | ||||
| functional oxygen | ||||
| saturation of arterial | ||||
| hemoglobin (SpO2) | ||||
| and pulse rate of | ||||
| adult and pediatric | ||||
| patients. It is | ||||
| indicated for spot- | ||||
| checking and / or | ||||
| continuous | ||||
| monitoring of patients | ||||
| during non-motion | ||||
| and under well- | ||||
| perfused conditions. | ||||
| The intended | ||||
| environment of use is | ||||
| hospital. This system | ||||
| is a reusable device. | ||||
| Patient | ||||
| population | Adult and pediatric | Adult and pediatric, | ||
| infant, and neonatal | ||||
| patients | Adult | Adults and pediatrics | ||
| Item | Subject Device | Primary Predicate | Reference Device | Reference Device |
| Environment of use | The Guardian Angel | |||
| Rx GA2000 Digital | ||||
| Vital Sign Monitoring | ||||
| System | Avant 9600 Digital | |||
| Pulse Oximeter | ||||
| (K040589) with | ||||
| Reusable Flex | ||||
| sensors | ViSi Mobile Monitoring | |||
| System (K150361) | Guardian Angel | |||
| GA1000 Digital Vital | ||||
| Sign Monitoring | ||||
| System (K162580) | ||||
| Out-of-hospital | ||||
| transport | Hospitals, medical | |||
| facilities, home care, | ||||
| and subacute | ||||
| environments | Hospitals, medical | |||
| facilities, home care, | ||||
| and subacute | ||||
| environments | Hospital-based facilities | Hospitals, medical | ||
| facilities, home care, | ||||
| and subacute | ||||
| environments | ||||
| Motion | No | Yes | Not specified | No |
| Motion | Non-motion | Non-motion | ||
| Motion | Not specified | Non-motion | ||
| Perfusion | Well-perfused | Well-perfused | ||
| Poorly-perfused | Not specified | Well-perfused | ||
| Single-use or | ||||
| reusable | Reusable | Reusable | Reusable | Reusable |
| Measurement | Pulse rate and SpO2 | Pulse rate and SpO2 | Pulse rate, SpO2, | |
| ECG, blood pressure, | ||||
| respiration rate and | ||||
| skin temperature | Pulse rate and SpO2 | |||
| Technology of | ||||
| pulse oximetry | Red and Infrared | |||
| technology | Red and Infrared | |||
| technology | Red and Infrared | |||
| technology | Red and Infrared | |||
| technology | ||||
| LED | ||||
| wavelengths & | ||||
| output power of | ||||
| pulse oximetry | Red: 660 nm @ 1.8 | |||
| mw nominal | ||||
| Infrared: 905 nm @ 2 | ||||
| mw nominal | Red: 660 nm @ 0.8 | |||
| mw max. avg. | ||||
| Infrared: 910 nm @ | ||||
| 1.2 mw max. avg. | Red: 660 nm @ 6.5 mw | |||
| max. | ||||
| Infrared: 905 nm @ 5.2 | ||||
| mw max. | Red: 660 nm @ 1.8 | |||
| mw nominal | ||||
| Infrared: 905 nm @ 2 | ||||
| mw nominal | ||||
| Accuracy | ||||
| (No motion) | SpO2 | |||
| Pulse Rate | $SpO2 ± 3 digits (70-100%)$ | |||
| $Pulse Rate ± 3% (30-290 bpm)$ | $SpO2 ± 2 digits (70-100%)$ | |||
| $Pulse Rate ± 3 digits (30-240 bpm)$ | $SpO2 ± 3 digits (70-100%)$ | |||
| $Pulse Rate ± 3% (30-290 bpm)$ | ||||
| Displayed range | $SpO2 1-100%$ | |||
| $Pulse Rate 30-290 bpm$ | $SpO2 0-100%$ | |||
| $Pulse Rate 18-300 bpm$ | $SpO2 0-100%$ | |||
| $Pulse Rate 0-240 bpm$ | $SpO2 1-100%$ | |||
| $Pulse Rate 30-290 bpm$ | ||||
| Display | 10.1" LCD | LED | OLED | 7" LCD |
| Alarms | Visual and auditory | |||
| alarms | Visual and auditory | |||
| alarms | Visual and auditory | |||
| alarms | Visual and auditory | |||
| alarms | ||||
| Power Supply | Lithium battery, AC | |||
| adaptor | NiMH battery, AC | |||
| adaptor | Lithium battery, AC | |||
| adaptor | Lithium battery, AC | |||
| adaptor | ||||
| Wireless | ||||
| technology / | ||||
| Data | ||||
| transmission | Bluetooth | |||
| 802.11 | None | 802.11 | Bluetooth | |
| Biocompatibility | Skin (surface) contact | |||
| Prolonged contact | Skin (surface) contact | |||
| Prolonged contact | Skin (surface) contact | |||
| Prolonged contact | Skin (surface) contact | |||
| Prolonged contact |
Table 5.1 - Comparison with Predicate
6
7
5.8. Summary of Performance Testing
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:
- 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 adult subjects over the range of 70%-100% SpO2 through controlled induced hypoxia. Over 200 data points were collected. The Ams is less than 3 digits, compliant with FDA guidance 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.