(169 days)
Not Found
No
The description focuses on standard vital sign monitoring technology (transmittance, LEDs, Bluetooth) and alarm systems based on thresholds, with no mention of AI/ML terms or capabilities.
No
Explanation: The device measures and displays vital signs (SpO2 and pulse rate) and includes an alarm system, but it does not treat or cure a disease or condition; it is a monitoring device.
Yes
Explanation: The device is described as a "Digital Vital Sign Monitoring System" that measures and displays vital signs (SpO2 and pulse rate) and includes an alarm system to alert caregivers to abnormal values. This falls under the definition of a diagnostic device, as it provides information about a patient's physiological state to aid in the detection or monitoring of medical conditions.
No
The device description explicitly lists multiple hardware components including a Sensor Module, Display Unit, Finger Sensor, wristband, and charging adaptors. It also describes the physical mechanism of measurement (transmittance technology with LEDs) and data transmission via Bluetooth, indicating a significant hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Guardian Angel GA1000 Digital Vital Sign Monitoring System measures SpO2 and pulse rate by using sensors placed on the patient's finger. This is a non-invasive measurement performed on the body.
- Intended Use: The intended use clearly states it's for "measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients." This is a physiological measurement, not an analysis of a biological specimen.
The device is a vital sign monitor, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
Device Description
Aulisa's GA1000 is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation level. The system includes a self-contained wrist-worn Sensor Module and a portable, table-top wireless Display Unit. The Guardian Angel GA1000 Digital Vital Sign Monitoring System is also equipped with an alarm system that alerts the caregiver when a patient's pulse rate is too low or too high and when the patient's SpO2 is too low or too high.
Guardian Angel GA1000 Digital Vital Sign Monitoring System contains the following components.
- Sensor Module
- Display Unit
- Finger Sensor
- Sensor Module wristband
- Sensor Module Charging Adaptor
- Display Unit Charging Adaptor
- . Display Unit Stand
The GA1000 measures SpO2 and pulse rate based on transmittance technology, measuring the absorbance of red and infrared light passed through the tissue.
The GA1000 uses Bluetooth v4.0 to transmit data between the wrist-worn Sensor Module and the wireless Display Unit. Both the Sensor Module and the Display Unit is Bluetooth® 4.0 compatible.
The GA1000 uses non-invasive red and infrared LED sensors to measure the functional blood oxygen saturation and pulse rate. The measurements are wirelessly transmitted to the Display Unit, which displays the measurements using a Liquid-Crystal-Display (LCD) panel. The system provides adjustable visual and audio oxygen saturation, and pulse rate alarms through the LCD panel and speakers. Additional alarms are featured, including low battery on the Sensor Module, Sensor Cable disconnection, Sensor Module disconnection, Sensor Cable Probe fault, Sensor Probe detached from patient, Display Unit battery low.
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 patients.
Intended User / Care Setting
Hospital
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
Clinical data were collected to verify the performance accuracy of GA1000 on healthy adult subjects over the range of 70%-100% SpO through controlled induced hypoxia. The data was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Standard.
Over 200 data points were collected for each sensor. The Arms of each sensor is below 3%, compliant with FDA quidance on Pulse Oximeter -Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4t0, 2013.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
The following non-clinical testing has been conducted for the GA1000 Digital Vital Sign Monitoring System, performed according to GA1000 product requirement specification and quality system to illustrate substantial equivalence.
- Performance Testing: ISO 80601-2-61:2011
- Electrical Safety testing: IEC 60601-1:2005
- Biocompatibility Testing: ISO 10993-10: 2010, ISO 10993-5:2009
- Electrical Safety Testing and EMC Testing: IEC 60601-1-2:2007
- Alarm System: IEC 60601-1-8:2006
- Wireless Coexistence: FDA Guidance Radio Frequency Wireless Technology in Medical Devices (2013)
- Software Verification: IEC 62304:2006, FDA Guidance Off-The-Shelf Software Use in Medical Devices (1999)
- Pulse Oximetry Testing: ISO 80601-2-61:2011, FDA Pulse Oximeters Guidance (2013)
The tests performed on the GA1000 include: Functional Test, Push, Impact and Drop Test, Particulate and Water Ingress Test, Temperature and Humidity Test, Battery Life Test, Radio Frequency Compatibility, Emissions and Immunity Tests, Biocompatibility Test, Alarm System Test.
The subject device underwent bench tests following standards listed above. Software Validation and Verification was also performed following IEC 62304:2006. Biocompatibilities of patient contact materials have been tested, showing the materials to be biocompatible. The tests show compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-8, IEC 62304, ISO 10993-5, ISO 10993-10, and ISO 80601-2-61.
Clinical Testing:
Clinical data were collected to verify the performance accuracy of GA1000 on healthy adult subjects over the range of 70%-100% SpO through controlled induced hypoxia. The data was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Standard. Over 200 data points were collected for each sensor. The Arms of each sensor is below 3%, compliant with FDA quidance on Pulse Oximeter -Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4t0, 2013.
Key Results:
The results of the testing demonstrate that the Taiwan Aulisa Medical Technologies Guardian Angel GA1000 Digital Vital Sign Monitoring System is as safe and effective, as the legally marketed predicate device.
Performance test data demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: (Pediatrics : SC100M, ENSC100M; Adults: SC100L, ENSC100L) Adults/Pediatrics: 3 digits
Pulse Rate Accuracy: (SC100M, SC100L, ENSC100M, ENSC100L) Adults/Pediatrics: ±3 %
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of three stylized human profiles facing right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Taiwan Aulisa Medical Devices Technologies, Inc. % Don Mizota Consultant 725 Morninghome Rd Danville, California 94526
Re: K162580
Trade/Device Name: Guardian Angel GA1000 Digital Vital Sign Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 26, 2017 Received: January 30, 2017
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Guardian Angel GA1000 Digital Vital Sign Monitoring System
Indications for Use (Describe)
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.
| 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
"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 Summary Prepared: September 13th, 2016 | |
|---|---|
| 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: | Jenny Lai |
| RA | |
| 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: jenny.lai@aulisa.com
5.2. Name of Device
| Trade Name: | Guardian Angel GA1000 Digital Vital Sign Monitoring
System |
|-----------------|---------------------------------------------------------------|
| Common Name: | Pulse Oximeter |
| Classification: | Oximeter CFR §870.2700 |
| Class: | Class II |
| Product Code: | DQA |
5.3. Legally Marketed Predicate Devices for Claimed Equivalence
K052669, Avant Digital Pulse Oximetry System, Model 4000, 4100, Nonin Medical, Inc.
4
5.4. Device Description
Aulisa's GA1000 is a digital vital sign monitoring system that measures and displays a patient's pulse rate and oxygen saturation level. The system includes a self-contained wrist-worn Sensor Module and a portable, table-top wireless Display Unit. The Guardian Angel GA1000 Digital Vital Sign Monitoring System is also equipped with an alarm system that alerts the caregiver when a patient's pulse rate is too low or too high and when the patient's SpO2 is too low or too high.
Guardian Angel GA1000 Digital Vital Sign Monitoring System contains the following components.
- Sensor Module ●
- Display Unit ●
- Finger Sensor ●
- Sensor Module wristband ●
- Sensor Module Charging Adaptor ●
- Display Unit Charging Adaptor ●
- . Display Unit Stand
The GA1000 measures SpO2 and pulse rate based on transmittance technology, measuring the absorbance of red and infrared light passed through the tissue.
The GA1000 uses Bluetooth v4.0 to transmit data between the wrist-worn Sensor Module and the wireless Display Unit. Both the Sensor Module and the Display Unit is Bluetooth® 4.0 compatible.
The GA1000 uses non-invasive red and infrared LED sensors to measure the functional blood oxygen saturation and pulse rate. The measurements are wirelessly transmitted to the Display Unit, which displays the measurements using a Liquid-Crystal-Display (LCD) panel. The system provides adjustable visual and audio oxygen saturation, and pulse rate alarms through the LCD panel and speakers. Additional alarms are featured, including low battery on the Sensor Module, Sensor Cable disconnection, Sensor Module disconnection, Sensor Cable Probe fault, Sensor Probe detached from patient, Display Unit battery low.
5.5. Intended Use
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
5
patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.
Technological Characteristics 5.6.
The comparison table of technological characteristics for Guardian Angel GA1000 Digital Vital Sign Monitoring System and Nonin Avant Digital Pulse Oximetry System is shown as follows:
Table 5.1 - Comparison Table to Predicate Device
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Product code | DQA | DQA | ||
| Classification | Class II | Class II | ||
| Principles of | ||||
| Operation | Red and Infra-red | |||
| transmittance technology | Red and Infra-red | |||
| transmittance technology | ||||
| System | ||||
| Components | Sensor Module and | |||
| Display Unit | Patient Module and | |||
| Display Unit | ||||
| Wireless | ||||
| technology/ | ||||
| Data | ||||
| Transmission | Bluetooth v4.0 | Bluetooth 1.1 | ||
| Software level | ||||
| of concern | Medium | Medium | ||
| SpO2 | ||||
| Specifications | ||||
| (No Motion) | Displayed | |||
| Range: | 1-100% | Displayed | ||
| Range: | 0-100% | |||
| Declared | ||||
| Range: | 70-100% | Declared | ||
| Range: | 70-100% | |||
| Accuracy: | ||||
| (Pediatrics : | ||||
| SC100M, | ||||
| ENSC100M; | ||||
| Adults: | ||||
| SC100L, | ||||
| ENSC100L) | Adults/ | |||
| Pediatrics: | ||||
| 3 digits | Accuracy: | |||
| (Finger Clip | ||||
| Flexi, | ||||
| Flexifoam, | ||||
| 8000R, | ||||
| 8000Q) | Adults/ | |||
| Pediatrics: | ||||
| 2 digits | ||||
| 3 digits | ||||
| 4 digits | ||||
| Range: | 30-290 bpm | Range: | 18-300 bpm | |
| Pulse Rate | ||||
| Specifications | ||||
| (No motion) | Accuracy: | |||
| ( SC100M, | ||||
| SC100L, | ||||
| ENSC100M, | ||||
| ENSC100L) | Adults/ | |||
| Pediatrics: | ||||
| ±3 % | Accuracy: | |||
| (Finger Clip | ||||
| Flexi, | ||||
| Flexifoam, | ||||
| 8000R, | ||||
| 8000Q) | Adults/ | |||
| Pediatrics: | ||||
| ±3% |
6
| Measurement
Wavelengths
and Output
Power | Red 660 nm @ 1.8 mw
nominal
Infrared 905 nm @ 2 mw
nominal | Red 660 nm @ 3 mw nominal
Infrared 910 nm @ 3 mw
nominal |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Components | Sensor Module and
Display Unit | Patient Module and
Display Unit |
| Power Supply | Sensor Module: 3.7V
Lithium battery
Display Unit: Lithium
battery, AC adaptor | Patient Module: AA battery
Display Unit: NiMH battery,
AC adaptor |
| Sensor Form | Soft Finger Sensor | Clip and Wrap Sensor |
| Alarms | Audible and visual pulse
rate and oxygen saturation
alarms.
Low battery and critical
battery, disconnection
alarms. | Audible and visual pulse rate,
oxygen saturation, and
perfusion alarms.
Low battery and
disconnection alarms. |
| Indications For
Use | 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. | The NONIN® Avant®
4000 Digital Pulse Oximetry
System is indicated for
measuring and displaying
functional oxygen saturation
of arterial hemoglobin (SpO2)
and pulse rate of adult,
pediatric, and infant patients.
It is indicated for spot
checking and/or continuous
monitoring of patients during
both motion and no motion
conditions, and for patients
who are well or poorly
perfused. |
Substantial Equivalence 5.7.
The Guardian Angel GA1000 Digital Vital Sign Monitoring System uses technology which is equivalent to the legally marketed predicate device cleared under K052669. The subject device is indicated for monitoring adults and pediatric patients whereas the predicate is indicated for use for monitoring adults, pediatric, and infant patients. In addition, the subject
7
device is indicated to monitor during non-motion conditions and in poorly perfused patients. These differences are not critical to the intended diagnostic use of the device. The indications of the subject device encompass a smaller patient population and less conditions of use; thus, the differences do not affect the safety and effectiveness of the device when used as labeled.
5.8. Summary of Performance Testing
Accuracy of pulse oximeter, electrical, mechanical, electromagnetic compatibility, software and biocompatibility testing have been performed on the GA1000.
The results of the testing demonstrate that the Taiwan Aulisa Medical Technologies Guardian Angel GA1000 Digital Vital Sign Monitoring System is as safe and effective, as the legally marketed predicate device.
5.8.1. Non-clinical Testing
The following non-clinical testing has been conducted for the GA1000 Digital Vital Sign Monitoring System, performed according to GA1000 product requirement specification and quality system to illustrate substantial equivalence.
| Performance Testing | ISO 80601-2-61:2011 |
|---|---|
| Electrical Safety | |
| testing | IEC 60601-1:2005 |
| Biocompatibility | |
| Testing | ISO 10993-10: 2010, ISO 10993-5:2009 |
| Electrical Safety | |
| Testing and EMC | |
| Testing | IEC 60601-1-2:2007 |
| Alarm System | IEC 60601-1-8:2006 |
| Wireless Coexistence | FDA Guidance Radio Frequency Wireless |
| Technology in Medical Devices (2013) | |
| Software Verification | IEC 62304:2006 |
| FDA Guidance Off-The-Shelf Software Use | |
| in Medical Devices (1999) | |
| Pulse Oximetry | |
| Testing | ISO 80601-2-61:2011 |
| FDA Pulse Oximeters Guidance (2013) |
Table 5.2 - Utilization of Standards table
The tests performed on the GA1000 include:
- · Functional Test
8
- Push, Impact and Drop Test ●
- Particulate and Water Ingress Test .
- . Temperature and Humidity Test
- Battery Life Test ●
- Radio Frequency Compatibility ●
- Emissions and Immunity Tests ●
- Biocompatibility Test .
- Alarm System Test ●
The subject device underwent bench tests following standards listed above. Software Validation and Verification was also performed following IEC 62304:2006. Biocompatibilities of patient contact materials have been tested, showing the materials to be biocompatible. The tests show compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-8, IEC 62304, ISO 10993-5, ISO 10993-10, and ISO 80601-2-61.
5.8.2. Clinical Testing
Clinical data were collected to verify the performance accuracy of GA1000 on healthy adult subjects over the range of 70%-100% SpO through controlled induced hypoxia. The data was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Standard.
Over 200 data points were collected for each sensor. The Arms of each sensor is below 3%, compliant with FDA quidance on Pulse Oximeter -Premarket notification submissions [510(k)]: Guidance for Industry and Food and Drug Administration staff, Issued March 4t0, 2013.
Conclusion 5.9.
Based on the clinical data and non-clinical testing summarized in 510(k) submission, the result demonstrates Guardian Angel GA1000 Digital Vital Sign Monitoring System is in compliance with design specifications. applicable standards, and the intended use. Performance test data demonstrate substantial equivalence to the predicate device.