(438 days)
No
The summary describes a standard pulse oximeter that measures SpO2 and pulse rate using established non-invasive technology and transmits data via Bluetooth. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an oximeter module used for monitoring SpO2 and pulse rate, which supports diagnosis but does not provide therapy or treatment.
Yes
Explanation: The device measures SpO2 and pulse rate for monitoring patients, which directly aids in assessing a patient's health status, a core function of diagnostic tools.
No
The device description clearly states it is a "wireless, wrist-worn Sensor Module (SM)" that uses "non-invasive red and infrared technology" and has a "backlight of the vital sign will turn to RED colour as a visual alarm signal". These are hardware components, not solely software.
Based on the provided information, the Aulisa Oximeter Module (2nd Gen.) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the living body (in vitro).
- Aulisa Oximeter Function: The Aulisa Oximeter Module measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using non-invasive technology (red and infrared light). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs of patients, not performing laboratory tests on samples.
- Device Description: The description details a wrist-worn sensor that interacts with a mobile device to display vital signs, not a device for analyzing biological samples.
Therefore, the Aulisa Oximeter Module (2nd Gen.) falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
Product codes
DQA
Device Description
The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver.
The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.
The subject device contains an Oximeter Box and two Oximeter Sensor Cables resulting in device configurations and model names as listed below.
Oximeter Module: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007), Oximeter Box: Oximeter Box (GA-OB0003), Oximeter Sensor: Adult Reusable Oximeter Sensor Cable (GA-RS0005), Population: Adult, Parameters: SpO2, Pulse Rate
Oximeter Module: Aulisa Oximeter Module (2nd Gen.) (GA-OM0008), Oximeter Box: Oximeter Box (GA-OB0003), Oximeter Sensor: Pediatric Reusable Oximeter Sensor Cable (GA-RS0006), Population: Pediatric, Parameters: SpO2, Pulse Rate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
adult and pediatric patients
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
The results of the non-clinical testing demonstrate compliance to applicable standards. Below table summarizes test results for the subject device, which met the relevant requirements of the applicable recognized standards or claimed specifications.
Item: Electrical Safety, Reference: IEC 60601-1, IEC 60601-1-11, Result: Pass
Item: Temperature and Humidity, Reference: IEC 60601-1, IEC 60601-1-11, Result: Pass
Item: Atmospheric Pressure (Altitude), Reference: IEC 60601-1, Result: Pass
Item: Electromagnetic Immunity and Emissions, Reference: IEC 60601-1-2, Result: Pass
Item: Performance, Reference: ISO 80601-2-61, Result: Pass
Item: Mechanical Durability, Reference: IEC 60601-1, IEC 60601-1-11, Result: Pass
Item: Biocompatibility: In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Reference: ISO 10993-5, ISO 10993-10, ISO 10993-23, Result: Pass
Item: Software V&V, Reference: FDA Guidance Guidance for the Content of Premarket Submissions for Device Software Functions, Result: Pass
Item: Security Testing, Reference: FDA Guidance Cybersecurity in Medical Devices, Quality System Considerations and Content of Premarket Submissions, Result: Pass
Item: Wireless Coexistence Testing, Reference: ANSI C63.27, Result: Pass
Item: Clinical testing, Reference: FDA Guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Result: Pass
Item: Usability testing, Reference: FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, Result: Pass
Item: Bench testing, Reference: Manufacturer's specifications, Result: Pass
Item: Durability and Performance testing, Reference: Manufacturer's specifications, Result: Pass
Item: Battery Life Testing, Reference: Manufacturer's specifications, Result: Pass
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 Accuracy root-mean-square (ARMS) and the results which indicated that the subject device had an ARMs 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.
Key Metrics
SpO2 accuracy (No motion): ± 3 digits (70-100%)
PR accuracy (No motion): ± 3 digits (30-290 bpm)
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/0 description: The image shows the date February 25, 2025. The month is February, the day is the 25th, and the year is 2025. The date is written in a clear, legible font. The text is black on a white background.
FDA U.S. FOOD & DRUG
ADMINISTRATION
Taiwan Aulisa Medical Devices Technologies, Inc. Derow Ma Assistant Vice President 6F-2, No. 3-1, YuanQu St., Nangang Dist. Taipei City, 115603 Taiwan
Re: K233963
Trade/Device Name: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 5, 2024 Received: July 5, 2024
Dear Derow Ma:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh-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).
2
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Indications for Use (Describe)
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
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."
4
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 | December 15, 2023 |
|---|---|
| Company Identification | Taiwan Aulisa Medical Devices Technologies, Inc. |
| 6F-2, No. 3-1, YuanQu St., Nangang Dist., | |
| Taipei City 115 TW | |
| TEL.: +886-2-2655-7297 | |
| FAX: +886-2-2655-7260 | |
| Contact Person | Show Hsiao |
| Regulatory Affairs Assistant Manager | |
| Taiwan Aulisa Medical Devices Technologies, Inc. | |
| Email: show.hsiao@aulisa.com |
5.2 Trade/Device Name
Aulisa Oximeter Module (2nd Gen.)
5.3 Regulatory Information
| Regulation Number | Product | Classification Name | Device |
|---|---|---|---|
| Code | Class | ||
| 870.2700 | DQA | Oximeter | Class II |
5.4 Predicate Device
Primary Predicate
K162580, Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.
Secondary Predicate
K203208, Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.
5
ર્સ્ડ Device Description
The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver.
The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.
| Oximeter Module | Oximeter Box | Oximeter Sensor | Population | Parameters |
|---|---|---|---|---|
| Aulisa Oximeter | ||||
| Module (2nd Gen.) | ||||
| (GA-OM0007) | Oximeter Box | |||
| (GA-OB0003) | Adult Reusable | |||
| Oximeter Sensor | ||||
| Cable | ||||
| (GA-RS0005) | Adult | • SpO2 | ||
| • Pulse Rate | ||||
| Aulisa Oximeter | ||||
| Module (2nd Gen.) | ||||
| (GA-OM0008) | Oximeter Box | |||
| (GA-OB0003) | Pediatric Reusable | |||
| Oximeter Sensor | ||||
| Cable | ||||
| (GA-RS0006) | Pediatric | • SpO2 | ||
| • Pulse Rate |
The subject device contains an Oximeter Box and two Oximeter Sensor Cables resulting in device configurations and model names as listed below.
ર્ડ્યુ Indications for Use
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
5.7 Comparison with Predicate Device
6
The subject device has the same indications for use for measuring SpO2 and pulse rate as the predicate devices (K162580 & K203208) with the exception that the primary predicate device is indicated for use only in hospital while both subject device and secondary predicate device are indicated for use in hospitals, medical facilities, home care, and subacute environments and all three devices are for Rx use only. All three devices use wireless technology to transmit physiological data to a remote display through the software application.
Further, all three devices are wearable biosensors that adhere to the fingertip while both subject device and primary predicate device are indicated for reuse only, but the secondary predicate device can be reusable/ disposable depends on the types of sensor cable.
These differences do not affect the safety and effectiveness of the device when used as labelled. Table 5.7.1 lists the similarities and differences between the subject device and the predicate devices (K162580 & K203208) for more in detail.
7
Table 5.7.1
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
|---|---|---|---|---|
| Device name | Aulisa Oximeter Module | |||
| (2nd Gen.) | Guardian Angel GA1000 Digital | |||
| Vital Sign Monitoring System | Guardian Angel Rx GA2000 Series | |||
| Digital Vital Sign Monitoring System | ||||
| Model number | GA-OM0007, GA-OM0008 | GA1000 | GA2000 | |
| K number | - | K162580 | K203208 | |
| Manufacturer | Taiwan Aulisa Medical | |||
| Devices Technologies, Inc. | Taiwan Aulisa Medical Devices | |||
| Technologies, Inc. | Taiwan Aulisa Medical Devices | |||
| Technologies, Inc. | Identical | |||
| Regulation | ||||
| Number | 870.2700 | 870.2700 | 870.2700 | Identical |
| Product Code | DQA | DQA | DQA | Identical |
| Classification | II | II | II | Identical |
| Indications for | ||||
| use | The Aulisa Oximeter | |||
| Module (2nd Gen.) is | ||||
| indicated for spot-checking | ||||
| and/or continuous | ||||
| monitoring SpO2 and pulse | ||||
| rate of adult and pediatric | ||||
| patients during non-motion | ||||
| and under well-perfused | ||||
| conditions in hospitals, | ||||
| medical facilities, home | ||||
| care, and subacute | ||||
| environments. The | ||||
| parameters derived by the | ||||
| Aulisa Oximeter Module | ||||
| (2nd Gen.) are transmitted | ||||
| to a commercially available | ||||
| mobile device that runs an | ||||
| Aulisa developed | 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 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. | Similar, | |||
| The primary predicate device | ||||
| is indicated for use only in | ||||
| hospital while both subject | ||||
| device and secondary predicate | ||||
| device are indicated for use in | ||||
| hospitals, medical facilities, | ||||
| home care, and subacute | ||||
| environments | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| application for display and | ||||
| review. | ||||
| Patient | ||||
| population | adult, pediatric | adult, pediatric | adult, pediatric | Identical |
| Use | ||||
| environment | hospitals, medical facilities, | |||
| home care, subacute | ||||
| environments | hospital | hospitals, medical facilities, home | ||
| care, subacute environments | Similar, | |||
| The primary predicate device | ||||
| is indicated for use only in | ||||
| hospital while both subject | ||||
| device and secondary predicate | ||||
| device are indicated for use in | ||||
| hospitals, medical facilities, | ||||
| home care, and subacute | ||||
| environments | ||||
| Measurement | Pulse rate, SpO2 | Pulse rate, SpO2 | Pulse rate, SpO2 | Identical |
| Disposable or | ||||
| reusable | reusable | reusable | reusable/ disposable | Similar, |
| Both subject device and | ||||
| primary predicate device are | ||||
| indicated for reuse only, while | ||||
| the secondary predicate device | ||||
| can be reusable/ disposable | ||||
| depends on the types of sensor | ||||
| cable | ||||
| Wireless | ||||
| communication | Bluetooth | Bluetooth | Bluetooth | |
| Wi-Fi | Similar, | |||
| Both subject device and | ||||
| primary predicate device use | ||||
| Bluetooth technology for | ||||
| wireless communication, while | ||||
| the secondary predicate device | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| technology for wireless | ||||
| communication | ||||
| Measuring site | Finger | Finger | Finger | Identical |
| Out-of-hospital | No | No | No | Identical |
| transport | ||||
| Motion | Non-motion | Non-motion | Non-motion | Identical |
| Perfusion | Well-perfused | Well-perfused | Well-perfused | Identical |
| Technology | Red and Infrared technology | Red and Infrared technology | Red and Infrared technology | Identical |
| Wavelengths & | Red: | Red: | Red: | Identical |
| output power | 660 nm | 660 nm @ 1.8 mw | 660 nm @ 1.8 mw | Identical |
| Infrared: | Infrared: | Infrared: | Identical | |
| 905 nm | 905 nm @ 2 mw | 905 nm @ 2 mw | Identical | |
| Measurement | SpO2: | SpO2: | SpO2: | Identical |
| accuracy (No | ± 3 digits (70-100%) | 3 digits | ± 3 digits (70-100%) | |
| motion) | PR: | PR: | PR: | Identical |
| ± 3 digits (30-290 bpm) | ± 3% (30-290 bpm) | ± 3% (30-290 bpm) | ||
| Displayed range | SpO2: 1-100% | SpO2: 1-100% | SpO2: 1-100% | Identical |
| PR: 30-290 bpm | PR: 30-290 bpm | PR: 30-290 bpm | ||
| Power supply | Lithium battery | Lithium battery | Lithium battery | Similar, |
| AC adaptor (Type C) | AC adaptor | AC adaptor | Both predicate devices use a | |
| charging case for connecting to | ||||
| a charging adaptor, while the | ||||
| subject device connect to a | ||||
| charging adaptor directly | ||||
| through a Type C connector. | ||||
| Various testing has been | ||||
| conducted and results indicate | ||||
| that does not affect the safety | ||||
| and effectiveness of the device | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Biocompatibility | Skin (surface) contact | |||
| Prolonged contact | Patient contact | Skin (surface) contact | ||
| Prolonged contact | Identical |
8
9
10
11
5.8 Summary of Performance Testing
The results of the non-clinical testing demonstrate compliance to applicable 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 | |
| IEC 60601-1-11 | Pass | |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity and | ||
| Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61 | Pass |
| Mechanical Durability | IEC 60601-1 | |
| IEC 60601-1-11 | Pass | |
| Biocompatibility: | ||
| • In Vitro Cytotoxicity | ||
| • Skin Sensitization | ||
| • Skin Irritation | ISO 10993-5 | |
| ISO 10993-10 | ||
| ISO 10993-23 | Pass | |
| Software V&V | FDA Guidance | |
| Guidance for the Content of Premarket Submissions for | ||
| Device Software Functions | Pass | |
| Security Testing | FDA Guidance | |
| Cybersecurity in Medical Devices, Quality System | ||
| Considerations and Content of Premarket Submissions | Pass | |
| Wireless Coexistence Testing | ANSI C63.27 | Pass |
| Clinical testing | FDA Guidance | |
| Pulse Oximeters - Premarket Notification Submissions | ||
| [510(k)s]: Guidance for Industry and Food and Drug | ||
| Administration Staff | Pass | |
| Usability testing | FDA Guidance | |
| Applying Human Factors and Usability Engineering to | ||
| Medical Devices | Pass | |
| Bench testing | Manufacturer's specifications | Pass |
| Durability and Performance testing | Manufacturer's specifications | Pass |
| Battery Life Testing | Manufacturer's specifications | Pass |
12
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 Accuracy root-mean-square (ARMS) and the results which indicated that the subject device had an ARMs 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.
5.10 Conclusion
Based on the testing summarized in the 510(k) submission, the results demonstrate that the subject device is substantially equivalent to the predicate device. The differences do not raise any questions of safety or effectiveness when compared to its predicate device.