(412 days)
Not Found
No
The summary describes a standard pulse oximeter with data transmission and alarm functions, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is a vital signs monitor used for spot-checking and continuous monitoring of SpO2 and pulse rate. It does not provide any therapeutic intervention or treatment.
No
The device is described as a monitor for continuous measurement and display of pulse rate and oxygen saturation (SpO2), and while these vital signs can be used in diagnosis, the device itself does not diagnose conditions. Its purpose is to transmit and display data, and to alert caregivers if data falls outside pre-set limits, which is monitoring.
No
The device description explicitly states it includes a "wireless, foot-worn Sensor Module (SM)" which is a hardware component. While it interacts with a software application, the device itself is not solely software.
Based on the provided text, the Aulisa Infant Oximeter Module (2nd Gen.) is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Device Function: The Aulisa Infant Oximeter Module (2nd Gen.) is a non-invasive device that measures physiological parameters (SpO2 and pulse rate) directly from the patient's body (specifically, the foot) using light technology. It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring vital signs of infant patients, not for performing diagnostic tests on biological samples.
Therefore, the Aulisa Infant Oximeter Module (2nd Gen.) falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant 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 (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-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 GA1001 Series Digital Vital Sign Monitoring System (K182822) & 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 flashes LED light 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 an Oximeter Sensor resulting in device configuration and model names as listed below.
Oximeter Module: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
Oximeter Box: Infant Oximeter Box (GA-OB0004)
Oximeter Sensor: Infant Reusable Transmissive Oximeter Sensor (GA-RS0011)
Population: Infant
Parameters: SpO2, Pulse Rate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot
Indicated Patient Age Range
infant
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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: ISO 10993-5 - Pass
- Skin Sensitization: ISO 10993-10 - Pass
- Skin Irritation: 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
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 (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2: Accuracy root-mean-square (ARMS) less than 3 digits (70-100%)
SpO2: +/- 3 digits (70-100%)
PR: +/- 3 digits (30-290 bpm)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
January 30, 2025
Taiwan Aulisa Medical Devices Technologies, Inc. Derow Ma 6F-2, No. 3-1, YuanQu St., Nangang Dist. Taipei City, NA 115603 Taiwan
Re: K233956
Trade/Device Name: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 15, 2024 Received: December 23, 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.
1
y require a new premarket notification are provided in the FDA
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" (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 QS 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 Rule"). 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-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-regulatory
2
assistance/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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
Indications for Use (Describe)
The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant 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)
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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 Infant Oximeter Module (2nd Gen.) (GA-OM0018)
5.3 Regulatory Information
| Regulation Number | Product
Code | Classification Name | Device
Class |
|-------------------|-----------------|---------------------|-----------------|
| 870.2700 | DQA | Oximeter | Class II |
5.4 Predicate Device
Primary Predicate
K182822, Guardian Angel Rx GA1001 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 Descriptions
The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-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 GA1001 Series Digital Vital Sign Monitoring System (K182822) & 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 flashes LED light 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 an Oximeter Sensor resulting in device configuration and model names as listed below.
| Oximeter Module | Oximeter Box | Oximeter Sensor | Population | Parameters |
|---|---|---|---|---|
| Aulisa Infant | ||||
| Oximeter Module | ||||
| (2nd Gen.) | ||||
| (GA-OM0018) | Infant Oximeter Box | |||
| (GA-OB0004) | Infant Reusable | |||
| Transmissive | ||||
| Oximeter Sensor | ||||
| (GA-RS0011) | Infant | • SpO2 | ||
| • Pulse Rate |
5.6 Indications for Use
The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant 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 as the predicate devices (K182822 & K203208) and all three devices use wireless technology to transmit physiological data to a remote display through the software application and all three devices are used in the same healthcare settings: hospitals, medical facilities, home care, and subacute environments. Additionally, all three devices are indicated for Rx use only.
Further, 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.
Both primary and secondary predicate devices (K182822 & K203208) 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.
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 (K182822 & K203208) for more in detail.
7
| Table 5.7.1 | ||
|---|---|---|
| ------------- | -- | -- |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
|---|---|---|---|---|
| Device name | Aulisa Infant 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-OM0018 | GA1001 | GA2001 | - |
| 510(k) | - | K182822 | 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 Infant Oximeter | |||
| Module (2nd Gen.) is intended to | ||||
| measure SpO2 and pulse rate of | ||||
| infant patients during non- | ||||
| motion and under well-perfused | ||||
| conditions in hospitals, medical | ||||
| facilities, home care, and | ||||
| subacute environments. The | ||||
| parameters derived by Aulisa | ||||
| Infant Oximeter Module (2nd | ||||
| Gen.) are transmitted to a mobile | ||||
| device that runs Aulisa- | ||||
| developed application for | ||||
| displayed and reviewed. | The Guardian Angel Rx | |||
| GA1001 Digital Vital Sign | ||||
| Monitoring System is indicated | ||||
| for use in measuring and | ||||
| displaying functional oxygen | ||||
| saturation of arterial hemoglobin | ||||
| (SpO2) and pulse rate. It is | ||||
| indicated for spot-checking | ||||
| and/or continuous monitoring of | ||||
| pediatrics and infants 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 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 | Identical | |||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Patient | ||||
| population | infant | Pediatrics and infants | pediatric, infant | Similar, |
| Both predicate devices are | ||||
| indicated for pediatric, | ||||
| infant while subject device | ||||
| is indicated for use infant | ||||
| only | ||||
| Use | ||||
| environment | hospitals, medical facilities, | |||
| home care, subacute | ||||
| environments | Hospitals, medical facilities, | |||
| home care, and subacute | ||||
| environments | hospitals, medical facilities, home care, | |||
| subacute environments | Identical | |||
| 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 | ||||
| uses both Bluetooth & Wi- | ||||
| Fi technology for wireless | ||||
| communication | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Measuring site | Foot | Foot | Foot | Identical |
| Out-of-hospital | ||||
| transport | No | No | No | Identical |
| 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 & | ||||
| output power | Red: | |||
| 660 nm | ||||
| Infrared: | ||||
| 905 nm | Red: | |||
| 660 nm @ 9.8 mw | ||||
| Infrared: | ||||
| 880 nm @ 6.5 mw | Red: | |||
| 660 nm @ 9.8 mw | ||||
| Infrared: | ||||
| 880 nm @ 6.5 mw | Similar, | |||
| Both predicate devices use | ||||
| 880 nm for the Infrared, | ||||
| while subject device uses | ||||
| 905 nm for the Infrared | ||||
| Measurement | ||||
| accuracy (No | ||||
| motion) | SpO2: | |||
| ± 3 digits (70-100%) | ||||
| PR: | ||||
| ± 3 digits (30-290 bpm) | SpO2: | |||
| ± 3 digits (70-100%) | ||||
| PR: | ||||
| ± 3 digits (30-300 bpm) | SpO2: | |||
| ± 3 digits (70-100%) | ||||
| PR: | ||||
| ± 3 digits (18-300 bpm) | Identical |
Similar,
Both predicate devices
have the measurement
accuracy range between
30-300 bpm, while the
range of subject device is
30-290 bpm which is
stricter than predicate
devices and does not affect
the safety and
effectiveness of the device |
| Displayed range | SpO2: 1-100%
PR: 30-290 bpm | SpO2: 1-100%
PR: 30-300 bpm | SpO2: 0-100%
PR: 18-300 bpm | Similar,
Both predicate devices
have the measurement |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination |
| Power supply | Lithium battery
AC adaptor (Type C) | Lithium battery
AC adaptor | Lithium battery
AC adaptor | accuracy range between
30-300 bpm, while the
range of subject device is
30-290 bpm which is
stricter than predicate
devices and does not affect
the safety and
effectiveness of the device |
| Biocompatibility | Skin (surface) contact
Prolonged contact | Skin (surface) contact
Prolonged contact | Skin (surface) contact
Prolonged contact | Similar,
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 С
connector. Various testing
has been conducted and
results indicate that does
not affect the safety and
effectiveness of the device |
| | | | | 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.