(438 days)
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.
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 provided text is a 510(k) Summary for the Aulisa Oximeter Module (2nd Gen.). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the full study design and results of performance evaluations in the granular detail requested.
However, based on the information provided, here's an attempt to extract the relevant details for the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "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." This is the primary performance claim related to SpO2 accuracy.
| Acceptance Criteria (Metric) | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (ARMS) | Less than 3 digits | Less than 3 digits |
| SpO2 Range for Accuracy | 70-100% | 70-100% |
| Pulse Rate Accuracy | ± 3 digits (or ± 3%) | ± 3 digits (30-290 bpm) or ± 3% (30-290 bpm) |
| Pulse Rate Range for Accuracy | 30-290 bpm | 30-290 bpm |
| Electrical Safety | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Temperature and Humidity | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Atmospheric Pressure (Altitude) | Pass IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | Pass IEC 60601-1-2 | Pass |
| Performance (General) | Pass ISO 80601-2-61 | Pass |
| Mechanical Durability | Pass IEC 60601-1, IEC 60601-1-11 | Pass |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Pass ISO 10993-5, ISO 10993-10, ISO 10993-23 | Pass |
| Software V&V | Pass FDA Guidance | Pass |
| Security Testing | Pass FDA Guidance | Pass |
| Wireless Coexistence Testing | Pass ANSI C63.27 | Pass |
| Clinical Testing (General) | Pass FDA Guidance | Pass |
| Usability Testing | Pass FDA Guidance | Pass |
| Bench Testing | Pass Manufacturer's specifications | Pass |
| Durability and Performance | Pass Manufacturer's specifications | Pass |
| Battery Life Testing | Pass Manufacturer's specifications | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document only states "The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects." It does not specify the number of subjects (sample size).
- Data Provenance: The document does not explicitly state the country of origin. It describes the test as a "clinical evaluation," implying a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an oximeter, "ground truth" for SpO2 is typically established by arterial blood gas analysis, which does not involve experts in the same way as, for example, image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as the "ground truth" for SpO2 accuracy in oximetry is typically established by a direct comparison to a reference standard (e.g., co-oximetry of arterial blood samples), not by expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The Aulisa Oximeter Module is a device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic tool that requires human readers for interpretation. Its performance is evaluated against reference standards, not human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the SpO2 accuracy evaluation (against ISO 80601-2-61 and FDA Guidance) would be considered a standalone performance test of the device's ability to measure SpO2. The device directly measures and outputs these values, so its performance is inherently "standalone."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for SpO2 accuracy in oximetry studies is typically established using arterial blood gas analysis (specifically, co-oximetry) as the reference standard, allowing for precise measurement of arterial oxygen saturation. This is implied by the reference to ISO 80601-2-61, which outlines these methodologies.
8. The sample size for the training set
This information is not applicable/provided. This device is a hardware oximeter module that directly measures physiological signals and processes them to derive SpO2 and pulse rate. It does not appear to involve a machine learning model that would require a separate "training set" in the common sense of AI/ML development. Its "training" would be more akin to calibration and algorithm refinement based on engineering principles and physiological models.
9. How the ground truth for the training set was established
As per point 8, this is not applicable.
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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"
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(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).
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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
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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)
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Section 5: 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
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 TWTEL.: +886-2-2655-7297FAX: +886-2-2655-7260 |
| Contact Person | Show HsiaoRegulatory Affairs Assistant ManagerTaiwan 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.
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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 OximeterModule (2nd Gen.)(GA-OM0007) | Oximeter Box(GA-OB0003) | Adult ReusableOximeter SensorCable(GA-RS0005) | Adult | • SpO2• Pulse Rate |
| Aulisa OximeterModule (2nd Gen.)(GA-OM0008) | Oximeter Box(GA-OB0003) | Pediatric ReusableOximeter SensorCable(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
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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.
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Table 5.7.1
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
|---|---|---|---|---|
| Device name | Aulisa Oximeter Module(2nd Gen.) | Guardian Angel GA1000 DigitalVital Sign Monitoring System | Guardian Angel Rx GA2000 SeriesDigital Vital Sign Monitoring System | |
| Model number | GA-OM0007, GA-OM0008 | GA1000 | GA2000 | |
| K number | - | K162580 | K203208 | |
| Manufacturer | Taiwan Aulisa MedicalDevices Technologies, Inc. | Taiwan Aulisa Medical DevicesTechnologies, Inc. | Taiwan Aulisa Medical DevicesTechnologies, Inc. | Identical |
| RegulationNumber | 870.2700 | 870.2700 | 870.2700 | Identical |
| Product Code | DQA | DQA | DQA | Identical |
| Classification | II | II | II | Identical |
| Indications foruse | The Aulisa OximeterModule (2nd Gen.) isindicated for spot-checkingand/or continuousmonitoring SpO2 and pulserate of adult and pediatricpatients during non-motionand under well-perfusedconditions in hospitals,medical facilities, homecare, and subacuteenvironments. Theparameters derived by theAulisa Oximeter Module(2nd Gen.) are transmittedto a commercially availablemobile device that runs anAulisa developed | The Guardian Angel GA1000Digital Vital Sign MonitoringSystem is indicated for use inmeasuring and displayingfunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate of adult and pediatricpatients. It is indicated for spot-checking and / or continuousmonitoring of patients duringnon-motion and under Well-perfused conditions. Theintended environment of use ishospital. This system is areusable device. | The Guardian Angel Rx GA2000Series Digital Vital Sign MonitoringSystem (Model GA2000) is indicatedfor use in measuring, recording, anddisplaying functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR). Theintended environments of use arehospitals, medical facilities, homecare, and subacute environments. Thissystem is a reusable device.The Oximeter Module(s) is indicatedfor spot-checking and/or continuousmonitoring of SpO2 and PR of adultsand pediatrics during non-motion andunder well-perfused conditions. | Similar,The primary predicate deviceis indicated for use only inhospital while both subjectdevice and secondary predicatedevice are indicated for use inhospitals, medical facilities,home care, and subacuteenvironments |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| application for display andreview. | ||||
| Patientpopulation | adult, pediatric | adult, pediatric | adult, pediatric | Identical |
| Useenvironment | hospitals, medical facilities,home care, subacuteenvironments | hospital | hospitals, medical facilities, homecare, subacute environments | Similar,The primary predicate deviceis indicated for use only inhospital while both subjectdevice and secondary predicatedevice are indicated for use inhospitals, medical facilities,home care, and subacuteenvironments |
| Measurement | Pulse rate, SpO2 | Pulse rate, SpO2 | Pulse rate, SpO2 | Identical |
| Disposable orreusable | reusable | reusable | reusable/ disposable | Similar,Both subject device andprimary predicate device areindicated for reuse only, whilethe secondary predicate devicecan be reusable/ disposabledepends on the types of sensorcable |
| Wirelesscommunication | Bluetooth | Bluetooth | BluetoothWi-Fi | Similar,Both subject device andprimary predicate device useBluetooth technology forwireless communication, whilethe 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) contactProlonged contact | Patient contact | Skin (surface) contactProlonged contact | Identical |
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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 60601-1IEC 60601-1-11 | Pass |
| Temperature and Humidity | IEC 60601-1IEC 60601-1-11 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61 | Pass |
| Mechanical Durability | IEC 60601-1IEC 60601-1-11 | Pass |
| Biocompatibility:• In Vitro Cytotoxicity• Skin Sensitization• Skin Irritation | ISO 10993-5ISO 10993-10ISO 10993-23 | Pass |
| Software V&V | FDA GuidanceGuidance for the Content of Premarket Submissions forDevice Software Functions | Pass |
| Security Testing | FDA GuidanceCybersecurity in Medical Devices, Quality SystemConsiderations and Content of Premarket Submissions | Pass |
| Wireless Coexistence Testing | ANSI C63.27 | Pass |
| Clinical testing | FDA GuidancePulse Oximeters - Premarket Notification Submissions[510(k)s]: Guidance for Industry and Food and DrugAdministration Staff | Pass |
| Usability testing | FDA GuidanceApplying Human Factors and Usability Engineering toMedical Devices | Pass |
| Bench testing | Manufacturer's specifications | Pass |
| Durability and Performance testing | Manufacturer's specifications | Pass |
| Battery Life Testing | Manufacturer's specifications | Pass |
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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.
§ 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).