(412 days)
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.
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.
The provided text describes the acceptance criteria and performance study for the Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (No motion, 70-100%) | ± 3 digits |
| Pulse Rate Accuracy (No motion) | ± 3 digits (30-290 bpm) |
| Electrical Safety | Pass (IEC 60601-1, IEC 60601-1-11) |
| Temperature and Humidity | Pass (IEC 60601-1, IEC 60601-1-11) |
| Atmospheric Pressure (Altitude) | Pass (IEC 60601-1) |
| Electromagnetic Immunity and Emissions | Pass (IEC 60601-1-2) |
| Performance (Pulse Oximeter Standard) | Pass (ISO 80601-2-61) |
| Mechanical Durability | Pass (IEC 60601-1, IEC 60601-1-11) |
| Biocompatibility | Pass (Skin contact: ISO 10993-5, ISO 10993-10, ISO 10993-23) |
| Software V&V | Pass (FDA Guidance) |
| Security Testing | Pass (FDA Guidance) |
| Wireless Coexistence Testing | Pass (ANSI C63.27) |
| Clinical Testing (Pulse Oximeters) | Pass (FDA Guidance) |
| Usability Testing | Pass (FDA Guidance) |
| Bench Testing | Pass (Manufacturer's specifications) |
| Durability and Performance Testing | Pass (Manufacturer's specifications) |
| Battery Life Testing | Pass (Manufacturer's specifications) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact number of subjects used in the clinical evaluation. It mentions "healthy male and female, light to dark skinned subjects."
- Data Provenance: The study was a clinical evaluation conducted on human subjects. The details on the specific country of origin are not provided, but it pertains to the validation of a device manufactured by "Taiwan Aulisa Medical Devices Technologies, Inc." The study is prospective in nature, as it is a "clinical evaluation for SpO2 accuracy was conducted on healthy male and female..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts establishing ground truth for the test set or their qualifications. The clinical evaluation describes measuring SpO2 and pulse rate on subjects, which implies comparison against a reference oximeter or arterial blood gas measurements, but doesn't detail the expert review process for ground truth.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary clinical testing described is a standalone performance evaluation of the device's SpO2 accuracy against a reference method (likely arterial blood gas measurements, standard for pulse oximeter accuracy testing per ISO 80601-2-61), without a human-in-the-loop aspect being assessed. The device itself automatically measures and transmits data.
7. The type of ground truth used
The ground truth for SpO2 accuracy in the clinical evaluation was established by comparing the device's measurements against a reference method, typically arterial blood gas measurements (which are the gold standard for SpO2 calibration and accuracy testing in pulse oximetry, as implied by compliance with ISO 80601-2-61). The reported metric is Accuracy root-mean-square (ARMS).
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. For pulse oximeters, the development and verification typically involve laboratory calibration and then human clinical studies for validation. If any internal model training occurred, those details are not provided in this 510(k) summary.
9. How the ground truth for the training set was established
As no specific training set is mentioned for data-driven model training, the method for establishing its ground truth is not applicable or provided in this document. The device's performance is validated through clinical evaluation in accordance with established standards for pulse oximeters.
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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.
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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
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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
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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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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 Infant Oximeter Module (2nd Gen.) (GA-OM0018)
5.3 Regulatory Information
| Regulation Number | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|
| 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.
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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 InfantOximeter Module(2nd Gen.)(GA-OM0018) | Infant Oximeter Box(GA-OB0004) | Infant ReusableTransmissiveOximeter 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
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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.
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| 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 DigitalVital Sign Monitoring System | Guardian Angel Rx GA2000 SeriesDigital Vital Sign Monitoring System | - |
| Model number | GA-OM0018 | GA1001 | GA2001 | - |
| 510(k) | - | K182822 | K203208 | - |
| Manufacturer | Taiwan Aulisa Medical DevicesTechnologies, 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 Infant OximeterModule (2nd Gen.) is intended tomeasure SpO2 and pulse rate ofinfant patients during non-motion and under well-perfusedconditions in hospitals, medicalfacilities, home care, andsubacute environments. Theparameters derived by AulisaInfant Oximeter Module (2ndGen.) are transmitted to a mobiledevice that runs Aulisa-developed application fordisplayed and reviewed. | The Guardian Angel RxGA1001 Digital Vital SignMonitoring System is indicatedfor use in measuring anddisplaying functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate. It isindicated for spot-checkingand/or continuous monitoring ofpediatrics and infants duringnon-motion and under well-perfused conditions. Theintended environments of use arehospitals, medical facilities,home care, and subacuteenvironments. This system is areusable device | The Guardian Angel Rx GA2000Series Digital Vital Sign MonitoringSystem (Model GA2001) is indicatedfor use in measuring, recording, anddisplaying functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR). Theintended environments of use arehospitals, medical facilities, home care,and subacute environments. Thissystem is a reusable device.The Oximeter Module(s) is indicatedfor spot-checking and/or continuousmonitoring of SpO2 and PR ofpediatrics and infants during non-motion and under well-perfusedconditions | Identical |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Patientpopulation | infant | Pediatrics and infants | pediatric, infant | Similar,Both predicate devices areindicated for pediatric,infant while subject deviceis indicated for use infantonly |
| Useenvironment | hospitals, medical facilities,home care, subacuteenvironments | Hospitals, medical facilities,home care, and subacuteenvironments | hospitals, medical facilities, home care,subacute environments | Identical |
| Measurement | Pulse rate, SpO2 | Pulse rate, SpO2 | Pulse rate, SpO2 | Identical |
| Disposable orreusable | reusable | reusable | reusable/ disposable | Similar,Both subject device andprimary predicate deviceare indicated for reuseonly, while the secondarypredicate device can bereusable/ disposabledepends on the types ofsensor cable |
| Wirelesscommunication | Bluetooth | Bluetooth | BluetoothWi-Fi | Similar,Both subject device andprimary predicate deviceuse Bluetooth technologyfor wirelesscommunication, while thesecondary predicate deviceuses both Bluetooth & Wi-Fi technology for wirelesscommunication |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Measuring site | Foot | Foot | Foot | Identical |
| Out-of-hospitaltransport | 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 nmInfrared:905 nm | Red:660 nm @ 9.8 mwInfrared:880 nm @ 6.5 mw | Red:660 nm @ 9.8 mwInfrared:880 nm @ 6.5 mw | Similar,Both predicate devices use880 nm for the Infrared,while subject device uses905 nm for the Infrared |
| Measurementaccuracy (Nomotion) | 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) | IdenticalSimilar,Both predicate deviceshave the measurementaccuracy range between30-300 bpm, while therange of subject device is30-290 bpm which isstricter than predicatedevices and does not affectthe safety andeffectiveness 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 deviceshave the measurement |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | SE determination | |
| Power supply | Lithium batteryAC adaptor (Type C) | Lithium batteryAC adaptor | Lithium batteryAC adaptor | accuracy range between30-300 bpm, while therange of subject device is30-290 bpm which isstricter than predicatedevices and does not affectthe safety andeffectiveness of the device |
| Biocompatibility | Skin (surface) contactProlonged contact | Skin (surface) contactProlonged contact | Skin (surface) contactProlonged contact | Similar,Both predicate devices usea charging case forconnecting to a chargingadaptor, while the subjectdevice connect to acharging adaptor directlythrough a Type Сconnector. Various testinghas been conducted andresults indicate that doesnot affect the safety andeffectiveness of the device |
| 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).