(379 days)
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
The provided text is a 510(k) summary for the YUWELL® Finger Pulse Oximeter. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter, K101577). The key performance acceptance criteria can be inferred from the comparison table and the clinical study results.
Table of Acceptance Criteria and Reported Device Performance (Inferred from comparison and study results):
| Performance Characteristic | Acceptance Criteria (As per Predicate/Standards) | Reported Device Performance (YUWELL® Finger Pulse Oximeter) |
|---|---|---|
| SpO2 Accuracy (SpO2 Measurement Range) | 70%~100%, ± 2% (Predicate) | Arms less than 3% during steady states over the range of 70-100% (Clinical Study Result from ISO 80601-2-61) |
| SpO2 Accuracy (Specific Ranges) | 70% | 70%~80%, 80%~90%, 90%~100%, ± 2% (Subject Device listed values); < 70%, no definition |
| SpO2 Display Range | 0%~100% (Predicate) | 0%~100% |
| SpO2 Resolution | 1% (Predicate) | 1% |
| PR Accuracy | 30bpm | ±1% or ±1 bpm (larger) |
| PR Display Range | 0bpm~254bpm (Predicate) | 25bpm~250bpm |
| PR Measurement Range | 30bpm~235bpm (Predicate) | 25bpm~250bpm |
| PR Resolution | 1bpm (Predicate) | 1bpm |
| Biocompatibility | Compliance with ISO 10993-1 (Implied) | Cytotoxicity, Irritation, Sensitization tests conducted and met standards. Material evaluated as per ISO 10993-1. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-11 standards met. |
| EMC | Compliance with IEC 60601-1-2 | IEC 60601-1-2 standard met. |
| Software | Compliance with FDA Guidance for Software in Medical Devices (Implied) | Software verification and validation provided, moderate level of concern, work functionally as per FDA guidance. |
| Cleaning Validation | Reprocessing Medical Devices Guidance (Implied) | Cleaning and disinfection validation conducted as recommended by FDA. |
| Environmental Requirements | (Predicate ranges provided, but overall acceptance is through standard compliance) | Verified in accordance with IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61 standards. |
Study Information
The document describes a clinical study to verify the device's accuracy.
-
Sample size used for the test set and the data provenance:
- Sample Size: 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation).
- Data Provenance: The location of the study is not explicitly stated, but the company is based in China. The study was conducted to evaluate SpO2 accuracy during stationary (non-motion) conditions with induced hypoxia. This implies a prospective study design.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This indicates that CO-Oximetry was the ground truth reference.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No information on an adjudication method is provided, as the ground truth was based on a reference medical device (CO-Oximetry) and not expert reader consensus.
-
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:
- No MRMC study was conducted or mentioned. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical study conducted was a standalone performance evaluation of the pulse oximeter's accuracy in measuring SpO2 and pulse rate against a reference standard (CO-Oximetry), without human interpretation as part of the primary measurement.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was arterial blood CO-Oximetry. This is considered the reference standard for blood oxygen saturation measurement.
-
The sample size for the training set:
- The document does not mention a distinct "training set" or sample size for training. This device does not appear to be an AI/machine learning product that requires separate training and test sets in the conventional sense. Its principle is based on established photoelectric oximetry technology (Lambert Beer law, Spectrum Absorption Characteristics). The comparison notes mention that an "experience formula of data process is established taking use of Lambert Beer law according to Spectrum Absorption Characteristics...verified by a large amount of data." However, the size or provenance of this data is not detailed as a "training set."
-
How the ground truth for the training set was established:
- Since a formal "training set" for an AI model is not explicitly described, the method for establishing ground truth for such a set is also not provided. The phrase "verified by a large amount of data" suggests historical data or internal validation, but no specifics are given.
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August 16, 2022
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Yuzhuo Wang Medical Device Registered Engineer Yunyang Industrial Park Danyang, Jiangsu 212300 China
Re: K212385
Trade/Device Name: YUWELL Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2022 Received: July 18, 2022
Dear Yuzhuo Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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).
Sincerely,
for Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212385
Device Name
YUWELL® Finger Pulse Oximeter: YX102, YX103, YX301, YX306
Indications for Use (Describe)
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
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.
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510(K) SUMMARY
1. OWNER/SUBMITTER'S INFORMATION
| Company Name: | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLYCO.,LTD. |
|---|---|
| Company Address: | Yunyang Industrial Park 212300 Danyang Jiangsu PEOPLE'SREPUBLIC OF CHINA |
| Contact: | Wang, Yuzhuo |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | wang.yz@yuyue.com.cn |
| Date prepared: | July 12, 2022 |
2. TRADE NAME, COMMON NAME, CLASSIFICATION
| Trade Name: | YUWELL® Finger Pulse Oximeter |
|---|---|
| Common Name: | Finger Pulse Oximeter |
| Model: | YX102, YX103, YX301, YX306 |
| Product Code : | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K212385 |
3. DENTIFICATION OF PREDICATE DEVICE(S)
The identification of predicates within this submission is as follow:
| Manufacturer: | Beijing Choice Electronic Technology Co., Ltd. |
|---|---|
| Trade Name: | Fingertip Pulse Oximeter |
| Common Name: | Pulse Oximeter |
| Product Code: | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K101577 |
4、DESCRIPTION OF THE DEVICE
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.
The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured
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value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button
(YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
5、INTENDED USE
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.
6、TECHNOLOGICAL CHARACTERISTIC
Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer law according to Spectrum Absorption Characteristics of deoxyhaemoglobin (HHb) and Oxyhemoglobin (O2Hb ) in glow and near-infrared zones. Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of light (red light and infrared light) can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown display through process in electronic circuits and microprocessor.
| Description | Subject Device(K212385) | Predicate Device(K101577) | Remark |
|---|---|---|---|
| Manufacturer | JIANGSU YUYUE MEDICALEQUIPMENT & SUPPLYCO.,LTD. | Beijing Choice ElectronicTechnology Co., Ltd. | - |
| Product Name | Finger Pulse Oximeter | Fingertip Pulse Oximeter | - |
| Model | YX102,YX103,YX301,YX306 | MD300C63 | - |
| Intended Use | The YUWELL® Finger PulseOximeter is a non-invasive, non-sterile, reusable, spot checkingdevice which can measure anddisplay SpO2 and pulse ratethrough finger. It is intended foradults and children (weight >30kg) and is expected for homeand hospital inspection. Thedevice is not for continuousmonitoring, use during motion orfor patients with low perfusion. | Fingertip pulse oximeter is aportable, non-invasive devicesintended for spot- checking ofarterial hemoglobin oxygensaturation (SpO2) and pulserate of adult and pediatricpatient at home, and hospital(including clinical use ininternist/surgery, Anesthesia,and intensive care units). Notfor continuous monitoring. | Note 1 |
| Patient populations | adults and children (weight >30kg) | adult and pediatric patient | Note 1 |
| Measuringcharacteristics | Spot-checkingNot for continuous monitoring,use during motion or for patientswith low perfusion. | Spot-checkingNot for continuousmonitoring, using duringmotion or using with lowperfusion. | Same |
| Application sites | Finger | Finger | Same |
| Components | Power supply module, detectorand emitter LED, signal collectionand processor module, displaymodule. | Detector and emitter LED,signal amplify unit, CPU, datadisplay unit and power unit. | Same |
| Product principle | An experience formula of dataprocess is established taking useof Lambert Beer law according toSpectrum AbsorptionCharacteristics ofdeoxyhaemoglobin(HHb) andOxyhemoglobin(O2Hb) in glowand near-infrared zones. Operationprinciple of the instrument isPhotoelectric OxyhemoglobinInspection Technology is adoptedin accordance with Capacity PulseScanning and RecordingTechnology, so that two beams ofdifferent wavelength of light (redlight and infrared light) can befocused onto human nail tipthrough perspective clamp finger-type sensor. Then measured signalcan be obtained by aphotosensitive element,information acquired throughwhich will be shown displaythrough process in electroniccircuits and microprocessor. | An mathematical formula isestablished making use ofLambert Beer Law accordingto Spectrum AbsorptionCharacteristics of Reductivehemoglobin (RHb) andOxyhemoglobin (HbO2 ) inglow and near-infrared zones.Operation principle of theinstrument: PhotoelectricOxyhemoglobin InspectionTechnology is adopted inaccordance with CapacityPulse Scanning and RecordingTechnology, so that two beamsof different wavelength oflight (660nm glow and 940nmnear infrared light) can befocused onto a human nail tipthrough a clamping finger-type sensor. A measured signalobtained by a photosensitiveelement, will be shown on theoximerer's display throughprocess in electronic circuitsand microprocessor. | Same |
| Measurementwavelength Red | YX102, YX103, YX306:660 ±8nm | 660± 2nm | Note 2 |
| light | YX301: 660 ± 20nm | ||
| Measurementwavelength-Infraredlight | YX102, YX103, YX306: 905 ± 25nm | 940± 10nm | |
| YX301: 940 ± 25nm | |||
| Display Type | YX102, YX103: LED | Note 3 | |
| YX301, YX306: OLED | OLED | Same | |
| Power Supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | Same |
| Battery WorkingTime | YX102, YX103, YX306: Two AAA batteries can be operated continuously for 17 hours | Two AAA alkaline batteries can be operated continuously for 30 hours. | Note 4 |
| YX301: Two AAA batteries can be operated continuously for 45 hours | |||
| Display Content | YX102, YX103: SpO2, PR, Pulse bar, Low battery | SpO2, PR, Power low indicator, Pulse bar graph, Waveform | Note 5 |
| YX301, YX306: SpO2, PR, Pulse volume wave, Pulse bar, Battery level, Symbol of gravity sensing mode | |||
| User Interface | YX102, YX103: 1 display direction | 4 display directions | Note 6 |
| YX301, YX306: 4 display directions | Same | ||
| SpO2 Display Range | 0%~100% | 0~100% | |
| SpO2 MeasurementRange | 70%~100% | 70%~100% | Same |
| SpO2Accuracy | 70%~80%, 80%~90%,90%~100%, ± 2%;< 70%, no definition | 70% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| PR Display Range | 25bpm~250bpm | 0bpm~254bpm | |
| PR MeasurementRange | 25bpm~250bpm | 30bpm~235bpm | Note 7 |
| PR Accuracy | ±1% or ±1 bpm(larger) | 30bpm | |
| PR Resolution | 1bpm | 1bpm | Same |
| Sterile | No | No | Same |
| Operationenvironment | Ambient temperature:5°C | Operation Temperature:5°C ~40°CAmbient Humidity: ≤80% nocondensation in operation;Atmospheric pressure: Notmentioned | Note 8 |
| Storage & Transportenvironment | Ambient temperature:-20°C~+55°C;Relative humidity: ≤93%, nocondensation ;Atmospheric pressure:500hPa~1060hPa. | Storage Temperature:-20°C~+55°C:Ambient Humidity: ≤93% nocondensation in storage;Atmospheric pressure: Notmentioned | |
| Contactingmaterial | Enclosure: ABS | Enclosure: ABS | Same |
| Fingertip Cushion: MedicalSilicone Gel | Fingertip Cushion andButton : Medical Silicone Gel | Same | |
| YX301 Button: PC | Note 9 | ||
| YX102, YX103 Button: NoneYX306 Button: ABS | |||
| Performance | ISO 80601-2-61 | ISO 9919 | Note 10 |
| Electrical Safety | IEC 60601-1IEC 60601-1-11 | IEC 60601-1Not mentioned in IEC 60601-1-11 | Note 11 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
7、SUBSTANTIAL EQUIVALENCE
Comparison of technological characteristics
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K212385
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K212385
Analysis:
Note 1: The intended user, use place and measuring mode of the subject device and predicate device are the same. The difference is that the specific use places of the hospital is listed in the predicate device. The intended use of the subject device and the predicate device are substantially equivalent. Note 2: According to the principle of the product, red light and infrared light of different wavelengths are used to calculate the oxygen saturation measurement value through a fitting curve verified by a large amount of data. The performance of the subject equipment based on the selected wavelength and the determined fitting curve conforms to the standard ISO 80601-2-61 and FDA Guidance: Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff. Therefore, the difference in light of wavelength will not affect the substantial equivalence.
Note 3: Different from the OLED display type of the predicate device, the products of the YX102 and YX103 models are LED display types. Different display type will influence many aspects, such as working time, current, etc. However, the differences will not affect the substantial equivalence of the subject device.
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Note 4: Battery working time is related to the consumption of electronic components. Different power consumption will lead to different working hours, but the working time is sufficient to meet the needs of use. So, the differences will not affect the substantial equivalence of the subject device. Note 5: Whether it is pulse bar graph or waveform, it is a way of normalizing the original data; Symbol of gravity sensing mode represents the viewing direction of the current display interface. The display content depends on the display module, which is independent of data collection and data processing. Therefore, the difference in display content will not affect the accuracy and stability of the product data, and does not affect the substantial equivalence.
Note 6: Compared with the predicate device. YX102 and YX103 cannot change its display directions because of its display method, so there is only one display direction. But it does not affect the accuracy and stability of the product data.
Note 7: The pulse rate display range, measurement range and accuracy of the subject device is different from the predicate device. But the subject device with the claimed range and accuracy according to bench test report.
Note 8: There is a difference in atmospheric pressure and Relative humidity between the subject device and the predicate. But the subject device has been verified for environmental requirements in accordance with IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61 standards. Therefore, the subject device is confirmed to be as safe and as effective as the predicate.
Note 9: The button material of YX301, YX306 and MD300C63 are PC, ABS and medical silicone gel respectively. The material of the power button does not affect the function and performance of the product. And all the materials of the subject device have been evaluated in accordance with ISO 10993-1. Therefore, the difference in button materials will not affect the substantial equivalence.
Note 10: The ISO 80601-2-61 cancels and replaces the ISO 9919. Subject product meets current standards. So, the subject device is confirmed to be as safe and as effective as the predicate.
Note 11: The subject device can be used in a home environment. Therefore, the test was carried out according to the IEC 60601-1-11, and the results showed that the requirements were met, indicating that this difference would not affect the substantial equivalence of the subject device.
8、PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Software
Software verification and validation were provided in compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices. These verification and validations demonstrate that the subject device work functionally and the software for the device is considered as a "moderate" level of concern, as defined by the FDA guidance.
Biocompatibility testing
The biocompatibility evaluation for the YUWELL® Finger Pulse Oximeter was conducted in accordance with the FDA for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a risk management process". The biocompatibility testing included the following tests:
Cytotoxicity
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Irritation Sensitization
Cleaning Validation
Cleaning and disinfection validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling''.
Non-clinical data
The Pulse Oximeter has been tested according to the following standards:
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility Requirements and tests
) IEC 60601-1-11: 2015. Medical electrical equipment- Part 1-11: General requirements for basic safety and essential performance- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
FDA Guidance for Pulse Oximeters - Premarket Notification Submissions [510(k)s].
Clinical Study
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the required cleared Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation) were included in the study conducted to evaluate the SpO2 accuracy performance of proposed devices. Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison. The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms less than 3% during steady state conditions over the range of 70-100%.
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to substantially equivalent to the predicate device.
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9、CONCLUSION
The subject device has similar intended use and performance, equivalence testing standards, and all testing results have come back as positive results or pass for the subject device, which the subject device is as safety and effectiveness as the predicate device.
The subject device is substantial equivalence to the 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).