(273 days)
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
This FDA 510(k) summary provides information on the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter, including its acceptance criteria and the studies conducted to demonstrate its performance.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document relies on compliance with recognized standards for its acceptance criteria, particularly ISO 80601-2-61 for pulse oximeter equipment accuracy.
| Performance Metric | Acceptance Criteria (Standard/Range) | Reported Device Performance (MD300W628) |
|---|---|---|
| SpO2 Accuracy | $\text{ARMS} \leq 3.0%$ (standard for pulse oximeters) | $\text{ARMS} = 1.68%$ for SpO2 range 70-100% |
| SpO2 Display Range | Verified according to IEC 60601-1 and ISO 80601-2-61 requirements | $70% \sim 100%$ |
| PR Display Range | Verified according to IEC 60601-1 and ISO 80601-2-61 requirements | $30 \sim 250 \text{bpm}$ |
| PAI Accuracy | $0.3 \sim 1.0% (\pm 0.2 \text{digits})$; $1.1 \sim 20.0% (\pm 20%)$ | Test results available in System Test Report (specific values not detailed in summary) |
| Electrical Safety | Compliance with IEC60601-1, IEC 60601-1-11 | Conformed |
| EMC | Compliance with IEC60601-1-2 | Conformed |
| Biocompatibility | Compliance with ISO10993-1, ISO10993-5, ISO10993-10 | Met standard requirements |
| Software Validation | Compliance with FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices | Compliant (Moderate level of concern) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test (SpO2 Accuracy): 11 healthy adult volunteer subjects.
- Data Provenance: The clinical study was conducted at Yue Bei People's Hospital. The origin is inferred to be China, as Beijing Choice Electronic Technology Co., Ltd. is based in Beijing, China. The study appears to be prospective as it involved recruiting subjects and performing specific tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. It mentions that the clinical study evaluated SpO2 accuracy "as compared to arterial blood CO-Oximetry." CO-Oximetry is the gold standard for measuring arterial oxygen saturation, and its results are considered highly accurate, typically not requiring expert interpretation for ground truth establishment in this context.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given that the ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is an objective measurement, an adjudication method for disagreements on ground truth would generally not be necessary for this specific performance metric.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or of any effect size related to human readers improving with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve multiple human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The SpO2 accuracy performance study described is essentially a standalone performance study. The device's measurement of SpO2 is directly compared to an objective gold standard (arterial blood CO-Oximetry), without human intervention in the interpretation of the device's output. The device itself (algorithm) provides the SpO2 reading.
7. Type of Ground Truth Used
The ground truth used for the SpO2 accuracy testing was arterial blood CO-Oximetry.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. Pulse oximeters typically rely on established optical principles and signal processing algorithms rather than machine learning models that require large training datasets in the same way AI algorithms for image analysis might. The "algorithm" here refers to the signal processing rather than a deep learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of typical machine learning, there is no information on how ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.
November 30, 2023
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality director No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan District Beijing, Beijing 100041 China
Re: K230587
Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 1, 2023 Received: November 1, 2023
Dear Haiying Zhao:
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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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.
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.
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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,
Bradley Q. Quinn -S
Bradley Quinn 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
510(k) Number (if known) K230587
Device Name Wrist Pulse Oximeter
Indications for Use (Describe)
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use 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) |
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510(k) Summary
K230587
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
2.1 Submitter Information
Manufacturer Name: ●
Establishment Registration Number: 3005569927
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
● Contact Person:
Haiying Zhao
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
Phone: +86-10-88204631
Fax: +86-10-88204632
Email: cc@choicemmed.com
Date prepared: February 21, 2023
2.2 Subject Device Information
Regulation Name: Oximeter
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Device Trade/Proprietary Name: Wrist Pulse Oximeter
Model: MD300W628
Purpose of submission: 510 (k)
Regulation Number: 21 CFR 870.2700
Product Code: DQA
Class: II
Panel: Anesthesiology
Intended use:
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
2.3 Predicate Device
510(k) Number: K172366
Regulation Name: Oximeter
Device Trade/Proprietarv Name: Wrist Pulse Oximeter
Model: MD300W314
Product Code: DQA
Regulation Number: 21 CFR 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
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2.4 Device Description
The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The enclosure of the subject device is made of ABS. The contact duration is greater than 30 days.
The Wrist oximeter wristband is made of Silicone Gel. The contact duration is greater than 30 days.
The Probe is made of Silicone Gel. The contact duration is greater than 24 hours and less than 30 days.
The display screen is made of glass. The contact duration is greater than 30 days.
The button is made of Aluminium alloy. The contact duration is greater than 30 days.
The subject device is not for life-supporting or life-sustaining. not for implant.
The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription. The device does not contain drug or biological products.
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2.5 Comparison list of the technological characteristics
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
|---|---|---|---|---|
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | √ | |
| Classification | II | Ⅱ | √ | |
| Regulation Name | Oximeter | Oximeter | √ | |
| Product Code | DQA | DQA | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | ||
| Model | MD300W628 | MD300W314 | ||
| Indications for Use | The MD300W628 Wrist Pulse Oximeter isa portable, non-invasive device intended tomeasure, display, store and transferfunctional oxygen saturation of arterialhemoglobin (%SpO2) and pulse rate (PR)of adult, adolescent and child in hospitals,clinics, long-term care, and home use.The device intended for spot-checking andcan be reused, not intended for continuousmonitoring, use during motion or use withlow perfusion. | MD300W314 is a wrist pulse oximeterindicated for use in measuring,displaying, storing and transmittingfunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate foradult, adolescent, child and infantpatients. It is intended for spot-checkand / or data collection, recording andtransmitting. It can be used in sleep labs,long-term care, hospitals and home use. | Difference 1 | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Design Principle | The Wrist Pulse Oximeter works byapplying a sensor to a pulsating arteriolarvascular bed. The sensor contains a duallight source and photo detector. The onewavelength of light source is 660nm,which is red light; the other is 905nm,which is infrared-red light. Skin, bone,tissue and venous vessels normally absorba constant amount of light over time. Thephoto detector in finger sensor collects andconverts the light into electronic signalwhich is proportional to the light intensity.The arteriolar bed normally pulsates andabsorbs variable amounts of light duringsystole and diastole, as blood volumeincreases and decreases. The ratio of lightabsorbed at systole and diastole istranslated into an oxygen saturationmeasurement. This measurement is | The pulse oximeter works by applying asensor to a pulsating arteriolar vascularbed. The sensor contains a dual lightsource and photo detector. The one | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | ||
| Model | MD300W628 | MD300W314 | ||
| referred to as SpO2. | referred to as SpO2. | |||
| Components | Power supply module, detector and emitterLED, signal collection and processormodule, display module, Bluetoothmodule. | Power supply module, detector and emitterLED, signal collection and processormodule, display module, Bluetoothmodule. | V | |
| The site of application in thebody | Fingers | Fingers | V | |
| MeasurementWavelength | Red | 660±3nm | 660±3nm | V |
| Infrared | 905±10nm | 905±10nm | V | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| PerformanceSpecification | Display Type | OLED | LCD | Difference 2 |
| Power supply | Lithium-ion rechargeable battery | Lithium-ion rechargeable battery | √ | |
| Display Data | SPO2, PR , PAI | SPO2 , PR | Difference 3 | |
| SPO2 | SpO2 Display Range:70%~100%Measurement range: 70%~100%Accuracy: 70%~100%: ±2%; <69%:unspecified. | SpO2 Display Range:0%~100%Measurement range: 70%~100%Accuracy: 70%~100%: ±2%; <69%:unspecified. | Difference 4 | |
| PR | PR Display Range30 | PR Display Range30 | Difference 5 | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Pulse amplitudeindex (PAI) | Display range: 0.1 | NA | Difference 6 | |
| Network | Bluetooth | Bluetooth | √ | |
| WirelessTransmissionRange | 0~10m | 0~10m | √ | |
| Antenna Type | Internal | Internal | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| EnvironmentRequirements | Operating Temperature:5°C~40°CAmbient Humidity:15% | Operating Temperature:5~40°CAmbient Humidity:15% | √ | |
| Enclosure | ABS | ABS | Difference 7 | |
| ContactingMaterial | Wristoximeterwrist belt | Silicone | Silicone | |
| Fingertipsensor | Silicone | Silicone | ||
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Performance Testing | LaboratoryTesting | The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61 | The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61 | √ |
| ElectricalSafety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | √ | |
| Software andCybersecurity | Moderate level of concern | Moderate level of concern | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Compliance with:FDA Guidance for the content ofPremarket Submissions for SoftwareContained in Medical Devices and,FDA Guidance for Content of PremarketSubmission for Management ofCybersecurity in Medical DeviceRisk Management in Compliance withISO14971 | Compliance with:FDA Guidance for the content ofPremarket Submissions for SoftwareContained in Medical Devices and,FDA Guidance for Content of PremarketSubmission for Management ofCybersecurity in Medical DeviceRisk Management in Compliance withISO14971 | |||
| Label andLabeling | Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4,2013 | Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4,2013 | √ |
Table II-1 Performance Specification Comparison Table between the Subject Device and Predicate Device
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
● Difference 1: Indications for Use
The subject device and predicate device have a similar intended use.
Compared with the predicate device, the subject device is not suitable for infants' patients. In addition, the subject device has been verification and the result could meet the requirement of IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 2: Display Type
The subject device has the different display type with the predicate device.
Compared with the predicate device, the subject device is using the OLED display. The varies display type is due to different marked strategy. In addition, the subject device has been verification and validation and the result could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 3: Display Data
The subject device has the different display data with the predicate device.
Compared with the predicate device, the subject device can display PAI value. It will not affect the safety and effectives of subject device. The test results of PAI value see the System Test Report in the Performance Testing for reference.
● Difference 4: SPO2 display range
The subject device has the different SpO2 display range with the predicate device.
Compared with the predicate device, the subject device SpO2 Display Range is 70%-100% which the predicate device is 0%~100%. The SpO2 display range of the subject device was verified according to IEC 60601-1 and ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
● Difference 5: PR display range
The subject device has the different PR display range with the predicate device.
Compared with the predicate device, the subject device PR Display Range is 30250bpm which the predicate device is 30255bpm. The PR display range of the subject device was verified according to IEC 60601-1 and ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device I on safety and effectiveness.
● Difference 6: Pulse amplitude index (PAI)
The subject can display PAI test value, but predicate device cannot display this value. It will not affect the safety and effectives of subject device. The test results see the System Test Report in the Performance Testing.
● Difference 7: Contacting Material
The contact material of subject device is similar with the predicate device, but the supplier of the material is different. Therefore, the contact materials of the subject device and predicate device are considered to be different. All of the contact materials of the proposed device have been done the biocompatibility test per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safety and effectiveness.
2.6 Testing
The Wrist Pulse Oximeter MD300W628 was supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test
The Wrist Pulse Oximeter MD300W628 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
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Premarket Notification 510(k) Submission—Section II 510(k) Summary
- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical Electrical Equipment Part 1: ● General Requirements for basic safety and essential performance
- . IEC60601-1-11: 2015. AMD1:2020 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.
- IEC60601-1-2:2014, AMD1:2020 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- . ISO80601-2-61:2017 Medical electrical equipment - -- Part - 2-61: -Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
We have also conducted other performance test including SpO2, PR and pulse amplitude index (PAI) accuracy test. Device Output Time and Finger Out Time Test, Device Response Time Test, Weak Perfusion Test, High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].
The Software Validation is in compliance with FDA Guidance to Compliance with FDA
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
| 2 | Performance Test according to ISO 80601-2-61: 2017 |
| 3 | Electromagnetic Compatibility Test According to IEC60601-1-2:2014, AMD1:2020 |
| 4 | Electrical Safety Test According to IEC60601-1: 2005, AMD1:2012, AMD2:2020 |
| 5 | Used in the home healthcare environment test according toIEC60601-1-11: 2015, AMD1:2020 |
Table II-2 The list of non-clinical test performed on the subject devices.
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| Premarket Notification 510(k) Submission—Section II 510(k) Summary | |
|---|---|
| 6 | Bluetooth Wireless Test according to FCC Part 15B and Part 15C |
| 7 | Wireless coexistence testing |
| 8 | Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process ISO10993-1:2018 |
| 9 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO10993-5:2009 |
| 10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization ISO10993-10:2021 |
The test results indicate that the safety and effectiveness of the subject device is identical to that of the predicate device.
Clinical Test
The Clinical Study was conducted at Yue Bei people's Hospital. The study was conducted in accordance to ISO 14155-1, -2, ISO 80601-2-61:2017, and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to evaluate the SpO2 accuracy performance of the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G Sensor. during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. After Institutional Review Board (IRB) approval, 11 healthy adult volunteer subjects (ages 22-44yr, 53-85kg, 152-179cm, with light to dark pigmentation) were included in the study conducted June. 18, 2022 - Aug. 20, 2022 to evaluate the SpO2 accuracy performance of the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G SpO2 Sensor.
The SpO2 accuracy performance results showed the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G SpO2 Sensor to have an ARMS of 1.68 during steady state conditions over the range of 70-100%.
2.7 Determination of substantial equivalence
The subject device of Wrist Pulse Oximeter MD300W628 has the same classification information, same intended use, similar performance effectiveness as the predicated device. The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market 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).