(204 days)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit. 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. The one wavelength 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 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 and the fingertip cushion is made of Silicone Gel. 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.
Here's a breakdown of the acceptance criteria and the study details for the Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Subject Device MD300C19) |
|---|---|---|
| SpO2 Accuracy | 70%~100%, ±2% | ARMS of 1.5% (over 70-100% SpO2 range) |
| SpO2 Display Range | 0~100% | 0~100% |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Resolution | 1% | 1% |
| PR Display Range | 30bpm~250bpm (Predicate) | 0bpm~255bpm |
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm |
| PR Accuracy | 30bpm | 30bpm |
| PR Resolution | 1bpm | 1bpm |
| Operating Temperature | 5°C~40°C (Predicate) | 0°C~40°C |
| Biological Evaluation | ISO 10993-1, -5, -10 | Compliant (Biocompatibility tests done) |
| Electrical Safety | IEC60601-1, IEC60601-1-11 | Compliant |
| EMC | IEC60601-1-2 | Compliant |
| Software | FDA Guidance for Software in Medical Devices | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 11 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a controlled clinical setting. The specific country of origin is not explicitly stated, but the manufacturer is based in China. The study was prospective in nature, as it involved actively recruiting subjects and conducting measurements to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It states that the ground truth was obtained via "arterial blood CO-Oximetry," which is a laboratory method, not an expert assessment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for the test set. The ground truth was established through a direct objective measurement (arterial blood CO-Oximetry).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the Pulse Oximeter against an objective ground truth, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily assessed the standalone performance of the Pulse Oximeter (algorithm only, as it's a direct measurement device). The reported ARMS value of 1.5% is a measure of the device's accuracy in determining SpO2 levels without human interpretation beyond reading the display.
7. Type of Ground Truth Used
The ground truth used was arterial blood CO-Oximetry. This is considered a gold standard for measuring oxygen saturation in arterial blood.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. Pulse oximeters, particularly those based on established principles like spectrophotometry, often rely on physics-based algorithms and extensive calibration rather than machine learning models requiring large training datasets in the same way AI algorithms do.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth 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.
August 12, 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: K230172
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2023 Received: July 12, 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 (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.
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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 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 (QS) 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 medical devices and radiation-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.
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) K230172
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
| 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 II 510(k) Summary
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 10,2023 ●
2.2 Subject Device Information
Device Trade/Proprietary Name: Pulse Oximeter
Regulation Medical Specialty: Cardiovascular
Device Classification Name: Oximeter
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Premarket Notification 510(k) Submission—Section II 510(k) Summary
Model: MD300C19
Purpose of submission: 510 (k)
Regulation Number: 21 CFR 870.2700
Product Code: DQA
Class: II
Panel: Anesthesiology
2.3 Predicate Device
510(k) Number: K181503 Device Trade/Proprietary Name: Fingertip Pulse Oximeter Regulation Medical Specialty: Cardiovascular Device Classification Name: Oximeter Model: MD300CI218 Product Code: DQA Regulation Number: 21 CFR 870.2700 Device Class: II Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
2.4 Device Description
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection
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Premarket Notification 510(k) Submission—Section II 510(k) Summary
process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit.
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. The one wavelength 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 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 and the fingertip cushion is made of Silicone Gel.
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
Table II-1 Performance Specification Comparison Table between the Subject Device and Predicate Device
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
|---|---|---|---|---|
| Model | MD300C19 | MD300CI218 | - | |
| Item | Pulse Oximeter | Fingertip Pulse Oximeter | - | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | √ | |
| Classification | II | II | √ | |
| Device Classification Name | Oximeter | Oximeter | √ | |
| Product Code | DQA | DQA | √ | |
| Indications for use | The Pulse Oximeter is a handheldnon-invasive device intended forspot-checking of oxygen saturation ofarterial hemoglobin (SpO2) and PulseRate of adult, adolescent child and infantpatients in hospitals, hospital-typefacilities and homecare. The device is not | The Fingertip Pulse OximeterMD300CI218 is a handheldnon-invasive device intended forspot-checking of oxygen saturation ofarterial hemoglobin(SpO2) and Pulse Rate of adult,adolescent, child and infant patients in | Difference | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Model | MD300C19 | MD300CI218 | - | |
| intended for continuous monitoring, useduring motion or use with low perfusion.The device is intended for reuse. Thedevice is wearing on fingertips whileusing | hospitals, hospital-type facilities andhomecare environment. | |||
| Components | Power supply module, detector andemitter LED, signal collection andprocessor module, display module, userinterface and button control. | Power supply module, detector andemitter LED, signal collection andprocessor module, display module,Bluetooth module, user interface andbutton control. | Difference2 | |
| Design Principle | The pulse oximeter works by applying asensor to a fingertip. The sensor containsa dual light source and photo detector.The one wavelength of light source is660nm, which is red light; the other is905nm, which is infrared-red light. Skin,bone, tissue and venous vessels normallyabsorb a constant amount of light over | The fingertip pulse oximeter works byapplying a sensor to a pulsatingarteriolar vascular bed. The sensorcontains a dual light source and photodetector. The one wavelength of lightsource is 660nm, which is red light; theother is 905nm, which is infrared-redlight. Skin, bone, tissue and venous | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Model | MD300C19 | MD300CI218 | - | |
| time. The photo detector in finger sensorcollects and converts the light intoelectronic signal which is proportional tothe light intensity. The arteriolar bednormally pulsates and absorbs variableamounts of light during systole anddiastole, as blood volume increases anddecreases. The ratio of light absorbed atsystole and diastole is translated into anoxygen saturation measurement. Thismeasurement is referred to as SpO2. | vessels normally absorb a constantamount of light over time. The photodetector in finger sensor collects andconverts the light into electronic signalwhich is proportional to the lightintensity. The arteriolar bed normallypulsates and absorbs variable amountsof light during systole and diastole, asblood volume increases and decreases.The ratio of light absorbed at systoleand diastole is translated into an oxygensaturation measurement. Thismeasurement is referred to as SpO2. | |||
| MeasurementWavelength | Red | $660\pm3$ nm | $660\pm3$ nm | √ |
| Infrared | $905\pm10$ nm | $905\pm10$ nm | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Performance Specification | Model | MD300C19 | MD300CI218 | - |
| Display Type | LED | OLED | Difference3 | |
| User Interface | 2 display directions | 2 display directions | √ | |
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | √ | |
| Display Data | SpO2, PR | SpO2, PR | √ | |
| SpO2 DisplayRange | 0~100% | 0~100% | - | |
| SpO2MeasurementRange | 70%~100% | 70%~100% | √ | |
| SpO2 Accuracy | 70% | 70% | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Model | MD300C19 | MD300CI218 | - | |
| SpO2Resolution | 1% | 1% | √ | |
| PR DisplayRange | 0bpm~255bpm | 30bpm~250bpm | Difference4 | |
| PRMeasurementRange | 30bpm~250bpm | 30bpm~250bpm | √ | |
| PR Accuracy | 30bpm | 30bpm | √ | |
| PR Resolution | 1bpm | 1bpm | √ | |
| Transmitter | NA | Bluetooth Compliance:Version 4.0 | Difference5 | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Model | MD300C19 | MD300CI218 | - | |
| Environment | OperatingTemperature | 0°C~40°C | 5°C~40°C | |
| Storage/Transporttemperature | -25°C~+70°C | -25°C~+70°C | Difference6 | |
| RelativeHumidity | 15%~93% no condensation in operation;≤93% no condensation instorage/transport | 15%~93% no condensation inoperation;≤93% no condensation instorage/transport | ||
| AtmospherePressure | 70kPa~106kPa | 70kPa~106kPa | ||
| ContactingMaterial | Battery Cover | ABS | ABS | √ |
| Enclosure | ABS | ABS | √ | |
| Lens | PMMA | PMMA | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar orDifferent | |
| Model | MD300C19 | MD300CI218 | - | |
| Button | Silica gel pad | ABS | Difference 7 | |
| FingertipCushion | Silica gel pad | Silica gel pad | √ | |
| Testing | LaboratoryTesting | ISO 80601-2-61 | ISO 80601-2-61 | √ |
| Electrical Safety | Conformed to IEC60601-1, IEC60601-1-11 | Conformed to IEC60601-1, IEC60601-1-11 | √ | |
| ElectromagneticCompatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | √ | |
| Software | Compliance with FDA Guidance for thecontent of Premarket Submissions forSoftware Contained in Medical Devices | Compliance with FDA Guidance for thecontent of Premarket Submissions forSoftware Contained in Medical Devices | √ | |
| Label and Labeling | Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4 2013 | Compliance with the Guidance of pulseoximeter-premarket notification issuedon March 4,2013 | √ |
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
Difference 1: Indications for use ●
Compared with the intended use of predicate device, the subject device increases the description of the application location, application conditions and use frequency. The subject device has been verification and validation and the results 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 2: Components
The components of subject device are similar with predicate device but it does not have the Bluetooth module. The Bluetooth module is the independent module that does not affect other function of device. In addition, the subject device has been verification and validation and the results 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 Type
The subject device has the different display type with the predicate device. The subject device is configured with the LED display; the predicate 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 4: PR Display Range
The subject device has the different pulse rate display range with the predicate device. The subject device pulse rate display range is Obpm255bpm which the predicate device is 30bpm250bpm. The pulse rate 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: Transmitter ●
The subject device does not have the Bluetooth function which is different from predicate device. The Bluetooth is the independent function module; it will not affect other functions. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 6: Environment
The Operating Temperature of subject device is different with the predicate device and other environment requirements are same. The lower limit operating temperature of subject device is 0℃ which the predicate device is 5℃. However, the operating temperature of subject device has been verification according to standard 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.
● Difference 7: Contacting Material
The contact material of subject device is different with the predicate device. 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 Indications for use
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
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The Pulse Oximeter MD300C19 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 Pulse Oximeter MD300C19 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- 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
- . ISO 10993-1:2018 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
- . ISO10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
We have performance tests per FDA guidance "Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers".
The Software Validation is in compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Compliant to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
Table II-2 The list of non-clinical test performed on the subject 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 |
| 6 | Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process ISO 10993-1:2018 |
| 7 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO10993-5:2009 |
| 8 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization ISO10993-10:2010 |
The test results indicate that the safety and effectiveness of the subject device is substantially equivalent to that of the predicate device.
Clinical Test
The clinical study was conducted in accordance to ISO 14155-1, -2, ISO80601-2-61:2017, 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. MD300C19 Pulse Oximeter 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. MD300C19 Pulse Oximeter.
The SpO2 accuracy performance results showed the Beijing Choice Electronic Technology Co., Ltd. MD300C19 Pulse Oximeter to have an ARMS of 1.5 during steady state conditions over the range of 70-100%.
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Premarket Notification 510(k) Submission—Section II 510(k) Summary 2.8 Determination of substantial equivalence
The subject device of Pulse Oximeter MD300C19 has the same classification information, same intended use, similar components, same 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).