(121 days)
The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.
The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
Principle of the oximeter is as follows:
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. 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 proposed 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.
The device is software-driven and software validation is provided in Section XI Software.
The provided document details the 510(k) submission for the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CN310. It establishes the substantial equivalence of the proposed device to a predicate device (MD300C29-H) and outlines the testing conducted to support this claim.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides performance specifications for SpO2 and Pulse Rate accuracy. Since this is a 510(k) submission primarily focused on substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the new device performs at least as well as the predicate device and meets recognized standards. The reported device performance is listed as identical to the predicate device in terms of these accuracy specifications.
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (MD300CN310) |
|---|---|---|
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Accuracy (70%~100%) | ±2% | ±2% |
| SpO2 Accuracy (0%~69%) | No definition | No definition |
| SpO2 Resolution | 1% | 1% |
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm |
| PR Accuracy (30bpm~99bpm) | ±2bpm | ±2bpm |
| PR Accuracy (100bpm~250bpm) | ±2% | ±2% |
| PR Resolution | 1bpm | 1bpm |
| Operating Temperature | 5°C~40°C | 5°C~40°C |
| Storage/Transport Temperature | -40°C~55°C (predicate) | -25°C~70°C (proposed) - Note: Difference, but implied as acceptable due to SE determination |
| Relative Humidity (Operation) | ≤80% no condensation (predicate) | 15%~93% no condensation |
| Relative Humidity (Storage/Transport) | ≤93% no condensation | ≤93% no condensation |
| Atmosphere Pressure | 86kPa~106kpa | 70kPa~106kPa |
2. Sample size used for the test set and the data provenance
The document mentions "SpO2 and PR accuracy Test" and references ISO 80601-2-61. This standard outlines requirements for clinical testing with human subjects. However, the specific sample size used for the test set is NOT explicitly stated in this document.
The data provenance is implied to be prospective clinical data for the SpO2 and PR accuracy testing, as it states "We have also conducted other performance test including SpO2 and PR Accuracy Test... Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s]". Clinical testing for pulse oximeters involves human subjects whose oxygen saturation is varied, and measurements from the device are compared to reference measurements. The country of origin for the data is not specified, but the manufacturer is based in Beijing, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For a pulse oximeter, the "ground truth" for SpO2 accuracy is typically established by simultaneously measuring arterial oxygen saturation (SaO2) from blood samples analyzed by a co-oximeter, while the subject is varying oxygen levels. It does not involve human experts in the typical sense of radiologists reviewing images. Instead, it relies on highly precise laboratory equipment and trained medical staff for blood sampling and co-oximetry. The document does not specify the number or qualifications of clinicians/technicians involved in conducting such a study.
4. Adjudication method for the test set
Not applicable in the typical sense of expert adjudication for diagnostic imaging or subjective assessments. The "ground truth" for SpO2 and PR accuracy is derived from objective, quantitative measurements (co-oximetry for SaO2 and ECG for heart rate) compared against the device's readings. Discrepancies would be analyzed statistically, not through an adjudication process among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or required for this type of device (a pulse oximeter). MRMC studies are typically used for diagnostic devices that involve human interpretation of complex data (e.g., medical images), often in the context of Artificial Intelligence (AI) assistance. This device is a direct measurement tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the inherent performance of the device's algorithms for calculating SpO2 and Pulse Rate. The "SpO2 and PR Accuracy Test" performed according to ISO 80601-2-61 serves as the standalone performance evaluation. This test directly assesses the device's ability to accurately measure SpO2 and PR against a known reference, without human interpretation influencing the measurement itself.
7. The type of ground truth used
The ground truth used for the SpO2 and PR accuracy testing is implicitly reference measurements from established medical standards. For SpO2, this means arterial blood gas analysis using a co-oximeter (measuring SaO2). For pulse rate, it would typically involve an independent, highly accurate heart rate measurement method, such as an electrocardiogram (ECG). This falls under the category of objective physiological measurements rather than expert consensus or pathology.
8. The sample size for the training set
The document describes the device itself and its testing for regulatory approval. It does not mention any "training set" because this device is a traditional medical measurement device, not an AI/machine learning algorithm that requires a training set. Its algorithms are based on established biophysical principles of light absorption by blood.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2016
Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director North Building 3F No.9 Shuangyuan Road, Badachu Hi-tech Zone Shijingshan District Beijing, 100041 CHINA
Re: K161560
Trade/Device Name: Fingertip Pulse Oximeter MD300CN310 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 25, 2016 Received: August 29, 2016
Dear Lei Chen:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section II Indications for Use Statement
Indications for Use
510(k) Number (if known): K161560
Device Name: Fingertip Pulse Oximeter MD300CN310
Indications for Use:
The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.
| Prescription Use | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is K161560 .
3.1 Submitter Information
● Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104.No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China
● Contact Person:
Mr.Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com
- Date prepared: September 19, 2016
3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CN310 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology
3.3 Predicate Device
510(k) Number: K140682
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Premarket Notification 510(k) Submission-Section III 510(k) Summary
Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C29-H Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.
3.4 Device Description
The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
Principle of the oximeter is as follows:
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. 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 proposed 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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Premarket Notification 510(k) Submission—Section III 510(k) Summary
The device is software-driven and software validation is provided in Section XI Software.
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3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | |
| Model | MD300CN310 | MD300C29-H | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | II | II | |
| Classification Name | Oximeter | Oximeter | |
| Product Code | DQA | DQA | |
| Indications for Use | The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare. | The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital. | |
| Comparison Statement | The proposed device and the predicated device have the same classification and similar intended use. The difference exists that the proposed device can be used in the homecare environment while the predicate device can not. | ||
| Components | detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | |
| Design Principle | The pulse oximeter works by applying a | The pulse oximeter works by applying a | |
| sensor to a pulsating arteriolar vascular bed.The sensor contains a dual light source and | sensor to a pulsating arteriolar vascularbed. The sensor contains a dual light | ||
| photo detector. The one wavelength of light | source and photo detector.The one | ||
| source is 660nm, which is red light; the other | wavelength of light source is 660nm, | ||
| is 905nm, which is infrared-red light. Skin, | which is red light; the other is 905nm, | ||
| bone, tissue and venous vessels normally | which is infrared-red light. Skin, bone, | ||
| absorb a constant amount of light over time. | tissue and venous vessels normally absorb | ||
| The photo detector in finger sensor collects | a constant amount of light over time. The | ||
| and converts the light into electronic signal | photo detector in finger sensor collects and | ||
| which is proportional to the light intensity. | converts the light into electronic signal | ||
| The arteriolar bed normally pulsates and | which is proportional to the light intensity. | ||
| absorbs variable amounts of light during | The arteriolar bed normally pulsates and | ||
| diastole, as bloodsystoleandvolume | absorbs variable amounts of light during | ||
| increases and decreases. The ratio of light | systole and diastole, as blood volume | ||
| absorbed at systole and diastole is translated | increases and decreases. The ratio of light | ||
| into an oxygen saturation measurement. This | absorbedat systole anddiastoleis | ||
| measurement is referred to as SpO2. | into anoxygen saturationtranslated | ||
| isThismeasurement.measurement | |||
| referred to as SpO2. | |||
| Measurement | Red | 660±3nm | 660±3nm |
| Wavelength | Infrared | 905 ± 10nm | 905 ± 8nm |
| Comparison Statementmeasurement wavelength. | The proposed device and the predicate device have the same design principle and | ||
| Display Type | OLED | OLED | |
| Performance Specification | Working Time | Approximately 24 hours of continuous operation | Approximately 25 hours of continuous operation |
| User Interface | 6 display modes | 6 directions for display | |
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | |
| Display Data | SpO2, PR | SpO2 ,PR | |
| SpO2 Display Range | 0%~100% | 35%~100% | |
| SpO2 Measurement Range | 70%~100% | 70%~100% | |
| SpO2 Accuracy | 70% | 70% | |
| SpO2 Resolution | 1% | 1% | |
| PR Display Range | 30bpm~250bpm | 30bpm~250bpm | |
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm | |
| PR Accuracy | 30bpm | 30bpm | |
| PR Resolution | 1% | 1% |
Table 3-1 Performance Specification Comparison Table between the Proposed Device (MD300CN310) and Predicate Device
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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| Premarket Notification 510(k) Submission-Section III 510(k) Summary | ||
|---|---|---|
| --------------------------------------------------------------------- | -- | -- |
| OperatingTemperature | 5°C~40°C | 5°C~40°C | ||
|---|---|---|---|---|
| Storage/Transporttemperature | -25°C~70°C | -40°C~55°C | ||
| RelativeHumidity | 15%~93% no condensation in operation;≤93% no condensation in storage/transport | ≤80% no condensation in operation;≤93% no condensation in storage | ||
| AtmospherePressure | 70kPa~106kpa | 86kPa~106kpa | ||
| The proposed device has similar product specification as predicate device.Comparison Statement | ||||
| ContactingMaterial | Battery Cover | ABS | ABS | |
| Enclosure | ||||
| Fingertip CushionPower Button | Laser Etching Medical Silicone Gel | Laser Etching Medical Silicone Gel | ||
| Comparison Statement | The contacting materials of the proposed device are same to those of the predicatedevice. | |||
| Performance Testing | Laboratory Testing | The laboratory tests include SpO2 and PRaccuracy Test, Weak Perfusion Test, High andLow Temperature and Humidity Test,Performance Test After Cleaning andISO80601-2-61 | Meet the requirements of FDA Guidance | |
| Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1 | ||
| EMCandElectrical Safe | ElectromagneticCompatibility | Conformed to IEC60601-1-2:2014 | Conformed to IEC60601-1-2:2007 | |
| Software | Moderate level of concern | Moderate level of concern | ||
| 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 | |||
| Risk Management in Compliance withISO14971:2007 | Risk Management in Compliance withISO14971:2007 | |||
| Label and Labeling | Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4.2013 | Compliance with FDA guidance |
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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3.6 Intended use
The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.
3.7 Testing
The Fingertip Pulse Oximeter MD300CN310 was supported by laboratory 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 Fingertip Pulse Oximeter MD300CN310 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including: IEC 60601-1:2012 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 disturbances - Requirements and tests.
IEC 60601-1-11:2010 Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for mrdical electrical equipment and medical electrical systems used in the home healthcare environment.
ISO 80601-2-61:2011 Medical Electrical Equipment- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
We have also conducted other performance test including SpO2 and PR 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 |
The list of non-clinical test performed on the proposed devices.
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| 3 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
|---|---|
| 4 | Electrical Safety Test According to IEC 60601-1 |
| 5 | Used in the home healthcare environment test according to IEC 60601-1-11 |
Premarket Notification 510(k) Submission-Section III 510(k) Summary
The test results indicate that the safety and effectiveness of the proposed device is identical to that of the predicate device.
3.8 Determination of substantial equivalence
The proposed device of Fingertip Pulse Oximeter MD300CN310 has the same classification information, similar intended use, same design principle, similar product design and specifications as the predicated device. The main difference is that the proposed device can be used in the home healthcare environment while the predicate device can not. And we have conducted test according IEC 60601-1-11:2010 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. According to the test results, the proposed device is as safe and as effective as the predicate device. So the proposed 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).