Vital Signs Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 15, 2021 Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan District Beijing, 100041 China Re: K211754 Trade/Device Name: Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: October 14, 2021 Received: October 18, 2021 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). 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Sincerely, for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211754 Device Name Vital Signs Monitor Indications for Use (Describe) Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatic patients in hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Premarket Notification 510(k) Submission-Section II 510(k) Summary # 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. # 3.1 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 BEIJING, 100041, P.R.China #### ● Contact Person: Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone. Shijingshan District Beijing China 100041 Phone: +86-10-88204631 Fax: 861088204632 Email: cc@choicemmed.com - Date prepared: October 14, 2021 ● # 3.2 Proposed Device Information Device Common Name: Vital Signs Monitor Device Trade/Proprietary Name: Vital Signs Monitor Model: MD2000C Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulation Number: 870.2300 Product Code: MWI Class: II {4}------------------------------------------------ #### Premarket Notification 510(k) Submission-Section II 510(k) Summary Panel: Cardiovascular # 3.3 Predicate Device 510(k) Number: K100740 Common Name: Vital Signs Monitor Device Trade/Proprietary Name: Vital Signs Monitor Model: MD2000B Classification Name: Monitor, physiological, patient(Without Arrhythmia Detection Or Alarms) Product Code: MWI Regulation Number: 870.2300 Device Class: II Panel: Cardiovascular Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Intended Use: The vital signs monitor is a portable device indicated for use in noninvasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult and pediatric patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring of patients. # 3.4 Device Description The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm. Measurement Principle: Blood Pressure measurement principle: The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP).NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The device uses a blood pressure cuff to sense {5}------------------------------------------------ #### Premarket Notification 510(k) Submission-Section II 510(k) Summary these oscillations, which appear as tiny pulsations in cuff pressure. The device measures the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery.As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum(which approximates to the mean pressure), and then diminish. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures. Pulse Oxygen Saturation measurement principle: The pulse oxygen saturation is measured 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 660 mm, which is red light; the other is 905 nm, which is ultrared 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 device is for prescription. The device does not contain drug or biological products. The device is software-driven. {6}------------------------------------------------ # 3.5 Comparison list of the technological characteristics | Comparison Elements | Subject Device | Predicate Device | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Vital Signs Monitor | Vital Signs Monitor | | Model | MD2000C | MD2000B | | Regulation No. | 21 CFR 870.2300 | 21 CFR 870.2300 | | Classification | Ⅱ | Ⅱ | | Classification Name | Monitor, physiological, patient(Without<br>Arrhythmia Detection Or Alarms) | Monitor, physiological, patient(Without<br>Arrhythmia Detection Or Alarms) | | Product Code | MWI | MWI | | Indications for Use | Vital Signs Monitor MD2000C is a<br>portable device indicated for measuring<br>physiological parameters, such as NIBP,<br>SpO2, PR, and Pulse waveform of adult<br>and three years old and older pediatric<br>patients in hospitals, community<br>hospitals and medical facilities.<br>Vital Signs Monitor is intended for spot-<br>checking and/or continuous monitoring<br>of patients. | The vital signs monitor is a portable device<br>indicated for use in non-invasively measuring<br>and displaying functional oxygen saturation<br>of arterial hemoglobin (SpO2), pulse rate<br>(PR), Non-invasive measurement of blood<br>pressure (NIBP) of adult and pediatric<br>patients in hospitals, medical facilities, and<br>sub-acute environments.<br>The vital signs monitor is intended for spot-<br>checking and/or continuous monitoring of<br>patients. | | Comparison Statement | The proposed device and the predicate device have the same classification and<br>same intended use. | | Table 2-1 Performance Specification Comparison Table between the Proposed Device (MD200C) and Predicate Device {7}------------------------------------------------ | Performance Specification | Measurement | 660 nanometers | 660 nanometers | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------| | | Wavelengths | 905 nanometers | 940 nanometers | | | Display unit specification | TFT | LED & LCD | | | Display data | SpO2%, PR, PAI, SYS, DIA | SpO2%, PR, SYS,MAP,DIA | | | SpO2 measuring range | 70%-100% | 70%-100% | | | SpO2 resolution | 1% | 1% | | | SpO2 Accuracy | $\pm$ 2% | 80-100%: $\pm$ 2%; 70-79%: $\pm$ 3%; | | | SpO2 Alarm range | 85%-100% | 85%-100% | | | PR measuring range | 30~250 bpm | 30~235 bpm | | | PR resolution | 1 bpm | 1 bpm | | | PR Accuracy | $\pm$ 2bpm or $\pm$ 2% (choose larger) | 30-100, $\pm$ 2bpm; 101-235, $\pm$ 2% | | | Pulse Amptitude Index<br>measurment range | 0.1%-20% | / | | | PAI resolution | 0.1% | / | | | NIBP Measurement<br>Method: | Oscillometric method | Oscillometric method | | | NIBP Measurement Range: | Adult: SYS :60mmHg~255mmHg | Adult: SYS :30mmHg~255mmHg | | | | DIA:30mmHg~195mmHg | MAP:20mmHg~235mmHg | | | | Padiatric: SYS :60mmHg~215mmHg | DIA:15mmHg~220mmHg | | | | DIA:30mmHg~195mmHg | Padiatric: SYS :30mmHg~135mmHg | | | | | MAP:20mmHg~125mmHg | | | | | DIA:15mmHg~110mmHg | | | Static pressure measurement range | 20~280mmHg | 0~270mmHg | | | Maximum static pressure error | ±3mmHg | ±3mmHg | | | Alarm method | 3 levels audible and visual alarm | 3 levels audible and visual alarm | | Comparison Statement | The proposed device has similar product specification as predicate device.The<br>differences are Measurement Wavelengths,the measurement range and accuracy of PR<br>and NIBP, the measurement range of PAI,and we can verify that which will not effect<br>the basic safety and essential performance of the proposed device. | | | | Contacting Material | Fingertip Cushion | Silicone Gel | Silicone Gel | | | Blood Pressure Cuff | Nylon | Nylon | | Comparison Statement | The contacting materials of the proposed device are same to those of the predicate device. | | | {8}------------------------------------------------ K211754 {9}------------------------------------------------ #### K211754 | Performance Testing | Laboratory Testing | The laboratory tests include SpO2 , PR Accuracy Test, Device Response Time of SpO2/PR , SpO2/PR output time and finger out time , PAI measurement range , Static pressure Accuracy, High and Low Temperature and Humidity Test, Performance Test After Cleaning, ISO 80601-2-61, ISO 80601-2-30 | The laboratory tests include SpO2 , PR Accuracy Test, Device Response Time of SpO2/PR , SpO2/PR output time and finger out time , Static pressure Accuracy, High and Low Temperature and Humidity Test, Performance Test After Cleaning , ISO 9919, ISO 80601-2-30 | |-------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Electrical Safety | Conformed to IEC60601-1,IEC 60601-1-8,IEC 60601-2-49 | Conformed to IEC60601-1, IEC 60601-1-8,IEC 60601-2-49 | | EMC and Electrical Safe | Electromagnetic Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | | | Software | Major level of concern | Moderate level of concern | | | | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.<br>Risk Management in Compliance with ISO14971 | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.<br>Risk Management in Compliance with ISO14971 | {10}------------------------------------------------ K211754 | Label and Labeling | Conform to 21 CFR 801 | Conform to 21 CFR 801 | |----------------------|------------------------------------------------------------------------|-----------------------| | Comparison Statement | The proposed device is in conformity with the current latest standard. | | {11}------------------------------------------------ ### Premarket Notification 510(k) Submission-Section III 510(k) Summary # 3.6 Indications for Use Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients. # 3.7 Testing #### Biocompatibility Testing The patient contacted materials fingertip cushion used in the proposed device MD2000C are the same as the materials used in the predicate device MD300M which has been cleared by FDA on April 18, 2016 as K152563. The blood pressure cuff used in the proposed device MD2000C is same as the material in the predicate device CBP111,which has been cleared by FDA on February 10,2017 as K162089. #### Electrical safety and electromagnetic compatibility (EMC) The proposed device Vital Signs Monitor MD2000C is tested in accordance with IEC 60601-1, IEC 60601-1-2,IEC 60601-1-8,IEC 60601-2-49 to evaluate the electrical safety and EMC. #### Performance Test-Bench We have conducted safety and performance test for the proposed device MD2000C in accordance with ISO 80601-2-61, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, and accordance with IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers. We have also conducted other performance tests including SpO2, PR Accuracy Test, Device Response Time of SpO2/PR, SpO2/PR output time and finger out time, PAI measurement range, Static pressure Accuracy, Cleaning Test. High and Low Temperature & Humidity Test. Shelf-life Test. #### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was {12}------------------------------------------------ #### Premarket Notification 510(k) Submission-Section III 510(k) Summary provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern, since a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider. ### Clinical Testing The SpO2 module and sensor of the proposed device are identical same as whose of MD300M manufactured by Beijing Choice Electronic Technology Co., Ltd. MD300M has been cleared by FDA on April 18,2016 as K152563, so the clinical study for SpO2 was not repeated. The Clinical Test of MD300M was conducted in Yue Bei people's Hospital. 12 healthy adult volunteer subjects (6 females and 6 males ages 21-43yr, 47-82kg, 155-185cm, with representative range of pigmentation) were included in the study conducted September 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300M Pulse Oximeter. The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting Oximeter probe have an ARMS of 1.75 during steady state conditions over the range of 70-100%. The blood pressure module and cuff of Vital Signs Monitor MD2000C are identical as whose of Multi-parameters health Examination System manufactured by Beijing Choice Electronic Technology Co., Ltd, so the clinical study for blood pressure was not repeated. The clinical Test of Multi-parameters health Examination System was conducted in PLA Rocket Force Characteristic Medical Center. 85 subjects (35 child subjects aged between 3y and 12 y old and 50 adults subjects) were included in the study conducted from September 16, 2018 to September 20, 2019. The blood pressure accuracy performance results showed that the mean error is within ±5mmHg and the standard deviation is within 8mmHg. # 3.8 Determination of substantial equivalence The proposed device of the vital signs monitor MD2000C has the same classification information, same intended use, same design principle, similar product design and specifications as the predicate device. The main difference is that the proposed device has the function of PAI measurement, and we can verify that will not affect the basic safety and the essential performance of the proposed device. Therefore, the proposed device is Substantially Equivalent (SE) to the predicate device which is a US legally marketed device.