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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Monitor MD2000C based on the provided text:

Acceptance Criteria and Device Performance

The direct acceptance criteria for the Vital Signs Monitor MD2000C are not explicitly stated as a separate table within the document in terms of specific performance targets for NIBP, SpO2, and PR beyond accuracy ranges. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MD2000B and MD300M for SpO2, and Multi-parameters health Examination System for NIBP).

The performance data available relates to the MD300M (for SpO2) and Multi-parameters health Examination System (for NIBP), which the new device MD2000C claims to be identical to in those modules.

Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Parameter	Implied Acceptance Criteria (from predicate)	Reported Device Performance (from predicate studies)
SpO2 Accuracy	ARMS of ≤ 2-3% (common for pulse oximeters)	MD300M: ARMS of 1.75% (over 70-100% range)
NIBP Accuracy	Mean error within ±5mmHg, Standard deviation within 8mmHg (per ISO 81060-2:2018 or similar)	Multi-parameters health Examination System: Mean error within ±5mmHg, Standard deviation within 8mmHg
SpO2 Measuring Range	70%-100%	70%-100%
SpO2 Resolution	1%	1%
PR Measuring Range	30-235 bpm (predicate)	30-250 bpm (proposed)
PR Resolution	1 bpm	1 bpm
PR Accuracy	30-100 bpm: ±2bpm; 101-235 bpm: ±2% (predicate)	±2bpm or ±2% (choose larger) (proposed)
NIBP Measurement Method	Oscillometric method	Oscillometric method
Static pressure measurement range	0~270mmHg (predicate)	20~280mmHg (proposed)
Maximum static pressure error	±3mmHg	±3mmHg

Note: The "Implied Acceptance Criteria" are based on the performance of the predicate devices which the new device is seeking equivalence to. The direct acceptance criteria for the specific device are not explicitly listed in a regulatory numerical format but are demonstrated through equivalence to these predicate performances.

Study Information:

2. Sample sizes used for the test set and the data provenance:

SpO2 Accuracy Study (MD300M):
- Sample Size: 12 healthy adult volunteer subjects (6 females, 6 males)
- Demographics: Ages 21-43 years, 47-82 kg, 155-185 cm, with a representative range of pigmentation.
- Data Provenance: Conducted in Yue Bei People's Hospital. Prospective study. Country of origin not explicitly stated but implied to be China (as the manufacturer is Beijing Choice Electronic Technology Co., Ltd.)
NIBP Accuracy Study (Multi-parameters health Examination System):
- Sample Size: 85 subjects (35 child subjects aged 3-12 years, 50 adult subjects)
- Data Provenance: Conducted in PLA Rocket Force Characteristic Medical Center. Prospective study. Country of origin not explicitly stated but implied to be China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts used to establish ground truth for either the SpO2 or NIBP studies.
- For SpO2, ground truth is typically established using a co-oximeter in controlled desaturation studies (e.g., fractional oxyhemoglobin measurement compared to pulse oximeter readings).
- For NIBP, ground truth is typically established simultaneously with a reference auscultatory or invasive blood pressure measurement taken by qualified personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not provide details on any adjudication methods used for the test sets. The studies appear to be direct performance comparisons against a reference standard rather than assessments requiring multiple human interpretations.

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 MRMC study was performed. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides physiological parameters directly.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, standalone performance was evaluated. The studies described for SpO2 and NIBP accuracy directly measure the device's performance against a reference standard, without human interpretation of the device's output influencing the accuracy metrics. The device itself is designed to provide direct physiological measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

SpO2: The ground truth for SpO2 accuracy studies is typically established by fractional oxyhemoglobin measurement using a co-oximeter during controlled hypoxia conditions. This is considered the reference standard for pulse oximetry.
NIBP: The ground truth for NIBP accuracy studies is established by simultaneous measurements using a reference auscultatory method (e.g., mercury sphygmomanometer with stethoscope by trained observer) or an invasive arterial line, compared to the device's oscillometric readings.

8. The sample size for the training set:

The document does not specify sample sizes for training sets. It describes the device's performance through validation studies (test sets) for specific modules that were adopted from previously cleared devices. It's implied that the algorithms within these modules were developed and potentially trained using proprietary datasets not detailed in this 510(k) summary.

9. How the ground truth for the training set was established:

The document does not specify how ground truth was established for any potential training sets. This information would typically be part of the internal development process for the SpO2 and NIBP algorithms, which predates this 510(k) application (as the modules are reused from previously cleared devices).

Summary

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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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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-reporting-

combination-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,

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

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Indications for Use

510(k) Number (if known) K211754

Device Name Vital Signs Monitor

Indications for Use (Describe)

Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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

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

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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.

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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(WithoutArrhythmia Detection Or Alarms)	Monitor, physiological, patient(WithoutArrhythmia Detection Or Alarms)
Product Code	MWI	MWI
Indications for Use	Vital Signs Monitor MD2000C is aportable device indicated for measuringphysiological parameters, such as NIBP,SpO2, PR, and Pulse waveform of adultand three years old and older pediatricpatients in hospitals, communityhospitals and medical facilities.Vital Signs Monitor is intended for spot-checking and/or continuous monitoringof patients.	The vital signs monitor is a portable deviceindicated for use in non-invasively measuringand displaying functional oxygen saturationof arterial hemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of bloodpressure (NIBP) of adult and pediatricpatients in hospitals, medical facilities, andsub-acute environments.The vital signs monitor is intended for spot-checking and/or continuous monitoring ofpatients.
Comparison Statement	The proposed device and the predicate device have the same classification andsame intended use.

Table 2-1 Performance Specification Comparison Table between the Proposed Device (MD200C) and Predicate Device

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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 Indexmeasurment range	0.1%-20%	/
	PAI resolution	0.1%	/
	NIBP MeasurementMethod:	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.Thedifferences are Measurement Wavelengths,the measurement range and accuracy of PRand NIBP, the measurement range of PAI,and we can verify that which will not effectthe 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.

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K211754

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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.Risk Management in Compliance with ISO14971	Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.Risk Management in Compliance with ISO14971

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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.

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Premarket Notification 510(k) Submission-Section III 510(k) Summary

3.6 Indications for Use

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

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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.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).