(161 days)
No
The document does not mention AI, ML, DNN, or image processing, and the description focuses on standard physiological parameter measurement.
No
The device is described as a "Vital Signs Monitor" intended for measuring physiological parameters (NIBP, SpO2, PR) for spot-checking and continuous monitoring, which falls under diagnostic or monitoring functions rather than providing therapy.
No
This device is a vital signs monitor that measures physiological parameters. While these measurements can be used for patient assessment, the device itself is not explicitly described as providing a diagnosis or diagnostic interpretation of the measurements. It provides data which a healthcare professional would then use to diagnose.
No
The device description explicitly states it is a "portable device powered by internal electrical power source and external electrical power source" and lists hardware accessories like "SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter." This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Vital Signs Monitor MD2000C measures physiological parameters directly from the patient's body (in vivo). It measures NIBP (Non-invasive Blood Pressure) from the arm and SpO2 and PR (Pulse Rate) from the fingertip. These are direct measurements of the patient's vital signs, not tests performed on samples taken from the patient.
- Intended Use: The intended use describes measuring physiological parameters of patients, not analyzing samples.
- Device Description: The description details the measurement of SpO2, PR, and NIBP directly from the patient.
- Anatomical Site: The anatomical sites listed (Fingertip, Arm) are where the device is applied to the patient, not where samples are collected.
Therefore, based on the provided information, the Vital Signs Monitor MD2000C is a medical device for monitoring vital signs in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and three years old and older pediatric patients
Intended User / Care Setting
hospitals, community hospitals and medical facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing for SpO2:
SpO2 module and sensor of the proposed device are identical to MD300M (K152563).
Sample Size: 12 healthy adult volunteer subjects (6 females and 6 males ages 21-43yr, 47-82kg, 155-185cm, with representative range of pigmentation).
Study Conducted: September 20-22, 2014.
Key Results: 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%.
Clinical Testing for Blood Pressure:
Blood pressure module and cuff identical to Multi-parameters health Examination System.
Sample Size: 85 subjects (35 child subjects aged between 3y and 12 y old and 50 adults subjects).
Study Conducted: September 16, 2018 to September 20, 2019.
Key Results: The blood pressure accuracy performance results showed that the mean error is within ±5mmHg and the standard deviation is within 8mmHg.
Laboratory Testing:
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.
Electrical Safety:
Conformed to IEC60601-1,IEC 60601-1-8,IEC 60601-2-49.
Electromagnetic Compatibility:
Conformed to IEC60601-1-2.
Software Verification and Validation Testing:
Software for this device was considered as a "Major" 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: ARMS of 1.75 over the range of 70-100%.
Blood pressure accuracy: mean error within ±5mmHg and standard deviation within 8mmHg.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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). 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
1
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
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | |
| Arrhythmia Detection Or Alarms) | Monitor, physiological, patient(Without | |
| Arrhythmia Detection Or Alarms) | ||
| Product Code | MWI | MWI |
| 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. | The vital signs monitor is a portable device | |
| indicated for use in non-invasively 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. | ||
| Comparison Statement | The proposed device and the predicate device have the same classification and | |
| 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 | |||
| measurment range | 0.1%-20% | / | |
| PAI resolution | 0.1% | / | |
| NIBP Measurement | |||
| 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 | ||
| differences are Measurement Wavelengths,the measurement range and accuracy of PR | |||
| and NIBP, the measurement range of PAI,and we can verify that which will not effect | |||
| 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
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. | |||
| 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 |
10
| 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.