The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you quickly and easily measure your systolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

Device Description

Digital Automatic Wrist Blood Pressure Monitor MD2400 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Automatic Wrist Blood Pressure Monitor MD2400:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure measurement devices are typically defined by international standards like ISO 81060-2. The document references this standard, indicating its use for clinical accuracy testing. The specific criteria are based on the statistical agreement between the device measurements and a reference standard (auscultation).

Acceptance Criteria (Based on ISO 81060-2:2013)	Reported Device Performance
For all values (Systolic and Diastolic):
Mean difference (device - reference) ≤ ± 5 mmHg	Not explicitly stated in the provided text, but implied to have met the standard.
Standard deviation of differences ≤ 8 mmHg	Not explicitly stated in the provided text, but implied to have met the standard.
For individual values (Systolic and Diastolic):
Blood Pressure Measurement Accuracy: ± 3 mmHg	± 3 mmHg
Pulse Rate Measurement Accuracy: ± 5% of reading	± 5% of the reading

Note: The document states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report." This implies the device met the requirements of this standard, but the specific mean difference and standard deviation values are not directly presented in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 100 patients (49 males and 51 females).
Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "Clinical Test" and mentions "One hundred patients... were invited for the study." This suggests it was likely a prospective clinical study specifically conducted for this device's validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth was established using the "Standard auscultation method." This method involves human observers, typically trained medical professionals.

Number of Experts: Not explicitly stated, but typically at least two independent observers are required for auscultation in such studies to ensure accuracy and minimize observer bias, as per ISO 81060-2 standards.
Qualifications of Experts: Not explicitly stated. However, for a clinical study adhering to ISO 81060-2, the observers performing auscultation would be medically trained individuals (e.g., physicians, nurses, or trained technicians) proficient in blood pressure measurement via auscultation.

4. Adjudication Method for the Test Set

The document mentions that measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013."

Adjudication Method: Not explicitly detailed. ISO 81060-2 often specifies a protocol for how repeated measurements are compared and how discrepancies between observers (if multiple were used) are handled, but this document does not provide those specifics. It's implied that the auscultation readings served as the reference, but the method for reconciling multiple auscultation readings (if applicable) is not given.

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

This question is not applicable to this device. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance.

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

Yes, a standalone study was done. The entire clinical accuracy test described is a standalone performance evaluation. The device (Digital Automatic Wrist Blood Pressure Monitor MD2400) was tested on its own to measure blood pressure, and its readings were compared against the reference method (auscultation) without direct human intervention in the device's measurement process.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus (Standard auscultation method). This is considered the clinical gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not mentioned. Blood pressure monitors like the MD2400, which rely on oscillometric principles, are generally calibrated using established physical models and reference measurements, rather than being "trained" on large datasets in the way an AI algorithm would be. The clinical study described is a validation study, not a training study. The device likely uses pre-programmed algorithms based on physiological models and empirical data from general populations to convert oscillometric waveforms into blood pressure readings.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable as there isn't a "training set" in the sense of a machine learning-based device. The underlying algorithms for oscillometric blood pressure measurement are developed and refined based on extensive physiological research, engineering principles, and empirical data from various populations. The "ground truth" for developing these algorithms would stem from studies correlating oscillometric waveforms with invasive arterial pressure measurements or highly accurate auscultatory methods over many years of research in the field of blood pressure monitoring.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2015

Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, Guang Dong 518118 CN

Re: K143733

Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD2400 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 27, 2015 Received: February 27, 2015

Dear Patrick Chow,

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

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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 devicerelated 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 vours.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143733

K143733 Page 1 of 1

Device Name

Digital Automatic Wrist Blood Pressure Monitor, MD2400

Indications for Use (Describe)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"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."

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510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long GangDistrict, Shenzhen, Guang Dong, People's Republic of China
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Submission	29-Dec-2014

Submitter Identification 1.

Device Identification 2.

Trade Name	Digital Automatic Wrist Blood Pressure Monitor MD2400
Common Name	Non-invasive Blood Pressure Measurement System
Classification Name	Non-invasive Blood Pressure Measurement System(CFR 870.1130, Class II, Product Code DXN)

Predicate Device 3.

Predicate Device	Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K133618

Device Description 4.

The table below illustrate the feature presence in Digital Automatic Wrist Blood Pressure Monitor MD2400.

Model	Blood PressureMeasurement	Pulse RateMeasurement	WHOClassification	IrregularHeartbeat	LCD Type	User ×Memory
MD2400	✓	✓	✓	✓	PositiveReflective	2 × 60

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Indication for Use 5.

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

Comparison of Technological Characteristics between New Device and 6. Predicate Devices

Digital Automatic Wrist Blood Pressure Monitor MD2400 is compared to the predicate device, WBPM22 Series (K133618) in the device comparison table below.

Comparison between WBPM22 Series and Predicate device
Item	Predicate Device	MD2400	Comment
Indication for Use	Digital Automatic Blood Pressure MonitorWBPM22 Series is for use by medicalprofessional or home user. The WBPM22Series is intended to measure the systolic anddiastolic blood pressure, and pulse rate of anadult individual by using a non-invasivetechnique, in which an inflatable cuff iswrapped around the wrist.	The wrist blood pressure monitor is usedto carry out non-invasive measurementand monitoring of arterial blood pressurevalues in human adults. This allows youquickly and easily measure your systolicand diastolic pressure, and pulse ratethrough an inflatable cuff wrappedaround the wrist, save the measurementsand display the development of themeasurements.	Equivalent
MeasurementMethod	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
IHB Detection	Yes	Yes	Identical
Patient Population	Adult	Adult	Identical
BP MeasurementRange	Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic Pressure: 30 - 200 mmHg	Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic Pressure: 30 - 200 mmHg	Identical
Number of User	2 independent users	2 independent users	Identical
Memory Space	2 users × 120 memory space	2 users × 60 memory space	Equivalent
Resolution ofMeasurement	Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Identical
Blood PressureMeasurementAccuracy	$\pm$ 3 mmHg or 2% of reading	$\pm$ 3 mmHg	Equivalent
Pulse RateMeasurementRange	40 - 180 beats/min	40 - 180 beats/min	Identical
Pulse RateMeasurementAccuracy	$\pm$ 5 % of the reading	$\pm$ 5 % of the reading	Identical
Display Type	LCD	LCD	Identical
Power Source	2 × 1.5 V AAA-batteries	2 × 1.5 V AAA-batteries	Equivalent
PressurizationMode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
OperatingCondition	Temperature: +5 to +40 oCHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700 - 1060 hPa	Temperature: +5 to +40 oCHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700 - 1060 hPa	Identical
Storage andTransportationCondition	Temperature: -25 to +70 oCHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 - 1060 hPa	Temperature: -25 to +70 oCHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 - 1060 hPa	Identical

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Comparison between WBPM22 Series and Predicate device
Item	Predicate Device	MD2400	Comment
Material	Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging	Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging	Identical
Compatibility withEnvironment andOther Devices	No influence with environment and otherdevice	No influence with environment and otherdevice	Identical
ApplicableStandard	- EN 1060-1:1995+A2:2009- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- EN 60601-1-2:2007- FCC Part 15 Subpart B- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2009	- EN 1060-1:1995+A2:2009- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- IEC 60601-1-2:2007- FCC Part 15 Subpart B- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2013	Equivalent

Digital Automatic Wrist Blood Pressure Monitor MD2400 is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, a electric valve and an electronic control module together with an electric pump. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring blood pressure.

Clinical and Non-clinical Tests 7.

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report.

One hundred patients (49 males and 51 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left wrist. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.

Non-Clinical Test Summary

Digital Automatic Wrist Blood Pressure Monitor MD2400 has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:

EN 1060-1:1995+A2:2009 <>
EN 1060-3:1997+A2:2009
◆ IEC 60601-1:2012
ゃ IEC 60601-1-2:2007
◆ FCC Part 15 Subpart B
◆ ISO 10993-5:2009
ISO 10993-10:2010
IEC 62304:2006

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All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor MD2400 are same as the predicate device.

Also, bench testing, IEC 80601-2-30, is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor MD2400 is equivalent to the predicate device.

Conclusion 8.

Digital Automatic Wrist Blood Pressure Monitor MD2400 has the same intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series (K133618). Moreover both clinical and non- clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Wrist Blood Pressure Monitor MD2400 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).