The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.

Device Description

Digital Automatic Blood Pressure Monitor MD3600 (Subject Device) are non-invasive blood pressure measurement systems 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 Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm 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.

The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.

AI/ML Overview

Acceptance Cryiteria and Study Data for Digital Automatic Blood Pressure Monitor MD3600

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the predicate device's acceptance criteria, which are identical to the subject device's criteria given the statement "All of the clinical and non-clinical testing performed on the Subject Device are same as the Predicate Device. Therefore, no bench test is conducted to show the performance of the Subject Device are equivalent to the Predicate Device." The key performance criteria for a non-invasive blood pressure measurement system are accuracy and range.

Acceptance Criteria	Reported Device Performance (Subject Device MD3600)
Blood Pressure Accuracy	± 3 mmHg
Pulse Rate Accuracy	± 5 % of the reading
BP Measurement Range	Cuff Pressure: 0 - 300 mmHg
	Systolic Pressure: 50 - 250 mmHg
	Diastolic Pressure: 30 - 200 mmHg
Resolution of Measurement	Blood Pressure: 1 mmHg, Pulse Rate: 1 beat/min
Pulse Rate Measurement Range	40 - 180 beats/min

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 for the clinical study data or if it was retrospective or prospective. However, based on the submission being from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in "Shenzhen, People's Republic of China," and the clinical study being conducted to support FDA clearance, it is likely a prospective study. The location of the study subjects (e.g., country) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document implies that the ground truth for the test set was established using a "Standard auscultation method" by a medical professional or professionals.
Number of Experts: Not explicitly stated, but typically, auscultation involves at least one trained observer.
Qualifications of Experts: Not explicitly stated, but the "Standard auscultation method" implies a trained medical professional (e.g., a physician, nurse, or technician with appropriate training in blood pressure measurement).

4. Adjudication Method for the Test Set

The adjudication method appears to be a direct comparison against the "Standard auscultation method." Measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a comparative, side-by-side measurement rather than an adjudication process between multiple expert readings of the device outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The study described focuses on the standalone performance of the device against a reference standard (auscultation), not on how human readers' performance improves with or without AI assistance. The device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human-in-the-loop performance measurement.

6. Standalone Performance Study

Yes, a standalone study was done. The clinical test described focuses on the device's ability to accurately measure blood pressure and pulse rate independently, comparing its readings directly against the "Standard auscultation method." This is a standalone performance evaluation of the algorithm/device.

7. Type of Ground Truth Used

Expert Consensus (Auscultation): The ground truth used was established by a "Standard auscultation method," which relies on a trained human observer using a stethoscope and sphygmomanometer as the reference standard for blood pressure measurement. This is a form of expert-derived ground truth.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. Blood pressure monitors like this typically use algorithms developed and validated over many years, often using large, proprietary datasets, which are not usually detailed in 510(k) summaries unless they are novel AI/ML algorithms. The 510(k) summary focuses on the validation of the final device rather than the underlying algorithm development.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Similar to point 8, this information is typically part of the device's research and development and not always explicitly detailed in a 510(k) summary for a well-established device type like a blood pressure monitor. The assumption would be that the training data, if any specific to the algorithm, would have been established through clinically validated reference methods, likely auscultation, similar to the test set ground truth.

Summary

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

June 7, 2017

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District Shenzhen, 518118 CN

Re: K163679

Trade/Device Name: Digital Automatic Blood Pressure Monitor MD3600 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 7, 2017 Received: April 12, 2017

Dear Mr. 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 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.

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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/Resourcesfor You/Industry/default.htm.

Sincerely,

M.A. Willemen
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

510(k) Number (if known) K163679

Device Name

Digital Automatic Blood Pressure Monitor MD3600

Indications for Use (Describe)

The upper arm blood pressure monitor is used to carry out non-invasivement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressured values and display the development and average values of the measured values taken.

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K163679

Page 1 of 4

510(k) Summary

Submitter identification

510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	Block 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118,Shenzhen, People's Republic of China
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Submission	23-Dec-2016

Device identification 1.

Trade Name	Digital Automatic Blood Pressure Monitor MD3600[Model No.: MD3600]
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 2.

Predicate Device	Digital Automatic Blood Pressure Monitor MD2300
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K143735

Device Description 3.

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K163679

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Indication for use 4.

Comparison of technological characteristics between the Subject Device 5. and the Predicate Devices

The Subject Device are compared to the Predicate device comparison table below:

Item	Predicate Device (K143735)	Subject Device	Comment
Indication forUse	The upper arm blood pressure monitoris used for non-invasive measurementand monitoring for adult's arterial bloodpressure. You can use it to measure yoursystolic and diastolic pressure, and pulserate through an inflatable cuff wrappedaround the upper arm. Quickly andeasily, storing the results and displayingthe progressing of readings togetherwith average.	The upper arm blood pressuremonitor is used to carry out non-invasive measurement andmonitoring of the arterial bloodpressure values in adults. This allowsyou to quickly and easily measureyour blood pressure, save themeasured values and display thedevelopment and average values ofthe measured values taken.	Equivalent
PatientPopulation	Adult	Adult	Identical
MeasurementMethod	Non-invasive, Oscillometric	Non-invasive, Oscillometric	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
Resolution ofMeasurement	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Identical
Blood PressureMeasurementAccuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg	Identical
Pulse RateMeasurementRange	40 - 180 beats/min	40 - 180 beats/min	Identical
Pulse RateMeasurementAccuracy	$\pm$ 5 % of the reading	$\pm$ 5 % of the reading	Identical
IHB Detection	Yes	Yes	Identical
Number of User	2 independent users	4 independent users	Different1
Memory Space	2 users × 60 memory space(Total 120 memory space)	4 users ×30 memory space(Total 120 memory space)	Identical
Number ofbutton	3 (User 1, User 2 and Clock)	5 (Start/Stop, Memory, Set, Increaseand Decrease)	Different2
Bluetooth datatransmission	Absent	Present	Different3
Item	Predicate Device (K143735)	Subject Device	Comment
Backlight	Present	Present	Identical
Display Type	LCD	LCD	Identical
Power Source	4 x 1.5 V AA-batteries; and/orAC adaptor (6V/600mA)	4 x 1.5 V AA-batteries	Equivalent
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
Cuff size (Arm circumference)	22 – 36 cm	22 – 36 cm	Identical
Cuff Material	Nylon	Nylon	Identical
Cuff Design	Image: beurer cuff	Image: cuff	Equivalent
Operating Condition	Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa	Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa	Identical
Storage andTransportationCondition	Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa	Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa	Identical
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,batteries and packaging	Identical
CompatibilitywithEnvironment andOther Devices	No influence with environment andother device	No influence with environment andother device	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- IEC 81060-2:2009- IEC 80601-2-30:2009+A1:2013	- ISO 81060-1:2007- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- IEC 60601-1-2:2014- IEC 60601-1-11:2015- FCC Part 15 Subpart B- FCC Part 15 Subpart C- IEC 81060-2:2013- IEC 80601-2-30:2009+A1:2013- EN 300 328 V1.8.1 & EN 62479:2010- EN 301 489-1 V1.9.2 & EN 301 489-	Equivalent/Different4

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GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

510(k) Summary

1 The number of user between the Subject Device and the Predicate Device is different but this will neither raise any safety issues nor affect the essential performance of the Subject device.

2 The number of button between the Subject Device and the Predicate Device is different but this will neither raise any safety issues nor affect the essential performance of the Subject device.

3 A new Bluetooth data transmission is added to the Subject Device. This additional feature will not affect the essential performance of the Subject device.

4 The some of the standards used in Subject Device are updated and they are equivalent to the standards used in the Predicate Device.

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K163679

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Clinical and Non-clinical Tests 6.

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 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 arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

Non-Clinical Test Summary

The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:

ゃ ISO 81060-1:2007
ゃ EN 1060-3:1997+A2:2009
ゃ IEC 60601-1:2012
◆ IEC 60601-1-2:2007
ゃ IEC 60601-1-11:2015
ゃ IEC 80601-2-30:2009+A1:2013
や FCC Part 15 Subpart B
ゃ FCC Part 15 Subpart C
ゃ EN 300 328 V1.8.1 & EN 62479:2010
ゃ EN 301 489-1 V1.9.2 & EN 301 489-17 V2.2.1

All of the clinical and non-clinical testing performed on the Subject Device are same as the Predicate Device. Therefore, no bench test is conducted to show the performance of the Subject Device are equivalent to the Predicate Device.

7. Conclusion

The Subject Device has the same intended use and same technological characteristics as the Predicate Device. 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, the Subject Device are 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).