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 MD36 Series (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

Here's an analysis of the acceptance criteria and the study conducted for the Digital Automatic Blood Pressure Monitor MD36 Series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for blood pressure monitors is accuracy. The document refers to ISO 81060-2 for clinical accuracy testing.

Acceptance Criteria	Reported Device Performance
Blood Pressure Measurement Accuracy	± 3 mmHg
Pulse Rate Measurement Accuracy	± 5 % of the reading
Compliance with ISO 81060-2 (Clinical Test)	Met: Clinical test conducted according to ISO 81060-2, documented in a Clinical Test report. While the specific numerical results of the ISO 81060-2 test are not detailed in this summary, the statement "Testing to ensure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report" implies that the device met the standards set forth by ISO 81060-2.
Compliance with Non-Clinical Standards	Met: Various non-clinical tests conducted (e.g., EN 1060-3, IEC 60601-1, FCC Part 15) to demonstrate that all requirement specifications and standard requirements are met.

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

Sample Size: 100 patients for each cuff size (standard: 49 males and 51 females; universal: 44 males and 56 females).
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given that the manufacturer is Grandway Technology (Shenzhen) Limited, China, and the study was likely conducted to support a US FDA submission, it's possible the study was conducted in China or a region where clinical studies for international regulatory submissions are common. It is a prospective study, as patients were "invited for the study" and measurements were "repeated alternatively."

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

Number of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals. While the exact number isn't specified, it would imply at least one, and likely multiple, trained personnel performing the auscultation measurements.
Qualifications of Experts: The document states "Standard auscultation method was used as the reference blood pressure monitor." This implies trained medical personnel (e.g., nurses, doctors) who are proficient in manual blood pressure measurement using a stethoscope and sphygmomanometer. Specific qualifications like experience level (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set beyond obtaining measurements from the "standard auscultation method" and directly comparing them to the device's readings. The study design mentions measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2," suggesting a direct comparison without a separate adjudication panel.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This device is an automated blood pressure monitor, not an AI interpretation system for human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The clinical accuracy testing described in "Clinical Test Summary" is a standalone performance study, assessing the device's accuracy (algorithm only, as it's an automated device) against a reference standard (auscultation) without human-in-the-loop interpretation adjustment.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus (via standard auscultation method). The auscultation method, performed by a trained professional, serves as the clinical reference standard against which the automated device's measurements are compared.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This is typical for a medical device that relies on established physical principles and calibrated hardware (oscillometric methodology) rather than a machine learning model that requires explicit training data. The development and internal validation of the device would have involved calibration and testing, but not in the same sense as "training data" for an AI algorithm.

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

As mentioned above, the concept of a "training set ground truth" as it applies to AI/ML is not directly applicable here. The device's underlying principles are based on the oscillometric method. The accuracy claims are validated through the clinical performance study against the auscultation method.

Summary

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July 22, 2019

Grandway Technology (Shenzhen) Limited Patrick Chow General Manager No. 5, 2nd Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District Shenzhen, 518118 CHINA

Re: K191593

Trade/Device Name: Digital Automatic Blood Pressure Monitor MD36 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 27, 2019 Received: June 14, 2019

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. 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.

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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 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-reportingcombination-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,

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) K191593

Device Name

Digital Automatic Blood Pressure Monitor MD36 Series

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter identification 1.

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	No 5, The Second Industrial Zone, Zhukeng Community, Longtian Street, PingshanDistrict, 518118 ShenZhen, Guangdong, People's Republic of China.
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Submission	27-May-2019

Device identification 2.

Trade Name	Digital Automatic Blood Pressure Monitor MD36 Series[Model No.: MD36X0, M36X0A]X - The first character (0 and 1) is for the identification of add-on features.
Common Name	Non-invasive Blood Pressure Measurement System
Classification Name	Non-invasive Blood Pressure Measurement System

Predicate device 3.

Predicate Device	Digital Automatic Blood Pressure Monitor MD3600
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K163679

Device Description 4.

5. Indication for use

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Comparison of technological characteristics between the Subject Device and 6. the Predicate Devices

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

Item	Predicate Device (K163679)	Subject Device (MD36 Series)	Comment
Indication for Use	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.	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.	Identical
Patient Population	Adult	Adult	Identical
Measurement Method	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
BP Measurement Range	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 of Measurement	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Identical
Blood Pressure Measurement Accuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg	Identical
Pulse Rate Measurement Range	40 - 180 beats/min	40 - 180 beats/min	Identical
Pulse Rate Measurement Accuracy	$\pm$ 5 % of the reading	$\pm$ 5 % of the reading	Identical
IHB Detection	Yes	Yes	Identical
Number of User	4 independent users	4 independent users	Identical
Memory Space	4 users ×30 memory space(Total 120 memory space)	4 users ×30 memory space(Total 120 memory space)	Identical
Number of button	5 (Start/Stop, Memory, Set, Increase and Decrease)	5 (Start/Stop, Memory, Set, Increase and Decrease)	Identical
Bluetooth data transmission	Present	Present	Identical
Backlight	Present	Present	Identical
Display Type	LCD	LCD	Identical
Power Source	4 x 1.5 V AA-batteries	4 x 1.5 V AA-batteries; and/or DC adaptor (6V/600mA)	Different¹
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
Operating Condition	Temperature: +5 to +40 °CHumidity: 15 to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa	Temperature: +5 to +40 °CHumidity: 15 to 90 % R.H. maxAtmospheric Pressure: 700-1060 hPa	Different²
Storage and Transportation Condition	Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa	Temperature: -25 to +70 °CHumidity: up to 90% R.H. maxAtmospheric Pressure: 700-1060 hPa	Different³
Material	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet,	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet,	Identical
Item	Predicate Device (K163679)	Subject Device (MD36 Series)	Comment
Compatibility withEnvironment andOther Devices	No influence with environment andother device	No influence with environment andother device	Identical
Applicable Standard	- ISO 81060-1:2007- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- IEC 60601-1-2:2007- 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 301 489-17 V2.2.1	- 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 V2.1.1 & EN 62479:2010- EN 301 489-1 V2.2.0 & EN 301 489-17 V3.2.0	Equivalent/Different4

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GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

1 DC jack is optional in certain model. Several tests have been done for this additional feature. This additional feature will not affect the safety and essential performance of the Subject device.

² The humidity for the operating condition are updated according to IEC 60601-1-11:2015 and they are equivalent to the standards used in the Predicate Device. This will neither raise any safety issues nor affect the essential performance of the Subject device.

3 The humidity for the storage and transportation are updated according to IEC 60601-1-11:2015 and they are equivalent to the standards used in the Predicate Device. This will neither raise any safety issues nor affect the esential performance of the Subject device.

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

Clinical and Non-clinical Tests 7.

Clinical Test Summary

Testing to ensure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. One hundred patients for each cuff (standard: 49 males and 51 females; universal: 44 males and 56 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 include the follows:

ゃ EN 1060-3:1997+A2:2009
� IEC 60601-1:2012
� IEC 60601-1-2:2014
ゃ IEC 60601-1-11:2015
ゃ IEC 80601-2-30:2009+A1:2013
ゃ FCC Part 15 Subpart B
ゃ FCC Part 15 Subpart C

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GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

ゃ EN 300 328 V2.1.1 & EN 62479:2010

ゃ EN 301 489-1 V2.2.0 & EN 301 489-17 V3.2.0

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.

Conclusion 8.

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).