The wrist 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. You are also warned of possible existing irregular heartbeat.

Device Description

Digital Automatic Wrist Blood Pressure Monitor MD4300 (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 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.

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 a breakdown of the acceptance criteria and study information for the "Digital Automatic Wrist Blood Pressure Monitor MD4300" based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Metric / Acceptance Criteria	Device Performance (MD4300)	Study Proving Performance (Clinical Test Summary)
Blood Pressure Measurement Accuracy	± 3 mmHg	Clinical test in accordance with ISO 81060-2. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm.
Pulse Rate Measurement Accuracy	± 5% of the reading	Not explicitly stated as a separate acceptance criterion with a specific performance outcome in the table, but the Clinical Test Summary implies evaluation of accurate pulse rate as part of overall blood pressure monitoring.
General Clinical Accuracy	Met requirements of ISO 81060-2	Clinical test in accordance with ISO 81060-2, comparing against standard auscultation method.
Non-clinical Requirements (various standards)	Met all requirement specifications and standard requirements (e.g., IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, FCC Part 15, etc.)	Non-clinical tests to show compliance with various standards listed.

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

Sample Size for Clinical Test Set: 100 patients (60 males and 40 females).
Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The "Clinical Test Summary" just states that "One hundred patients...were invited for the study."

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The ground truth was established using the "Standard auscultation method," which implies trained medical professionals (e.g., doctors or nurses) for manual blood pressure measurement.

4. Adjudication Method for the Test Set

The text describes a comparison method: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison between the device's reading and the auscultation reading for each patient. There is no mention of an adjudication process (e.g., 2+1 or 3+1) if discrepancies arose.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device against a reference standard (auscultation), not a comparative effectiveness study with human readers assisted by AI.

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

Yes, the clinical test described is a standalone performance test of the device itself (algorithm and hardware) against the auscultation ground truth. There is no mention of "human-in-the-loop performance" or AI assistance in the context of this device.

7. The Type of Ground Truth Used

The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method." This is considered a gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The document describes a clinical validation study (test set) of 100 patients. It does not mention a "training set" or any machine learning model training process for this device. The device likely relies on established oscillometric principles and calibration, not a data-driven machine learning model that requires a distinct training set.

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

As no training set is mentioned or implied for a machine learning model, this question is not applicable. The device's operation is based on oscillometric methodology rather than AI training.

Summary

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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.

April 10, 2018

Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenzhen, China 518118

Re: K171379

Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD4300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 1, 2018 Received: March 1, 2018

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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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K171379

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MA Wilhelm

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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Indications for Use

510(k) Number (if known) K171379

Device Name

Digital Automatic Wrist Blood Pressure Monitor MD4300

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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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	05-May-2017

Submitter identification 1.

Device identification 2.

Trade Name	Digital Automatic Wrist Blood Pressure Monitor MD4300[Model No.: MD4300]
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 MD2400
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K143733

Device Description 4.

5. Indication for use

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

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

Item	Predicate Device (K143733)	Subject Device	Comment
Indication for Use	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 blood pressure, save the measurements and display the development of the measurements. You are also warned of possible existing cardiac arrhythmia.	The wrist 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. You are also warned of possible existing irregular heartbeat.	Equivalent
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	2 independent users	2 independent users	Identical
Memory Space	2 users × 60 memory space(Total 120 memory space)	2 users × 60 memory space(Total 120 memory space)	Identical
Number of button	4 (Memory, Clock, User, Start/Stop)	3 (M1, M2 and Start/Stop)	Different1
Bluetooth data transmission	Absent	Present	Different2
Backlight	Absent	Present	Different3
Display Type	LCD	LCD	Identical
Power Source	2 × 1.5 V AAA-batteries	2 × 1.5 V AAA-batteries	Identical
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 93% R.H. maxAtmospheric Pressure: 700-1060 hPa	Identical
Storage and Transportation	Temperature: -25 to +70 °CHumidity: up to 93% R.H. max	Temperature: -25 to +70 °CHumidity: up to 93% R.H. max	Identical
Item	Predicate Device (K143733)	Subject Device	Comment
Material	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Identical
Compatibility withEnvironment andOther Devices	No influence with environment and other device	No influence with environment and other 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 60601-1-2:2007- 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	Equivalent/Different4

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1 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.

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

3 A new backlight illumination function 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.

Clinical and Non-clinical Tests 7.

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 (60 males and 40 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:

や ISO 81060-1:2007
ゃ EN 1060-3:1997+A2:2009
ゃ IEC 60601-1:2012
◆ IEC 60601-1-2:2007

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ゃ IEC 60601-1-11:2015
� IEC 80601-2-30:2009+A1:2013
� FCC Part 15 Subpart B
� FCC Part 15 Subpart C
� EN 300 328 V1.8.1 & EN 62479:2010
� 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.

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).