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 to 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.

Device Description

Digital Automatic Wrist Blood Pressure Monitor MD3200 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

The document describes the Digital Automatic Wrist Blood Pressure Monitor MD3200 and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against accuracy values for blood pressure and pulse rate measurements.

Acceptance Criteria (Standard ISO 81060-2:2013, likely)	Reported Device Performance
Blood Pressure Measurement Accuracy: ± 3 mmHg	± 3 mmHg
Pulse Rate Measurement Accuracy: ± 5 % of the reading	± 5 % of the reading

Note: The document explicitly states that the device's accuracy for BP measurement is ± 3 mmHg and for pulse rate measurement is ± 5% of the reading. It also mentions compliance with ISO 81060-2:2013 for clinical accuracy, which is the standard outlining these accuracy requirements.

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

Sample Size: 100 patients (45 males and 55 females)
Data Provenance: The document does not explicitly state the country of origin but mentions the study was conducted to insure clinical accuracy in accordance with ISO 81060-2:2013. The nature of the study (patients invited for measurements) indicates it was prospective.

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

Number of Experts: The document does not specify the number of experts but states that the "Standard auscultation method was used as the reference blood pressure monitor". This implies trained medical professionals (e.g., doctors, nurses, or technicians certified in blood pressure measurement) would have performed the auscultation.
Qualifications of Experts: Not explicitly stated, but implicitly, they would be qualified to perform the auscultation method accurately.

4. Adjudication Method for the Test Set

The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This implies a direct comparison method where readings from the device are compared to the reference standard (auscultation) taken at the same time or in alternating sequences. There's no mention of an "adjudication" process in the typical sense of multiple experts independently reviewing and then resolving discrepancies. The auscultation itself serves as the ground truth.

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

No, an MRMC comparative effectiveness study was not done. This study concerns a standalone blood pressure monitoring device. It does not involve human readers interpreting images or data, nor does it involve AI assistance in that context. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, a standalone performance study was done. The device itself is an "Automatic Wrist Blood Pressure Monitor," implying it operates autonomously to measure and display blood pressure and pulse rate. The clinical test evaluated the accuracy of this device's measurements against a reference standard (auscultation) in a clinical setting, without a human "in the loop" to interpret the device's readings and make a diagnosis. The device generates the readings directly.

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its size. Blood pressure monitors like this typically do not involve machine learning models that require a distinct training set in the same way an AI diagnostic tool would. The device's calibration and algorithm development would have occurred during its engineering phase, likely using internal testing data, but this is not discussed in terms of a "training set" for regulatory submission.

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

As a training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided in the document.

Summary

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

August 7, 2015

Grandway Technology (shenzhen) Limited Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District, Shenzhen, 518118 CN

Re: K151587

Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not dated Received: June 11, 2015

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

Bram D. Zuckerman -S

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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K151587

Page 1 of 1

510(k) Number (if known): K 151587

Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over - The Counter Use X

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510(k) Summary

Submitter Identification 1.

510(k) Submitter	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Address	Block 7, Zhu Keng Industrial Zone, Ping Shan District, 518118Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Phone Number	(00852)-2851-6789
Fax Number	(00852)-2851-6278
Contact Person	Mr. Patrick Chow
Date of Submission	10-Jun-2015

2. Device Identification

Trade Name	Digital Automatic Wrist Blood Pressure Monitor MD3200[Model No.: MD3200]
Common Name	Non-invasive Blood Pressure Measurement System
Classification Name	Non-invasive Blood Pressure Measurement System(CFR 870.1130, Class II, Product Code DXN)

3. Predicate Device

Predicate Device	Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
Manufacturer	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Number	K142088

4. Device Description

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

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K151587

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detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The table below illustrates the feature presence in Digital Automatic Wrist Blood Pressure Monitor MD3200.

Model	Blood PressureMeasurement	Pulse RateMeasurement	WHOClassification	IrregularHeartbeat	LCD Type	User ×Memory
MD3200	✓	✓	✓	✓	PositiveReflective	2 × 60

Indication for Use 5.

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

Digital Automatic Wrist Blood Pressure Monitor MD3200 is compared to the predicate device, SWBPM22 Series (K142088) in the device comparison table below.

Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device
Item	Predicate Device	Digital Automatic Wrist BloodPressure Monitor MD3200	Comment
Indication forUse	This device is for use by medicalprofessional or home users. It isintended to measure the systolic anddiastolic blood pressure of an adultindividual by using a non-invasivetechnique, in which an inflatable cuffis wrapped around the wrist.	The wrist blood pressure monitor isused to carry out non-invasivemeasurement and monitoring ofarterial blood pressure values inhuman adults. This allows you toquickly and easily measure yoursystolic and diastolic pressure, andpulse rate through an inflatable cuffwrapped around the wrist, save themeasurements and displaythedevelopment of the measurements	Equivalent
MeasurementMethod	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
IHB Detection	Yes	Yes	Identical
PatientPopulation	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	Similar

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Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device
Item	Predicate Device	Digital Automatic Wrist Blood Pressure Monitor MD3200	Comment
Resolution of Measurement	Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min	Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min	Similar
Blood Pressure Measurement Accuracy	± 3 mmHg	± 3 mmHg	Identical
Pulse Rate Measurement Range	40 - 180 beats/min	40 - 180 beats/min	Identical
Pulse Rate Measurement Accuracy	± 5 % of the reading	± 5 % of the reading	Identical
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 Condition	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, batteries and packaging	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Identical
Compatibility with Environment and Other Devices	No influence with environment and other device	No influence with environment and other device	Identical
Applicable Standard	- 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 81060-2:2009	- ISO 81060-1:2007- 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 MD3200 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, an electric valve, an electronic control module, and 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.

Digital Automatic Wrist Blood Pressure Monitor MD3200

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K151587

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One hundred patients (45 males and 55 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 MD3200 has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:

ISO 81060-1:2007 <>
EN 1060-3:1997+A2:2009 や
IEC 60601-1:2012 <>
IEC 60601-1-2:2007 <>
や FCC Part 15 Subpart B
や ISO 10993-5:2009
や ISO 10993-10:2010
IEC 62304:2006 や

All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor MD3200 is same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor MD3200 is equivalent to the predicate device.

Conclusion 8.

Digital Automatic Wrist Blood Pressure Monitor MD3200 has the equivalent intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K142088). Moreover 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 MD3200 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).