The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Device Description

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

AI/ML Overview

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like accuracy for the subject device (Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B).

Instead, it states that:

The subject device is considered "identical" to a predicate device (BP3NN1-3E, K151330) from a clinical validation standpoint for blood pressure measurement.
Therefore, "no repeated clinical testing was required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."

To answer the request fully, the clinical validation study for the predicate device (BP3NN1-3E, K151330) would need to be reviewed. The provided document points to "AAMI / ANSI/IEC81060-2" as the standard for clinical validation, but it does not detail the specific results for the predicate or subject device against those criteria within this submission.

Therefore, I cannot populate the table or answer all the sub-questions directly from the provided text for the subject device.

However, I can extract the general accuracy criteria typically expected for such devices, as mentioned in the comparison table for Pressure and Pulse Rate Accuracy, which is shared between the subject device and Predicate device No.1.

Here's what can be extracted based on the provided text's limited information regarding performance for the subject device, and an acknowledgement of assumptions made based on shared specifications with the predicate device:

Acceptance Criteria and Device Performance (Based on shared specifications with Predicate Device No.1, as a clinical study was not performed on the subject device due to substantial equivalence claim):

There is no specific clinical study detailed for the subject device (BP3GK1-4B) in this document to prove it meets acceptance criteria, as the manufacturer claims substantial equivalence to a predicate device (BP3NN1-3E, K151330) and leverages its clinical validation. The acceptance criteria listed below are common performance specifications for such devices, and for this submission, the subject device is considered to meet these based on its substantial equivalence to the predicate device which presumably met these in its own 510(k) submission (K151330).

1. Table of Acceptance Criteria and the Reported Device Performance (for clinical accuracy)

Acceptance Criteria (from Predicate Device No.1, presumed for subject device)	Reported Device Performance (for Subject Device BP3GK1-4B)
Pressure Accuracy: Within ± 3 mmHg or 2% of reading > 200mmHg	Pressure Accuracy: Within ± 3 mmHg or 2% of reading > 200mmHg (claimed identical to Predicate No.1)
Pulse Accuracy: ± 5 % of the reading	Pulse Accuracy: ± 5 % of the reading (claimed identical to Predicate No.1)

2. Sample size used for the test set and the data provenance:

Not provided for the subject device (BP3GK1-4B). The document explicitly states: "There was no repeated clinical testing required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."
To obtain this information, the 510(k) submission K151330 for the predicate device BP3NN1-3E would need to be reviewed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Blood pressure monitor validation studies typically involve comparison against reference measurements taken by trained operators.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Standards like AAMI/ANSI/IEC 81060-2 specify requirements for comparing automated blood pressure measurements against auscultatory measurements by human observers.

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:

Not applicable. This device is an automated blood pressure monitor for direct blood pressure and pulse rate measurement, not an AI-assisted diagnostic tool for human readers. It does not involve "human readers" in its primary function for diagnosis, but rather provides direct readings to the user.

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

Yes, implicitly. The device operates standalone to provide blood pressure readings. The claim of substantial equivalence for blood pressure measurement performance means the device's algorithm performs its intended function without human intervention in the measurement process itself. The clinical validation referenced by the predicate (K151330) against the AAMI / ANSI/IEC81060-2 standard would have assessed this standalone performance against reference measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Presumed to be reference blood pressure measurements. For blood pressure monitors, the ground truth is typically established using a reference method, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or another validated reference device, following international standards like AAMI/ANSI/IEC 81060-2.

8. The sample size for the training set:

Not applicable / Not provided. For a hardware device with an embedded algorithm like this, there isn't typically a "training set" in the machine learning sense for the end-user product. The algorithm development may have involved internal data for calibration and optimization, but this is distinct from a clinical validation "test set." The document does not provide details on algorithm development data.

9. How the ground truth for the training set was established:

Not applicable / Not provided. (See point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

November 4, 2021

Microlife Intellectual Property GmbH % Vaibhav Rajal Official Correspondent for Microlife Intellectual Property GmbH mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K211288

Trade/Device Name: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 28, 2021 Received: October 6, 2021

Dear Vaibhav Rajal:

We have reviewed vour 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.

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

{1}------------------------------------------------

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,

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K211288

Device Name

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B

Indications for Use (Describe)

The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

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

X 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 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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

K211288

510(k) SUMMARY

The assigned 510(k) number is K211288

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: November 2, 2021

Contact: Mr. Gerhard Frick Vice President of Technical and Service Microlife Intellectual Property GmbH, Switzerland Tel: +41 79 216 0070 E-Mail: gerhard.frick@microlife.ch

2. Name of the Device:

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B

Regulation Number: 21 CFR Part 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN

Information for the 510(k) Cleared Device (Predicate Device): 3.

1. Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E, K151330, Microlife Intellectual Property GmbH.
1. Omron Wrist Blood Pressure Monitor Model BP4350, K182166, Omron Healthcare, Inc.

4. Device Description:

The device detects the appearance of irregular heartbeat during measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

ഗ് Indications for Use:

{4}------------------------------------------------

detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

6. Comparison to the 510(k) Cleared Device (Predicate Device):

Microlife Wrist Watch Blood Pressure Monitor BP3GK1-4B has been compared to the "Microlife Wrist Watch Blood Pressure Monitor BP3NN1-3E, K151330" & "Omron Wrist Blood Pressure Monitor BP4350, K182166" as reference for substantial equivalence. A table comparing the predicate device to the subject device, BP3GK1-4B, is shown as the following:

ltem	Predicate device No.1:Microlife Wrist Watch BPMBP3NN1-3E,Microlife IntellectualProperty GmbHK151330	Predicate device No.2:Omron Wrist Blood PressureMonitor Model BP4350,Omron Healthcare, Inc.K182166	Modified device:Microlife Wrist Watch BPMBP3GK1-4B,Microlife Intellectual PropertyGmbH	SimilarorDifferent
Indications forUse	The Wrist Watch BloodPressure Monitor, ModelBP3NN1-3E is a deviceintended to measure thesystolic and diastolic bloodpressure and pulse rate of anadult individual by using anon-invasive oscillometrictechnique in which aninflatable cuff is wrappedaround the wrist for acircumference range from13.5 to 21.5cm.	The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient populationwith wrist circumferenceranging from 5.3 inches to 8.5inches (13.5cm to 21.5cm).	The Wrist Watch BloodPressure Monitor, ModelBP3GK1-4B is a deviceintended to measure thesystolic and diastolic bloodpressure and pulse rate of anadult individual by using a non-invasive oscillometrictechnique in which aninflatable cuff is wrappedaround the wrist for acircumference range from 13.5to 21.5cm.	Similar
	The device detects theappearance of irregularheartbeat duringmeasurement and gives awarning signal with thereading once the irregularheartbeat is detected.	The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal with readings.	The device detects theappearance of irregularheartbeat during measurementand gives a warning signal withthe reading once the irregularheartbeat is detected.The device can be used inconnection with a smart phonerunning the APP. The memorydata can be transferred to thesmart phone via Bluetooth.
DeviceTechnology	Oscillometric method	Oscillometric method	Oscillometric method	identical
MeasuringLocation	Wrist	Wrist	Wrist	identical

{5}------------------------------------------------

Appearance (IDdesign)				different
Item	Predicate device No.1:Microlife Wrist Watch BPMBP3NN1-3E,Microlife IntellectualProperty GmbHK151330	Predicate device No.2:Omron Wrist Blood PressureMonitor Model BP4350,Omron Healthcare, Inc.K182166	Modified device:Microlife Wrist Watch BPMBP3GK1-4B,Microlife Intellectual PropertyGmbH	SimilarorDifferent
Microprocessor	MB95F718J1. Fujitsu MCU core2. Main clock frequency: 8MHz3. Sub clock frequency:32.768 kHz4. System voltage level: 3.3V5. Pressure sensor type:Semiconductor sensor6. The amount of MCU pins:80 pins	N/A	HY16F198B1. HYCOM MCU core2. Main clock frequency: 8 MHz3. Sub clock frequency: 32.768kHz4. System voltage level: 3.3V5. Pressure sensor type:Semiconductor sensor6. The amount of MCU pins:100 pins	different
Sensor	Semiconductor sensor	Semiconductor sensor	Semiconductor sensor	identical
F/W reversionof Algorithm	FK51. Blood pressure algorithm:Wrist for inflationmeasurement2. Signal filter: FIR filter3. Algorithm: Oscillometricmeasurement4. Irregular heart beatdetection: IHD	N/A	yi21. Blood pressure algorithm:Wrist for inflationmeasurement2. Signal filter: FIR filter3. Algorithm: Oscillometricmeasurement4. Irregular heart beatdetection: IHD	different
SignalDetectionTechnology	Detect electrical signals whileinflating(called "IMT" technology)	Detect electrical signals whileinflating	Detect electrical signals whileinflating(called "IMT" technology)	identical
Display	Digital liquid crystal displayImage: TIME PM 38-88MONTH-DAY18881888188M 188	Digital liquid crystal displayImage: THIS WEEKAM38%88288High288OK off	Digital liquid crystal displayImage: 28:8888.8888188	different
		K211288
Pressure andPulse RateAccuracy	Pressure within ± 3 mmHg or2% of reading >200mmHgPulse ± 5 % of the reading	Pressure within ± 3 mmHgPulse ± 5 % of the reading	Pressure within ± 3 mmHg or2% of reading >200mmHgPulse ± 5 % of the reading	identicalto No.1
Item	Predicate device No.1:Microlife Wrist Watch BPMBP3NN1-3E,Microlife IntellectualProperty GmbHK151330	Predicate device No.2:Omron Wrist Blood PressureMonitor Model BP4350,Omron Healthcare, Inc.K182166	Modified device:Microlife Wrist Watch BPMBP3GK1-4B,Microlife Intellectual PropertyGmbH	SimilarorDifferent
MeasuringRange	SYS/DIA: 30 to 280 mmHgPulse: 40 to 200 per minutes	SYS: 60 to 260 mmHg DIA: 40to 215 mmHgPulse: 40 to 180 per minutes	SYS: 60-255 mmHg DIA: 40-200 mmHg40 to 199 per minute	different
PressureResolution	1mmHg	1mmHg	1mmHg	identical
Cuff DisplayRange	0 to 299mmHg	0 to 299mmHg	0 to 299mmHg	identical
Power Source	2 Batteries, size AAA 1.5V	2 Batteries, size AAA 1.5V	2 Batteries, size AAA 1.5V	identical
Low BatteryVoltageDetection	Yes	Yes	Yes	identical
User	2	2	2	identical
LastMeasurementRecall	2*60 sets	2*100 sets	2*100 sets	identicalto No.2
BeeperIndication	Yes	No	Yes	identicalto No.1
IrregularHeartbeatDetectionFunction	Yes	Yes	Yes	identical
Traffic LightFunction	Yes	Yes (Hypertension Indicator)	Yes	identical
MAM function	No	No	Yes	different
Wrist PositionCheck function	No	Yes (Heart Zone Indicator)	Yes	identicalto No.2
Cuff fit checkfunction	No	Yes (Cuff Wrap Guide)	Yes	different
MyCheckfunction	No	No	Yes	different
MyBP function	No	No	Yes	different
AM/PMAverage StoredFunction	No	Yes (Morning Averages)	Yes	different
Bluetoothfunction	No	Yes	Yes Using Bluetooth(4.2)	identicalto No.2
Item	Predicate device No.1:Microlife Wrist Watch BPMBP3NN1-3E,Microlife IntellectualProperty GmbHK151330	Predicate device No.2:Omron Wrist Blood PressureMonitor Model BP4350,Omron Healthcare, Inc.K182166	Modified device:Microlife Wrist Watch BPMBP3GK1-4B,Microlife Intellectual PropertyGmbH	SimilarorDifferent
	Property GmbHK151330	K182166	GmbH
Operation Range	+10°Cto +40°Cat RH 15% to 90%	+10°Cto +40°Cat RH 15% to 90%	+10°Cto +40°Cat RH 15% to 90%	identical
Storage Range	-20°Cto +55°Cat RH 15% to 90%	-20°Cto +60°Cat RH 10% to 90%	-20°Cto +55°Cat RH 15% to 90%	identical to No.1
Life Time	At least 10000 times of operation	5 years	At least 10000 times of operation	identical to No.1
Cuff material	Flannelette cuff clothPVC bladder		Flannelette cuff clothPVC bladder	identical to No.1
Accessories	Necessary :	Necessary :	Necessary :
	Cuff for wrist circumference13.5-21.5cmAAA batteriesInstruction manualGift box	Cuff for wrist circumference13.5-21.5cmAAA batteriesInstruction manualGift box	Cuff for wrist circumference13.5-21.5cmAAA batteriesInstruction manualGift box	Similar

{6}------------------------------------------------

{7}------------------------------------------------

The subject (Modified) device BP3GK1-4B uses the same oscillometric method as the predicate device No.1 BP3NN1-3E with the same fundamental scientific technology to determine the systolic and diastolic blood pressure and pulse rate. Wrist cuff is inflated automatically by pump and the pressures are transferred via tubing to a sensor in these two units. The Wrist Position is identical technology to predicate device No.2 Omron BP4350 with an accelerometer to measure the arm in relation to the table.

The subject (Modified) device No.1 BP3GK1-4B and the predicate device BP3NN1-3E both have traffic light function, IHD function, and IMT technology. The differences between the devices are:

1. Indications for Use

The subject device BP3GK1-4B and predicate device BP3NN1-3E both are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique. The differences between subject device and predicate device both are the bluetooth function and wrist circumference. The subject device can be used in connection with a smart phone running the APP and the memory data can be transferred to the smart phone via Bluetooth. However, this function is only a way to transfer the data and does not affect the effectiveness and safety. It does not affect the effectiveness according to the essential performance testing.

2. Physical Dimension

The physical dimension of the subject device BP3GK1-4B is 81 x 65 x 21mm, while predicate device BP3NN1-3E is 75 x 63 x 20mm. The difference is caused because of their different appearance, but the difference does not raise any new safety and effectiveness questions. This has been tested and confirmed according to IEC 60601-1-2 EMC Test Report, IEC 60601-1, AAMIANSI ES60601-1 Safety Test Report and IEC 80601-2-30 Test Report.

3. Microprocessor

The microprocessor of the subject device BP3GK1-4B is HY16F198B, whereas the microprocessor of the predicate device BP3NN1-3E is MB95F718J. Their calculation algorithms are the same. But the amount of MCU pins is different. It does not affect performance and accuracy which was evaluated in the performance testing.

4. Algorithm

The algorithm of subject device BP3GK1-4B is yi2, while predicate device BP3NN1-3E is FK5. The only difference is the algorithm version, because these two models have different microprocessor. However, their calculation algorithm is the same. It does not affect performance and accuracy which was evaluated in the performance testing.

{8}------------------------------------------------

5. Display

The subject device BP3GK1-4B and predicate device BP3NN1-3E both have digital liguid crystal display. The only difference is the UI, because these two models have different ID design. It does not affect the effectiveness according to the essential performance testing.

6. Measuring Range

The measurement range between the subject (Modified) device BP3GK1-4B and the predicate device BP3NN1-3E is different. The subject device has a smaller measuring range. This does not affectiveness according to the essential performance testing. It does not introduce any new risk to the device.

7. Last Measurement Recall

The subject device BP3GK1-4B can store 100 results per a user, while the predicate device BP3NN1-3E can store 60 results per a user. The subject device just has a greater storage capacity, so this doesn't affect the clinical test.

8. MAM function

The subject device BP3GK1-4B has the MAM function, whereas the predicate device BP3NN1-3E does not have the function. The MAM function is to give a simple average result based on three measurements are taken. This function is based on the measured results, so this doesn't affect the clinical test.

9. Wrist Position Check function

The subject device BP3GK1-4B has the Wrist Position Check function, whereas the predicate device BP3NN1-3E does not have the function. This function will be compared with predicate device No.2 Omron BP4350 in following section.

10. Cuff fit check function

The subject device BP3GK1-4B has the cuff fit check function, whereas the predicate device BP3NN1-3E does not have the function. The cuff fit check function is to check pulse strength during measurement, and indicates if pulse strength is OK. If pulse is too weak, nothing is indicated. This function is just a reference for properly wearing the cuff and does not affect the accuracy and efficacy of the use according to the clinical and essential performance testing, so it does not affect the safety or effectiveness.

11. AM/PM Average Stored Function

The subject device BP3GK1-4B has the AM/PM average stored function, whereas the predicate device BP3NN1-3E does not have the function. The AM/PM average stored function is to give an average result based on AM or PM measurements are taken. This function is based on the measured data, so this doesn't affect the clinical test.

12. MyCheck function

The subject device BP3GK1-4B has the MyCheck function, whereas the predicate device BP3NN1-3E does not have the function. The MyCheck function is to compare the systolic blood pressure values from current measurement to the average of Systole & Diastole values in memory from the past 28 days. This function is based on the measured data, so this doesn't affect the clinical test.

13. MyBP function

The subject device BP3GK1-4B has the MyBP function, whereas the predicate device BP3NN1-3E does not have the function. The MyBP function is to take blood pressure values from mornings of a period between 3 and 7 days (depending on number of measurements taken) to provide an average blood pressure level. This function is based on the measured data, so this doesn't affect the clinical test.

{9}------------------------------------------------

14. Bluetooth function

The subject device BP3GK1-4B has the Bluetooth function, whereas the predicate device BP3NN1-3E does not have the function. This function is only a way to transfer the data and is based on the measured data, so it does not affect effectiveness and safety according to the performance testing and safety testing.

15. Accessories

The subject (Modified) device BP3GK1-4B and the predicate device No.2 Omron BP4350 both have Wrist Position Check function. The only difference of this feature between the devices is the symbols displayed on LCD screen. The acceptable range of angle of the arm in relation to the instruction in IFU between two devices are identical.

Based upon the aforemention, the subject (Modified) device BP3GK1-4B and predicate device No.1 BP3NN1-3E & device No.2 Omron BP4350 are substantially equivalent.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-48 in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notifications", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate device:

The following National and International Standards were utilized for testing the subject device:

1. IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R) 2012
1. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements And Tests.
1. ISO 14971: 2007 Medical devices Application of risk management of medical devices.
1. AAMI/ANSI/ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation And Testing Within A Risk Management Process.
1. AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity.
1. AAMI / ANSI / ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
1. AAMI/ANSI/ISO 10993-12: 2012, Biological evaluation of medical devices Part 12: Sample preparation and reference materials
1. AAMI/ANSI/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, 2013
1. IEC 60601-11:2015 Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical

{10}------------------------------------------------

K211288

Electrical Systems Used In The Home Healthcare Environment

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

From a clinical validation standpoint, the subject device is identical to the 510(k) cleared predicate device, BP3NN1-3E, K151330, in blood pressure measurement.

Regarding clinical validation concerning the compliance of ANSI/AAMI/IEC 81060-2, the subject blood pressure monitor Model BP3GK1-4B is from a technical point of view, identical to the predicate blood pressure monitor Model BP3NN1-3E.

The subject device BP3GK1-4B and the predicate device BP3NN1-3E both intended to measure systolic and diastolic blood pressures, pulse rate for use in an adult. And they both detect the appearance of irregular heartbeat during measurement and give a warning signal with the reading once the irregular heartbeat is detected.

The differences between the two models are addressed in VOL 5, 001 Comparison Chart. According to the information from the comparison chart, all the differences listed in the comparison chart do not affect the accuracy and normal use of this device because they use the same firmware of algorithm and fundamental scientific technology. Therefore the performance of BP3GK1-4B in terms of blood pressure measurement would be essential equivalent with performance of the predicate device BP3NN1-3E. There was no repeated clinical testing required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330. Repeat clinical testing in accordance with the standard AAMI / ANSI/IEC81060-2 for the subject device BP3GK1-4B regarding blood pressure measurement for use in adults is therefore not warranted.

9. Software information:

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

10. Conclusions:

Conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, effective, and performs as well as 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).