The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W 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 upper arm for a circumference range from 22 to 52cm.

The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.

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 via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Device Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using 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 to define the systolic 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, and the symbol " "\\ "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (ANSI/AAMI/ISO 81060-2:2019)	Reported Device Performance (Microlife BP3KV1-5W, validated via BP3KT1-3N)
Blood Pressure Accuracy	Sphygmomanometer against auscultatory measurement: • Mean difference (device - reference) ≤ ± 5 mmHg. • Standard deviation of differences ≤ 8 mmHg. • For at least 85% of subjects, the absolute difference between device and average auscultatory readings must be ≤ 5 mmHg.	Passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard.
Pulse Rate Accuracy	± 5% of the reading	± 5% of the reading (stated as identical to BP3KT1-3N)
Pressure Resolution	1 mmHg	1 mmHg (stated as identical to BP3KT1-3N)
Measuring Range (SYS)	60-255 mmHg	60-255 mmHg (stated as identical to BP3KT1-3N)
Measuring Range (DIA)	40-200 mmHg	40-200 mmHg (stated as identical to BP3KT1-3N)
Measuring Range (Pulse)	40 to 199 beats per minute	40 to 199 beats per minute (stated as identical to BP3KT1-3N)
Overall Clinical Validation Outcome	Device passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard for accuracy.	Passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard.

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

The document states that a clinical study was conducted using the BP3KT1-3N (European Device) for validation. This study was a "prospective, open-label, non-randomized, single-center validation study." The study followed the ANSI/AAMI/ISO 81060-2:2019 test standard.

While the exact sample size for the test set is not explicitly stated in the provided text, the ANSI/AAMI/ISO 81060-2:2019 standard typically requires a minimum of 85 subjects for validation of blood pressure devices (as referenced in the acceptance criteria regarding absolute differences).

The data provenance is prospective, single-center, and from a European Device (BP3KT1-3N). The specific country is not mentioned beyond "European Device."

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. However, for a clinical validation study following the ANSI/AAMI/ISO 81060-2:2019 standard, the ground truth for blood pressure measurements is typically established by at least two trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, meticulously following standardized auscultatory procedures. These observers are usually trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. In clinical validation studies conforming to the ANSI/AAMI/ISO 81060-2 standard, when multiple observers are used for ground truth, a common adjudication method involves taking the average of the observers' readings, or in cases of significant discrepancy, a third observer might be used to mediate or resolve differences. The standard itself outlines specific requirements for how observer readings should be handled.

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 conducted. The provided information describes a clinical validation study for the device's accuracy against a reference standard, not a study comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done for the blood pressure measurement component. The clinical study for the BP3KT1-3N device validated its accuracy according to the ANSI/AAMI/ISO 81060-2:2019 standard. This standard assesses the device's ability to accurately measure blood pressure on its own, without direct human interpretation or modification of the measurement itself during the process (though a human activates the device and applies the cuff). The study concluded that "The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard," which is a testament to its standalone measurement accuracy.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation study was auscultatory measurement (reference sphygmomanometry). This is implied by the ANSI/AAMI/ISO 81060-2:2019 standard which compares the automated device's readings against a series of auscultatory measurements by trained observers.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. The clinical study mentioned is a validation study, which typically involves a separate set of subjects from any training data used for algorithm development.

9. How the 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, as details about the training process and data are not included.

Summary

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May 19, 2023

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: K222979

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 26, 2022 Received: September 28, 2022

Dear Vaibhav Rajal:

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.

Kenneth J. Cavanaugh -S

for

Robert Kazmierski Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality 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) K222979

Device Name

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3K V1-5W

Indications for Use (Describe)

The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.

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

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)

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Microlife Intellectual Property GmbH

Espenstrasse 139 9443 Widnau Switzerland

Tel: +41717277000 Fax: +41717277059

510(k) SUMMARY

The assigned 510(k) number is K222979

1. Submitter's Identification:

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

Date Summary Prepared: May 18, 2023

Contact: Mrs. Ariel Wang Global Regulatory Affairs & Quality management Director Microlife Intellectual Property GmbH, Switzerland Tel: 886-2-87971288 # 366 E-Mail: ariel.wanq@microlife.com.tw

2. Name of the Device:

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W

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

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

Primary Predicate:

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B, K153077, Microlife Intellectual Property GmbH.

Reference Predicate:

b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC), K183469, Microlife Intellectual Property GmbH.

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4. Device Description:

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

5. Indications for Use:

The Upper Arm Blood Pressure Monitor. Model BP3KV1-5W 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 upper arm for a circumference range from 22 to 52cm.

The device is suitable for use by adults, including adults with conditions of diabetes, preqnancy, or preeclampsia.

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

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

Based on information from the comparison chart:

The differences and changes are the microprocessor and firmware versions. The measurement algorithm and mechanism of operation, as well as the safety & essential performance of the devices remain identical before and after the changes.

The subject (Modified) device BP3KV1-5W uses the same oscillometric method as the predicate device BP3GX1-5X/3MW1-4B with the same fundamental scientific technology to determine the systolic and diastolic blood pressure and pulse rate. Cuff is inflated automatically by pump and the pressures are transferred via tubing to a sensor in these units.

The subject (Modified) device BP3KV1-5W and the predicate device BP3MW1-4B have traffic light function, IHD function, MAM function, Bluetooth function and DMT technology and the predicate device BP3GX1-5X have traffic light function, MAM function and DMT technology.

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The differences between these devices are:

1) Physical Dimension

The physical dimension of the subject device BP3KV1-5W is 157.5 x 105 x 61.5mm, while predicate device BP3GX1-5X is 85 x 143 x 58mm and predicate device BP3MW1-4B is 110 x 120 x 85mm. 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.

2) Display

The display of the Predicate device BP3MW1-4B is with touch pad; however, the display of the subject device BP3KV1-5W and the predicate device BP3GX1-5X is without touch pad. The functionality of the icons among the predicate devices (BP3MW1-4B and BP3GX1-5X) and subject device (BP3KV1-5W) are same, except that the subject device (BP3KV1-5W) has three additional icons representing the functions of Cuff fit check, My check and My BP.

3) Microprocessor

The microprocessor of the subject device BP3KV1-5W is R5F11NMEAFB, whereas the microprocessor of the predicate device BP3GX1-5X is R5F2LA8CANFP and predicate device BP3MW1-4B is C38D59GF. The microprocessors have different connection pin specifications, but the computing architectures are the same, but the computing architectures are the same. This difference does not affect performance and accuracy which was evaluated in the performance testing.

4) Sensor

The microprocessor of the subject device BP3KV1-5W is semiconductor sensor, whereas the microprocessor of the predicate device BP3GX1-5X and predicate device BP3MW1-4Bare capacitive sensor. Their calculation algorithms are the same. But the type of sensor is different. It does not affect performance and accuracy which was evaluated in the performance testing.

5) Cuff Fit Check Function

The subject device BP3KV1-5W has the cuff fit check function, whereas the predicate device BP3GX1-5X/3MW1-4B 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.

6) 28 Days Average Function

The subject device BP3KV1-5W has the 28 days average function. whereas the predicate device BP3GX1-5X/3MW1-4B does not have the function. The 28days average function is an indication of the blood pressure level of the most recent 4 weeks. This stands for the average of measurement values from the last 28 days, so this doesn't affect the clinical test.

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7) MyCheck Function

The subject device BP3KV1-5W has the MyCheck function, whereas the predicate device BP3GX1-5X/3MW1-4B does not have the function. The MyCheck function displays a qualitative comparison of the most recent measurement versus the 4-week measurement average (stored in memory), to provide an immediate, simplified indication whether the current measurement is similar, above or below the 4-week average, without additional operations.

8) MvBP Function

The subject device BP3KV1-5W has the MyBP function, whereas the predicate device BP3GX1-5X/3MW1-4B does not have the function. The MyBP function shows an averaged value, which includes only readings taken in the morning or evening of the most recent 3 to 7 days for computation, per clinical guideline suggestion. The value is displayed only when sufficient number of readings meeting the criteria (below) have been obtained, to provide a more clinically relevant average. If data in the memory are insufficient, it is not displayed. This function is based on the measured data, so this doesn't affect the clinical test.

Based upon the aforementioned information, the three devices 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 Upper Arm Automatic Digital Blood Pressure Monitor. Model BP3KV1-5W 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 Notification Submissions", 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 devices:

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 to medical devices.
1. AAMI/ANSI//ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices Part 1: Evaluation And Testing Within A Risk Management Process.
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/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, 2018
1. AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity
1. IEC 60601-1-11:2015 Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical

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Electrical Equipment And Medical 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 Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W tested met all relevant requirements of the aforementioned tests

8. Discussion of Clinical Tests Performed:

The proposed subject Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W device uses the same deflation valve and sensor as BP3KT1-3N (European Device). Below is a comparison between the proposed BP3KV1-5W device and the BP3KT1-3N European Device:

Item	BP3KT1-3N European device	Proposed Subject BP3KV1-5W device	Similar or Different
Indications for Use	This oscillometric blood pressuremonitor is intended for measuringnon-invasive blood pressure inpeople aged 12 years or older.It is clinically validated in patients withhypertension, hypotension, diabetes,pregnancy, pre-eclampsia,atherosclerosis, end-stage renaldisease, obesity and the elderly.The device can detect an irregularpulse suggestive of Atrial Fibrillation(AF). Please note that the device isnot intended to diagnose AF. Adiagnosis of AF can only beconfirmed by ECG. The patient isadvised to see a physician.Note: Content above from the CEMark version IFU.This device is indicated for cuffscovering the upper armcircumference range from 17 to 52cm(refer to"Accessories").	The Upper Arm Blood PressureMonitor, Model BP3KV1-5W is adevice intended to measure thesystolic and diastolic blood pressureand pulse rate of an adult individual byusing a non-invasive oscillometrictechnique in which an inflatable cuff iswrapped around the upper arm for acircumference range from 22 to 52cm.The device is suitable for use byadults, including adults with conditionsof diabetes, pregnancy, orpre-eclampsia.The device detects the appearance ofirregular heartbeat duringmeasurement and gives a warningsignal with the reading once theirregular heartbeat is detected.The device can be used in connectionwith a smart phone via Bluetooth orwith a personal computer (PC) viaUSB. The measurement data can betransferred to a smart phone runningthe Microlife Connected Health+mobile software (App) or a PC runningthe Microlife BPAnalyzer+ (BPA+) software	Different
DeviceTechnology	Oscillometric method	Oscillometric method	√
MeasuringLocation	Upper Arm	Upper Arm	√
Appearance (ID Design)			Different

Physical Dimension	138 x 94.5 x 62.5 mm	157.5mm x 105mm x 61.5mm	Different
Microprocessor	HY16F198B1. Hycon IC2. Main clock frequency: 16 MHz3. Sub clock frequency:32.768 kHz4. System voltage level: 3.3 V5. Pressure sensor type:Semiconductor Sensor6. The amount of MCU pins: 100pins(package type)	R5F11NMEAFB1. Renesas MCU core2. Main clock frequency: 16 MHz3. Sub clock frequency: 32.768 kHz4. System voltage level: 3.3 V5. Pressure sensor type:Semiconductor Sensor6. The amount of MCU pins: 80 pins	Different
Sensor	Semiconductor sensor	Semiconductor sensor	√
Deflation Valve	Electromechanical solenoid valve	Electromechanical solenoid valve	√
Algorithm	1. Blood pressure algorithm: Upperarm for deflation measurement2. Signal filter: FIR filter3. Algorithm: Oscillometricmeasurement4. Irregular heart beat detection: Yes	1. Blood pressure algorithm: Upperarm for deflation measurement2. Signal filter: FIR filter3. Algorithm: Oscillometricmeasurement4. Irregular heart beat detection: Yes	√
Display	Digital liquid crystal display (WithoutTouch pad)	Digital liquid crystal display (WithoutTouch pad)	Different
Pressure andPulse RateAccuracy	Pressure within ± 3 mmHg or 2% ofreading >200mmHg Pulse ± 5 % ofthe reading	Pressure within ± 3 mmHg or 2% ofreading >200mmHg Pulse ± 5% of thereading	√
MeasuringRange	SYS: 60-255 mmHgDIA: 40-200 mmHgPulse: 40 to 199 beats per minute	SYS: 60-255 mmHgDIA: 40-200 mmHgPulse: 40 to 199 beats per minute	√
PressureResolution	1mm Hg	1mm Hg	√
Cuff DisplayRange	O to 299mm Hg	O to 299mm Hg	√
Power Source	4 AA batteries,Or AC adapter 6 V DC 600 mA	4 AA batteries,Or AC adapter 6 V DC 600 mA	√
Low BatteryVoltageDetection	YES	YES	√
Atrial FibrillationDetection	YES	NO	Different
User	1	2	Different
LastMeasurementRecall	1X99 sets	2X99 sets	Different
BeeperIndication	NO	YES	Different
IrregularHeartbeatDetectionFunction	YES	YES	√
Traffic LightFunction	YES	YES	√
MAM Function	YES	YES	√
PC-link function	NO	YES	Different
Blood PressureAnalyzerSoftware	NO	YES	Different
Cuff Fit CheckFunction	YES	YES	√
MyCheckFunction	NO	YES	Different
MyBP Function	NO	YES	Different
Display Backlight	NO	YES	Different
AC/DC AdaptorCompatible	YES	YES	√
28 Day MemoryDay Average	NO	YES	Different
All MemoryAverage	YES	No	Different
BluetoothFunction	NO	Yes. Using Bluetooth(4.2) to connectwith the smart mobile devices runningthe APP	Different
Operation Range	+10°Cto +40°Cat RH 15% to 90%	+10°Cto +40°Cat RH 15% to 90%	√
Storage Range	-20°Cto +55°Cat RH 15% to 90%	-20°Cto +55°Cat RH 15% to 90%	√
Life Time	At least 10000 times of operation	At least 10000 times of operation	√
Cuff Material	Nylon cuff fabric	Nylon cuff fabric	√
Accessories	Standard:M-L size (wide range) cuff forcircumference 22-42cmCarrying PunchSpecial (Optional)1. S size cuff for arm circumference17-22cm2. M size cuff for arm circumference22-32cm3. L size cuff for arm circumference32-42cm4. L-XL size cuff for armcircumference 32-52cm5. Adapter (out 6V DC/600 mA)	Standard:Wide range cuff for circumference22-42cm USB (A to mini B) cableCarrying PunchSpecial (Optional)1. L-XL size cuff for arm circumference32-52cm2. Adapter (out 6V DC/600 mA)	Different

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microlife

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microlife

That said, we are supporting our clinical testing with using the clinical study validation conducted on the BP3KT1-3N (European Device).

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The AIM of the clinical study conducted using the BP3KT1-3N was validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 test standard. This is a prospective, open-label, non-randomized, single-center validation study following ANSI/AAMI/ISO 81060-2:2019 test standard.

Conclusion: The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard.

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 and clinical tests demonstrate that the subject device is as safe, effective, and performs as well as the predicate devices.

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).