The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 14 -52 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm.

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 your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Device Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual 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 uses a pressure 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 " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable.

AI/ML Overview

The provided FDA 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) includes information about clinical validation testing. However, it does not provide all the specific details requested regarding acceptance criteria, reported performance, and the full methodology of the study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a clinical validation was conducted in accordance with ISO 81060-2. This standard defines the accuracy requirements for automated non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, they are implicitly those outlined in ISO 81060-2.

The summary states: "Results were passing and the subject device was found to be substantially equivalent to the predicate device." This indicates that the device met the acceptance criteria defined by ISO 81060-2 for blood pressure measurement accuracy.

Therefore, for the table:

Acceptance Criteria (from ISO 81060-2)	Reported Device Performance
(Not explicitly detailed in document, but implies compliance with ISO 81060-2) For example, for systolic and diastolic BP: - Mean difference between device and reference: ≤ ±5 mmHg - Standard deviation of differences: ≤ 8 mmHg (These are examples from ISO 81060-2 and might not be the exact numbers used or reported if different versions of the standard apply, but the device must meet some such criteria)	"Results were passing"
Irregular Heartbeat Detection Accuracy (if applicable in ISO 81060-2 for this device type)	"The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected." (No specific accuracy metrics reported here, but functionally stated as working)

Acceptance Criteria (from ISO 81060-2)

Reported Device Performance

(Not explicitly detailed in document, but implies compliance with ISO 81060-2) For example, for systolic and diastolic BP: - Mean difference between device and reference: ≤ ±5 mmHg - Standard deviation of differences: ≤ 8 mmHg (These are examples from ISO 81060-2 and might not be the exact numbers used or reported if different versions of the standard apply, but the device must meet some such criteria)

"Results were passing"

Irregular Heartbeat Detection Accuracy (if applicable in ISO 81060-2 for this device type)

"The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected." (No specific accuracy metrics reported here, but functionally stated as working)

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

The document does not explicitly state the sample size used for the clinical validation in accordance with ISO 81060-2.

Sample Size: Not explicitly stated. ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution).
Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies for device clearance are almost always prospective.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

ISO 81060-2 typically requires measurements by multiple trained observers (e.g., at least two) to establish reference blood pressure readings using a standardized auscultatory method. These observers must be highly trained and follow strict protocols. Their qualifications are usually medical professionals with specific training in blood pressure measurement.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method.

In clinical validation according to ISO 81060-2, the reference blood pressure is typically determined by two independent observers. If there is a significant discrepancy between their readings, a third observer might be used, or the readings might be discarded. This can be considered a form of 2-or-3 observer consensus for ground truth establishment rather than a formal "adjudication" in the AI sense.

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

No. An MRMC comparative effectiveness study is not mentioned or described. The clinical validation appears to be a standalone accuracy study of the device against a reference method, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes. The clinical validation study described is a standalone performance study of the device (which includes its algorithm) against a reference method (auscultatory blood pressure measurement according to ISO 81060-2). The summary focuses on the device's ability to accurately measure blood pressure.

7. Type of Ground Truth Used

The ground truth for blood pressure measurement in this context is established by expert auscultatory measurements (often referred to as a "reference standard" or "gold standard") carried out by trained observers according to strict protocols defined by standards like ISO 81060-2.

8. Sample Size for the Training Set

The document describes the submission as a 510(k) for a medical device that uses an "oscillometric method" with an algorithm to define systolic and diastolic blood pressure. It states the device "uses the same algorithm" as a predicate device. This implies the algorithm was already developed and potentially refined using historical data.

However, the summary does not provide any information about the sample size used for training this underlying algorithm. This information is typically not included in a 510(k) summary unless the AI/ML algorithm itself is novel and part of the substantial equivalence claim, requiring specific validation of its training pipeline. In this case, it appears the algorithm is considered established.

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

Since no training set information is provided, how its ground truth was established is also not documented in this 510(k) summary. For a blood pressure algorithm, the training set would ideally consist of blood pressure recordings (oscillometric waveforms) paired with simultaneously taken auscultatory reference measurements.

Summary

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Public Health Service

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

December 16, 2015

Microlife Intellectual Property Gmbh Ms. Susan Goldstein-Falk Official Correspondent For Microlife Intellectual Property, Gmbh 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K153450

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 24, 2015 Received: November 30, 2015

Dear Ms. Susan Goldstein-Falk,

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

Mitchell Stei

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) K153450

Device Name

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort)

Indications for Use (Describe)

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)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

The assigned 510(k) number is:

1. Submitter's Identification:

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

Date Summary Prepared: November 24, 2015

Mr. Gerhard Frick Contact: 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 Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort)

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

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

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471, Microlife Intellectual Property GmbH.

4. Device Description:

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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 " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable.

5. Indications for Use:

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, ModelBP3MS1-4A (BP A200 Comfort) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 14 - 52 cm by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.

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):

The modified device model BP3MS1-4A (BP A200 Comfort) uses the same algorithm to determine the systolic and diastolic blood pressure and pulse rate. An upper arm cuff is inflated by an electrical pump, the inflation pressure is transferred via tubing to a sensor in the device.

Although the cuff used with the subject BP3MS1-4A(BP A200 Comfort) is changed to WRS conical cuff, it is the same with the one cleared in BP3GT1-6X, which was proved in K131346. The other differences also do not affect the accuracy and usability of the modified device based on the clinical declaration of identity and clinical testing comparing different functions.

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The nylon material used for the cuff (WRS Conical Cuff) is identical to the cuff material of the Microlife BP3GT1-6X, as it was approved in K131346 meets ISO 10993-1 requirements and does not need make biocompatibility test.

Based upon the aforementioned information, the two 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, ModelBP3MS1-4A (BP A200 Comfort) 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 1988 A1:1991 A21995
1. IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 3:2007-03
1. EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements 1995: Amendment 2, 2009
1. EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. 1997: Amendment 2, 2009
1. ISO 14971 Medical devices Application of risk management to medical devices.2007
1. AAMI/ANSI/ISO 10993-1-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 2010
1. AAMI/ANSI/ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity, 2009

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1. AAMI / ANSI / ISO 10993-10:2010, 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, 2013

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 BP3MS1-4A (BP A200 Comfort) tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

Clinical Validation Concerning the Compliance of ANSI/AAMI ISO 81060-2:

A clinical validation was conducted in accordance with ISO 81060-2 testing. Results were passing and the subject device was found to be substantially equivalent to the predicate device.

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 ".In addition, since our device requires the use of off-the-shelf software to operate the PC- link function, we adhered to the FDA September 1999 document "Guidance for Off-The- Shelf Software Use 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 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).