The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual 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. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Device Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B 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 use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert 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 with the reading. The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document is a 510(k) premarket notification for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. It briefly mentions non-clinical and clinical tests but does not provide the specific data points requested in the prompt.

Here's a breakdown of what is mentioned, and what is missing:

What is mentioned:

Non-Clinical Tests: The document states that testing was conducted in accordance with FDA guidance and various national and international standards (e.g., IEC 60601-1, AAMI/ANSI SP10, EN 1060-1, ISO 14971, AAMI/ANSI/IEC 80601-2-30). These standards typically define performance requirements and test methods for electrical safety, EMC, and blood pressure measurement accuracy.
Clinical Tests: It explicitly states that repeat clinical testing in accordance with ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B was not necessary. The justification is that the subject device is technically identical to the predicate device (BP3MC1-PC) in terms of its blood pressure measurement algorithm and program codes, meaning their performance should be identical.
Predicate Device: The clinical performance of the device is inferred from the performance of its predicate devices, specifically "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471". While the standards listed (like AAMI/ANSI SP10 and AAMI/ANSI/IEC 80601-2-30) define accuracy requirements, the document does not report the specific performance metrics of the predicate device or the subject device against these requirements.
Sample Size (Clinical): Not applicable for the subject device, as no new clinical study was performed.
Ground Truth (Clinical): Not directly applicable for a new clinical study. The implied ground truth would be from the clinical studies conducted for the predicate device, likely using auscultation by trained observers.

What is missing from the provided text to fulfill your request:

A table of acceptance criteria and the reported device performance: This is the most crucial missing piece. While standards like AAMI/ANSI SP10 and IEC 81060-2-30 are mentioned, which contain accuracy criteria (e.g., mean difference and standard deviation between device and reference measurements), the document does not report the actual performance of the device against these criteria. It only states that the device "met all relevant requirements."
Sample sized used for the test set and the data provenance: Not provided, as no new clinical study was documented for this submission. This information would be found in the original clinical validation for the predicate device(s).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This information would be part of the predicate device's clinical validation report.
Adjudication method: Not provided. This information would be part of the predicate device's clinical validation report.
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 a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone algorithm for blood pressure measurement. However, the specific performance metrics are not reported here.
The type of ground truth used: Implied to be auscultatory reference measurements by trained observers for the predicate device's clinical validation, as per standard blood pressure validation protocols (e.g., AAMI/ANSI/ISO 81060-2).
The sample size for the training set: Not applicable. This document pertains to the evaluation of a medical device, not the development of a machine learning model with a distinct training set. The "algorithm" here refers to the oscillometric measurement method.
How the ground truth for the training set was established: Not applicable.

In summary, the document leverages the concept of substantial equivalence by arguing that no new clinical data is needed because crucial components, especially the measurement algorithm, are identical to a previously cleared predicate device. Therefore, the detailed acceptance criteria and performance data for the subject device are not presented, but are implicitly covered by the predicate device's prior approval against relevant standards.

Summary

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

Microlife Intellectual Property Gmbh, Switzerland % Ms. Susan Goldstein-Falk Official Correspondent for Microlife Intellectual Property Gmbh mdi Consultants, Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021

K151869 Re:

Trade/Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 6, 2015 Received: July 9, 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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 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 vours.

Mitchell Stein

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K151869

Device Name

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B

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)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperw ork Reduction Act of 1995.

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510(k) SUMMARY

The assigned 5l0(k) number is:

1. Submitter's Identification:

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

Date Summary Prepared: July 2, 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 BP3NF1-2B

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

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

a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471, Microlife Intellectual Property GmbH.
b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (Twin200), K082357, Microlife Intellectual Property GmbH.

4. Device Description:

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The device detects the appearance of irregular heartbeat during measurement,

and the symbol " device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC

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

5. Indications for Use:

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual 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. The device can also be used in connection with 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):

The modified device model BP3NF1-2B and the predicate device model BP3MC1-PC use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically, deflation rate is controlled by one factory set exhaust valve and the deflation pressures are transferred via tubing to one sensor.

They differ by Bluetooth function. The subject device BP3NF1-2B is added the function of transferring the memory data to the smart phone via Bluetooth. However, this function is only a way to transfer the data and will not affect the clinical accuracy.

Although the cuff used with the subject BP3NF1-2B is changed to WRR conical cuff, it is the same with the one cleared in BP3AP1-3E, which was cleared in K111652.

The modified device model BP3NF1-2B uses the same oscillometric method as the predicate device WatchBP Office (Twin200). The have the function of transferring

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the memory data via Bluetooth. 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, Model BP3NF1-2B 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. AAMI/ANSI SP10 Manual, electronic, or automated sphygmomanometers 2002 (R) 2008, 2002 A1:2003
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 o 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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K151869

1. AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part
1. Tests for Irritation and skin sensitization, 2010
1. AAMI/ANSI/IEC 80601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive 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 BP3NF1-2B 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: The subject device Model BP3NF1-2B is from the technical point of view. identical to the predicate blood pressure monitor BP3MC1-PC. Moreover, the measurement algorithm and its program codes of BP3MC1-PC remain unchanged. The fundamental scientific technology of the modified BP3NF1-2B device is the same as the predicate device BP3MC1-PC. Therefore the performance of the BP3NF1-2B in terms of blood pressure measurement would be identical with performance of the predicate device BP3MC1-PC. Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B is therefore not necessary as clinical testing results were not affected by the changes to the subject modified 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 PClink 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).