The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP).

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 accurately measure in pregnant patients including those with known or suspected preeclampsia.

Device Description

ProBP 2400 Digital Blood Pressure Device is designed to measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure (MAP) 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 can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device has 1x, 3x, and MANUAL measurement modes and has irregular heartbeat detection function, inflation pressure setting function, measurement intervals setting function etc.

The 1x mode is selected to perform single blood pressure measurement of patients.

The 3x mode is selected to complete a fully-automated triple measurements. Taking fewer than three measurements can be stopped by pressing the Start/Stop button.

The MANUAL mode is selected for blood pressure measurement of patients to confirm if a patient is suitable for the oscillometric method.

AI/ML Overview

The provided document is a 510(k) summary for the Microlife ProBP 2400 Digital Blood Pressure Device. It discusses the device's technical specifications, intended use, and substantial equivalence to predicate devices, supported by non-clinical and clinical testing.

Here's the information requested based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document bases its acceptance on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. Specific numerical acceptance criteria for BP measurement accuracy are not explicitly detailed for the ProBP 2400 itself in this summary, but rather referenced through compliance with standards and equivalence to a clinically validated predicate.

Acceptance Criterion (Implicit based on Standards)	Reported Device Performance (via Equivalence & Standards Adherence)
Blood Pressure Measurement Accuracy (General, for non-invasive sphygmomanometers)	The device is from the technical point of view, identical to predicate device Model WatchBP Office Afib (TWIN200 AFS). The measurement algorithm remains unchanged. Complies with ANSI/AAMI ISO 81060-2 (Blood Pressure Measurement Accuracy) via clinical validation results of the predicate device.
Blood Pressure Measurement Accuracy in Pregnant/Preeclamptic Patients	The accuracy measurement in pregnancy and pre-eclampsia for the ProBP 2400 is from the technical point of view, identical to what is utilized in predicate device Model BP3MW1-4X(R). The clinical test report of BP3MW1-4X(R), K140572 in pregnancy and preeclampsia, is applicable.
Safety and Essential Performance (Electrical, Mechanical, Environmental)	Demonstrated through reliability testing (storage, operating, vibration, drop, life testing) and compliance with various IEC, AAMI/ANSI, and EN standards (IEC 60601-1, IEC 60601-1-2, AAMI/ANSI SP10, EN 1060-1, EN 1060-3, ISO 14971, AAMI/ANSI/ISO 10993-1-1, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10, AAMI/ANSI/IEC 80601-2-30). No design characteristics violated requirements or resulted in safety hazards.
Software Validation (for Software Contained in Medical Devices and Off-The-Shelf Software)	Software validation conducted in accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (November 2005) and "Guidance for Off-The-Shelf Software Use in Medical Devices" (September 1999) for the PC-link function.
Irregular Heartbeat Detection Function	The device detects the appearance of irregular heartbeat during measurement and gives a warning signal. (Details of accuracy for IHD not quantified in this summary, but the function is part of the device's capabilities).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for BP Measurement Accuracy (General): Not explicitly stated for the ProBP 2400 itself, as it relies on the clinical validation of a predicate device (WatchBP Office Afib(TWIN200 AFS)) in accordance with ANSI/AAMI IEC 81060-2. The standard mandates specific minimum sample sizes per demographic group.
Sample Size for BP Measurement Accuracy in Pregnant/Preeclamptic Patients: Not explicitly stated for the ProBP 2400 itself, as it relies on the clinical test report of predicate device Model BP3MW1-4X(R). This clinical test determined the accuracy in pregnancy and pre-eclampsia.
Data Provenance: Not specified in this document. The manufacturer is Microlife Intellectual Property GmbH, Switzerland.

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

This information is not provided in the supplied text. The document refers to compliance with standards like ANSI/AAMI IEC 81060-2, which dictates methodology for validation studies including reference measurements, but does not detail the personnel involved in establishing ground truth for the predicate device studies.

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

This information is not provided in the supplied text. Adjudication methods are typically part of detailed clinical study protocols, which are not fully reproduced here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation. Its function is to provide direct measurements.

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

Yes, in essence, standalone performance was assessed through the clinical validation of its predicate devices. The device's performance, being "identical" to its predicate devices in terms of its measurement algorithm, means its standalone accuracy was established by the predicate devices adhering to standards like ANSI/AAMI IEC 81060-2. This standard focuses on the accuracy of the automated device against reference measurements, which is an assessment of its "algorithm only" performance.

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

For blood pressure measurement accuracy (general and in special populations), the ground truth in studies adhering to standards like ANSI/AAMI IEC 81060-2 is typically established by simultaneous or near-simultaneous measurements by trained observers using a reference standard (e.g., auscultatory mercury sphygmomanometer). This is a form of expert reference measurement, but not "expert consensus" in the sense of multiple experts interpreting an image.

8. The sample size for the training set:

Not applicable / Not provided. The document describes a medical device, not an AI/Machine Learning model that would typically have a distinct "training set." The oscillometric algorithm for blood pressure measurement is a well-established technique. If any embedded software was developed using machine learning, the details are not included here. The "training" for such devices is based on established physiological models and statistical methods validated through clinical studies.

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

Not applicable / Not provided. See explanation for point 8.

Summary

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

April 21, 2015

Microlife Intellectual Property GmbH c/o Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd. Ste 200 Great Neck, NY 11021

Re: K143341

Trade/Device Name: ProBP 2400 Digital Blood Pressure Device Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 12, 2015 Received: March 13, 2015

Dear Ms. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Susan D. Goldstein-Falk

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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

forBram 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) K143341

Device Name ProBP 2400 Digital Blood Pressure Device

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.

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

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)

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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510(k) SUMMARY

The assigned 5l0(k) number is: K143341

1. Submitter's Identification:

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

Date Summary Prepared: April 10, 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:

ProBP 2400 Digital Blood Pressure Device

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 WatchBP Office Afib(TWIN200 AFS), K101275, Microlife Intellectual Property GmbH.
b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R), K140572, Microlife Intellectual Property GmbH.

4. Device Description:

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The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device has 1x, 3x, and MANUAL measurement modes and has irregular heartbeat detection function, inflation pressure setting function, measurement intervals setting function etc.

The 1x mode is selected to perform single blood pressure measurement of patients.

The 3x mode is selected to complete a fully-automated triple measurements. Taking fewer than three measurements can be stopped by pressing the Start/Stop button.

The MANUAL mode is selected for blood pressure measurement of patients to confirm if a patient is suitable for the oscillometric method.

5. Intended Use:

The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric Technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP).

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

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

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

The modified device model ProBP 2400 and the predicate device model WatchBP Office Afib(TWIN200 AFS) 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 the intended use, early preeclampsia detection function, dual-arm must be measured simultaneously in SCREEN mode, measurement modes name.

Although the modified device ProBP 2400 is validated for preeclampsia, which is the same as with the BP3MW1-4X(R), the subject device, ProBP 2400 does not have the screen mode, which must be measured dual-arm simultaneously, and has a 1x mode, 3x mode, and manual mode which is the same as with the AUSCULTATION MODE of TWIN200 AFS. The differences do not affect the accuracy and normal use of this device because they use the same fundamental scientific technology based on clinical declaration of identity.

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The modified device model ProBP 2400 uses the same oscillometric method as the predicate device BP3MW1-4X(R). They have the same IHD function and are validated in preeclampsia. 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 ProBP 2400 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:

Reliability testing that included storage testing, operating testing, vibration testing, drop testing and life testing was conducted to verify that the subject device functions meet required specifications.

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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1. AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part
- 10: 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 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 the BP 2400 Digital Blood Pressure Device tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

a) Clinical Validation Concerning the Compliance of ANSI/AAMI ISO 81060-2: The subject modified device. Model ProBP 2400, is from the technical point of view, identical to our predicate device Model WatchBP Office Afib(TWIN200 AFS). Moreover, the measurement algorithm of WatchBP Office Afib(TWIN200 AFS) remain unchanged. The fundamental scientific technology of the modified WatchBP Office Afib(TWIN200 AFS) device is the same as the predicate device ProBP 2400. Therefore the performance of the ProBP 2400 in terms of blood pressure measurement would be identical with performance of the predicate device WatchBP Office Afib(TWIN200 AFS). Repeat clinical testing in accordance with the standard ANSI/AAMI IEC 81060-2 for the subject device ProBP 2400 is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.
b) Clinical validation concerning detection for women in pregnancy and preeclampsia:

The accuracy measurement in pregnancy and pre-eclamplsia utilized in the subject modified device Model ProBP 2400 is from the technical point of view, identical to what is utilized in our predicate device Model BP3MW1-4X(R). The clinical test report of BP3MW1-4X(R), K140572 in pregnancy and preeclampsia, is applicable to our subject modified ProBP 2400.

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).