The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic blood pressures, pulse rate and mean arterial pressure (MAP) for use in pediatric and adult populations with arm cuff circumference sizes ranging from 14 - 52 cm.

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 irreqular 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

Here's an analysis of the provided text regarding the ProBP 2400 Digital Blood Pressure Device, structured to address your specific questions.

Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often references previous studies rather than presenting entirely new, exhaustive clinical trials for every aspect. Where specific details are not explicitly stated, it will be noted.

Acceptance Criteria and Device Performance

The primary acceptance criteria for blood pressure devices are typically defined by recognized standards such as AAMI/ANSI SP10, EN 1060-1, EN 1060-3, and ANSI/AAMI/ISO 81060-2. These standards outline requirements for accuracy (mean difference and standard deviation between device and reference measurements) and other performance metrics. The provided document states that the device passed these standards but does not provide a table of the specific acceptance criteria thresholds or the exact reported performance numbers for the ProBP 2400. It simply states "Results were passing."

However, based on the reference to ANSI/AAMI/ISO 81060-2 (2013), we can infer the typical acceptance criteria for accuracy. For adult populations, this standard generally requires:

Mean difference: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
Standard deviation of the differences (SD): ≤ 8 mmHg for both systolic and diastolic blood pressure.

Since the document does not provide the specific performance data for the ProBP 2400, a table of acceptance criteria and reported performance cannot be fully constructed from this text. It only states that "Results were passing."

Inferred Table of Acceptance Criteria (based on ANSI/AAMI/ISO 81060-2) and Reported Device Performance:

Performance Metric	Acceptance Criteria (e.g., ANSI/AAMI/ISO 81060-2)	Reported Device Performance (ProBP 2400)
Systolic BP: Mean Difference (device - reference)	≤ ±5 mmHg	"Passing" (specific value not reported)
Systolic BP: Standard Deviation of Differences	≤ 8 mmHg	"Passing" (specific value not reported)
Diastolic BP: Mean Difference (device - reference)	≤ ±5 mmHg	"Passing" (specific value not reported)
Diastolic BP: Standard Deviation of Differences	≤ 8 mmHg	"Passing" (specific value not reported)
(Additional metrics as per standard, e.g., heart rate if applicable)	(Varies by standard)	"Passing" (specific value not reported)

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states: "A clinical validation was conducted in accordance with ISO 81060-2 testing."
- Sample Size: The exact sample size used for the ISO 81060-2 clinical validation is not specified in this document for the subject device. However, ISO 81060-2 (2013) typically requires a minimum of 85 participants for accuracy validation in a standard adult population.
- Data Provenance: Not explicitly stated. The study for the subject device was a clinical validation. The language "clinical validation was conducted" suggests a prospective study for that component.
- For the "pregnancy and pre-eclampsia" claim, the document states: "The clinical test report referenced in K143341 supporting measurement accuracy in pregnancy and pre-eclampsia use is applicable to our subject device." This implies the data for this specific population was from a previous study associated with the predicate device (K143341), meaning it could be retrospective to the current submission, but was likely prospective when originally conducted for the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- For blood pressure validation studies according to ISO 81060-2, the "ground truth" (reference blood pressure measurements) is established by two trained observers (experts) using a standardized auscultatory method, often with a double-stethoscope setup.
- Qualifications of Experts: The standard requires trained observers who are blinded to the device's readings. Specific experience levels (e.g., "radiologist with 10 years of experience") are not typically detailed in 510(k) summaries for blood pressure studies, but they are expected to be competent and trained in auscultatory blood pressure measurement.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For ISO 81060-2, the reference measurements are typically taken by two independent observers. If their readings differ significantly (e.g., by more than a predefined threshold, commonly 4 mmHg or 5 mmHg), a third observer or a re-measurement procedure is often employed, which implies a form of 2+1 adjudication or a similar conflict resolution mechanism, though the exact method isn't specified in this summary. The standard requires the average of the two observers' readings or a specific procedure for discrepancies.
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, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance. Therefore, there is no "effect size of how much human readers improve with AI."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The entire clinical validation described for the ProBP 2400 (and its predicate) is a standalone performance assessment of the oscillometric algorithm against a well-established reference measurement (auscultation by human observers). The device's measurement is entirely algorithmic, without a human "in-the-loop" to modify its output for a single measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used for the clinical validation was expert consensus (of two trained observers performing auscultatory blood pressure measurement). This is often referred to as the "reference measurement" in blood pressure validation standards.
The sample size for the training set:
- Not specified. 510(k) summaries for devices of this type typically do not detail the training set size for the underlying algorithm, especially when substantial equivalence to a predicate is the primary claim. The "oscillometric method" is a well-established technique used by many devices, and the core algorithm would have been developed and "trained" (or calibrated) using extensive data over time, but these details are not part of the current submission.
How the ground truth for the training set was established:
- Not specified. Similar to the training set size, the method for establishing the ground truth for an algorithm's internal training/calibration is not typically disclosed in a 510(k) summary. It would likely involve a large dataset of comparative measurements against a recognized reference standard (e.g., invasive arterial pressure or auscultatory measurements by experts) during the device's original development cycle.

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

October 21, 2015

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

Re: K152770

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: September 23, 2015 Received: September 25, 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 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 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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Indications for Use

510(k) Number (if known) K152770

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:

1. Submitter's Identification:

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

Date Summary Prepared: October 16, 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

Name of the Device: 2.

ProBP 2400 Digital Blood Pressure Device

Requlation 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):

Microlife Digital Blood Pressure Device, Model ProBP 2400, (K143341), Microlife Intellectual Property, GmbH

4. Device Description:

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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. Indications for 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) for use in pediatric and adult populations with arm cuff circumference sizes ranging from 14 -52 cm.

The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irreqular 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 predicate 510(k), K143341 ProBP 2400 Digital Blood Pressure Device was cleared with a medium and large cuff as standard accessories. The subject device, Model ProBP 2400 is identical to the predicate, K143341, ProBP 2400.

Microlife is now adding a small and large-extra large cuff as optional accessories.

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:

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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
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
1. ANSI/AAMI/ISO 81060-2: Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type, 2013

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8. Discussion of Clinical Tests Performed:

a) Clinical Validation Concerning the Compliance of ANSI/AAMI ISO 81060-2
The subject device ProBP2400 is identical to our predicate device ProBP 2400 except for the addition of a small and large-extra large cuff. 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.
b) Clinical validation concerning detection for women in pregnancy and preeclampsia:
The clinical test report referenced in K143341 supporting measurement accuracy in pregnancy and pre-eclampsia use is applicable to our subject device.

The accuracy measurement in pregnancy and pre-eclamplsia utilized in the subject modified device Model ProBP 2400 is identical to what is utilized in our predicate device referenced in the predicate device K143341.

9. Conclusions:

Conclusions drawn form 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).