(26 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and irregular heartbeat detection, with no mention of AI or ML techniques.
No
The device measures blood pressure and detects irregular heartbeats, which are diagnostic functions. It does not provide treatment or modify bodily functions for therapeutic purposes.
No
The device is described as a non-invasive digital blood pressure device that measures systolic blood pressure, pulse rate, and mean arterial pressure. While it can detect irregular heartbeats and is accurate for patients with preeclampsia, its primary function is measurement, not diagnosis. It provides data that a healthcare professional might use for diagnosis, but the device itself does not make a diagnosis.
No
The device description explicitly mentions hardware components like an inflatable cuff, resistive pressure sensors, and electrical signals, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided text, the ProBP 2400 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ProBP 2400 Function: The ProBP 2400 is described as a non-invasive digital blood pressure device that measures blood pressure and pulse rate using an upper-arm cuff and oscillometric technique. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
The description clearly indicates a non-invasive, physical measurement of physiological parameters, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper-arm
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with its arms outstretched.
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
1
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
2
Indications for Use
510(k) Number (if known) K152770
Device Name ProBP 2400 Digital Blood Pressure Device
Indications for Use (Describe)
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.
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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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:
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".
4
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.
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:
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- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 1988 A1:1991 A21995
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- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 3:2007-03
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- AAMI/ANSI SP10 Manual, electronic, or automated sphygmomanometers 2002 (R) 2008, 2002 A1:2003
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- EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements 1995: Amendment 2, 2009
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- EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. 1997: Amendment 2, 2009
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- ISO 14971 Medical devices Application of risk management o medical devices. 2007
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- AAMI/ANSI/ISO 10993-1-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 2010
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- AAMI/ANSI/ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity, 2009
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- AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for Irritation and skin sensitization, 2010
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- 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
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- 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:
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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.