ProBP 2400 Digital Blood Pressure Device

K152770 · Microlife Intellectual Property GmbH · DXN · Oct 21, 2015 · Cardiovascular

Device Facts

• Record ID: K152770
• Device Name: ProBP 2400 Digital Blood Pressure Device
• Applicant: Microlife Intellectual Property GmbH
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 21, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

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) 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 Story

ProBP 2400 is a non-invasive digital blood pressure monitor; utilizes oscillometric technique via upper-arm cuff. Device employs two resistive pressure sensors to convert cuff pressure alterations into electrical signals; analyzes signals to calculate systolic/diastolic pressure, pulse rate, and mean arterial pressure (MAP). Features include 1x measurement mode, 3x automated triple measurement mode, and manual mode; includes irregular heartbeat detection with warning signal. Designed for clinical use; operated by healthcare providers. Provides digital output of blood pressure and pulse metrics; assists clinicians in patient monitoring and hypertension management. Benefits include accurate blood pressure assessment in diverse populations, including pregnant patients with preeclampsia.

Clinical Evidence

Clinical validation conducted per ISO 81060-2 for the modified cuff sizes; results were passing. Accuracy for pregnancy and pre-eclampsia was established via clinical data referenced from the predicate device (K143341).

Technological Characteristics

Oscillometric measurement using two resistive pressure sensors. Supports arm circumferences 14-52 cm. Complies with IEC 60601-1, IEC 60601-1-2, AAMI/ANSI SP10, EN 1060-1/3, AAMI/ANSI/IEC 80601-2-30, and ANSI/AAMI/ISO 81060-2. Biocompatibility testing per ISO 10993-1, 5, and 10.

Indications for Use

Indicated for pediatric and adult populations with arm cuff circumferences 14-52 cm for non-invasive measurement of systolic/diastolic blood pressure, pulse rate, and mean arterial pressure. Includes use in pregnant patients, including those with known or suspected preeclampsia.

Regulatory Classification

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.

Predicate Devices

• Microlife Digital Blood Pressure Device, Model ProBP 2400 (K143341)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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)

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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: [phone] E-Mail: [e-mail]

#### 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".

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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 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:

- 1) IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 1988 A1:1991 A21995
- 2) IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 3:2007-03
- 3) AAMI/ANSI SP10 Manual, electronic, or automated sphygmomanometers 2002 (R) 2008, 2002 A1:2003
- 4) EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements 1995: Amendment 2, 2009
- 5) EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. 1997: Amendment 2, 2009
- 6) ISO 14971 Medical devices Application of risk management o medical devices. 2007
- 7) AAMI/ANSI/ISO 10993-1-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 2010
- 8) AAMI/ANSI/ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity, 2009
- 9) AAMI/ANSI/ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for Irritation and skin sensitization, 2010
- 10) 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
- 11) 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.