(307 days)
No
The document describes a standard oscillometric blood pressure monitor that connects to a smartphone or PC for display and data transfer. There is no mention of AI, ML, or any advanced data analysis beyond basic blood pressure and pulse rate calculation using a well-established method. The performance studies focus on electrical, mechanical, and environmental reliability, not algorithmic performance.
No.
The device is a blood pressure monitor, which is used for measurement and monitoring, not for therapy or treatment.
Yes.
The device measures systolic and diastolic blood pressure, and pulse rate, which provides information about a person's physiological state for the purpose of identifying health conditions or risks.
No
The device description clearly states that the device is a "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M)" which uses an inflatable cuff and resistive pressure sensors to measure blood pressure. While it integrates with software on an iPhone, iPad, iPod Touch, or PC for display and data transfer, the core blood pressure measurement is performed by hardware components. The performance studies also include testing of electrical, mechanical, and environmental performance, further indicating the presence of hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The description clearly states that the device measures blood pressure and pulse rate using a non-invasive oscillometric technique on the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample in vitro (in a lab setting).
- Intended Use: The intended use is to measure blood pressure and pulse rate of an adult individual. This aligns with a vital signs monitor, not an IVD.
The device's integration with other devices (iPhone, iPad, PC) and data transfer capabilities are related to data display and management, not the fundamental diagnostic method, which is non-invasive blood pressure measurement.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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 one inflatable cuff is wrapped around the single upper arm.
The Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch.
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 via cable with the PC.
Product codes
DXN
Device Description
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. Because the device does not contain an LCD or other display components, it is necessary for the device to connect with an iPhone, iPad, or iPod Touch containing supporting software to constitute a complete blood pressure measure system.
In addition, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
single upper arm
Indicated Patient Age Range
adult
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)
Non-Clinical Tests:
Testing information demonstrating safety and effectiveness of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+(BP4GAPO-2M) 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:
- a. Reliability Test Storage test
- Reliability Test Operating test
- Reliability Test Vibration test
- Reliability Test Drop test
- Reliability Test Life test
- EMC Test
- g. IEC 60601-1 Safety Test
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 CARDIO+(BP4GAPO-2M) tested met all relevant requirements of the aforementioned tests.
Clinical Tests:
The subject modified device Model Cardio+ (BP4GAPO-2M) is, from the technical point of view, identical to the blood pressure monitor Model BP3AC1-1 PC. The differences between these two devices do not relate to blood pressure measurement technology. Therefore, the clinical accuracy in terms of blood pressure detection will not be affected. Based on this, repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Exhibit#1
510(k) SUMMARY
MAY 1 3 2013
This summary of 5/0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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, 2012
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 Cardio+ (BP4GAPO-2M)
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 BP3AC1-1
PC, K060686, Microlife Intellectual Property GmbH.
- b. Fully Atuomatic Arm Cuff Electronic Blood Pressure Dock, K102939, Model iHealth BP3, ANDON HEALTH CO.,LTD
4.' Device Description:
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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
1
K122013
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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. Because the device does not contain an LCD or other display components, it is necessary for the device to connect with an iPhone, iPad, or iPod Touch containing supporting software to constitute a complete blood pressure measure system.
In addition, 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.
5. Intended Use:
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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 one inflatable cuff is wrapped around the single upper arm.
The Cardio+ (BP4GAPO-2M) achieves its function by integrate the device with an iPhone. iPad, or iPod.
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 via cable with the PC.
6. Comparison to the 510(k) Cleared Device (Predicate Device):
The modified device Model Cardio+(BP4GAPO-2M) and the predicate device Model BP3AC1-1 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 (or two) sensor(s).
The differences between the two models are appearance, sensor type, software analyzer, cuff and display way (the subject device must connect with an iPhone , iPad, or iPod Touch to display and achieve its function, but the predicate BP3AC1 -1 PC need not). However, the differences do not affect the accuracy and normal use of this device based on the documentation accompanying this submission. .
In addition, the modified device Model Cardio+ (BP4GAPO-2M) can achieve its function with an iPhone, iPad or iPod Touch, which is the same as with the predicate device, iHealth BP3, K102939.
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 Cardio+(BP4GAPO-2M) in the intended environment of use is supported by testing that was conducted in
2
K122013
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:
- a. Reliability Test Storage test
- Reliability Test Operating test ﻗ
- Reliability Test Vibration test C.
- Reliability Test Drop test ರ.
- Reliability Test Life test e.
- EMC Test f.
- g. IEC 60601-1 Safety Test
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 CARDIO+(BP4GAPO-2M) tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
The subject modified device Model Cardio+ (BP4GAPO-2M) is, from the technical point of view, identical to the blood pressure monitor Model BP3AC1-1 PC. The . differences between these two devices do not relate to blood pressure measurement technology. Therefore, the clinical accuracy in terms of blood pressure detection will not be affected. Based on this, repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required.
Software information: 9.
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:
We have demonstrated that there are no significant differences between the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) and the predicate devices, Model BP3AC1-1 PC and Model iHealth BP3, in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and the ANSI/AAMI Voluntary Standard, SP10: 2008.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K122013
Trade/Device Name: Microlife Upper Arm Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: April 29, 2013 Received: April 30, 2013
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.
4
Page 2 - Ms. Susan D. Goldstein-Falk
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 of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ______________K122013
Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M)
Indications For Use:
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ ( BP4GAPO-2M ) 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 one inflatable cuff is wrapped around the single upper arm.
The Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch.
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 via cable with the PC.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.05.13
'16:25:33 -04'00'
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