(67 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and atrial fibrillation detection using established techniques, with no mention of AI or ML.
No.
This device is a diagnostic tool used to measure various blood pressure parameters and detect atrial fibrillation. It does not actively treat or alleviate a medical condition, which is the primary function of a therapeutic device.
Yes
The device measures blood pressure, pulse rate, and calculates various metrics. Crucially, it "detects the appearance of atrial fibrillation during measurement and gives a warning signal." Detecting a medical condition like atrial fibrillation and providing a warning makes it a diagnostic device.
No
The device description clearly outlines hardware components like inflatable cuffs, pressure sensors, and an LCD screen. The performance studies also include tests for electrical, mechanical, and environmental performance, which are relevant to hardware. While there is mention of accompanying software, the core device is a physical blood pressure monitor.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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 this device measures blood pressure, pulse rate, and calculates related indices (PP, MAP, ABI) using a non-invasive oscillometric technique with cuffs wrapped around the arm and ankle. It also detects atrial fibrillation based on these measurements.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The measurements are taken externally and directly from the body.
Therefore, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP). Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an adult individual bv using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI 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 WatchBP Office ABI (TWIN200 ABI) is designed to measure systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle. 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, Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI), which is a well - known technique in the market called the "oscillometric method".
The device has >, > and > measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
The > mode is selected to complete fully-automated triple measurements on both arms according to recommended ESH/AHA blood pressure measurement protocols for a patient's first office visit.
The > mode is selected to perform automated triple measurements on the preferred arm for prompt and accurate office measurements.
The > mode is selected for Ankle Brachial Index pressure measurement. Select the lateral with the higher blood pressure value according to the measurement result of > mode.
The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm(s), ankle
Indicated Patient Age Range
adult individual
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)
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 WatchBP Office ABI (TWIN200 ABI) 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
- b. Reliability Test Operating test
- Reliability Test Vibration test C.
- d. Reliability Test Drop test
- e. Reliability Test Life test
- EMC Test f.
- 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 WatchBP Office ABI (TWIN200 ABI) tested met all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed:
The subject modified device Model WatchBP Office ABI (TWIN200 ABI) is from the technical point of view, identical to the blood pressure monitor Model WatchBP Office (Twin200). The differences between them do not relate to blood pressure measurement technology so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required.
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".
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
DEC - 5 2011
Exhibit#1
112845
114
510(k) SUMMARY
This summary of 5l0(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: June 16, 2011
Contact: Mr. Gerhard Frick 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:
Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI)
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 (Twin200), K082357, Microlife Intellectual Property GmbH.
- b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-
2D, K080337, Microlife Intellectual Property GmbH.
c. VP-2000/1000, K013434, Colin Corporation.
Device Description: 4.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) is designed to measure systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle. Our method to define systolic and diastolic
1
K112845
P2/4
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, Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI), which is a well - known technique in the market called the "oscillometric method".
The device has >, > and > measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
The > mode is selected to complete fully-automated triple measurements on both arms according to recommended ESH/AHA blood pressure measurement protocols for a patient's first office visit.
The > mode is selected to perform automated triple measurements on the preferred arm for prompt and accurate office measurements.
The > mode is selected for Ankle Brachial Index pressure measurement. Select the lateral with the higher blood pressure value according to the measurement result of > mode.
The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.
5. Intended Use:
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP). Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an adult individual bv using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI 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 WatchBP Office ABI (TWIN200 ABI) and the predicate device model WatchBP Office (Twin200) use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff(s) is (are) inflated automatically, deflation rate is
2
controlled by one (or two) factory set exhaust valve(s) and the deflation pressures are transferred via tubing to one (or two) sensor(s).
73/4
The solely differences between the two models are the intended use, measurement modes name, sensor type, cuff bladder material, atrial fibrillation detection function, Ankle Brachial Index (ABI) calculating function and data transferring method etc.. However, the differences do not affect the accuracy and normal use of this device based on the internal clinical tests comparing different sensors and cuff bladder materials.
Atrial fibrillation detection function is same with what is used in predicate device model BP3MQ1-2D, with 510(k) cleared number K080337.
The upper arms and ankle measurements and Pulse Pressure (PP) and Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) automatically calculation functions are similar with what was used in predicate device VP-2000/1000, with 510(k) cleared number K013434.
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 WatchBP Office ABI (TWIN200 ABI) 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
- b. Reliability Test Operating test
- Reliability Test Vibration test C.
- d. Reliability Test Drop test
- e. Reliability Test Life test
- EMC Test f.
- IEC 60601-1 Safety Test ਹੋਂ
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 WatchBP Office ABI (TWIN200 ABI) tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
The subject modified device Model WatchBP Office ABI (TWIN200 ABI) is from the technical point of view, identical to the blood pressure monitor Model WatchBP Office (Twin200). The differences between them do not relate to blood pressure measurement technology so the clinical accuracy in terms of blood pressure
3
Image /page/3/Picture/0 description: The image shows the text "K112845" on the top line and "p4/4" on the bottom line. The text is written in a handwritten style. The numbers are clearly visible and the letters are easily readable.
detection will not be affected. Therefore repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required.
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:
We have demonstrated that there are no significant differences between the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) and the predicate devices, Model WatchBP Office (Twin200) and Model BP3MQ1-2D, 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC = 5 2011
Microlife Intellectual Property GmbH, Switzerland c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021
K112845 Re:
Trade/Device Name: MicroLife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI)
Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: September 28, 2011 Received: September 29, 2011
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becaren as (a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreative to the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. uceries mar have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, moreloro, market the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (see associations affecting major regulations affecting your device can be It may be subject to additional controller Enterior Life and to 898. In addition, FDA may found in the Code of rederal regared. Angeless in the Federal Register.
5
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 (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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
KITZ 845
Exhibit B
Indications for Use
510(k) Number (if known):
Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model_WatchBP_Office_ABI_(TVNIN200_ABI)_
Indications For Use:
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Cardiovascular Devices
Page of ﺌﮯ
510(k) Number K112875