(171 days)
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm.
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor pressure sensor rather than a stethoscope and mercury manometer. The sensor converts 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 detect electrical signals while inflating. And the device has Irreqular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irregular heart beat symbol "44 " is displayed on the LCD screen if any irreqular heart beat signal has been detected. ' In addition, the device has traffic light function.
The provided text does not contain detailed acceptance criteria and a study that proves the device meets specific performance criteria. Instead, it describes a 510(k) summary for a blood pressure monitor, focusing on its substantial equivalence to predicate devices and general non-clinical testing.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states that a repeated clinical test in accordance with the standard ANSI/AAMI SP10 was not necessary because the subject device (BP3MO1-3P) is technically identical to a predicate device (BP3MK1-3) and internal testing demonstrated that design changes did not affect clinical accuracy.
Therefore, specific numeric acceptance criteria and reported device performance from a dedicated clinical study against those criteria are not available in this document. The "Performance" is indirectly reported by the claim of substantial equivalence and no impact on accuracy from internal testing.
| Acceptance Criteria (Inferred from industry standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Blood pressure detection accuracy (e.g., mean difference and standard deviation from reference method as per ANSI/AAMI SP10) | "The internal clinical test on BP3MO1-3P demonstrates that the clinical accuracy in terms of blood pressure detection and normal use of this device is not affected by change of signal detection technology to IMT technology. The other differences (traffic light function and medication alarm function) have no impact on the clinical accuracy in terms of blood pressure detection." |
| Irregular Heartbeat Detection (IHD) function performance | Device "detects the appearance of irregular heartbeat during measurement and gives a warning signal." (No specific accuracy metrics provided). |
| Pulse rate detection accuracy | Implied to be accurate and unaffected, similar to blood pressure. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions an "internal clinical test on BP3MO1-3P," but it does not specify the sample size for this test. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document provides no information on the number of experts used or their qualifications for establishing ground truth for any internal clinical testing mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the test set.
5. 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:
The document describes a medical device (blood pressure monitor), not an AI algorithm. Therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a standalone blood pressure monitor. The performance described is its inherent function of measuring blood pressure and detecting irregular heartbeats. However, the document does not use the term "standalone performance" in the context of an algorithm. The entire device's performance is standalone as per its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood pressure monitors, the "ground truth" for accuracy is typically established by simultaneous measurements using a reference standard auscultatory method (e.g., using a mercury manometer and stethoscope by trained observers), often following protocols like those outlined in ANSI/AAMI SP10. While not explicitly stated, this is the standard practice for such devices.
8. The sample size for the training set:
The document does not mention a training set in the context of an AI algorithm or machine learning. The device operates based on the "oscillometric method," which is a well-known and established technique, not one that typically requires a large-scale "training set" in the modern AI sense.
9. How the ground truth for the training set was established:
As no training set is mentioned in the context of AI/ML, this information is not applicable/provided.
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2 2012 AUG
Exhibit#1
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510{k) number is:
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland
Date Summary Prepared: May 2, 2012
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:
Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P
Requiation 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 Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100), K073398, Microlife Intellectual Property GmbH.
b. OMRON Digital Wrist Blood Pressure Monitor, Model HEM-609N, K042505,
Omron Healthcare, Inc.
c. Microlife Upper Arm Blood Pressure Monitor BP3MC1-PC, K061471,Microlife Intellectual Property GmbH
4. Device Description:
Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and
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diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device can detect electrical signals while inflating. And the device has Irreqular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irregular heart beat symbol "44 " is displayed on the LCD screen if any irreqular heart beat signal has been detected. ' In addition, the device has traffic light function.
5. Intended Use:
The Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm..
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
The subject BP3MO1-3P and the predicate device model BP3MK1-3 (BP W100). use the same oscillometric method with the same fundamental scientific technology to determine the systolic and diastolic blood pressure and pulse rate. Wrist cuff is inflated automatically by pump and the pressures are transferred via tubing to a sensor in these two units.
to
The differences between the two models are the IMT technology, traffic light function and medication alarm function. The traffic light function is added to the subject device, while the medication alarm function is removed from subject device. But the differences do not affect the accuracy and normal use of this device because they use the same fundamental scientific technology based on the internal clinical test on BP3MO1-3P.
The signal detection technology is same with what is used in the predicate device. Model HEM-609N, with 510(k) cleared number K042505.
The subject BP3MO1-3P and the predicate BP3MC1-PC both have traffic light function. And the traffic light function has no impact on the clinical accuracy in terms of blood pressure detection.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P 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:
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- a. Reliability Test Storage test
- Reliability Test Operating test ﻗ
- Reliability Test Vibration test ﻥ
- d. Reliability Test Drop test
- e. Reliability Test Life test
- EMC Test f.
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 Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P tested met all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
The subject device Model BP3MO1-3P is from the technical point of view, identical to the predicate blood pressure monitor Model BP3MK1-3 (BP3MK1-3). The internal clinical test on BP3MO1-3P demonstrates that the clinical accuracy in terms of blood pressure detection and normal use of this device is not affected by change of signal detection technology to IMT technology. The other differences (traffic light function and medication alarm function) have no impact on the clinical accuracy in terms of blood pressure detection. Therefore repeated clinical test in accordance with the standard ANSI/AAMI SP10 is not necessary.
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".
10. Conclusions:
We have demonstrated that there are no significant differences between the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P and the predicate devices, Model BP3MK1-3 (BP W100), Model HEM-609N, and model BP3MC1-PC 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 2012 AUG
Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K120430
Trade/Device Names: Microlife Wrist Watch Blood Pressure Monitor, BP3MO1-3P Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: July 2, 2012 Received: July 3, 2012
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.
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.
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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/CDRH0ffices/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/ReportalProblem/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
Pram 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
K120430 510(k) Number (if known):
Device Name: Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P
Indications For Use:
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm.
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
Prescription Use (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)
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K120430 |
| Page | 1 of 1 |
|---|---|
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§ 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).