(80 days)
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
The Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique with an inflatable cuff wrapped around wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor pressure sensor instead of a stethoscope and uses an electronic convention to define the systolic, diastolic and electrical signals, by analyzing those signals. The method for calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".
The provided text describes the Microlife Blood Pressure Monitor Model BP3AX1 and its 510(k) submission. However, it does not contain a detailed table of acceptance criteria, reported device performance metrics, or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test/training sets, ground truth establishment details, MRMC study results, etc.).
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP-3BU1-5, K# 021305) and lists the non-clinical and clinical tests performed at a high level.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from standard) | Reported Device Performance (from study) |
|---|---|
| Clinical Performance: Per ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | "All relevant sections were met" (for the clinical standard) |
| Non-Clinical Performance: | |
| - General Functions Test: (Met, implies compliance) | |
| - Reliability Test Operation Conditions: (Met, implies compliance) | |
| - Reliability Test Drop Testing: (Met, implies compliance) | |
| - Reliability Test Storage: (Met, implies compliance) | |
| - Reliability Test Vibrating Testing: (Met, implies compliance) | |
| - EMC Test: (Met, implies compliance) | |
| - IEC 60601-1 Safety Test: (Met, implies compliance) |
Missing Information: The document states that the device "met all relevant requirements" of AAMI SP10-1992. However, it does not provide the specific numerical acceptance criteria (e.g., mean difference, standard deviation limits) or the actual measured performance data (e.g., 2.3 mmHg ± 5.6 mmHg) from the clinical study. Similarly, for non-clinical tests, it only states "None of the testing demonstrated any design characteristics that violated the requirements" and "the relevant requirements...were met," without providing specific pass/fail criteria or quantitative results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions that ANSI/AAMI SP10-1992 testing was performed, but does not provide the number of subjects or measurements included in this clinical validation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a clinical validation study for a blood pressure monitor, it would typically be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not specified. For a blood pressure monitor, "ground truth" during clinical validation is typically established by trained human observers using a mercury sphygmomanometer simultaneously or sequentially with the automated device on the same subject, following a standardized protocol like AAMI SP10. The document does not specify the number or qualifications of these human observers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified. The document does not describe any specific adjudication method for discrepancies during the clinical testing. For AAMI SP10, there are specific requirements for agreement between observers, but the details of implementation are not provided here.
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
Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation or complex clinical decision support. Therefore, an MRMC study and effect size for human readers improving with AI are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, effectively. The "standalone" performance here refers to the device's ability to accurately measure blood pressure on its own. The clinical testing against the ANSI/AAMI SP10-1992 standard is a standalone performance evaluation of the automated device against a reference standard (typically a trained human observer using a mercury sphygmomanometer). The results state that "All relevant sections were met," indicating its standalone performance was deemed acceptable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study would have been established by trained human observers using a reference standard (e.g., auscultation with a mercury sphygmomanometer), as prescribed by the ANSI/AAMI SP10-1992 standard. This is the accepted method for validating automated blood pressure devices.
8. The sample size for the training set
Not applicable/Not specified. This is an oscillometric blood pressure monitor, not a machine learning or AI-based device that typically requires a distinct "training set" in the context of model development. The algorithm for oscillometric measurement is well-established, and its "training" would be more akin to calibration and design refinement rather than statistical model training. If any internal data was used for initial algorithm development or parameter tuning, it is not disclosed as a "training set" here.
9. How the ground truth for the training set was established
Not applicable/Not specified. As mentioned above, a "training set" in the context of machine learning is not directly applicable here. The fundamental principles of oscillometric measurement are physics-based, and calibration procedures would rely on traceable pressure standards, not "ground truth" derived from clinical data in the same way an AI model's training data would be established.
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510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in This summary of Jio(K) Salety and Shoulds.
accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K04000 2
Submitter's Identification: 1.
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: December 30, 2003
Contact: Mr. Gerhard Frick
Name of the Device: 2.
Microlife Blood Pressure Monitor Model BP3AX1
Predicate Device Information: 3.
The Microlife Wrist Watch Automatic Blood Pressure Monitor, Models BP3AX1 is The Microllie Wrist Waternatio Blood Pressure Monitor, Monitor, Model BP-3BU1-5, K# 021305.
Device Description: বা
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calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".
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Intended Use: 5.
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device The Microllie While While William and diastolic blood pressure and pulse rate of an intelluou to modours the a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Comparison to Predicate Devices: 6.
All devices use the well known oscillometric method within the software algorithm All develop as a no diastolic blood pressure and pulse rate. A wrist to determine the cystem and artically; deflate rate is controlled by one linear inniatuolo oun 10 innition pressures are transferred via tubing to a sensor in all valve and the donation procession uses semiconductor pressure sensor instead afma. Dut our revir me sensor on the predicate device to translate the pressure or capacitive proceere signals that can be interpreted by an integrating circuit. vance to oloothour determined each unit operates the linear valve to release the pressure to zero.
Unlike the predicate device, our new model BP3AX1 uses a piezo-resitive Onlike the products consolternation of cuff pressure. The basic theory of the sensor is stated below:
The diffusion-type semiconductor pressure sensor has four pressure senitive rho diffact type ossistors which are formed on the diaphragm surface of silicon of in substrate by a conventional diffusion process of IC production technique.
The piezo resistors change those resistivity by applied stress called as piezo r no prozo rother oven the diaphragm is formed by the applied pressure.
The resistivity change of the four resisters which consist of the wheatstone brige r no rooletinty onany on need and bridge output voltage by a externally supplied driving current or voltage.
V oc P
Where V is the sensor output voltage P is the applied pressure
In addition in our pressure monitor, we have deleted the printer function.
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Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife l esting information demonstrating school, and the intended environment Automatic Blood Fressure Monitor, Model Bridge, Model in accordance with the FDA
of use is supported by testing that was conducted in accordance with the FDA of use is supported by tooting the were for Premarket Notification November 1993 Drait Treviewer Guidanos for and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing ்.
- Reliability Test Storage ರ.
- Reliability Test Vibrating Testing e.
- EMC Test بت
- IEC 60601-1 Safety Test ದ.
None of the testing demonstrated any design characteristics that violated the None of the testing demonistratou any courgh ulted in any safety hazards. It was requirements of the Renovife Automatic Blood Pressure Monitor, Model our conclusion that the mievant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated ANOI/VAMI OF 10 1652 * 16 1652 * 15ting was performed. All relevant sections were Sphyghlomanometers tooling was ponomical relevant requirements of this standard.
Conclusions: 9.
We have demonstrated that the Microlife Automatic Blood Pressure Monitor, We have domonistrative as the and effective as the predicate, the Microlife Automatic Blood Pressure Monitor, Model BP-3BU1-5 based on electrical, Automatic Blood Frossars well as the FDA as well as the FDA DCRND nechanioal and Driver Guidance for Premarket Notification November 1950 Drat: "Ronows Standard, SP10-1992 testing results.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with three stylized human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K040002
Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 30, 2003 Received: January 2, 2004
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 such 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
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Page 2 -- Ms. Susan D. Goldstein-Falk
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. lochner
Image /page/4/Picture/5 description: The image shows a simple, hand-drawn symbol. It appears to be a stylized representation of a knot or a loop, with lines intersecting and curving to form a closed shape. The drawing is somewhat rough, suggesting it was created quickly or informally.
() 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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Exhibit B
Page __ 1 __ of __ 1 __ 1 __
510(k) Number (if known): __ k 04000 2
Microlife Wrist Watch Blood Pressure Monitor, Model Device Name: BP3AX1
Indications For Use:
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use _X (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Kirchner
J-vision Sign-Off) ് നടിന്ന് വ്യൂസ് വിശ്വാസ Devices
510(k) Number_k 040002
§ 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).