(108 days)
The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.
The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
The provided text describes the Zewa MFM-007 Blood Pressure Monitor. However, it does not explicitly state acceptance criteria in a structured table or detail a specific study proving the device meets performance criteria beyond general statements about compliance with technical specifications.
Based on the provided information, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The text states:
- "The Zewa® MFM-007 Blood Pressure Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening."
This is a general statement about compliance but does not list specific numerical acceptance criteria (e.g., accuracy ranges for systolic/diastolic pressure) or the measured performance results.
2. Sample sized used for the test set and the data provenance:
This information is not provided. The document makes no mention of a test set, patient data, sample size, or the provenance of any data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As there's no mention of a test set involving human evaluation or ground truth establishment, this detail is absent.
4. Adjudication method for the test set:
This information is not provided. Given the lack of a test set description, an adjudication method is not mentioned.
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:
This information is not provided. The device is an automated blood pressure monitor and does not involve human readers or AI assistance in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone, automated blood pressure monitor. The "device testing" mentioned refers to its intrinsic performance. However, there's no specific "standalone study" detailed in terms of methodology or results. The entire function of the device is algorithm-driven (measuring blood pressure automatically), so its general testing covers its "standalone performance."
7. The type of ground truth used:
This information is not explicitly stated in a way that aligns with typical "ground truth" for diagnostic devices (e.g., pathology, outcomes data). For a blood pressure monitor, the "ground truth" for accuracy would typically be simultaneous measurements from a highly accurate reference device (e.g., a mercury sphygmomanometer or an invasive arterial line). The document only states "compliance with numerous technical specifications," implying that the device's readings were compared against established standards for blood pressure measurement accuracy, but the specifics of how this ground truth was established are not detailed.
8. The sample size for the training set:
This information is not provided. The device does not appear to involve machine learning in a way that would typically require a "training set" of patient data in the modern sense. It's an automated medical device based on established oscillometric principles.
9. How the ground truth for the training set was established:
This information is not applicable/provided as there's no mention of a training set.
In summary, the provided 510(k) summary focuses on the device description, predicate device, and general statement of compliance with technical specifications, rather than a detailed clinical or performance study report with specific acceptance criteria and results.
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510(K) SUMMARY SECTION 16
1. DATE PREPARED
June 2, 2004
2. SPONSOR INFORMATION
Zewa Inc. Mr. Thomas Zeindler 3537 N.W. 115th Avenue Miami, Florida 33178
(305) 463-7551 (telephone) (305) 463-7553 (facsimile)
3. DEVICE NAME
Proprietary Name: Zewa® MFM-007 Blood Pressure Monitor Common/Usual Name: MFM-007 Blood Pressure Monitor Classification Name: System, Measurement, Blood Pressure, Non Invasive
4. DEVICE DESCRIPTION AND INTENDED USE
The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.
PREDICATE DEVICE న్.
It is substantially equivalent to the Meditec MD-800 Noninvasive Blood Pressure Measurement System cleared by FDA on July 21, 1999, under 510(k) K992328.
TECHNOLOGICAL CHARACTERISTICS 6.
The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and
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diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
DEVICE TESTING 7.
The Zewa® MFM-007 Blood Pressure Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening.
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Public Health Service
Image /page/2/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of an eagle with three stripes across its body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2004
Zewa, Inc. c/o Mr. Thomas Zeindler Vice President 3537 N.W. 115th Avenue Miami, FL 33178
Re: K041491
. Trade/Device Name: Zewa MFM-007 Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: June 2, 2004 Received: June 4, 2004
Dear Mr. Zeindler:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bectoril 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regars nement date of the Medical Device Americal Ford. Days commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been reclassined in asses approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the device, poolee requirements for annual registration, listing of general controls provisions of the flev labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see abort) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to such additional consolors, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous cements concerning your device in the Federal Register.
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Page 2 – Mr. Thomas Zeindler
Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuation of a buobained with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a determination that your are for a level Federal agencies. You must or any Federal Statutes and regulations damading, but not limited to: registration and listing (21 l comply with an the Act 3 requirements, mercess comments on the practice requirements as set CFK Part 807), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of 1 vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your be I his letter will anow you to begin maileting your antial equivalence of your device to a legally premitset notification. The PDA miang of basification 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 If you desire specific advice for your de 110 - 110 - 4648. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 594-4648. Also, please note Colliact the Office of Compunation at (50 m ) (21CFR Part 807.97). You may obtain " Misorationing by reletence to premanton notifications in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dffimmuma for
Brain 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): K041491
Device Name: Zewa MFM-007 Blood Pressure Monitor
Indications For Use:
The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood moderately active to machie in ste) by using an inflated cuff which is wrapped around the upper arm.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimma for
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K041491
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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).