(366 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard oscillometric blood pressure measurement.
No
The device is a blood pressure monitor designed to measure vital signs, not to treat any medical condition.
No
The device is a blood pressure monitor that measures systolic/diastolic pressures and heart rate, which are physiological measurements and not explicitly stated as diagnosing a disease or condition. While the data obtained can be used in a diagnostic process, the device itself is a measurement tool.
No
The device description explicitly states "Automatic Inflation Wrist Digital Blood Pressure Monitors," indicating a physical hardware device with automatic inflation capabilities, not solely software.
Based on the provided information, the Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Daiwa Model 180 clearly states its function is to measure blood pressure and heart rate directly from the patient's wrist using the oscillometric method. This is a non-invasive measurement taken in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
Therefore, the device falls under the category of a medical device used for physiological measurement, but not an IVD.
N/A
Intended Use / Indications for Use
The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation
Product codes
74 DXN
Device Description
Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitors
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, possibly representing water or movement. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
DAIWA PRODUCTS, INC. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K983616 DAIWA MODEL 180 Regulatory Class: II (TWO) Product Code: 74 DXN Dated: July 27, 1999 : Received: July 28, 1999
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. E.J. Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
2
x 98 3616 510(k) Number (if known):
Device Name: Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitors
Classification Panel:
Indications for Use:
The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation
Bute Cooperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 11983616 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
or
Over-the-Counter Use ﺳﺴﺎ