(154 days)
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No
The description details standard oscillometric blood pressure measurement technology with basic memory functions and an LCD display. There is no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No.
This device is a diagnostic tool used to measure blood pressure, not to treat a condition. While the information it provides can be used to inform therapeutic decisions, the device itself does not provide therapy.
Yes
The device is a sphygmomanometer that measures systolic and diastolic blood pressure and pulse, which are diagnostic indicators of a patient's health status.
No
The device description explicitly states it is a "noninvasive blood pressure measurement system" contained in a "hard plastic housing" with a "microprocessor and air pump" connected to an "adjustable arm cuff." These are all physical hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device function: The Citizen CH-491, CH-481, and CH-471 digital arm sphygmomanometers measure blood pressure and pulse directly from the user's upper arm. This is a non-invasive measurement taken on the living body.
The device description and intended use clearly indicate that it is a non-invasive blood pressure measurement system, not a device that performs tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.
The Citizen CH-491, CH 481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse in adults and are intended to be sold over-the-counter and not primarily under the order or direction of a physician.
Product codes
DXN
Device Description
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers are noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's upper arm. The units are contained in a hard plastic housing that contains a user interface panel, microprocessor and air pump and is connected byu tubing to an adjustable arm cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD"). The user interface panel for the CH-481 has an additional switch to control the memory function, while the user interface panel for the CH-491 has additional switches to control the clock and memory functions.
The device measures blood pressure through the use of an automatically-inflating arm cuff. The cuff automatically deflates during blood pressure measurement. Model CH-471 has a memory function that displays the last blood pressure readout when the system is turned on. Model CH-481 has a memory function that allows the user to retain seven (7) prior blood pressure measurements. Model CH-491 has a memory function that allows the user to retain thirty (30) prior blood pressure measurements and also includes an LCD display that shows blood pressure measurement in a graph format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
User's upper arm
Indicated Patient Age Range
Adults
Intended User / Care Setting
Over-the-counter and to health care professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Citizen Watch Company, Ltd. CH-401 Blood Pressure Monitor
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
4/28/99
K9842223
510(k) SUMMARY
Citizen Watch Company, Ltd. Models CH-491, CH-481, and CH-471 Blood Pressure Meters
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
Citizen Watch Company, Ltd. Medical Device Section, NP Development Department 1-12, 6-Chome, Hon-cho Tanashi-shi, Tokyo, 188 JAPAN
਼ :
Contact: Joseph D. Edmondson, Jr., Esq. Foley & Lardner, 3000 K Street, N.W., Suite 500 Washington, D.C. 20007 Phone: (202) 672-5300 (202) 672-5399 Fax:
Date Prepared: November 24, 1998
NAME OF DEVICE
| Trade Name: | CH-491, CH-481, and CH-471 Blood Pressure Meter |
|---|---|
| Common Name: | Digital Arm Sphygmomanometer (blood pressure meters) |
| Classification Name: | System, Measurement, Blood Pressure, Non-Invasive |
| (21 C.F.R. § 870.1130) |
PREDICATE DEVICE
- Citizen Watch Company, Ltd. CH-401 Blood Pressure Monitor (1)
INTENDED USE
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.
DEVICE DESCRIPTION
The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers are noninvasive blood pressure measurement systems that measure systolic and diastolic blood
1
pressure and pulse from the user's upper arm. The units are contained in a hard plastic housing that contains a user interface panel, microprocessor and air pump and is connected byu tubing to an adjustable arm cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD"). The user interface panel for the CH-481 has an additional switch to control the memory function, while the user interface panel for the CH-491 has additional switches to control the clock and memory functions.
The device measures blood pressure through the use of an automatically-inflating arm cuff. The cuff automatically deflates during blood pressure measurement. Model CH-471 has a memory function that displays the last blood pressure readout when the system is turned on. Model CH-481 has a memory function that allows the user to retain seven (7) prior blood pressure measurements. Model CH-491 has a memory function that allows the user to retain thirty (30) prior blood pressure measurements and also includes an LCD display that shows blood pressure measurement in a graph format.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Citizen models CH-491, CH-481, and CH-471 represent design changes over the Citizen model CH-401 with respect to the method and procedure for inflation and deflation of the arm cuff. Model CH-491 also adds a clock/watch function and all models have a modified LCD display.
Citizen has determined that these changes have no influence on the correct measuring and the accuracy of systolic and diastolic blood pressure.
-2-
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Citizen Watch Co., Ltd c/o Mr. Joseph D. Edmondson, Jr., Esq. Counsel for Citizen Watch Co., Ltd Foley & Lardner 3000 K Street, NW, Suite 500 Washington, DC 20007-5109
K984223 Re: Blood Pressure Meter, Models CH-491, CH-481 and CH-471 Requlatory Class: II (Two) 74 DXN Product Code: Dated: March 29, 1999 March 30, 1999 Received:
Dear Mr. Edmondson:
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 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). 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 requlation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. 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 requlations.
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Page 2 - Mr. Joseph D. Edmondson, Jr., Esq.
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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K98-4223 510(k) Number (if known):
Blood Pressure Meter, Models CH-491, CH-481 and CH-471 Device Name: Citizen Watch Co.
Indications For Use:
The Citizen CH-491, CH 481 and CH-471 digital arm sphyggomanomerers (b)od pressure The Citizen LH-491, CH 481 and Cr-471 digital measurement of of colic and diastolic
meters) are intended to be used for oscillometrials of color of color of meters) are intended to be used for oscripment a measure sold over-the-counter blood pressure and poise in adults and are meence to be of the order or direction of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bace & Bencee
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K984223
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)