CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER

K973613 · Foley & Lardner · DXN · Apr 14, 1998 · Cardiovascular

Device Facts

• Record ID: K973613
• Device Name: CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
• Applicant: Foley & Lardner
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Citizen CH-611B and CH-611C digital wrist sphygmomanometers (blood pressure meters) are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse. They are intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.

Device Story

Handheld digital wrist sphygmomanometer; measures systolic/diastolic blood pressure and pulse via oscillometric method. Input: pressure oscillations detected by wrist cuff during automatic inflation/deflation cycle. Processing: microcomputer-controlled analysis of pressure signals. Output: LCD display of blood pressure and pulse. CH-611B stores last reading; CH-611C stores last seven readings and calculates average. Used in home or clinical settings by patients or healthcare professionals. Provides objective BP data to assist in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Laboratory data submitted to establish accuracy of blood pressure and pulse measurements compared to the Omron predicate device. Accuracy reported as ± 3 mmHg or ± 2% for BP, and ± 5% for pulse.

Technological Characteristics

Microcomputer-controlled digital wrist sphygmomanometer. Hard plastic housing with LCD interface. Auto-inflate wrist cuff (135-195 mm circumference) with velcro adjustment. Electric pump and automatic air-release valve. Powered by four AAA batteries. Operating range: 50°F to 104°F, 30% to 85% relative humidity.

Indications for Use

Indicated for oscillometric measurement of systolic and diastolic blood pressure and pulse in individuals with wrist circumferences between 135 mm and 195 mm. Suitable for over-the-counter use by the general population and by health care professionals.

Regulatory Classification

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.

Predicate Devices

• Omron HEM-601 Wrist Digital Blood Pressure Monitor

Submission Summary (Full Text)

{0}------------------------------------------------

K9736013

APR 1 4 1998

# 510(k) SUMMARY

# Citizen Watch Company, Ltd. CH-611B and CH-611C Digital Wrist Sphygmomanometers (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 Person: | Joseph D. Edmondson, Jr., Esq.<br>Yoichuro Yamaguchi, Esq. |
|-----------------|------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |

Date Prepared: September 19, 1997

NAME OF DEVICE

| Trade Name: | CH-611B and CH-611C Digital Wrist Sphygmomanometers (Blood Pressure Meters) |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Wrist Sphygmomanometer (blood pressure meter) |
| Classification Name: | Noninvasive blood pressure measuring system, per 21 C.F.R. § 870.1130 |

#### PREDICATE DEVICES

(1) Omron HEM-601 Wrist Digital Blood Pressure Monitor

INTENDED USE

The Citizen CH-611B and CH-611C digital wrist sphygmomanometers (blood pressure meters) are intended to be used for the oscillometric measurement of systolic and diastolic blood They are intended to be sold over-the-counter and to health care pressure and pulse. professionals, and not primarily under the order or direction of a physician.

#### DEVICE DESCRIPTION

The Citizen CH-611B and CH-611C digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel to which an adjustable wrist cuff is attached by rubber tubing. The user interface panel has a power switch, and a liquid crystal display

{1}------------------------------------------------

("LCD") for displaying the systolic and diastolic blood pressure and pulse, and a memory switch.

The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-611B and the CH-611C is that the CH-611B has a memory function which is able to display the last measured systolic and diastolic blood pressure readings (but not the pulse) when a memory recall switch is pressed, while the CH-611C is able to display the last seven measured systolic and diastolic blood pressure readings (but not the pulse) as well as an average of the seven.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Both the Citizen Sphygmomanometers and the Omron predicate device measure the diastolic and systolic blood pressure from the left wrist using oscillometric methods. Both systems are microcomputer controlled, digital, auto-inflate, wrist sphygmomanometers. The Omron predicate device does not have a memory function.

Like the Omron predicate, the Citizen sphygmomanometers display systolic and diastolic pressure ranges from 0 and 280 mm Hg. Both devices have a blood pressure measurement accuracy of the greater of ± 3mm Hg or ± 2% of the reading. The pulse measurement range of the Citizen devices and the Omron predicate are also the same, from 40 to 200 pulses/minute. The accuracy of the pulse measurements for both the Citizen sphygmomanometers and the Omron predicate device are + 5% of the measured pulse frequency. Citizen submitted , laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device.

Both the Citizen and the Omron devices utilize an auto-inflate wrist cuff system for blood pressure measurement. The Citizen and Omron devices are designed to measure blood pressure and pulse from the left wrist. The wrist cuff for both systems is designed to accommodate wrists with a circumference of between 135 mm and 195 mm. The wrist cuff on the Citizen device and the predicate device are both adjusted by velcro. Inflation of the wrist cuff for the Citizen devices and the Omron predicate are accomplished with an electric pump and pressure is released during deflation by an automatic air-release valve.

The Citizen devices, like the Omron predicate, have a "POWER" switch, a "START" switch, and an LCD display. The operating environment for the Citizen sphygmomanometers and the Omron predicate are also the same: 50°F and 104°F and 30% to 85% relative humidity. Although the Citizen devices use four "AAA" size batteries, the Omron predicate device uses four "AA" batteries. Any minor differences in the appearance, technology, or manufacture of the Citizen devices and the predicate device do not raise any new questions of safety or effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains a single letter, "S", in a simple, sans-serif font. The letter is black and stands out against a white background. The letter is in uppercase.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

APR 1 4 1998

Citizen Watch Company, Ltd c/o Mr. Joseph D. Edmondson, Jr. Foley & Lardner 3000 K Street, N.W. Suite 500 Washington, DC 20007

K973613 Re : CH-611B and CH-611C Digital Wrist Sphygmomanometer Regulatory Class: II (Two) Product Code: DXN Dated: January 16, 1998 Received: January 16, 1998

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 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 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 regulation may result in regulatory action. In addition, FDA may publish further 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 regulations.

{3}------------------------------------------------

#### Page 2 - Mr. Joseph D. Edmondson, Jr.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

{4}------------------------------------------------

of of of Page

510(k) Number (if known):__________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

### STATEMENT OF INDICATIONS FOR USE

The Citizen CH-611B and CH-611C digital wrist sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold over-the-counter and to health care professionals, and not primarily under 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)

Thomas L. Callahon

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)