BLOOD PRESSURE METER, MODEL CH-658

K102303 · Citizen Systems Japan Co., Ltd. · DXN · Sep 10, 2010 · Cardiovascular

Device Facts

• Record ID: K102303
• Device Name: BLOOD PRESSURE METER, MODEL CH-658
• Applicant: Citizen Systems Japan Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Device Story

Citizen Model CH-658 is a non-invasive, oscillometric wrist blood pressure monitor for home use. Device uses an inflatable cuff to measure systolic/diastolic blood pressure and pulse rate. Integrated software detects irregular heartbeats during measurement and provides a warning signal alongside the blood pressure reading. Intended for personal health monitoring by lay users without physician supervision. Output is displayed on the device screen to inform the user of their cardiovascular metrics.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determined via regulatory review.

Technological Characteristics

Non-invasive oscillometric wrist-cuff blood pressure monitor. Features electronic pressure sensing and automated pulse rate calculation. Includes irregular heartbeat detection algorithm. Designed for home use.

Indications for Use

Indicated for home use by individuals for non-invasive oscillometric measurement of systolic/diastolic blood pressure and pulse rate via a wrist cuff. Includes detection and warning of irregular heartbeats.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

SEP 1 0 2010

Citizen Systems Japan Co. Ltd. c/o Mr. Nathan A. Beaver Foley & Lardner LLP 3000 K Street NW, Suite 600 Washington, DC 20007

Re: K102303

> Trade/Device Name: Model CH-658 Blood Pressure Meter Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 16, 2010 Received: August 16, 2010

## Dear Mr. Beaver:

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 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.

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Page 2 - Mr. Nathan A. Beaver

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

- If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## Indications for Use

K102303

## SEP 1 0 2010

| 510(k) Number: | K102303 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Model CH-658 Blood Pressure Meter |
| Indications For Use: | The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. |
| | The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. |
| | The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician. |

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X
(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)Page 1 of **_**

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K102303