BLOOD PRESSURE METER, MODEL CH-609

K100055 · Citizen Systems Japan Co., Ltd. · DXN · Aug 30, 2010 · Cardiovascular

Device Facts

• Record ID: K100055
• Device Name: BLOOD PRESSURE METER, MODEL CH-609
• Applicant: Citizen Systems Japan Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Model CH-609 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Device Story

Model CH-609 is an automated, non-invasive blood pressure monitor for home use. Device utilizes oscillometric method to measure systolic/diastolic blood pressure and pulse rate. User applies cuff to arm; device inflates/deflates automatically; processes pressure oscillations to derive hemodynamic values. Output displayed on integrated screen for user review. Intended for personal health monitoring; does not require physician oversight. Benefits include convenient, accessible blood pressure tracking for self-management.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and comparison to established regulatory standards for non-invasive blood pressure measurement systems.

Technological Characteristics

Oscillometric measurement principle; automated inflation/deflation; digital display; battery-powered; home-use form factor. Complies with 21 CFR 870.1130 requirements for non-invasive blood pressure measurement systems.

Indications for Use

Indicated for individuals requiring personal health monitoring of systolic and diastolic blood pressure and pulse rate at home. Not intended for use under the primary direction of a physician.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

:

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

AUG 3 0 2010

Re: K100055

> Trade/Device Name: Model CH-609 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: July 29, 2010 Received: July 29, 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. Iisting 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 vours.

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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Version 1

## Indications for Use

## 510(k) Number (if known):

.

Device Name: Model CH-609 Blood Pressure Meter

Indications For Use:

Model CH-609 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (ODE)

A. J. M. A.

(Division Sign-Off) Division of Cardiover ular Devices

510(k) Number K100055