OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC

K021682 · Omron Healthcare, Inc. · DXN · Dec 12, 2002 · Cardiovascular

Device Facts

• Record ID: K021682
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (from 22 cm to 42 cm).

Device Story

Digital blood pressure monitor; utilizes oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Features IntelliSense™ technology for automated cuff inflation to appropriate level. Intended for non-prescription, home use by adult patients. Device consists of main unit and arm cuff; operates via battery or AC adapter. User wraps cuff around arm; initiates measurement via button press. Device automatically inflates cuff, detects pressure oscillations, calculates values, and displays results on LCD screen. Provides non-invasive monitoring of cardiovascular parameters to assist in health management.

Clinical Evidence

Bench testing only. Device performance validated through comparative testing against standard auscultatory methods to ensure accuracy of blood pressure and pulse rate measurements within specified ranges.

Technological Characteristics

Oscillometric measurement principle; IntelliSense™ automated inflation technology. Digital display; battery or AC power source. Designed for adult arm circumferences 22-42 cm. Non-invasive, cuff-based system.

Indications for Use

Indicated for measuring blood pressure and pulse rate in adult patients with arm circumferences between 9 and 17 inches (22-42 cm).

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-712C (K013488)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three bars above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 12 2002

Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 300 Lakeview Parkway Vernon Hills, Illinois 60061

Re: K021682

Trade Name: Omron Automatic Blood Pressure Monitor with IntelliSense™, Model HEM-773AC

Regulation Number: 21 CFR 870.1130

Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 11, 2002 Received: September 13, 2002

Dear Mr. Kojima:

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 such 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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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

1 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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## Indication for use statement a.

Following is the new indication for use statement for the HEM-773AC

Applicant: 510(k) Number: Device Name:

K021682

OMRON HEALTHCARE, INC.

OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE™, Model HEM-773AC

Indication for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (from 22 cm to 42 cm).

(Division Sign-Off) Division of Cardiovascular and Respiratory Devices

510(k) Number K021682

Non-prescription use ✓