OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3

K061822 · Omron Healthcare, Inc. · DXN · Aug 2, 2006 · Cardiovascular

Device Facts

• Record ID: K061822
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Special
• 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 (22 cm - 42 cm). The device detects the appearance of irreqular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension quideline of 135/85 mmHq. The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Story

Digital blood pressure monitor; uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Input: pressure oscillations from inflatable arm cuff. Processing: automated algorithm detects pressure changes; identifies irregular heartbeats; compares average results against AHA hypertension guideline (135/85 mmHg). Output: digital display of blood pressure, pulse rate, and irregular heartbeat warning signal. Used in home or clinical settings; operated by patient or healthcare provider. Provides non-diagnostic monitoring; alerts user to consult physician if hypertensive values detected.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to predicate device.

Technological Characteristics

Oscillometric measurement principle; digital display; arm cuff for 22-42 cm circumference. Battery or AC power. Software-based signal processing for pressure oscillation analysis and irregular heartbeat detection.

Indications for Use

Indicated for adult patients with arm circumferences 22-42 cm for measurement of blood pressure and pulse rate. Not for diagnostic use.

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-773AC (K052336)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

OMRON Healthcare, Inc. c/o Ms. Donna Djinovich Regulatory Affairs Manager 1200 Lakeside Drive Bannockburn, IL 60015

Re: K061822

Automatic Blood Pressure Monitor Model: HEM 780N3 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 27, 2006 Received: June 28, 2006

Dear Ms. Djinovich:

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 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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Page 2 -- Ms. Donna Djinovich

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 (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. 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

B. Hemmimer fer

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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## OMRON

Attachment 2

## Indications for Use Statement

KOG1822 510(k) Number Device Name OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N3

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 (22 cm - 42 cm).

> The device detects the appearance of irreqular heartbeats during measurement and gives a warning signal with readings.

This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension quideline of 135/85 mmHq.

The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Humana

(Division Sign-Cit) Division of Cardiovascular Devices 510(k) Nymber /

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use