OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC

K052154 · Omron Healthcare, Inc. · DXN · Sep 8, 2005 · Cardiovascular

Device Facts

• Record ID: K052154
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Story

Digital blood pressure monitor; measures blood pressure and pulse rate in adults. Uses oscillometric method to detect arterial pressure oscillations; identifies irregular heartbeats during measurement. Provides visual output of readings and warning signal for irregular heartbeats. Designed for over-the-counter or prescription use; operated by patient or clinician. Assists in monitoring cardiovascular health; provides data for clinical decision-making regarding hypertension management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Digital oscillometric blood pressure monitor. Measures blood pressure and pulse rate. Includes irregular heartbeat detection feature. Standalone device; battery or AC powered. Non-invasive.

Indications for Use

Indicated for adult patients for the measurement of blood pressure and pulse rate. Detects irregular heartbeats during measurement.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2005

Omron Healthcare, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K052154

Trade Name: Omron Automatic Blood Pressure Monitor, Model HEM-711AC Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 24, 2005 Received: August 25, 2005

Dear Ms. Ankova:

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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Page 2 - Ms. Silvia Ankova

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the start of the samplies with other requirements of the Ac Please be advised that FDA's issuance of a substantial complies with other requirements of the Act
that FDA has made a determination that your device aderal agencies. You mu that FDA has made a determination inalyou divisions aderal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listi or any Federal statutes and regulations administred to: recisitation and listing
comply with all the Act's requirements, including, but not limited to: requirements a comply with all the Act's requirements, including out not many of seguirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements (21 CFR Part 807); labeling (21 CFR Part 801); good manataly; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applica forth in the quality systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 31 casescri)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice and premarket notification. The FDA finding of substantial equivalite of 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
r (1) (1) (1) (1) (1) (1) (1) (1) (11) (11) (11) (1) (1) (1) (1) (1) (1) If you desire specific advice for your device on our hoomig regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation in contact the Office of Compliance at [phone] Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to prematical ionnitation " (2) Cr Cr Architer of Small
other general information on your responsibilities under the Act from the (800) 638-204 other general information on your responsibilities under [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (800) on Manufacturers, International and Consumer Assistance at 10 for Ire Same (4)
[phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimimova for

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

Applicant:

OMRON HEALTHCARE, INC.

510(k) Number:

K

Device Name:

Indication for Use:

OMRON Automatic Blood Pressure Monitor, Model: HEM-711ACN

(OMRON Internal Model Name: HEM-7011-Z)

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumimor

Islon Slan-Of rdiovascular D

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