TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A

K071075 · Terumo Corp. · DXN · May 25, 2007 · Cardiovascular

Device Facts

• Record ID: K071075
• Device Name: TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
• Applicant: Terumo Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.

Device Story

Non-invasive blood pressure monitor; measures systolic/diastolic pressure and pulse rate. Inputs: pulse wave and pressure signals from upper arm cuff. Operation: oscillometric method (automated) or manual sphygmomanometer (using stethoscope). Output: digital display of pressure and pulse values. Used in clinical settings by healthcare professionals. Benefits: provides accurate blood pressure monitoring for pediatric (3+) and adult populations.

Clinical Evidence

Clinical evaluation conducted in accordance with ANSI/AAMI Standard SP10:2002, Electronic or Automated Sphygmomanometers. Study included pediatric patients to validate accuracy for the expanded age range. Results demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Non-invasive oscillometric and manual auscultatory blood pressure monitor. Features upper arm cuff, electronic pulse wave/pressure signal detection, and amplification circuitry. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for pediatric patients (age 3+) excluding neonates/infants, and adults. Used for non-invasive blood pressure and pulse rate measurement at the upper arm via oscillometric method or manual auscultatory method with a stethoscope. Intended for professional 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

• A & D Lifesource, UA-704 Digital Blood Pressure Monitor (K032499)
• American Diagnostic Corporation e-sphyg digital Aneroid Blood Pressure Instrument (K962655)

Submission Summary (Full Text)

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K071075

## MAY 2 5 2007

## SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address:

Terumo Corporation 44-1, 2-chome, Hatagaya, Shibuya-ku, Tokyo. 151-0072, Japan

Manufacturing site name, address:

Suruga factory of Terumo Corporation 150, Maimaigi-cho, Fujinomiya-shi, Shizuoka-pref 418-0015, Japan

Submission Correspondent:

Classification Name:

Common / Usual Name: Proprietary Name:

Lyle Howard Corporation 106 East 5th Avenue Mount Dora, Florida 32757 USA Attention: Lynette Howard 352.383.8333

Noninvasive Blood Pressure Measurement System Blood Pressure Monitor Terumo Digital Blood Pressure Monitor ES-H55A

Class II, Reg. # 870.1130, DXN. Cardiovascular Devices Panel

Performance Standards:

21 CFR Part 898 and 1010

Substantial Equivalence:

Classification:

The legally marketed devices to which substantial equivalence is demonstrated are A & D Lifesource, UA-704 Digital Blood Pressure Monitor (K032499) and the American Diagnostic Corporation e-sphyg digital Aneroid Blood Pressure Instrument (K962655).

The subject device is substantially equivalent with the predicate devices in the intended use, design, principle of operation, i.e., oscillometric/auscultatory method, specifications and performance.

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The principal difference between the subject device and predicates is the intended population. For Terumo Digital Blood Pressure Monitor ES-H55A, the intended population is Pediatric (age 3 and above) except for neonate and infant, and Adult, while the intended population for predicates is Adult. By performing the bench test and clinical evaluation incl. pediatric patients in accordance with ANSI/AAMI Standard SP10:2002, Electronic or Automated Sphygmomanometers, it is clear that the difference raises no new questions with respect to either safety or effectiveness.

Testing conducted or standards applied to assure safety and effectiveness includes but is not limited to:

Clinical Performance and Accuracy: ANSI/AAMI Standard SP10-2002. Electronic or Automated Sphygmomanometers, approved October 28, 2002.

Electrical safety: IEC60601-1 2nd as amended

Electromagnetic Compatibility: IEC 60601-1-2, 2001 with test procedures according to IEC 61000-4-2, 2001; IEC 61000-4-3, 2002; IEC 61000-4-8, 2001.

Description of the new device:

The Terumo Digital Blood Pressure Monitor ES-H55A is a non-invasive device to measure patient's blood pressure by electrically detecting and amplifying the pulse wave and pressure signal obtained from the inside of the cuff. As an automated Blood Pressure Monitor, it measures the systolic and diastolic blood pressure and pulse rate using Oscillometric method. Also as a manual sphygmomanometer (pressure gauge), it displays the pressure values.

Intended Use:

The Terumo Digital Blood Pressure Monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.

Safety and Efficacy Information:

The Terumo Digital Blood Pressure Monitor ES-H55A is well recognized as being safe and effective for the stated intended use. The TerumoDigital Blood Pressure Monitor ES-H55A has the same operating principals and intended uses as the predicate Blood Pressure Monitor systems already in commercial distribution.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human figures connected by flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2007

Terumo Corporation c/o KEMA Quality B.V. Patricia L. Murphy 4377 Country Line Rd. Chalfont, PA 18914

Re: K071075

Trade/Device Name: Terumo Digital Blood Pressure Monitor ES-H55A Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 11, 2007 Received: May 14, 2007

Dear Ms. Murphy:

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.

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

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Page 2 - Ms. Patricia L. Murphy

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 240-276-0120. 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,

Bhomtoma for

Bram &. 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

510(k) Number (if known): K071075

Device Name: TERUMO Digital Blood Pressure Monitor ES-H55A

Indications for Use:

The TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.

Prescription Use x (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)

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B. Bummerman

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number