(39 days)
Not Found
No
The document describes a standard oscillometric blood pressure monitor and a manual sphygmomanometer. There is no mention of AI, ML, image processing, or any data training/testing that would indicate the use of such technologies.
No.
This device is a diagnostic device used to measure blood pressure and heart rate, not to treat a condition.
No
This device measures blood pressure and pulse rate, which are physiological parameters. While these measurements can be used in a diagnostic process, the device itself does not provide a diagnosis of a disease or condition. It is a measurement device.
No
The device description explicitly states it 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." This indicates the presence of hardware components (cuff, electrical sensors, amplifier) beyond just software.
Based on the provided information, the TERUMO digital blood pressure monitor ES-H55A is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a non-invasive blood pressure monitor that measures blood pressure at the upper arm. It does not involve analyzing samples taken from the body.
- Method: It uses the oscillometric method and can also function as a manual sphygmomanometer, both of which are external measurement techniques.
Therefore, the TERUMO digital blood pressure monitor ES-H55A falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
pediatric(age 3 and above ) except for neonate and infant, and adult
Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
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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.
子
1
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 (800) 638-2041 or (240) 276-3150 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)
Page 1 of 1
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B. Bummerman
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number