(39 days)
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.
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.
This document pertains to the Terumo Digital Blood Pressure Monitor ES-H55A (K071075) and its conformity to the ANSI/AAMI Standard SP10-2002 for Electronic or Automated Sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors are defined by the ANSI/AAMI SP10-2002 standard. This standard sets limits for the difference between the device's readings and a reference measurement (auscultation).
| Acceptance Criteria (ANSI/AAMI SP10-2002) | Reported Device Performance | Comments |
|---|---|---|
| Mean difference (± SD) between device and reference measurement: | Not explicitly provided in the document. | The document states that the device was evaluated "in accordance with ANSI/AAMI Standard SP10:2002," implying compliance. However, specific values for mean difference and standard deviation are not detailed in this summary. |
| - Mean difference ≤ ±5 mmHg | ||
| - Standard deviation (SD) ≤ 8 mmHg |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size for the clinical evaluation. However, it indicates that the study included "pediatric patients" in addition to adults. The ANSI/AAMI SP10 standard typically requires a minimum of 85 subjects for accuracy validation. Given the inclusion of pediatric patients, the sample would likely be structured to represent both age groups adequately.
- Data Provenance: The study was a "clinical evaluation" conducted to comply with the ANSI/AAMI SP10:2002 standard. The document does not specify the country of origin for the data or whether it was retrospective or prospective. Clinical evaluations for medical devices are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth. For clinical accuracy studies of blood pressure monitors following ANSI/AAMI SP10, the ground truth (reference measurements) is typically established by trained observers (technicians or clinical personnel) using auscultation with a mercury sphygmomanometer or validated equivalent. These observers are trained to recognize Korotkoff sounds accurately.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method. In clinical accuracy studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings might be averaged, or discrepancies might be resolved through a pre-defined protocol. However, these specific details are not provided in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. An MRMC study is typically used to assess the effectiveness of an AI-powered diagnostic tool by comparing the performance of multiple human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI diagnostic tool designed to assist human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The clinical evaluation "in accordance with ANSI/AAMI Standard SP10:2002" assesses the device's accuracy (algorithm only, as it's an automated device) against a reference measurement (human-read auscultation). The device operates independently to measure blood pressure without human interpretation of its internal signals.
7. Type of Ground Truth Used
The ground truth used for calibration and validation of automated blood pressure monitors, as per ANSI/AAMI SP10, is expert auscultation (manual blood pressure measurement using a stethoscope and sphygmomanometer). This is considered the clinical gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
The document does not provide the sample size for a training set. This is because the device, while automated, is likely based on established oscillometric principles and calibrated using standard methods rather than a deep learning approach that requires a distinct "training set" in the AI sense. The clinical evaluation mentioned serves as a validation set.
9. How the Ground Truth for the Training Set Was Established
Since the device does not employ a deep learning or similar AI algorithm that typically requires a training set, the concept of establishing ground truth for a training set in this context is not directly applicable. The device's underlying oscillometric algorithm would have been developed and refined using physiological principles and potentially smaller, internal datasets for initial calibration, with the clinical evaluation serving as the primary validation against a recognized standard (expert auscultation).
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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 (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)
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6
B. Bummerman
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
§ 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).