(48 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is for use by medical professional or at home. The WBPM10 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist of an individual.
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel. The WBPM10 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.
The provided text describes the acceptance criteria and the study conducted for the Grandway Technology (Shenzhen) Limited Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets the requirement of ANSI/AAMI SP-10-2002 | The clinical test results demonstrated that WBPM10 Series meets the requirement of ANSI/AAMI SP-10-2002. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "A systematic & independent clinical test was conducted to validate the performance," but it does not specify the sample size used for this clinical test.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the clinical test. However, for a device validating against a standard like ANSI/AAMI SP-10-2002, blood pressure measurements from trained healthcare professionals are typically considered the reference.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC comparative effectiveness study was not conducted. The study was a clinical validation against a standard, not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Yes, a standalone study was done. The device itself is an automated blood pressure monitor; its performance was evaluated inherently as a standalone algorithm/device without human intervention in the measurement process. The clinical test evaluated the device's accuracy in measuring blood pressure against a recognized standard.
7. The Type of Ground Truth Used
The ground truth used was measured blood pressure readings from a reference method as per the ANSI/AAMI SP-10-2002 standard. This standard typically requires comparative measurements against a sphygmomanometer used by trained observers.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. As this is a medical device and not an AI model in the modern sense of deep learning, it's unlikely there's a "training set" in the context of machine learning. The device employs an oscillometric methodology, which is a well-established principle, and its "training" would be more akin to calibration and design optimization rather than learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
As noted above, the concept of a "training set" with established ground truth in the machine learning sense is not explicitly mentioned or implied for this device. The oscillometric methodology relies on detecting oscillations in pressure in the cuff, and the "ground truth" for its development would be based on fundamental physiological principles and engineering design, coupled with iterative testing and refinement. The clinical validation against ANSI/AAMI SP-10-2002 serves to ensure the designed system accurately translates these oscillations into blood pressure readings.
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MAR 2 1 2011
Section IV: 510k Summary
Applicant's Identification
- Applicant Phone Number Fax Number Contact Person Date of Application
Grandway Technology (Shenzhen) Limited (00852)-2851-6789 (00852)-2851-6278 Mr. Patrick Chow 31st Jan, 2011
Device's Identification
Device Proprietary Name Series
Digital Automatic Wrist Blood Pressure Monitor WBPM10
Model No.: MD10xv
x --- The first character (0-0 or A-Z) is for the identification of cabinet (housing).
y --- The second character (0-9 or A-Z) is for the minor change revision of device. The mentioned "minor change" refers to those device changes not to be affected the conformity test results of EMC & safety as well as device performance, i.e. IEC 60601-1 and EN 60601-1-2.
Common Name Classification Name Non-invasive Blood Pressure Measurement System Non-invasive Blood Pressure Measurement System (Class II per 21 CFR 870.1130)
Marketed Devices to which Equivalence is Claimed
| DEVICE | MANUFACTURER | 510(k) Number |
|---|---|---|
| AViTA BPM1 Series (Wrist Type) BloodPressure Meter (or Monitor) | AViTA Corp | K030230 |
Device Description
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel.
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The WBPM10 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.
Intended Use (Indication for Use)
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is for use by medical professional or at home. The WBPM10 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist of an individual.
Comparison of Technological Characteristics between New Device and Predicate Devices
The Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is a non-invasive measuring device and utilizes the oscilliometric methodology to measure the blood pressure reading. The key components of device are a pressure sensor, electric valve and an electronic control module together with an electric pump, which inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring the blood pressure reading.
Clinical & Non-clinical Tests
A systematic & independent clinical test was conducted to validate the performance of the Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series. The results demonstrated that WBPM10 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate WBPM10 Series is safe for use. Tests include
EN1060-1:1995/A2:2009 EN1060-3:1997/A2:2009 IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) EN60601-1-2:2007 FCC Part 15 10010993-5:2009 ISO10993-10:2002 + A1:2006 EN60601-1-4:2007
Conclusion
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series has the same intended use and similar technological characteristics as predicate device (K030230). Moreover,
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bench testing contained in this submission and clinical testing supplied demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, the Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The eagle faces to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Grandway Technology (Shenzhen) Limited c/o Mr. Patrick Chow General Manager Building 6 and 7 Zhu Keng Industrial Zone, Ping Shan, Long Gang District Shenshen, Guang Dong China 518118
MAR 2 1 2011
Re: K110299
Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 26, 2011 Received: February 1, 2011
Dear Mr. Chow:
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, Orug, 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 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 -- Mr. Patrick Chow
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 lisuing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours/
J. Hiller
S 1 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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Section V: Statement of Indications for Use
510(k) Number (if known):
Device Name: ·
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series
Model No .: MD10xy
x --- The first character (0-0 or A-Z) is for the identification of cabinet (housing). y --- The second character (0-9 or A-Z) is for the minor change revision of device. The mentioned "minor change" refers to those device changes not to be affected the conformity test results of EMC & safety as well as device performance, i.e. IEC 60601-1 and EN 60601-1-2.
Indications For Use:
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is for use by medical professional or at home. The WBPM10 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist of an individual.
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 CD! ice of Device Evaluation (ODE)
3/2/2011 scular Devices
§ 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).