(48 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI or ML components.
No
The device is intended to measure blood pressure and pulse rate, not to treat any medical condition.
Yes
The device is intended to "measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate)" which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is a "non-invasive blood pressure measurement system" that utilizes an "inflatable cuff" wrapped around the wrist and displays readings on a "digital panel." These are hardware components, indicating it is not a software-only device.
Based on the provided information, this device 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 Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series measures blood pressure and pulse rate by using a non-invasive technique involving an inflatable cuff on the wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXN
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional or at home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
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) Blood | ||
| Pressure 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.
7
1
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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2
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.
9
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
5
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