(346 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series is for use by medical professional or at home. The WBPM15 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. The inflatable cuff circumference is limited to 13.5cm -19.5cm.
Digital Automatic Wrist Blood Pressure Monitor WBPM15 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 WBPM15 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 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.
This response is based on the provided text only, and thus cannot include details not present in the document.
Acceptance Criteria and Study for Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10-2002 | Meets the requirement of ANSI/AAMI SP-10-2002 |
Note: The specific numerical targets for accuracy (e.g., mean difference, standard deviation) as defined by ANSI/AAMI SP-10-2002 are not explicitly stated in the provided text, only that the device "meets the requirement" of the standard.
2. Sample Size Used for the Test Set and Data Provenance
The provided text states that a "systematic & independent clinical test was conducted," but does not specify the sample size used for this clinical test, nor does it specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. For blood pressure monitors, ground truth is typically established by trained clinicians using a reference sphygmomanometer following a specific protocol.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This type of study is more common for diagnostic imaging AI, not typically for blood pressure monitors.
6. Standalone Performance Study (Algorithm Only)
The device is a physical blood pressure monitor that uses an "oscillometric methodology" and "converts the movements into a digital reading." The clinical test mentioned assesses the performance of the device as a whole. While the oscillometric method involves an algorithm, the provided text does not specifically describe a standalone algorithm-only performance study separate from the overall device performance.
7. Type of Ground Truth Used
The ground truth for validating blood pressure monitors against standards like ANSI/AAMI SP-10-2002 typically involves concurrent measurements by trained human observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or validated electronic reference device) following a specific protocol to obtain the true blood pressure readings. The document does not explicitly state the type of ground truth used, but this is the standard methodology for such devices.
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. For traditional medical devices like blood pressure monitors, "training data" in the AI sense is not typically used. The device relies on established oscillometric principles rather than a learned AI model that requires a training set.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied within the context of a traditional blood pressure monitor, this information is not applicable and not provided in the document.
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~ Section IV: 510k Summary
Applicant's Identification
Applicant Phone Number Fax Number Contact Person Date of Application
Device's Identification
Device Proprietary Name
Grandway Technology (Shenzhen) Limited (00852)-2851-6789 (00852)-2851-6278 Mr. Patrick Chow 24th Feb, 2012
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series
Model No.: MD15xy
x --- The first character (0, 2, 3, 6 or 9) 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. y --- The second character (which is always 0) is for the identification of cabinet (housing).
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 | |
|---|---|---|
| Digital Automatic Wrist Blood Pressure | Grandway Technology | K110299 |
| Monitor WBPM10 Series (Model No.: | (Shenzhen) Limited | |
| MD10xy) |
Device Description
Digital Automatic Wrist Blood Pressure Monitor WBPM15 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.
FEB 1 4 2013
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Additional information of K120673
· The WBPM15 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 WBPM15 Series is for use by medical professional or at home. The WBPM15 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. The inflatable cuff circumference is limited to 13.5cm - 19.5cm.
Comparison of Technological Characteristics between New Device and Predicate Devices
The Digital Automatic Wrist Blood Pressure Monitor WBPM15 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 WBPM15 Series. The results demonstrated that WBPM15 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate WBPM15 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 ISO10993-5:2009 ISO10993-10:2002 + A1:2006 EN60601-1-4:2007
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Conclusion
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series has the same intended use and similar technological characteristics as predicate device (K110299). Moreover, 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 WBPM15 Series is substantially equivalent to the predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 14, 2013
Grandway Technology (Shenzhen) Limited c/o Mr. Patrick Chow, General Manager Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong People's Republic of China
Re:
Trade/Device Names: Digital Automatic Blood Pressure Monitor with models MD1500, MD1520, MD1530, MD1560 and MD1590 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 5, 2013 Received: February 8, 2013
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, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 listing (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 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 100-1050.
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/CDRHQffices/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" (2) CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for 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): K120673
Device Name:
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series
Model No.: MD15xy
x --- The first character (0, 2, 3, 6 or 9) 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.
y --- The second character (which is always 0) is for the identification of cabinet (housing).
Indications For Use:
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series is for use by medical professional or at home. The WBPM15 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. The inflatable cuff circumference is limited to 13.5cm -19.5cm.
Prescription Use (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/15 description: The image shows the name "Owen P. Faris - S" in a stylized font. The name is written in black ink and is centered on the page. The letters are large and easy to read. The "P. Faris" portion of the name is stylized with a geometric pattern.
§ 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).