(161 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No.
The device is intended to measure blood pressure and pulse rate, not to treat a condition or disease.
Yes
The device measures physiological parameters (blood pressure and pulse rate) to provide information about the user's health status, which can be used for health monitoring and detection of abnormalities, aligning with the definition of a diagnostic device.
No
The device description explicitly mentions an "inflatable cuff" and a "digital panel" for displaying readings, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device measures blood pressure and pulse rate directly from the individual's upper arm using a non-invasive technique (an inflatable cuff). It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly state it measures physiological parameters directly from the individual. It measures blood pressure and pulse rate by detecting blood movement through the brachial artery.
Therefore, the Digital Automatic Blood Pressure Monitor BPM03 Series 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 Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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 upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.
Product codes
DXN
Device Description
Digital Automatic Blood Pressure Monitor BPM03 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 BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm 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.
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
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 Blood Pressure Monitor BPM03 Series. The results demonstrated that BPM03 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM03 Series is safe for use. Tests include:
EN1060-1:1995/A1:2002
EN1060-3:1997/A1:2005
IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)
EN60601-1-2:2007
FCC Part 15
ISO10993-5:2009
ISO10993-10:2010
EN60601-1-4:2007
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K123073 Page 1 of 3
Section IV: 510k Summary
MAR 1 ,1 2013
| Applicant's Identification | |
|---|---|
| Applicant | Grandway Technology (Shenzhen) Limited |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Application | 21st September 2012 |
Device's Identification
Device Proprietary Name
Digital Automatic Blood Pressure Monitor BPM03 Series
Model No.: MD03x0
x --- The first character (0, 1, 2, 3, 4, 5 or 6) 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 Il per 21 CFR 870.1130)
Marketed Devices to which Equivalence is Claimed
| DEVICE | MANUFACTURER | 510(k) Number |
|---|---|---|
| AVITA BPM6 Series Blood Pressure Meter | ||
| (or Monitor) | AViTA Corp | K033397 |
Device Description
Digital Automatic Blood Pressure Monitor BPM03 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 BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm 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.
-**
1
Intended Use (Indication for Use)
Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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 upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.
Comparison of Technological Characteristics between New Device and Predicate Devices
The Digital Automatic Blood Pressure Monitor BPM03 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 Blood Pressure Monitor BPM03 Series. The results demonstrated that BPM03 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM03 Series is safe for use. Tests include
EN1060-1:1995/A1:2002 EN1060-3:1997/A1:2005 IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) EN60601-1-2:2007 FCC Part 15 ISO10993-5:2009 ISO10993-10:2010 EN60601-1-4:2007
Conclusion
Digital Automatic Blood Pressure Monitor BPM03 Series has the same intended use and similar technological characteristics as predicate device (K033397). 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
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol consists of a staff with a serpent entwined around it, representing healing and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2013
Grandway Technology (Shenzhen) Limited c/o Mr. Patrick Chow Building 6 and 7, Zhu Keng Industrial Zone Ping Shan, Long Gang District, Shenzhen CHINA 518118
Re: K123073
Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM03 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 17, 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.
4
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 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/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
5
Section V: Statement of Indications for Use
K123073 510(k) Number (if known):
Device Name:
Digital Automatic Blood Pressure Monitor BPM03 Series
Model No.: MD03x0
x --- The first character (0, 1, 2, 3, 4, 5 or 6) 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 Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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 upper arm of an individual. The inflatable cuff circumference is limited to 17cm – 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR . .
Over-The-Counter Use ਮ (21 CFR 801 Subpart C)
.
Arab
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.03.11
11:03:52 -04'00'