(346 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI/ML components or capabilities.
No.
The device is intended for measurement and monitoring of blood pressure and pulse rate, not for treating or preventing a disease or condition.
No
The device measures physiological parameters (blood pressure and pulse rate) but does not provide a diagnosis or interpretation of those measurements. It merely displays the readings.
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 (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device measures blood pressure and pulse rate in vivo (within the body) by applying a cuff to the upper arm. It does not analyze any bodily fluids or tissues.
The description clearly states it's a "non-invasive blood pressure measurement system" that uses an inflatable cuff wrapped around the upper arm. This is a classic example of an in vivo diagnostic device, not an in vitro one.
N/A
Intended Use / Indications for Use
Digital Automatic Blood Pressure Monitor BPM11 Series is for use by medical professional or at home. The BPM11 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 (comma separated list FDA assigned to the subject device)
DXN
Device Description
Digital Automatic Blood Pressure Monitor BPM11 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 BPM11 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.
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 BPM11 Series. The results demonstrated that BPM11 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM11 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
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
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 24th Feb, 2012
Device's Identification
Device Proprietary Name
Digital Automatic Blood Pressure Monitor BPM11 Series
Model No .: MD11xy
x --- The first character (0, 1, 3, 5, 6 or 8) 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 |
|---|---|---|
| AVITA BPM6 Series Blood Pressure Meter | ||
| (or Monitor) | AVITA Corp | K033397 |
Device Description
Digital Automatic Blood Pressure Monitor BPM11 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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The BPM11 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.
Intended Use (Indication for Use)
Digital Automatic Blood Pressure Monitor BPM11 Series is for use by medical professional or at home. The BPM11 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 BPM11 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 BPM11 Series. The results demonstrated that BPM11 Series meets the requirement of ANSI/AAMI SP-10-2002.
Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM11 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
Conclusion
2
Digital Automatic Blood Pressure Monitor BPM11 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 to be raised. Thus, the Digital Automatic Blood Pressure Monitor BPM11 Series is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
February 14, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
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: K120675
Trade/Device Names: Digital Automatic Blood Pressure Monitor with models MD1100, MD1110, MD1130, MD1150, MD1160 and MD1180 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 6, 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 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
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Section V: Statement of Indications for Use
510(k) Number (if known): K120675
Device Name:
Digital Automatic Blood Pressure Monitor BPM11Series
Model No.: MD11xy
x --- The first character (0, 1, 3, 5, 6 or 8) 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.
v --- The second character (which is always 0) is for the identification of cabinet (housing).
Indications For Use:
Digital Automatic Blood Pressure Monitor BPM11 Series is for use by medical professional or at home. The BPM11 Series is intended to measure the systelic 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 21CFR 801Subpart D) AND/OR
Over-The-Counter Use X (21CFR 801Subpart 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 text "Owen P. Faris -S" in a bold, sans-serif font. The letters "DA" are stylized with a geometric, three-dimensional design. The text is horizontally aligned and appears to be a name or title.
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