(123 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The testing described is for clinical accuracy against a reference method and standard compliance, not for evaluating an AI/ML algorithm.
No.
This device is for measurement and monitoring of blood pressure, not for treating a condition or disease.
No
The device measures physiological parameters (blood pressure and pulse rate) but does not provide a diagnosis of a disease or condition. It is used for monitoring.
No
The device description explicitly states it is a "Digital Automatic Blood Pressure Monitor" that utilizes an "inflatable cuff" and displays readings on a "digital panel," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures blood pressure and pulse rate directly from the patient's upper arm using a cuff and oscillometric methodology. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for non-invasive measurement and monitoring of arterial blood pressure, not for analyzing samples.
Therefore, based on the provided information, this blood pressure monitor falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Digital Automatic Blood Pressure Monitor BPM28 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 of an individual in each measurement and then display the readings on a digital panel.
The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement 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
Age 16 or above
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)
Clinical Test Summary:
Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 is documented in Clinical Test report.
One hundred patients (46 males and 54 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.
Non-Clinical Test Summary:
Digital Automatic Blood Pressure Monitor BPM28 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- EN 1060-1:1995+A2:2009
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- EN 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
Also, bench testing, IEC 80601-2-30, is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM28 Series is equivalent to the predicate device.
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, forming the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2015
Grandway Technology (Shenzhen) Limited Patrick Chow Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong, 518118 CN
K143734 Re: Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM28 Series -MD2800, MD2810 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 27, 2015 Received: March 27, 2015
Dear Patrick 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.
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
1
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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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 Industry and Consumer Education 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 vours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Druq Administration |
Indications for Use
| 510(k) Number (if known) | K143734 |
|---|---|
| K143734 | Page 1 of 1 |
| Device Name |
Digital Automatic Blood Pressure Monitor BPM28 Series, MD2800, MD2810
Indications for Use (Describe)
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang |
| District, Shenzhen, Guang Dong, People's Republic of China | |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 30-Dec-2014 |
Submitter Identification 1.
Device Identification 2.
| Trade Name | Digital Automatic Blood Pressure Monitor BPM28 Series |
|---|---|
| [Model No.: MD28x0] | |
| x --- The first character (0 and 1) is for the identification of add- | |
| onfeatures. | |
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System |
| (CFR 870.1130, Class II, Product Code DXN) |
Predicate Device 3.
| Predicate Device | Digital Automatic Blood Pressure Monitor BPM18 Series |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K133619 |
Device Description 4.
Digital Automatic Blood Pressure Monitor BPM28 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 of an individual in each measurement and then display the readings on a digital panel.
The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM28 Series.
| Model | BP
Measurement | Pulse Rate
Measurement | WHO | IHB | LCD Type | Key Type | DC Jack | Key Ring
Illustration |
|--------|-------------------|---------------------------|-----|-----|---------------------|----------|---------|--------------------------|
| MD2800 | ✓ | ✓ | ✓ | ✓ | Positive Reflective | Hard | ✓ | ✓ |
| MD2810 | ✓ | ✓ | ✓ | ✓ | Positive Reflective | Soft | x | x |
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Indication for Use 5.
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.
Comparison of Technological Characteristics between New Device and 6. Predicate Devices
Digital Automatic Blood Pressure Monitor BPM28 Series is compared to the predicate device, BPM18 Series (K133619) in the device comparison table below.
| Comparison between BPM28 Series and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | BPM28 Series | Comment |
| Indication for Use | Digital Automatic Blood Pressure | ||
| Monitor BPM18 Series is for use by | |||
| medical professional or home user. The | |||
| BPM18 Series is intended to measure the | |||
| systolic and diastolic blood pressure, and | |||
| pulse rate of an adult individual by using | |||
| a non-invasive technique, in which an | |||
| inflatable cuff is wrapped around the | |||
| upper arm. | The upper arm blood pressure monitor is | ||
| used for non-invasive measurement and | |||
| monitoring of adults' arterial blood | |||
| pressure. You can use it to measure your | |||
| systolic and diastolic pressure, and pulse | |||
| rate through an inflatable cuff wrapped | |||
| around the upper arm. Quickly and | |||
| easily, storing the results and displaying | |||
| the progression of readings together with | |||
| the average. | Equivalent | ||
| Measurement | |||
| Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient Population | Age 16 or above | Age 16 or above | Identical |
| BP Measurement | |||
| Range | Cuff Pressure: 0 - 300 mmHg | ||
| Systolic Pressure: 50 - 250 mmHg | |||
| Diastolic Pressure: 30 - 200 mmHg | Cuff Pressure: 0 - 300 mmHg | ||
| Systolic Pressure: 50 - 250 mmHg | |||
| Diastolic Pressure: 30 - 200 mmHg | Identical | ||
| Number of User | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Equivalent |
| Resolution of | |||
| Measurement | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg | ||
| Pulse Rate: 1 beat/ min | Identical | ||
| Blood Pressure | |||
| Measurement | |||
| Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse Rate | |||
| Measurement | |||
| Range | 30 - 180 beats/min | 40 - 180 beats/min | Equivalent |
| Pulse Rate | |||
| Measurement | |||
| Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AAA-batteries; and/or | ||
| AC adaptor (6V/600mA) | 4 × 1.5 V AAA-batteries; and/or | ||
| AC adaptor (6V/600mA) | Identical | ||
| Pressurization | |||
| Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating | |||
| Condition | Temperature: 10 - 40 °C | ||
| Humidity: 30 - 85 % R.H. max | |||
| Atmospheric Pressure: 700 - 1060 kPa | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700 - 1060 kPa | Equivalent |
5
| Comparison between BPM28 Series and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | BPM28 Series | Comment |
| Storage and | |||
| Transportation | |||
| Condition | Temperature: -20 - 60 °C | ||
| Humidity: 10 - 95 % R.H. max | |||
| Atmospheric Pressure: 700 - 1060 kPa | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric Pressure: 700 - 1060 hPa | Equivalent | ||
| Material | Resistances, capacitance, transistors, | ||
| amplifiers, pressure sensor, CPU, PCB, | |||
| cuff ABS button, ABS cabinet, batteries | |||
| and packaging | Resistances, capacitance, transistors, | ||
| amplifiers, pressure sensor, CPU, PCB, | |||
| cuff ABS button, ABS cabinet, batteries | |||
| and packaging | Identical | ||
| Compatibility with | |||
| Environment and | |||
| Other Devices | No influence with environment and other | ||
| device | No influence with environment and other | ||
| device | Identical | ||
| Applicable | |||
| Standard | - EN 1060-1:1995+A2:2009 |
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- EN 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
- IEC 81060-2:2009 | - EN 1060-1:1995+A2:2009
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- EN 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
- IEC 81060-2:2013 | Equivalent |
Digital Automatic Blood Pressure Monitor BPM28 Series is a non-invasive measuring device and utilize the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring blood pressure.
Clinical and Non-clinical Tests 7.
Clinical Test Summary
Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013is documented in Clinical Test report.
One hundred patients (46 males and 54 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.
Non-Clinical TestSummary
Digital Automatic Blood Pressure Monitor BPM28 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
-
EN 1060-1:1995+A2:2009
- や EN 1060-3:1997+A2:2009
- や IEC 60601-1:2012
- ゃ EN 60601-1-2:2007
- ◆ FCC Part 15 Subpart B
- <> ISO 10993-5:2009
6
- ISO 10993-10:2010 ゃ
- ゃ IEC 62304:2006
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM28 Series are as same as the predicate device.
Also, bench testing, IEC 80601-2-30, is conducted to show the performance ofDigital Automatic Blood Pressure Monitor BPM28 Series is equivalent to the predicate device.
Conclusion 8.
Digital Automatic Blood Pressure Monitor BPM28 Series has the same intended use and same technological characteristics as the predicate device, BPM18 Series (K133619). Moreover both clinicaland non- clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Blood Pressure Monitor BPM28 Series is substantially equivalent to the predicate device.