(123 days)
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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Grandway Technology (Shenzhen) Limited Digital Automatic Blood Pressure Monitor BPM28 Series:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (BPM28 Series) | Comment |
|---|---|---|---|
| Indication for Use | Non-invasive measurement and monitoring of arterial blood pressure in adults. | Non-invasive measurement and monitoring of adults' arterial blood pressure. Measure systolic, diastolic, and pulse rate. Store results, display progression, and average. | Equivalent. The BPM28 Series provides additional functionality of storing results and displaying progression/average, which is a feature enhancement and not a deviation from the core indication. |
| 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 | 0 - 300 mmHg | Identical |
| BP Measurement Range - Systolic | 50 - 250 mmHg | 50 - 250 mmHg | Identical |
| BP Measurement Range - Diastolic | 30 - 200 mmHg | 30 - 200 mmHg | Identical |
| Number of Users | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Equivalent. The memory space is smaller for the BPM28 Series, but this would likely be considered equivalent if the reduced memory doesn't negatively impact the intended use or safety. The document does not specify why this is acceptable, but for an over-the-counter device, 60 memory slots per user might be considered sufficient. |
| Resolution of Measurement - BP | 1 mmHg or 0.1 kPa | 1 mmHg | Identical. The "or 0.1 kPa" might be a unit conversion, so 1 mmHg is the primary specification. |
| Resolution of Measurement - Pulse | 1 beat/min | 1 beat/min | Identical |
| Blood Pressure Measurement Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent. The predicate standard includes "or 2% of reading" which is often a more stringent requirement for higher blood pressure values. By only stating "± 3 mmHg", the BPM28 Series is meeting the absolute criteria, but it's important to note the slight difference in wording from the predicate. However, in the context of many blood pressure monitor standards (like AAMI/ISO), ±3 mmHg is a common primary accuracy criterion. |
| Pulse Rate Measurement Range | 30 - 180 beats/min | 40 - 180 beats/min | Equivalent. The lower limit for the pulse rate measurement is higher in the BPM28 Series (40 vs 30 beats/min). This could be considered a minor difference, potentially affecting patients with very low pulse rates, but for a general "adults" indication, it may be deemed clinically 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 | +5 to +40 °C | Equivalent. The lower temperature limit is extended, but the upper limit remains the same. |
| Operating Condition - Humidity | 30 - 85 % R.H. max | 15 to 93 % R.H. max | Equivalent. The range of acceptable humidity is expanded for BPM28 Series. |
| Operating Condition - Pressure | 700 - 1060 kPa | 700 - 1060 kPa | Identical |
| Storage/Transport Condition - Temperature | -20 - 60 °C | -25 to +70 °C | Equivalent. The storage temperature range is notably wider for the BPM28 Series, indicating greater robustness to environmental conditions during storage and transport. |
| Storage/Transport Condition - Humidity | 10 - 95 % R.H. max | up to 93% R.H. max | Equivalent. The upper limit for humidity is slightly reduced but within a similar range. |
| Storage/Transport Condition - Pressure | 700 - 1060 kPa | 700 - 1060 hPa | Identical (assuming kPa and hPa are equivalent units in this context; 1 kPa = 10 hPa, so there might be a unit error in the document, or it intends to say hPa for both which would be equivalent.) Given the context, it's likely a typo and intended to be 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 Standards | EN 1060-1, EN 1060-3, IEC 60601-1, EN 60601-1-2, FCC Part 15 Subpart B, ISO 10993-5, ISO 10993-10, IEC 62304, IEC 81060-2:2009 | EN 1060-1, EN 1060-3, IEC 60601-1, EN 60601-1-2, FCC Part 15 Subpart B, ISO 10993-5, ISO 10993-10, IEC 62304, IEC 81060-2:2013 | Equivalent. The updated standard for IEC 81060-2 (2013 vs 2009) is a positive change, indicating compliance with a more recent version of the standard for non-invasive sphygmomanometers. |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 patients (46 males, 54 females)
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "Clinical Test report" and does not specify if it was retrospective or prospective, but the description of "patients were invited for the study" and "measurements were repeated alternatively" suggests a prospective design.
-
Number of Experts and Qualifications for Ground Truth:
- The document implies the "standard auscultation method" was used as the reference blood pressure measurement. This method involves a trained professional (e.g., doctor, nurse) using a stethoscope and sphygmomanometer. However, it does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). It relies on the inherent understanding of "standard auscultation method" implying qualified medical personnel.
-
Adjudication Method for the Test Set:
- Not applicable in the typical sense for a diagnostic device reviewing images or complex data. The "ground truth" (reference blood pressure) was established through the standard auscultation method, and the device measurements were compared against these. There is no mention of multiple experts adjudicating discrepancies between readings.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance to measure a change in diagnostic accuracy or efficiency. For a blood pressure monitor, the performance is compared against a gold standard measurement, not against human interpretation of the device's output.
-
Standalone (Algorithm Only) Performance:
- Yes, the clinical test described is essentially a standalone (algorithm only) performance assessment. The device's measurements are directly compared to the reference standard (auscultation) without human intervention in the device's measurement process or interpretation of its output.
-
Type of Ground Truth Used:
- Expert consensus/Reference Standard: The "standard auscultation method" performed by presumably trained medical professionals served as the ground truth. This is the established clinical method for accurate blood pressure measurement against which automated devices are validated.
-
Sample Size for the Training Set:
- The document does not specify a separate training set for the algorithm. For a device like a blood pressure monitor using oscillometric methodology, the core algorithm is typically developed and refined using extensive engineering and testing against physiological models and clinical data during R&D phases (which would constitute a large internal "training" process), but a distinct "training set" in the machine learning sense is not explicitly detailed in the regulatory submission summary provided. The clinical test described is a validation test (test set) for the final product.
-
How Ground Truth for the Training Set Was Established:
- As a distinct training set is not explicitly mentioned or quantified, how its ground truth was established is also not detailed. However, the oscillometric method itself is based on well-established physiological principles and previous generations of blood pressure monitors. The development would involve internal calibration and validation using reference sphygmomanometers and potentially human subjects, similar to the method used for the clinical validation.
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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
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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
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| 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 GangDistrict, 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 | BPMeasurement | Pulse RateMeasurement | WHO | IHB | LCD Type | Key Type | DC Jack | Key RingIllustration |
|---|---|---|---|---|---|---|---|---|
| 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 PressureMonitor BPM18 Series is for use bymedical professional or home user. TheBPM18 Series is intended to measure thesystolic and diastolic blood pressure, andpulse rate of an adult individual by usinga non-invasive technique, in which aninflatable cuff is wrapped around theupper arm. | The upper arm blood pressure monitor isused for non-invasive measurement andmonitoring of adults' arterial bloodpressure. You can use it to measure yoursystolic and diastolic pressure, and pulserate through an inflatable cuff wrappedaround the upper arm. Quickly andeasily, storing the results and displayingthe progression of readings together withthe average. | Equivalent |
| MeasurementMethod | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient Population | Age 16 or above | Age 16 or above | Identical |
| BP MeasurementRange | Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic Pressure: 30 - 200 mmHg | Cuff Pressure: 0 - 300 mmHgSystolic Pressure: 50 - 250 mmHgDiastolic 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 ofMeasurement | Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min | Blood Pressure: 1 mmHgPulse Rate: 1 beat/ min | Identical |
| Blood PressureMeasurementAccuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse RateMeasurementRange | 30 - 180 beats/min | 40 - 180 beats/min | Equivalent |
| Pulse RateMeasurementAccuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AAA-batteries; and/orAC adaptor (6V/600mA) | 4 × 1.5 V AAA-batteries; and/orAC adaptor (6V/600mA) | Identical |
| PressurizationMode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| OperatingCondition | Temperature: 10 - 40 °CHumidity: 30 - 85 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa | Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa | Equivalent |
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| Comparison between BPM28 Series and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | BPM28 Series | Comment |
| Storage andTransportationCondition | Temperature: -20 - 60 °CHumidity: 10 - 95 % R.H. maxAtmospheric Pressure: 700 - 1060 kPa | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 - 1060 hPa | Equivalent |
| Material | Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging | Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging | Identical |
| Compatibility withEnvironment andOther Devices | No influence with environment and otherdevice | No influence with environment and otherdevice | Identical |
| ApplicableStandard | - 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
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- 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.
§ 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).