(29 days)
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 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 key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump.
The information provided describes the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure measurement devices are typically defined by international standards like ISO 81060-2. The document explicitly references compliance with IEC 81060-2:2009 (and
the new device uses IEC 81060-2:2013). While the document does not list the specific numerical acceptance criteria from this standard, it states that the device was tested in accordance with it and shows the reported performance for key metrics.
| Acceptance Criteria (Based on ISO 81060-2 standards)* | Reported Device Performance (Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series) |
|---|---|
| Blood Pressure Measurement Accuracy: | ± 3 mmHg (Comparable to predicate device) |
| - Mean difference (systolic) should be within ±5 mmHg | Implicitly met by ±3 mmHg accuracy claim |
| - Standard deviation (systolic) should be within 8 mmHg | Implicitly met by ±3 mmHg accuracy claim |
| - Mean difference (diastolic) should be within ±5 mmHg | Implicitly met by ±3 mmHg accuracy claim |
| - Standard deviation (diastolic) should be within 8 mmHg | Implicitly met by ±3 mmHg accuracy claim |
| Pulse Rate Measurement Accuracy: | ± 5 % of the reading |
Note: The document states compliance with ISO 81060-2. The numerical acceptance criteria for mean difference and standard deviation are standard requirements within ISO 81060-2 for evaluating automated sphygmomanometers. While not explicitly listed with these specifics in the document, the stated "± 3 mmHg" for blood pressure accuracy implies compliance with these underlying statistical criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: One hundred patients (49 males and 51 females).
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as patients were "invited for the study" and measurements were taken during the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document does not explicitly state the number of experts. However, it indicates that "Standard auscultation method was used as the reference blood pressure monitor," which implies measurement by trained human observers (likely medical professionals) using a stethoscope and sphygmomanometer.
- Qualifications of Experts: Not specified. However, for a clinical accuracy study using auscultation as the reference, the operators are typically trained medical personnel (e.g., physicians, nurses, or trained technicians) who are proficient in the auscultatory method.
4. Adjudication Method for the Test Set
- The document implies that the auscultation method serves as the ground truth comparator. It states, "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison method rather than an adjudication process between multiple automated device readings or between the device and multiple human observers. There is no mention of 2+1, 3+1, or other adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the accuracy of the device against a gold standard (auscultation), not on how human readers might improve with or without AI assistance, as AI is not a component of this blood pressure monitor. The device is a standalone measurement system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was done. The clinical test evaluated the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series as a standalone device, measuring its accuracy against the reference auscultation method without human intervention in the device's measurement process.
7. Type of Ground Truth Used
- The ground truth used was established by the standard auscultation method. This is considered the clinical gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- There is no mention of a training set in the provided document. This device is a traditional medical device (blood pressure monitor) that operates based on a pre-programmed algorithm (oscillometric methodology) rather than a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set, the question is not applicable.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2015
Grandway Technology (shenzhen) Limited Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District, Shenzhen, 518118 CN
Re: K152483
Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 31, 2015 Received: August 31, 2015
Dear Mr. 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 yours.
Mitchell Stein
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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Indications for Use
510(k) Number (if known) K152483
Device Name
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
Indications for Use (Describe)
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 4
1. Submitter identification
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118,Shenzhen, People's Republic of China |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 28-Aug-2015 |
Device identification 2.
| Trade Name | Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series |
|---|---|
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System(CFR 870.1130, Class II, Product Code DXN) |
3. Predicate device
| 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 BPM30 and BPM31 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 BPM30 and BPM31 Series.
| Model | BPMeasurement | Pulse RateMeasurement | WHOClassification | IHB | LCD Type | Backlight | DCJack | V.A Size |
|---|---|---|---|---|---|---|---|---|
| MD3000 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | X | 60 x 70 mm |
| MD3010 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | ✓ | 60 x 70 mm |
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| Model | BPMeasurement | Pulse RateMeasurement | WHOClassification | IHB | LCD Type | Backlight | DCJack | V.A Size |
|---|---|---|---|---|---|---|---|---|
| MD3020 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 60 x 70 mm |
| MD3030 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3040 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 60 x 70 mm |
| MD3050 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3001 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 50 x 60 mm |
| MD3011 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 50 x 60 mm |
| MD3021 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 50 x 60 mm |
| MD3031 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 50 × 60 mm |
| MD3041 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 50 x 60 mm |
| MD3051 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 50 x 60 mm |
| MD3100 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 60 x 70 mm |
| MD3110 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 60 × 70 mm |
| MD3120 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 60 x 70 mm |
| MD3130 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3140 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 60 x 70 mm |
| MD3150 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3101 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 50 x 60 mm |
| MD3111 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 50 x 60 mm |
| MD3121 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 50 x 60 mm |
| MD3131 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 50 x 60 mm |
| MD3141 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 50 x 60 mm |
| MD3151 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 50 x 60 mm |
5. Indication for use
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Comparison of technological characteristics between new Device and 6. predicate Devices
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is compared to the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619) in the device comparison table below.
| Item | Predicate Device | New device | Comment |
|---|---|---|---|
| Indication for Use | Digital Automatic Blood PressureMonitor BPM18 Series is for use bymedical professional or home user.The BPM18 Series is intended tomeasure the systolic and diastolicblood pressure, and pulse rate of anadult individual by using a non-invasive technique, in which aninflatable cuff is wrapped around theupper arm. | This device is for use by medicalprofessional or home users. It isintended to measure the systolic anddiastolic blood pressure on an adultindividual by using a non-invasivetechnique, in which an inflatable cuffis wrapped around the upper arm. | Equivalent |
| MeasurementMethod | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Item | Predicate Device | New device | Comment |
| PatientPopulation | Adult | Adult | Identical |
| BPMeasurementRange | 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 | 4 independent users | More user |
| Memory Space | 2 users × 120 memory space | 4 users × 120 or 240 memory space | More usermemory |
| Resolution ofMeasurement | Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPaPulse Rate: 1 beat/ min | Identical |
| Blood PressureMeasurementAccuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse RateMeasurementRange | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| 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/or ACAdaptor | 4 × 1.5 V AAA-batteries and/or ACAdaptor | Identical |
| PressurizationMode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| OperatingCondition | Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa | Temperature: +5 to +40 °CHumidity: 15 to 93 % R.H. maxAtmospheric Pressure: 700-1060 hPa | Identical |
| Storage andTransportationCondition | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700-1060 hPa | Identical |
| 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 |
| CompatibilitywithEnvironmentand OtherDevices | No influence with environment andother device | No influence with environment andother device | 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- IEC 81060-2:2009 | - EN 1060-1:1995+A2:2009- EN 1060-3:1997+A2:2009- IEC 60601-1:2012- IEC 60601-1-2:2007- FCC Part 15 Subpart B- IEC 81060-2:2013 | Equivalent |
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Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive measuring device and utilizes 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.
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K152483
Page 4 of 4
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 as documented in Clinical Test report.
One hundred patients (49 males and 51 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.
Non-Clinical Test Summary
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 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
- � IEC 60601-1-2:2007
- ゃ FCC Part 15 Subpart B
All of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is equivalent to the predicate device.
Conclusion 8.
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series has the same intended use and same technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619). Moreover both clinical and 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 BPM30 and BPM31 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).