(29 days)
No
The description focuses on standard oscillometric methodology and hardware components (pressure sensor, valve, pump, control module) without mentioning any AI/ML algorithms or capabilities. The testing described is standard clinical validation against a reference method (auscultation) according to ISO standards, not performance evaluation of an AI/ML model.
No
The device is intended to measure blood pressure, not to treat or prevent a condition.
Yes
The device measures physiological parameters (systolic and diastolic blood pressure, and pulse rate) which can be used by medical professionals or home users to monitor health, fitting the definition of a diagnostic device.
No
The device description explicitly lists hardware components: a pressure sensor, an electric valve, an electronic control module, and an electric pump.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- Device Function: This device measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure on an adult individual using a non-invasive technique. This aligns with a physiological measurement device, not an IVD.
- Device Description: The description details the components and methodology for measuring blood pressure directly from the body's blood flow, not from a sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes
DXN
Device Description
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 device's key components are: a pressure sensor, an electric valve and an electronic control module together with an electric pump. The electric pump inflates (and deflates) the inflatable cuff automatically.
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
adult individual
Intended User / Care Setting
medical professional or home users.
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
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.
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 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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, one behind the other, with their arms raised.
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
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 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 | BP
Measurement | Pulse Rate
Measurement | WHO
Classification | IHB | LCD Type | Backlight | DC
Jack | V.A Size |
|--------|-------------------|---------------------------|-----------------------|-----|---------------------|-----------|------------|------------|
| MD3000 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | X | 60 x 70 mm |
| MD3010 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | ✓ | 60 x 70 mm |
4
| Model | BP
Measurement | Pulse Rate
Measurement | WHO
Classification | IHB | LCD Type | Backlight | DC
Jack | 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 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. | 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. | Equivalent | ||
| Measurement | |||
| Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Item | Predicate Device | New device | Comment |
| Patient | |||
| Population | Adult | Adult | 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 | 4 independent users | More user |
| Memory Space | 2 users × 120 memory space | 4 users × 120 or 240 memory space | More user |
| memory | |||
| Resolution of | |||
| Measurement | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Identical | ||
| Blood Pressure | |||
| Measurement | |||
| Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse Rate | |||
| Measurement | |||
| Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| 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 | 4 × 1.5 V AAA-batteries and/or AC | ||
| Adaptor | Identical | ||
| Pressurization | |||
| Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating | |||
| Condition | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Identical | ||
| Storage and | |||
| Transportation | |||
| Condition | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric 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 | ||
| 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
- 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.