(57 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is described as a "non-invasive blood pressure measurement system" used for "measurement and monitoring" of blood pressure and pulse rate, which are diagnostic and monitoring functions, not therapeutic ones.
No
Explanation: A wrist blood pressure monitor measures blood pressure and pulse rate, which are physiological parameters. It does not provide information to diagnose a disease or condition. While the measurements can be used by a medical professional as part of a diagnostic process, the device itself is for monitoring and measurement, not diagnosis.
No
The device description explicitly states it is a "Digital Automatic Wrist Blood Pressure Monitor" that utilizes an "inflatable cuff wrapped around the wrist" and displays readings on a "digital panel." This indicates 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 Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this device is a "non-invasive measurement and monitoring of arterial blood pressure values in human adults." It measures blood pressure and pulse rate directly from the wrist using an inflatable cuff. This is a measurement taken on the body, not from a sample taken from the body.
- No Mention of Samples: There is no mention of collecting or analyzing any biological samples (blood, urine, etc.) in the intended use or device description.
Therefore, this wrist blood pressure monitor falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Digital Automatic Wrist Blood Pressure Monitor MD3200 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 wrist 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
wrist
Indicated Patient Age Range
human adults
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
One hundred patients (45 males and 55 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left wrist. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.
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 as documented in Clinical Test report. One hundred patients (45 males and 55 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left wrist. 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 Wrist Blood Pressure Monitor MD3200 has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:
- ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor MD3200 is same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor MD3200 is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood Pressure Measurement Accuracy: ± 3 mmHg
Pulse Rate Measurement Accuracy: ± 5 % of the reading
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Grandway Technology (shenzhen) Limited Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District, Shenzhen, 518118 CN
Re: K151587
Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not dated Received: June 11, 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Bram D. Zuckerman -S
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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Page 1 of 1
510(k) Number (if known): K 151587
Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200
Indications For Use:
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over - The Counter Use X
3
510(k) Summary
Submitter Identification 1.
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 7, Zhu Keng Industrial Zone, Ping Shan 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 | 10-Jun-2015 |
2. Device Identification
| Trade Name | Digital Automatic Wrist Blood Pressure Monitor MD3200
[Model No.: MD3200] |
|---------------------|----------------------------------------------------------------------------------------------|
| 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 Wrist Blood Pressure Monitor SWBPM22 Series |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K142088 |
4. Device Description
Digital Automatic Wrist Blood Pressure Monitor MD3200 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 wrist of an individual, for blood pressure measurement. This means the monitor
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K151587
Page 2 of 4
detects your blood's movement through your brachial artery and converts the movement into a digital reading.
The table below illustrates the feature presence in Digital Automatic Wrist Blood Pressure Monitor MD3200.
| Model | Blood Pressure
Measurement | Pulse Rate
Measurement | WHO
Classification | Irregular
Heartbeat | LCD Type | User ×
Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|------------------------|------------------|
| MD3200 | ✓ | ✓ | ✓ | ✓ | Positive
Reflective | 2 × 60 |
Indication for Use 5.
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements
Comparison of Technological Characteristics between New Device and 6. Predicate Devices
Digital Automatic Wrist Blood Pressure Monitor MD3200 is compared to the predicate device, SWBPM22 Series (K142088) in the device comparison table below.
| Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | Digital Automatic Wrist Blood | |
| Pressure Monitor MD3200 | Comment | ||
| 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 of an adult | |||
| individual by using a non-invasive | |||
| technique, in which an inflatable cuff | |||
| is wrapped around the wrist. | The wrist blood pressure monitor is | ||
| used to carry out non-invasive | |||
| measurement and monitoring of | |||
| arterial blood pressure values in | |||
| human adults. This allows you to | |||
| quickly and easily measure your | |||
| systolic and diastolic pressure, and | |||
| pulse rate through an inflatable cuff | |||
| wrapped around the wrist, save the | |||
| measurements and display | |||
| the | |||
| development of the measurements | Equivalent | ||
| Measurement | |||
| Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| 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 | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Similar |
5
| Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Comment |
| Resolution of Measurement | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg | ||
| Pulse Rate: 1 beat/ min | Similar | ||
| Blood Pressure Measurement Accuracy | ± 3 mmHg | ± 3 mmHg | Identical |
| 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 | 2 × 1.5 V AAA-batteries | 2 × 1.5 V AAA-batteries | 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
- IEC 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
- IEC 81060-2:2009 | - ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 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 Wrist Blood Pressure Monitor MD3200 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, an electronic control module, and 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 81060-2:2013 as documented in Clinical Test report.
Digital Automatic Wrist Blood Pressure Monitor MD3200
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K151587
Page 4 of 4
One hundred patients (45 males and 55 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left wrist. 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 Wrist Blood Pressure Monitor MD3200 has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:
- ISO 81060-1:2007 <>
- EN 1060-3:1997+A2:2009 や
- IEC 60601-1:2012 <>
- IEC 60601-1-2:2007 <>
- や FCC Part 15 Subpart B
- や ISO 10993-5:2009
- や ISO 10993-10:2010
- IEC 62304:2006 や
All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor MD3200 is same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor MD3200 is equivalent to the predicate device.
Conclusion 8.
Digital Automatic Wrist Blood Pressure Monitor MD3200 has the equivalent intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K142088). Moreover clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Wrist Blood Pressure Monitor MD3200 is substantially equivalent to the predicate device.