(334 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor with Bluetooth connectivity for data transfer. There is no mention of AI, ML, or any advanced algorithms beyond basic signal processing for blood pressure and pulse detection. The clinical testing follows a standard protocol for blood pressure monitor accuracy.
No
The device is solely for measurement and monitoring of blood pressure and pulse rate, and warns of irregular heartbeat, but does not provide any treatment or therapy.
Yes
Explanation: The device measures and monitors arterial blood pressure and warns of irregular heartbeats, which are diagnostic indicators of health conditions related to the circulatory system.
No
The device description explicitly states it is a "Digital Automatic Wrist Blood Pressure Monitor" that utilizes an "inflatable cuff" and measures blood movement, indicating it is a hardware device with integrated software.
No, 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.
- Device Function: The description clearly states that this device is a wrist blood pressure monitor that performs non-invasive measurements of arterial blood pressure and pulse rate. It does this by using an inflatable cuff and the oscillometric method, which detects blood movement.
- No Sample Analysis: The device does not analyze any samples taken from the body. It directly measures a physiological parameter (blood pressure) from the wrist.
Therefore, based on the provided information, the device is a non-invasive medical device for monitoring vital signs, 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 the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat.
Product codes
DXN
Device Description
Digital Automatic Wrist Blood Pressure Monitor MD4300 (Subject Device) are non-invasive blood pressure measurement systems 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 Subject Device utilize 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.
The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
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
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 as documented in Clinical Test report. One hundred patients (60 males and 40 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: The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows: ISO 81060-1:2007, EN 1060-3:1997+A2:2009, IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2015, IEC 80601-2-30:2009+A1:2013, FCC Part 15 Subpart B, FCC Part 15 Subpart C, EN 300 328 V1.8.1 & EN 62479:2010, EN 301 489-1 V1.9.2 & EN 301 489-17 V2.2.1.
All of the clinical and non-clinical testing performed on the Subject Device are same as the Predicate Device. Therefore, no bench test is conducted to show the performance of the Subject Device are 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 10, 2018
Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenzhen, China 518118
Re: K171379
Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD4300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 1, 2018 Received: March 1, 2018
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MA Wilhelm
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) K171379
Device Name
Digital Automatic Wrist Blood Pressure Monitor MD4300
Indications for Use (Describe)
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 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 | 05-May-2017 |
Submitter identification 1.
Device identification 2.
| Trade Name | Digital Automatic Wrist Blood Pressure Monitor MD4300
[Model No.: MD4300] |
|---------------------|----------------------------------------------------------------------------------------------|
| 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 Wrist Blood Pressure Monitor MD2400 |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K143733 |
Device Description 4.
Digital Automatic Wrist Blood Pressure Monitor MD4300 (Subject Device) are non-invasive blood pressure measurement systems 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 Subject Device utilize 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.
The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
5. Indication for use
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat.
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6. Comparison of technological characteristics between the Subject Device and the Predicate Devices
The Subject Device are compared to the Predicate device comparison table below:
| Item | Predicate Device (K143733) | Subject Device | Comment |
|---|---|---|---|
| Indication 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 quickly and easily measure your blood pressure, save the measurements and display the development of the measurements. You are also warned of possible existing cardiac arrhythmia. | The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat. | Equivalent |
| Patient Population | Adult | Adult | Identical |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | 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 | ||
| Resolution of Measurement | Blood Pressure: 1 mmHg | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg | ||
| Pulse Rate: 1 beat/min | Identical | ||
| Blood Pressure Measurement Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Identical |
| Pulse Rate Measurement Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate Measurement Accuracy | $\pm$ 5 % of the reading | $\pm$ 5 % of the reading | Identical |
| IHB Detection | Yes | Yes | Identical |
| Number of User | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 60 memory space | ||
| (Total 120 memory space) | 2 users × 60 memory space | ||
| (Total 120 memory space) | Identical | ||
| Number of button | 4 (Memory, Clock, User, Start/Stop) | 3 (M1, M2 and Start/Stop) | Different1 |
| Bluetooth data transmission | Absent | Present | Different2 |
| Backlight | Absent | Present | Different3 |
| 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 | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | Identical | ||
| Item | Predicate Device (K143733) | Subject Device | Comment |
| 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
- IEC 80601-2-30:2009+A1:2013 | - ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2007
- IEC 60601-1-11:2015
- FCC Part 15 Subpart B
- FCC Part 15 Subpart C
- IEC 81060-2:2013
- IEC 80601-2-30:2009+A1:2013
- EN 300 328 V1.8.1 & EN 62479:2010
- EN 301 489-1 V1.9.2 & EN 301 489-17 V2.2.1 | Equivalent/
Different4 |
5
1 The number of button between the Subject Device and the Predicate Device is different but this will neither raise any safety issues nor affect the essential performance of the Subject device.
2 A new Bluetooth data transmission function is added to the Subject Device. This additional feature will not affect the essential performance of the Subject device.
3 A new backlight illumination function is added to the Subject Device. This additional feature will not affect the essential performance of the Subject device.
4 The some of the standards used in Subject Device are updated and they are equivalent to the standards used in the Predicate Device.
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 (60 males and 40 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
The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- や ISO 81060-1:2007
- ゃ EN 1060-3:1997+A2:2009
- ゃ IEC 60601-1:2012
- ◆ IEC 60601-1-2:2007
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- ゃ IEC 60601-1-11:2015
- � IEC 80601-2-30:2009+A1:2013
- � FCC Part 15 Subpart B
- � FCC Part 15 Subpart C
- � EN 300 328 V1.8.1 & EN 62479:2010
- � EN 301 489-1 V1.9.2 & EN 301 489-17 V2.2.1
All of the clinical and non-clinical testing performed on the Subject Device are same as the Predicate Device. Therefore, no bench test is conducted to show the performance of the Subject Device are equivalent to the Predicate Device.
Conclusion 8.
The Subject Device has the same intended use and same technological characteristics as the Predicate Device. 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, the Subject Device are substantially equivalent to the Predicate Device.