(162 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and Bluetooth data transfer, with no mention of AI/ML terms or capabilities.
No.
The device is for monitoring and measurement of blood pressure, not for therapy or treatment.
Yes
The device measures and monitors arterial blood pressure values to identify potential health issues related to blood pressure, which is a diagnostic function.
No
The device description explicitly states it is a "Digital Automatic Blood Pressure Monitor" that utilizes an "inflatable cuff" and "detects your blood's movement through your brachial artery." These are hardware components essential to the device's function, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and monitor arterial blood pressure in adults. This is a physiological measurement taken directly from the body.
- Device Description: The device is a non-invasive blood pressure monitor that uses the oscillometric method. It measures blood movement through the brachial artery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, disease, or condition. This blood pressure monitor does not analyze any bodily fluids or tissues outside the body.
The device is a medical device used for physiological monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The upper arm 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 pressured values and display the development and average values of the measured values taken.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Digital Automatic Blood Pressure Monitor MD3600 (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 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 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
Upper arm (brachial artery)
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 (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: 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.)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District Shenzhen, 518118 CN
Re: K163679
Trade/Device Name: Digital Automatic Blood Pressure Monitor MD3600 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 7, 2017 Received: April 12, 2017
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 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.
1
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/Resourcesfor You/Industry/default.htm.
Sincerely,
M.A. Willemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163679
Device Name
Digital Automatic Blood Pressure Monitor MD3600
Indications for Use (Describe)
The upper arm blood pressure monitor is used to carry out non-invasivement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressured values and display the development and average values of the measured values taken.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K163679
Page 1 of 4
510(k) Summary
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 | 23-Dec-2016 |
Device identification 1.
| Trade Name | Digital Automatic Blood Pressure Monitor MD3600
[Model No.: MD3600] |
|---------------------|----------------------------------------------------------------------------------------------|
| 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 2.
| Predicate Device | Digital Automatic Blood Pressure Monitor MD2300 |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K143735 |
Device Description 3.
Digital Automatic Blood Pressure Monitor MD3600 (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 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 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.
4
Page 2 of 4
Indication for use 4.
The upper arm 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.
Comparison of technological characteristics between the Subject Device 5. and the Predicate Devices
The Subject Device are compared to the Predicate device comparison table below:
| Item | Predicate Device (K143735) | Subject Device | Comment |
|---|---|---|---|
| Indication for | |||
| Use | The upper arm blood pressure monitor | ||
| is used for non-invasive measurement | |||
| and monitoring for adult's 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 progressing of readings together | |||
| with average. | The upper arm 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. | 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 | 4 independent users | Different1 |
| Memory Space | 2 users × 60 memory space | ||
| (Total 120 memory space) | 4 users ×30 memory space | ||
| (Total 120 memory space) | Identical | ||
| Number of | |||
| button | 3 (User 1, User 2 and Clock) | 5 (Start/Stop, Memory, Set, Increase | |
| and Decrease) | Different2 | ||
| Bluetooth data | |||
| transmission | Absent | Present | Different3 |
| Item | Predicate Device (K143735) | Subject Device | Comment |
| Backlight | Present | Present | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 x 1.5 V AA-batteries; and/or | ||
| AC adaptor (6V/600mA) | 4 x 1.5 V AA-batteries | Equivalent | |
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Cuff size (Arm circumference) | 22 – 36 cm | 22 – 36 cm | Identical |
| Cuff Material | Nylon | Nylon | Identical |
| Cuff Design | Image: beurer cuff | Image: cuff | Equivalent |
| 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
- IEC 80601-2-30:2009+A1:2013 | - ISO 81060-1:2007
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2014
- 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- | Equivalent/
Different4 |
5
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Summary
1 The number of user 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 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.
3 A new Bluetooth data transmission 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.
6
Page 4 of 4
Clinical and Non-clinical Tests 6.
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
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:
- ゃ ISO 81060-1:2007
- ゃ EN 1060-3:1997+A2:2009
- ゃ IEC 60601-1:2012
- ◆ IEC 60601-1-2:2007
- ゃ IEC 60601-1-11:2015
- ゃ IEC 80601-2-30:2009+A1:2013
- や FCC Part 15 Subpart B
- ゃ FCC Part 15 Subpart C
- ゃ EN 300 328 V1.8.1 & EN 62479:2010
- ゃ 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.
7. Conclusion
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.