(38 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The testing described is for clinical accuracy against a reference method, not for evaluating an AI/ML algorithm.
No.
The device is used for non-invasive measurement and monitoring of arterial blood pressure, which is a diagnostic function, not a therapeutic one. It provides data for managing health but does not administer treatment.
Yes
The device measures and monitors arterial blood pressure values to assess the health of an individual, which falls under diagnostic purposes. While it doesn't diagnose a specific disease, it provides quantitative physiological measurements essential for medical diagnosis and monitoring.
No
The device description clearly states it is a "Digital Automatic Blood Pressure Monitor" that utilizes an "inflatable cuff" and measures blood movement through the brachial artery. This indicates a hardware component is essential for the device's function, not 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 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. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is an upper arm blood pressure monitor that performs non-invasive measurement of arterial blood pressure. It measures blood movement through the brachial artery using an inflatable cuff. This is a physical measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure and monitor blood pressure values in adults. This is a physiological measurement, not a diagnostic test performed on a biological 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
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Digital Automatic Blood Pressure Monitor MD36 Series (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
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 ensure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. One hundred patients for each cuff (standard: 49 males and 51 females; universal: 44 males and 56 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 include the follows:
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2014
- 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 V2.1.1 & EN 62479:2010
- EN 301 489-1 V2.2.0 & EN 301 489-17 V3.2.0
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).
0
Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2019
Grandway Technology (Shenzhen) Limited Patrick Chow General Manager No. 5, 2nd Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District Shenzhen, 518118 CHINA
Re: K191593
Trade/Device Name: Digital Automatic Blood Pressure Monitor MD36 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 27, 2019 Received: June 14, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191593
Device Name
Digital Automatic Blood Pressure Monitor MD36 Series
Indications for Use (Describe)
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.
| 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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3
Submitter identification 1.
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | No 5, The Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan |
| District, 518118 ShenZhen, Guangdong, People's Republic of China. | |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 27-May-2019 |
Device identification 2.
| Trade Name | Digital Automatic Blood Pressure Monitor MD36 Series
[Model No.: MD36X0, M36X0A]
X - The first character (0 and 1) is for the identification of add-on features. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System |
Predicate device 3.
| Predicate Device | Digital Automatic Blood Pressure Monitor MD3600 |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K163679 |
Device Description 4.
Digital Automatic Blood Pressure Monitor MD36 Series (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.
5. Indication 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 pressure, save the measured values and display the development and average values of the measured values taken.
4
Comparison of technological characteristics between the Subject Device and 6. the Predicate Devices
The Subject Device are compared to the Predicate device comparison table below:
| Item | Predicate Device (K163679) | Subject Device (MD36 Series) | Comment |
|---|---|---|---|
| Indication 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 pressure, save the measured values and display the development and average values of the measured values taken. | 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. | Identical |
| 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 | 4 independent users | 4 independent users | Identical |
| Memory Space | 4 users ×30 memory space | ||
| (Total 120 memory space) | 4 users ×30 memory space | ||
| (Total 120 memory space) | Identical | ||
| Number of button | 5 (Start/Stop, Memory, Set, Increase and Decrease) | 5 (Start/Stop, Memory, Set, Increase and Decrease) | Identical |
| Bluetooth data transmission | Present | Present | Identical |
| Backlight | Present | Present | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 x 1.5 V AA-batteries | 4 x 1.5 V AA-batteries; and/or DC adaptor (6V/600mA) | Different¹ |
| 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 90 % R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Different² | ||
| 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 90% R.H. max | |||
| Atmospheric Pressure: 700-1060 hPa | Different³ | ||
| Material | Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, | Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, | Identical |
| Item | Predicate Device (K163679) | Subject Device (MD36 Series) | Comment |
| Compatibility with | |||
| Environment and | |||
| Other Devices | No influence with environment and | ||
| other device | No influence with environment and | ||
| other device | Identical | ||
| Applicable Standard | - 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 | - 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 V2.1.1 & EN 62479:2010
- EN 301 489-1 V2.2.0 & EN 301 489-
17 V3.2.0 | Equivalent/
Different4 |
5
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
1 DC jack is optional in certain model. Several tests have been done for this additional feature. This additional feature will not affect the safety and essential performance of the Subject device.
² The humidity for the operating condition are updated according to IEC 60601-1-11:2015 and they are equivalent to the standards used in the Predicate Device. This will neither raise any safety issues nor affect the essential performance of the Subject device.
3 The humidity for the storage and transportation are updated according to IEC 60601-1-11:2015 and they are equivalent to the standards used in the Predicate Device. This will neither raise any safety issues nor affect the esential performance of the Subject device.
4 Some of the standards used in Subject Device are updated and they are equivalent to the Predicate Device.
Clinical and Non-clinical Tests 7.
Clinical Test Summary
Testing to ensure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. One hundred patients for each cuff (standard: 49 males and 51 females; universal: 44 males and 56 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 include the follows:
- ゃ EN 1060-3:1997+A2:2009
- � IEC 60601-1:2012
- � IEC 60601-1-2:2014
- ゃ IEC 60601-1-11:2015
- ゃ IEC 80601-2-30:2009+A1:2013
- ゃ FCC Part 15 Subpart B
- ゃ FCC Part 15 Subpart C
6
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
ゃ EN 300 328 V2.1.1 & EN 62479:2010
ゃ EN 301 489-1 V2.2.0 & EN 301 489-17 V3.2.0
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.