(205 days)
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 progression of readings together with the average.
Digital Automatic Blood Pressure Monitor MD2300 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 acceptance criteria for the Digital Automatic Blood Pressure Monitor MD2300, and the study proving its adherence to these criteria, can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (based on ISO 81060-2:2013) | Reported Device Performance (MD2300) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Mean difference: ≤ ± 5 mmHg | Achieved (as per clinical test report) |
| Standard Deviation: ≤ 8 mmHg | Achieved (as per clinical test report) | |
| Pulse Rate Measurement Accuracy | ± 5% of the reading | Achieved (as per device specifications) |
Note: The specific numerical values for mean difference and standard deviation from the clinical test report are not provided in the document, but the document states that the testing was done "in accordance with ISO 81060-2:2013." This standard specifies the acceptance criteria for accuracy of non-invasive sphygmomanometers. Therefore, it is inferred that the device met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 patients (49 males and 51 females).
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: Prospective, as patients were "invited for the study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts. However, it mentions that the "Standard auscultation method was used as the reference blood pressure monitor." This method typically involves trained medical professionals. The ISO 81060-2:2013 standard requires that reference measurements be taken by a trained observer.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for disagreements between ground truth measurements. It states that "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This standard has specific requirements for the comparison of measurements between the test device and the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a standard auscultation method, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical test described focused on the standalone performance of the Digital Automatic Blood Pressure Monitor MD2300 in measuring blood pressure and pulse rate, without a human-in-the-loop component for interpretation or assistance beyond the standard operation of the device.
7. The Type of Ground Truth Used
The ground truth used was expert measurements via the standard auscultation method. This is considered a gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The study described focuses on the validation of the device's accuracy. As a non-AI driven device (it uses an oscillometric methodology, not machine learning that would require a distinct training phase), the concept of a "training set" as understood in AI/ML contexts does not directly apply here.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly mentioned or relevant for this type of device based on the provided information, how its ground truth was established is not applicable. The device's operation is based on established physical principles of oscillometry, not on learning from a dataset.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
Grandway Technology (shenzhen) Limited Patrick Chow Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, 518118 CN
- Re: K143735
Trade/Device Name: Digital Automatic Blood Pressure Monitor MD2300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2015 Received: June 24, 2015
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
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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 (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.
Sincerelv vours.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Digital Automatic Blood Pressure Monitor MD2300, MD2300
Page 1 of 1
Indications for Use (Describe)
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 progression of readings together with the average.
| l ype of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| ا Prescription Use (Part 21 CFR 801 Subpart D) | ال Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||||
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and complete |
and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long GangDistrict, Shenzhen, Guang Dong, People's Republic of China |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 29-Dec-2014 |
1. Submitter Identification
Device Identification 2.
| Trade Name | Digital Automatic Blood Pressure Monitor MD2300 |
|---|---|
| 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 Blood Pressure Monitor BPM18 Series | |
|---|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED | |
| 510(k) Number | K133619 |
Device Description 4.
Digital Automatic Blood Pressure Monitor MD2300 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 MD2300.
| Model | Blood PressureMeasurement | Pulse RateMeasurement | WHOClassification | IrregularHeartbeat | LCD Type | BacklightIllumination | User ×Memory |
|---|---|---|---|---|---|---|---|
| MD2300 | ✓ | ✓ | ✓ | ✓ | PositiveTransmissive | ✓ | $2 \times 60$ |
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5. 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 progression of readings together with the average.
6. Comparison of Technological Characteristics between New Device and Predicate Devices
Digital Automatic Blood Pressure Monitor MD2300 is compared to the predicate device, BPM18 Series (K133619) in the device comparison table below.
| Comparison between BPM18 Series and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | MD2300 | Comment |
| Indication for Use | Digital Automatic Blood Pressure Monitor | The upper arm blood pressure monitor is | Equivalent |
| Series is for use bymedicalBPM18 | used for non-invasive measurement and | ||
| professional or home user. The BPM18 Series | monitoring for adult's arterial blood | ||
| is intended to measure the systolic and | pressure. You can use it to measure your | ||
| diastolic blood pressure, and pulse rate of an | systolic and diastolic pressure, and pulse | ||
| adult individual by using a non-invasive | rate through an inflatable cuff wrapped | ||
| technique, in which an inflatable cuff iswrapped around the upper arm. | around the upper arm. Quickly and easily, | ||
| storing the results and displaying the | |||
| progression of readings together with the | |||
| average. | |||
| Measurement | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| Method | |||
| IHB Detection | Yes | Yes | Identical |
| Patient Population | Adult | Adult | Identical |
| BP Measurement | Cuff Pressure: 0 - 300 mmHg | Cuff Pressure: 0 - 300 mmHg | Identical |
| Range | Systolic Pressure: 50 - 250 mmHg | Systolic Pressure: 50 - 250 mmHg | |
| Diastolic Pressure: 30 - 200 mmHg | Diastolic Pressure: 30 - 200 mmHg | ||
| Number of User | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Equivalent |
| Resolution of | Blood Pressure: 1 mmHg or 0.1kPa | Blood Pressure: 1 mmHg | Identical |
| Measurement | Pulse Rate: 1 beat/ min | Pulse Rate: 1 beat/ min | |
| Blood Pressure | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Measurement | |||
| Accuracy | |||
| Pulse Rate | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Measurement | |||
| Range | |||
| Pulse Rate | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Measurement | |||
| Accuracy | |||
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AAA-batteries and/or AC | 4 × 1.5 V AA-batteries and/or AC | Equivalent |
| Adaptor | Adaptor | ||
| Pressurization | Automatic Inflation | Automatic Inflation | Identical |
| Mode | |||
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating | Temperature: +5 to +40 °C | Temperature: +5 to +40 °C | Identical |
| Condition | Humidity: 15 to 93 % R.H. max | Humidity: 15 to 93 % R.H. max | |
| Atmospheric Pressure: 700 - 1060 hPa | Atmospheric Pressure: 700 - 1060 hPa |
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| Comparison between BPM18 Series and Predicate device | |||
|---|---|---|---|
| Item | Predicate Device | MD2300 | Comment |
| Storage andTransportationCondition | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 - 1060 hPa | Temperature: -25 to +70 °CHumidity: up to 93% R.H. maxAtmospheric Pressure: 700 - 1060 hPa | Identical |
| Material | Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging | Resistances, capacitance, transistors,amplifiers, pressure sensor, CPU, PCB,cuff ABS button, ABS cabinet, batteriesand packaging | Identical |
| Compatibility withEnvironment andOther Devices | No influence with environment and otherdevice | No influence with environment and otherdevice | Identical |
| ApplicableStandard | - 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- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2009 | - 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- ISO 10993-5:2009- ISO 10993-10:2010- IEC 62304:2006- IEC 81060-2:2013 | Equivalent |
Digital Automatic Blood Pressure Monitor MD2300 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, a electric valve and an electronic control module together with 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.
7. Clinical and Non-clinical Tests
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 (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 81060-2:2013.
Non-Clinical Test Summary
Digital Automatic Blood Pressure Monitor MD2300 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 や
- IEC 60601-1:2012 �
- ゃ IEC 60601-1-2:2007
- ゃ FCC Part 15 Subpart B
- や ISO 10993-5:2009
- ISO 10993-10:2010 や
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� IEC 62304:2006
All of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor MD2300 are same as the predicate device.
Also, bench testing, IEC 80601-2-30, is conducted to show the performance of Digital Automatic Blood Pressure Monitor MD2300 is equivalent to the predicate device.
8. Conclusion
Digital Automatic Blood Pressure Monitor MD2300 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 MD2300 is substantially equivalent to the predicate device.
§ 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).