(196 days)
Not Found
No
The description focuses on standard oscillometric methodology and does not mention any AI/ML components or algorithms. The testing described is for clinical accuracy against a reference method, not for evaluating AI/ML performance.
No
The device is intended to measure blood pressure, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
Yes
The device measures blood pressure and pulse rate, providing physiological data that can be used to assess health status, which is a key characteristic of a diagnostic device.
No
The device description explicitly states it is a "Digital Automatic Blood Pressure Monitor" and utilizes an "inflatable cuff" and "digital panel" to display readings, indicating it includes 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.
- Device function: This device measures blood pressure using a non-invasive technique (inflatable cuff on the upper arm) and the oscillometric method. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure, which is a physiological parameter, not to diagnose a condition based on in vitro analysis.
Therefore, this device falls under the category of a non-invasive medical device for monitoring a physiological function, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 upper arm.
Product codes
DXN
Device Description
Digital Automatic Blood Pressure Monitor BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 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.
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
adult
Intended User / Care Setting
medical professional or home users.
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.
For the Subject Device (BPM 41 Series), one hundred patients (50 males and 50 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.
For the Subject Device (BPM 45 Series), one hundred patients (51 males and 49 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 (for BPM45 Series only)
- IEC 60601-1-2:2014 (for BPM41 Series only)
- IEC 60601-1-11:2015
- IEC 80601-2-30:2009+A1:2013
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles superimposed on its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
GRANDWAY TECHNOLOGY (SHENZEN) LIMITED Mr. Patrick Chow General Manager Block 7. Zhu Keng Industrial Zone. Ping Shan, Long Gang District, Shenzhen, 518118 China
Re: K163648
Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 7, 2017 Received: June 8, 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.
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 (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.
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,
M.A. Hillemann
for
for Bram D. Zuckerman, M.D.
Director 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)
Device Name
Digital Automatic Blood Pressure Monitor BPM41 Series; Digital Automatic Blood Pressure Monitor BPM45 Series
Indications for Use (Describe)
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 upper arm.
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.
| 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 | 22-Dec-2016 |
Device identification 2.
| Trade Name | Digital Automatic Blood Pressure Monitor BPM41 Series
[Model No.: MD41X0]
x --- The character (0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A & B) is for the minor change
revision of device. The mentioned "minor change" refers to those device
changes not to be affecting the conformity test results of EMC & safety as well
as device performance, i.e. IEC 60601-1 and IEC 60601-1-2. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Digital Automatic Blood Pressure Monitor BPM45 Series
[Model No.: MD45X0]
x --- The character (0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A & B) is for the minor change
revision of device. The mentioned "minor change" refers to those device
changes not to be affecting the conformity test results of EMC & safety as well
as device performance, i.e. IEC 60601-1 and IEC 60601-1-2. |
| 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 BPM25 & BPM 26 Series |
|---|---|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K150373 |
Device Description 4.
Digital Automatic Blood Pressure Monitor BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 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 table below illustrate the feature presence in the Subject Device:
4
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
510(k) Summary
| Series | Model | LCD type | Backlight | Sound | DC jack |
|---|---|---|---|---|---|
| MD41 Series | MD4100 | Positive Reflective | No | Buzzer | No |
| MD4110 | Positive Reflective | No | Voice | Yes | |
| MD4120 | Positive Reflective | No | Buzzer | Yes | |
| MD4130 | Positive Reflective | No | Voice | No | |
| MD4140 | Negative transmissive | Yes | Buzzer | Yes | |
| MD4150 | Negative transmissive | Yes | Buzzer | No | |
| MD4160 | Negative transmissive | Yes | Voice | Yes | |
| MD4170 | Negative transmissive | Yes | Voice | No | |
| MD4180 | Positive transmissive | Yes | Buzzer | Yes | |
| MD4190 | Positive transmissive | Yes | Buzzer | No | |
| MD41A0 | Positive transmissive | Yes | Voice | Yes | |
| MD41B0 | Positive transmissive | Yes | Voice | No | |
| MD45 Series | MD4500 | Positive Reflective | No | Buzzer | No |
| MD4510 | Positive Reflective | No | Voice | Yes | |
| MD4520 | Positive Reflective | No | Buzzer | Yes | |
| MD4530 | Positive Reflective | No | Voice | No | |
| MD4540 | Negative transmissive | Yes | Buzzer | Yes | |
| MD4550 | Negative transmissive | Yes | Buzzer | No | |
| MD4560 | Negative transmissive | Yes | Voice | Yes | |
| MD4570 | Negative transmissive | Yes | Voice | No | |
| MD4580 | Positive transmissive | Yes | Buzzer | Yes | |
| MD4590 | Positive transmissive | Yes | Buzzer | No | |
| MD45A0 | Positive transmissive | Yes | Voice | Yes | |
| MD45B0 | Positive transmissive | Yes | Voice | No |
5. 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 on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
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:
5
K163648
| Item | Predicate Device (K150373) | Subject Device (BPM41 Series) | Subject Device (BPM45 Series) | 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 upper arm. | This device is for use by medical | |||
| professional or home users. It is | ||||
| intended to measure the systolic and | ||||
| diastolic blood pressure on an adult | ||||
| individual by using a non-invasive | ||||
| technique, in which an inflatable cuff is | ||||
| wrapped around the upper arm. | This device is for use by medical | |||
| professional or home users. It is | ||||
| intended to measure the systolic and | ||||
| diastolic blood pressure on an adult | ||||
| individual by using a non-invasive | ||||
| technique, in which an inflatable cuff is | ||||
| wrapped around the upper arm. | Identical | |||
| Patient Population | Adult | Adult | Adult | Identical |
| Measurement Method | Non-invasive, Oscillometric | 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 | Cuff Pressure: 0 - 300 mmHg | |||
| Systolic Pressure: 50 - 250 mmHg | ||||
| Diastolic Pressure: 30 - 200 mmHg | Identical | |||
| Resolution of | ||||
| Measurement | Blood Pressure: 1 mmHg or 0.1kPa | |||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPa | |||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPa | |||
| Pulse Rate: 1 beat/ min | Identical | |||
| Blood Pressure | ||||
| Measurement Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Identical |
| Pulse Rate Measurement | ||||
| Range | 40 - 180 beats/min | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate Measurement | ||||
| Accuracy | $\pm$ 5 % of the reading | $\pm$ 5 % of the reading | $\pm$ 5 % of the reading | Identical |
| IHB Detection | Yes | Yes | Yes | Identical |
| Number of User | 2 independent users | 4 independent users | 2 independent users | Different (BPM41 Series)1 |
| Identical (BPM45 Series) | ||||
| Memory Space | 2 users × 120 memory space | |||
| (Total 240 memory space) | 4 users × 120 memory space | |||
| (Total 480 memory space) | 2 users x 240 memory space | |||
| (Total 480 memory space) | Different2 | |||
| Voice function | Present (depends on model) | Present (depends on model) | Present (depends on model) | Identical |
| Alarm clock function | Absent | Present | Present | Different3 |
| Backlight | Present (depends on model) | Present (depends on model) | Present (depends on model) | Identical |
| Display Type | LCD | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AA-batteries; and/or | |||
| AC adaptor (6V/600mA) | 4 x 1.5 V AAA-batteries; and/or | |||
| AC adaptor (6V/600mA) | 4 x 1.5 V AA-batteries; and/or | |||
| AC adaptor (6V/600mA) | Different (BPM41 Series)4 | |||
| Identical (BPM45 Series) | ||||
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Item | Predicate Device (K150373) | Subject Device (BPM41 Series) | Subject Device (BPM45 Series) | Comment |
| 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 | 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 | 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 | 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 | 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
- IEC 81060-2:2013
- 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
- IEC 81060-2:2013
- IEC 80601-2-30:2009+A1:2013 | Equivalent5 |
6
1 The number of user betwen the Subject Device is different but this will neither raise any safety issues no affect the esserial performance of the subject device.
? The total memory space between the Predicate Device is different but this will neither raise any safety issues nor affect the essential performance of the subject device.
³ The Subject Device has a new alam this new function will neither raise any safety issues nor affect the essential performance of the subject device.
- The battery type used in Subject Device is different but this will neither raise any safety issues nor affect the essential performance of the subject device.
5 The standards used in Subject Device are updated and they are equivalent to the standards used in the Predicate Device.
7
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.
For the Subject Device (BPM 41 Series), one hundred patients (50 males and 50 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.
For the Subject Device (BPM 45 Series), one hundred patients (51 males and 49 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
- や IEC 60601-1-2:2007 (for BPM45 Series only)
- や IEC 60601-1-2:2014 (for BPM41 Series only)
- ゃ IEC 60601-1-11:2015
- や IEC 80601-2-30:2009+A1:2013
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.