(118 days)
No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI/ML components or capabilities. The performance studies are standard clinical validation against a reference method, not AI/ML model training or testing.
No.
The device is strictly for measurement and display of blood pressure; it does not provide any therapy or treatment.
No
The device measures and displays blood pressure and pulse rate, which are physiological parameters. It does not indicate the presence or absence of a disease or condition, which is the function 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 is a hardware device with integrated software, not a software-only device.
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 (a 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, not to diagnose a condition based on analysis of a biological sample.
Therefore, this device falls under the category of a non-invasive physiological measurement device, 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 BPM25 & BPM26 Series 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 key components of device are: a pressure sensor, an electric valve, an electronic control module, and an electric pump.
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 individual
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 81060-2:2013 as documented in Clinical Test report.
One hundred patients (54 males and 46 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper 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 BPM25 & BPM26 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- EN 1060-3:1997+A2:2009
- IEC 60601-1:2012
- IEC 60601-1-2:2007
- FCC Part 15 Subpart B
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
Grandway Technology (Shenzhen) Limited Mr. Patrick Chow. General Manager Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, Guang Dong People's Republic of China
Re: K150373
Trade/Device Name: Digital Automatic Blood Pressure Monitor Bpm25 & Bpm26 Series [model No.: Md25x0/ Md26x0] Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 7, 2015 Received: May 11, 2015
Dear Mr. 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
1
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.
Sincerely yours.
Arnold Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 6 Indication for Use Statement (Form FDA 3881)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | | |
| Device Name | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 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) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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 the
time 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
"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."
| FORM FDA 3881 (1/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series
3
510(k) Summary
Submitter Identification 1.
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang |
| District, 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 | 12th February, 2015 |
2. Device Identification
| Trade Name | Digital Automatic Blood Pressure Monitor BPM25 & | ||||||
|---|---|---|---|---|---|---|---|
| BPM26 Series [Model No.: MD25x0/ MD26x0] | |||||||
| x --- The first 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) |
3. Predicate Device
| 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 BPM25 & BPM26 Series 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
4
510(k) PREMARKET NOTIFICATION
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 BPM25 & BPM26 Series.
| Model | BP
Measurement | Pulse Rate
Measurement | WHO | IHB | LCD Type | Backlight | DC
Jack | Voice
Function | Memory |
|--------|-------------------|---------------------------|-----|-----|------------------|-----------|------------|-------------------|---------|
| MD2500 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | X | Buzzer | 2 × 120 |
| MD2510 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | ✓ | Voice | 2 × 120 |
| MD2520 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | ✓ | Buzzer | 2 × 120 |
| MD2530 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | X | Voice | 2 × 120 |
| MD2540 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | ✓ | Buzzer | 2 × 120 |
| MD2550 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Buzzer | 2 × 120 |
| MD2560 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | ✓ | Voice | 2 × 120 |
| MD2570 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | X | Voice | 2 × 120 |
| MD2580 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | ✓ | Buzzer | 2 × 120 |
| MD2590 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Buzzer | 2 × 120 |
| MD25A0 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | ✓ | Voice | 2 × 120 |
| MD25B0 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Voice | 2 × 120 |
| MD2600 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | X | Buzzer | 2 × 120 |
| MD2610 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | ✓ | Voice | 2 × 120 |
| MD2620 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | ✓ | Buzzer | 2 × 120 |
| MD2630 | ✓ | ✓ | ✓ | ✓ | +ve Reflective | X | X | Voice | 2 × 120 |
| MD2640 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | ✓ | Buzzer | 2 × 120 |
| MD2650 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Buzzer | 2 × 120 |
| MD2660 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | ✓ | Voice | 2 × 120 |
| MD2670 | ✓ | ✓ | ✓ | ✓ | -ve Transmissive | ✓ | X | Voice | 2 × 120 |
| MD2680 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | ✓ | Buzzer | 2 × 120 |
| MD2690 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Buzzer | 2 × 120 |
| MD26A0 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | ✓ | Voice | 2 × 120 |
| MD26B0 | ✓ | ✓ | ✓ | ✓ | +ve Transmissive | ✓ | X | Voice | 2 × 120 |
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 of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
5
Comparison of Technological Characteristics between New Device and 6. Predicate Devices
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is compared to the predicate device, BPM18 Series (K133619) in the device comparison table below.
| Item | Predicate Device (K133619) | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series | Comment |
|---|---|---|---|
| Indication for Use | Digital Automatic Blood Pressure Monitor BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate 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 of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm. | Equivalent |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient Population | Adult | Adult | 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 | ||
| Number of User | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 120 memory space | Identical |
| Resolution of Measurement | Blood Pressure: 1 mmHg or 0.1kPa | ||
| Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1 kPa | ||
| Pulse Rate: 1 beat/ min | Identical | ||
| Blood Pressure Measurement Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse Rate Measurement Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AAA-batteries; and/or AC adaptor (6V/600mA) | 4 × 1.5V AA batteries and/or 6V AC adaptor | Equivalent |
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating Condition | Temperature: 10 - 40 °C | ||
| Humidity: 30 - 85 % R.H. max | |||
| Atmospheric Pressure: 700 – 1060hPa | Temperature: +5 to +40 °C | ||
| Humidity: 15 to 93 % R.H. max | |||
| Atmospheric Pressure: 700 – 1060hPa | Equivalent | ||
| Storage and Transportation Condition | Temperature: -20 - 60 °C | ||
| Humidity: 10 - 95 % R.H. max | |||
| Atmospheric Pressure: 700 – 1060hPa | Temperature: -25 to +70 °C | ||
| Humidity: up to 93% R.H. max | |||
| Atmospheric Pressure: 700 – 1060hPa | Equivalent | ||
| Comparison between Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series and Predicate device | |||
| Item | Predicate Device (K133619) | Digital Automatic Blood Pressure | |
| Monitor BPM25 & BPM26 Series | 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
- 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 |
6
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series 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, an electric valve, an electronic control module, and 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 (54 males and 46 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper 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 BPM25 & BPM26 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met.
7
The tests includes the follows:
510(k) PREMARKET NOTIFICATION
-
や EN 1060-3:1997+A2:2009
-
IEC 60601-1:2012 や
-
IEC 60601-1-2:2007 や
-
FCC Part 15 Subpart B <> ISO 10993-5:2009 >> ISO 10993-10:2010 <> IEC 62304:2006 <>
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is equivalent to the predicate device.
8. Conclusion
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series has the similar intended use and same technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619). Moreover 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 BPM25 & BPM26 Series is substantially equivalent to the predicate device.