(231 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components. The detection of irregular heartbeat is a common feature in blood pressure monitors and does not necessarily indicate AI/ML.
No
This device is intended to measure blood pressure and heart rate, not to treat a condition. While it can detect an irregular heartbeat, it does not provide any therapeutic intervention.
Yes
This device measures systolic and diastolic blood pressures and heart rate, providing information about a patient's physiological state to aid in the detection or monitoring of medical conditions.
No
The device description clearly outlines physical hardware components such as an inflatable cuff, internal pump, silicon integrate pressure sensor, mechanical valve, and LCD display, indicating it is 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: The BPA-002 Electronic Blood Pressure Monitor measures blood pressure and heart rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample in vitro (outside the body).
- Intended Use: The intended use clearly states it's for measuring blood pressure and heart rate, which are physiological parameters measured directly from the patient.
- Device Description: The description details the mechanical and electronic process of taking a blood pressure reading on the arm, not analyzing a biological sample.
Therefore, the BPA-002 Electronic Blood Pressure Monitor is a medical device, but it falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel.
It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
Product codes
DXN
Device Description
BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds. There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically
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 departments or for home use
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 Tests: Subject device BPA-002 is compliant to the SP10:2002/(R) 2008&ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
Non-Clinical Tests:
The subject device was tested to evaluate its safety and effectiveness according to the following standards:
a. Electrical Safety Test according to IEC 60601-1, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
b. Electromagnetic Compatibility Test according to IEC 60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.
c. Biocompatibility Test according to ISO 10993-5: 2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.
d. Performance Effectiveness Test according to SP10:2002/(R) 2008&ANSI/AAMI SP 10: 2002/A 1: 2003/ (Manual, electronic or automated sphygmomanometers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: +/-3mmHg, Pulse:
§ 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).
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Image /page/0/Picture/0 description: The image shows a logo with the letters J, X, B, and D. The letters are in a bold, sans-serif font. The letters J, X, and B are solid black, while the letter D is black with white dots inside. There is a small, abstract design to the right of the letter D.
K130232 Jinxinbao Electronic Co., Ltd
Section 5 510(k) Summary
(As required by 21 CFR 807.92(a))
5.1 Submitter Information
SEP 17 2013
- · Company: Jinxinbao Electronic Co.,Ltd
· Address: No.38, Huanzhenxi Road, Dagang Town, Nansha, Guangzhou, China
· Phone: 086-20-34938449
- · Fax: 086-20-22865301
- · Email: xhoucc@jxb-htb.net
· Contact: Jiacheng Guo, General Manager
· Date: November 15, 2012.
5.2 Device Information
· Trade/Proprietary Name: Electronic Blood Pressure Monitor for Upper Arm, Model
BPA-002
· Common Name: Blood Pressure Monitor
· Classification: Device Class: 2
Review Panel: Cardiovascular
Name: Non-invasive Blood Pressure Measurement System
Regulation Number: 21 CFR 870.1130
Product Code: DXN
· Predicate Device: Fully Automatic Digital Blood Pressure Monitor, Model BP-1307.
K120554
· Device Description:
BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by
an internal pump in the device. The systolic and diastolic blood pressures are
determined by oscillometric method and silicon integrate pressure sensor technology.
The deflation rate is controlled by a preset mechanical valve at a constant rate. The Page 1 of 5
1
Image /page/1/Picture/0 description: The image shows a logo with the letters J, X, and B in a bold, sans-serif font. The letters are arranged horizontally, with J on the left, X in the middle, and B on the right. The letter B has a design element on the top right that resembles a chain or a series of connected circles. The logo is in black and white.
K130232 Jinxinbao Electronic Co., Ltd
pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds.
There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically
· Intended Use:
BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel.
It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| Device Name | Electronic Blood Pressure | ||
| Monitor for Upper Arm | |||
| Model BPA-002 | Fully Automatic Digital | ||
| Blood Pressure Monitor | |||
| Model BP-1307 | |||
| (K120554) | |||
| Method of Measurement | Oscillometric | Oscillometric | |
| Inflation Method | Automatic Internal Pump | Automatic Internal Pump | |
| Deflation Method | Preset Mechanical Valve at | ||
| a Constant Rate | Preset Mechanical Valve at | ||
| a Constant Rate | |||
| Anatomical Site | Upper Arm | Upper Arm | |
| Range of Measurement | Pressure: | ||
| 0mmHg~280mmHg |
Pulse:
30160 Beats/minute | Pressure:300mmHg
0mmHg
Pulse:
30~180 Beats/minute | |
5.3 Comparison of Required Technology Characteristics
2
| Portugues of | Jinxinbao Electronic Co., Ltd | K130232 |
|---|---|---|
| Accuracy | Pressure: ±3mmHg | Pressure: ±3mmHg |
| Pulse: ≤5% | Pulse: ±5% | |
| Operating Conditions | Temperature: 5℃~40℃ | Temperature: 5°C ~40°C |
| RH: 15%-85% | RH: Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: Undated Received: August 7, 2013 |
Dear Ms. Nan:
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
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Page 2 - Ms. Helen Nan
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Owen P. Faris -S
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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Image /page/7/Picture/0 description: The image shows a logo with the letters J, X, and B. The letters are in a bold, sans-serif font and are arranged horizontally. The letters are filled with a textured pattern, giving them a slightly rough appearance. There is a small symbol to the right of the letter B.
Jinxinbao Electronic Co., Ltd
Section 4 Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
BPA-002 Electronic Blood Pressure Monitor for Upper Arm_ Device Name:
Indications for Use:
BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel.
It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
Clwez
Digitally signed by Owen P. Faris -S Date: 2013.09.19 14:21:12 -04'00'
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