(51 days)
Not Found
No
The description mentions a "CPG (correct position guidance) algorithm" and an "irregular heartbeat indicator," but these are standard algorithmic functions in blood pressure monitors and do not indicate the use of AI or ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
This device measures blood pressure and pulse rate, providing information for diagnosis, but it does not actively treat or directly prevent any disease or condition.
Yes
The device measures physiological parameters (blood pressure and pulse rate) and includes an "irregular heartbeat indicator" which suggests it provides information that can be used to aid in diagnosis, even if it doesn't make a definitive diagnosis itself.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, LCD, and device memory, indicating it is a physical medical device with integrated software, not a software-only device.
No, 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 UB-543 measures blood pressure and pulse rate by applying pressure to the wrist and using the oscillometric method. This is a physical measurement taken on the body, not a test performed on a sample taken from the body.
The device description clearly indicates it's a non-invasive blood pressure monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The A&D Medical UB-543 family digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
Product codes
DXN
Device Description
UB-543 uses an inflatable cuff which is wrapped around the patient's wrist. After the user pushes the "START" button, cuff is inflated automatically by an internal pump once the condition of the CPG (correct position guidance) algorithm is met. Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UB-543 will not inflate the cuff higher than 300mmHg. UB-543 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adults with 12 years older
Intended User / Care Setting
Not Found
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)
Not Found
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).
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K141179 Page 1/3
510(k) Summary
This summary of 510(k) safety and effective information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
-
- Date Prepared May 27, 2014
2. Submitter's Information
A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andonline.com
3. Device Information
Proprietary Name: A&D Medical UB-543Digital Blood Pressure Monitor Common/Usual Name: Blood Pressure Monitor Classification name: Non-invasive blood pressure measurement System 21 CFR 870-1130, Class II, 74DXN,
Predicate Devices 4.
A&D Model UB-511 & UB-512 Digital Blood Pressure Monitors with 510(k) number K042967. Predicate devices are designed and manufactured by the same company and facilities as the modified devices UB-543.
Device Description - Technological and Operaional Characteristics ડ.
UB-543 uses an inflatable cuff which is wrapped around the patient's wrist. After the user pushes the "START" button, cuff is inflated automatically by an internal pump once the condition of the CPG (correct position guidance) algorithm is met. Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UB-543 will not inflate the cuff higher than 300mmHg. UB-543 will turn on an irregular
heartbeat indicator if an irregular heartbeat was detected during the measurement process.
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At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.
6. Intended Use
The A&D Medical UB-543 family digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
The intended user and the indication for use of A&D Medial UB-543 as described in the labeling are the same as their predicated devices, UB-511 & UB-512.
7. Summary of Substantial Equivalence
Modifications made from the predicate devices:
- Change the plastic molds so UB-543 has a different appearance .
- Increase LCD display size .
- Increase memory size ●
- Add time and date function .
- Add correct position guideance (CPG) indicator .
Product Specification Comparison
| Parameter | Predicate Devices
(UB-511 & UB-512) | Modified Devices
(UB-543) |
|--------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Power source | 2 AAA size batteries | No change - the same |
| Battery Life | 4 months with daily measurement | No change - the same |
| BP Measurement
Method | Oscillometric Method | No change - the same |
| Measurement
Range | BP : 20 to 280 mmHg
Pulse : 40 to 200 pulse/min | BP : 0 to 299 mmHg
Pulse : 40 to 200 pulse/min |
| Accuracy | BP : +/- 3mmHg or +/- 2% of
measured value, whichever is
greater
Pulse : +/- 5 % (pulse) | BP : +/- 3mmHg
Pulse : +/- 5 % |
| Pressurization
Source | Automatic internal pump | No change - the same |
| Cuff Deflation
Method | Quick exhaust valve | No change - the same |
| Display Type &
Size | Liquid crystal display with 3.8 cm
(1.5") x 2.3 cm (0.9") | Liquid crystal display with
6.0 cm (2.4") x 4.0 cm (1.6") |
| IHB (Irregular
Heartbeats
Detection) | More than +/-25% to the mean
interval of all pulse intervals | No change - the same |
002_510(k) Summary_UB-543 (revised).doc-1/JW
2
| Operating
Environment | 50°F (10°C) to 104°F (40°C)
15 %RH to 85% RH | No change - the same |
|--------------------------------------|--------------------------------------------------|----------------------------------------------------|
| Storage
Environment | 14°F (-20°C) to 140°F (60°C)
10 %RH to 95% RH | No change - the same |
| Pressure Indicator | USA JNC VII guideline | No change - the same |
| Data Memory Size
with Time & Date | Last 30 measurements | Last 60 measurements each
for user 1 and user 2 |
| Pressure Sensor
design | Static electricity capacity type | No change - the same |
| Number of user | UA-511 : one
UB-512 : two | The same as UB-512 |
| Dimensions in mm | 58 (H) x 156 (W) x 145 (L) | 88 (H) x 56 (W) x 18 (D) |
| Weight | 82g without batteries | 103g without batteries |
| Wrist Size | 5.1 inches (13.0 cm) to 15.2 inches
(38.6 cm) | No change - the same |
Key Features Comparison
| Parameter | Predicate Devices
(UB-511 & UB-512) | Modified Devices
(UB-543) |
|---------------------------|----------------------------------------|------------------------------|
| Field service | Not allowed | No Change - the same |
| Automatic zero at "START" | Yes | No Change - the same |
| Manual zero adjustment | Not allowed | No Change - the same |
| Calibration | Not allowed in the field | No Change - the same |
| Sterilization | Not needed | No Change - the same |
Substantial Equivalence Conclusion:
UB-543 Digital blood pressure monitors have the following similarities to the predicate devices, UB-411 and UB-412 digital blood pressure monitors, which previously received the 510(k) clearance.
- Same Indication of Use .
- Same intended use .
- Same oscillometric method to determine the blood pressure & pulse rate .
- Same inflation method -- automatic internal pump �
- Same deflation method fast exhaust valve ●
- ◆ Same materials, no new materials used
- Same manufacturing processes at the same facility .
As a conclusion, the intended use of the modified device, UB-543 as described in its labeling, has not changed as a result of the modifications. The fundamental scientific technology of the modified device, UB-543, has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring MD 20993-0002
A & D Co., Ltd. c/o Dr. Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, California 95131
Re: K141179
Trade/Device Name: A&D Medical UB-543 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Monitor Regulatory Class: Class II (two) Product Code: DXN Dated: May 29, 2014 Received: May 30, 2014
June 27, 2014
Dear Dr. Wang:
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
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Page 2 - Dr. Jerry Wang
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 OIR and Part 809; medical device reporting of medical device-related 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 OIR and Part 809, please contact 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. 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 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/Resourcesfor You/Industry/default.htm.
Image /page/4/Picture/9 description: The image shows the text "Sincerely yours," followed by a logo that appears to say "FDA". There is a signature over the logo. The signature is illegible, but it appears to say "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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Indications for Use
510(k) Number (if known): _
Device Name: A&D Medical UB-543 Digital Blood Pressure Monitor
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/11 description: The image shows a logo with the letters FDA in the center. To the right of the logo, there is a date and time stamp that reads 2014.06.27 5:43:16 04:00.
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