(155 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with no mention of AI or ML algorithms for measurement or analysis. The irregular heartbeat detection is a common feature in such devices and doesn't necessarily imply AI/ML.
No
The device is intended to measure blood pressure and pulse rate, which are diagnostic functions, not therapeutic functions (treating or alleviating a disease or condition).
Yes
The device measures blood pressure and pulse rate, providing information relevant to a patient's health status. While it doesn't diagnose specific diseases, the results can be used for diagnostic purposes by a healthcare professional. Additionally, it features an irregular heartbeat indicator, which flags a potential health concern that may require further diagnostic evaluation.
No
The device description explicitly details hardware components such as an inflatable cuff, internal pump, exhaust valve, LCD, and internal memory, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Measure blood pressure (systolic and diastolic) and pulse rate." This is a physiological measurement taken directly from the patient's body.
- Device Description: The device uses an inflatable cuff on the upper arm and the oscillometric method to measure blood pressure. This is a non-invasive method of measuring a physiological parameter.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device does not analyze samples taken from the body; it measures a physiological parameter directly. Therefore, it falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes
DXN
Device Description
UA-651 uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-651. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. 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. UA-651 will not inflate the cuff higher than 300mmHg. UA-651 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
patient's upper arm
Indicated Patient Age Range
older than twelve (12) years
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol of a human figure, represented by three stylized profiles facing to the right, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 7, 2014
A & D Engineering, Inc. Mr. Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, CA 95131
Re: K141160
Trade/Device Name: A&D Medical UA-651Digital Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: September 5, 2014 Received: September 8, 2014
Dear Mr. 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.
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Page 2 - Mr. Jerry Wang
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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -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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Indications for Use
510(k) Number (if known): K141160
Device Name: A&D Medical UA-651 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
X ============================================================================================================================================================================ 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)
Page 1 of _ 1
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K141160
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
Octorber 03, 2014
- Date Prepared
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 UA-651Digital Blood Pressure Monitor |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System |
| 21 CFR 870.1130, Class II, 74DXN. |
4. Predicate Devices
A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686
A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 Predicate devices are designed and manufactured by the same company and facilities as the modified devices UA-651.
ട്. Device Description - Technological and Operational Characteristics
UA-651 uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-651. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. 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. UA-651 will not inflate the cuff higher than 300mmHg. UA-651 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. The detail comparisons among devices are listed below. Main features of the UA-651 are listed below.
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6. Intended Use & Indicator for Use
Indended use: The A&D Medical UA-651 family digital blood pressure monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.
Indications for Use: Measure blood pressure (systolic and diastolic) and pulse rate.
The intended user and the indication for use of A&D Medial UA-651 as described in the labeling are the same as their predicated devices, UA-1000 family and UA-767PBT.
7. Summary of Substantial Equivalence
Modifications made from the predicate devices:
- Change the plastic molds so UA-651 has a different appearance ●
- Reduce memory size and remove AM / PM function ●
- Remove the following functions from UA-1000 family Voice, Tricheck, and ● AM/PM measurement average.
- . Remove the Bluetooth wireless communication from UA-767PBT.
| Parameter | Predicate Devices
(UA-1000 family & UA-767PBT) | Modified Devices
(UA-651) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Power source | 4 AA size batteries and AC
adaptor as an option | No Change – the same |
| Battery Life | 4 months with daily measurement | No change – the same |
| Measurement
Method | Oscillometric Method | No change – the same |
| Measurement
Range | BP : 20 to 280 mmHg
Pulse : 30 to 200 pulse/min | No change – the same |
| Accuracy | BP : +/- 3mmHg or +/- 2% of
measured value, whichever is
greater
Pulse : +/- 5 % (pulse) | No change – the same |
| Pressurization
Source | Automatic internal pump | No change – the same |
| Cuff Deflation
Method | UA-767PBT – Standard exhaust
valve
UA-1000 family – Constant speed
electrical controlled exhaust valve
(ECEV method) | No change – the same as
UA-767PBT |
| Display Type | Liquid crystal display | No change – the same |
| Cuff Attachment
Method | By plastic hose connected to
monitor | No change – the same |
| IHB (Irregular | More than +/-25% to the mean | No change – the same |
Product Specification Comparison
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| Heartbeats
| Detection) | interval of all pulse intervals | |
|---|---|---|
| Operating | ||
| Environment | 50°F (10°C) to 104°F (40°C) | |
| 30 %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 | UA-1000 family (Yes) under USA | |
| JUC VII guideline | No change - the same | |
| Data Memory Size | ||
| with Time & Date | 90 memories for UA-1000 family | |
| 40 memories for UA-767PBT | Reduce to 30 memories | |
| Pressure Sensor design | Static electricity capacity type | No change - the same |
| Dimensions in mm | UA-767PBT: 163.7 x 111 x 66.7 | |
| UA-1000 Family: 140 x 60 x 105 | 190 x 83 x 165 | |
| Weight | UA-1010–265g | |
| UA-1020–285g | ||
| UA-1030T–300g without batteries | 300g without batteries | |
| Cuff Design | UA-767PBT – D-ring cuffs | |
| UA-1000 family – U-shape cuffs | No change - the same as | |
| UA-767PBT | ||
| Arm Size | UA-289 small cuff : 16 to 24 cm | |
| UA-290 medium cuff : 23 to 37 cm | ||
| UA-291 large cuff : 31 to 45 cm | No change | |
| Clock (Time/Date) | Yes for UA-1020 and UA-1030T | Removed |
| Talking | Yes - UA-1030T, No - others | Removed |
| AM/PM | Yes – UA-1020 & UA-1030T | Removed |
| Wireless Radio | ||
| Connectivity | UA-1000 family (No), UA- | |
| 767PBT (Yes) | Removed | |
| Personal PC | ||
| Analysis Software | UA-1000 family (No), UA- | |
| 767PBT (Yes) | Removed |
Key Features Comparison
| Parameter | Predicate Devices
(UA-1000 family & UA-
767PBT) | Modified Devices
(UA-651) |
|---------------------------|-------------------------------------------------------|------------------------------|
| 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 |
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Substantial Equivalence Conclusion:
UA-651 Digital blood pressure monitors have the following similarities to the predicate devices, UA-1000 family and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance.
- Same intended use. ●
- Same oscillometric method to determine the blood pressure & pulse rate
- Same inflation method - automatic internal pump
- Same deflation method - standard 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, UA-651 as described in its labeling, has not changed as a result of the modifications. The fundamental scientific technology of the modified device, UA-651, 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.