A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR

K141160 · A & D Co., Ltd. · DXN · Oct 7, 2014 · Cardiovascular

Device Facts

• Record ID: K141160
• Device Name: A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A & D Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 7, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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.

Device Story

Digital blood pressure monitor for home use; operated by patient. Device uses inflatable arm cuff; automatic internal pump inflates cuff; oscillometric method determines systolic/diastolic pressure and pulse rate. Internal exhaust valve controls deflation; includes quick-exhaust mechanism. Safety limit set at 300mmHg. Device detects irregular heartbeats (IHB) if pulse interval variation exceeds +/-25%. Results displayed on LCD and stored in internal memory. Provides non-invasive monitoring; assists in tracking blood pressure and pulse trends; aids in identifying potential irregular heart rhythms.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparison of technical specifications, measurement accuracy, and operational parameters against predicate devices.

Technological Characteristics

Oscillometric measurement; automatic internal pump; static electricity capacity pressure sensor; LCD display; battery-powered (4 AA); cuff-based; non-sterile. No wireless connectivity or PC analysis software.

Indications for Use

Indicated for individuals older than 12 years to measure systolic and diastolic blood pressure and pulse rate.

Regulatory Classification

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.

Predicate Devices

• A&D Model UA-1000 Family Digital Blood Pressure Monitors (K111686)
• A&D Model UA-767PBT Digital Blood Pressure Monitor (K043217)

Submission Summary (Full Text)

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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 [phone] or [phone] 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)

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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.

- 1. Date Prepared
Octorber 03, 2014

#### 2. Submitter's Information

A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: [phone] Fax: [phone] Email: [e-mail]

#### 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<br>(UA-1000 family & UA-767PBT) | Modified Devices<br>(UA-651) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Power source | 4 AA size batteries and AC<br>adaptor as an option | No Change – the same |
| Battery Life | 4 months with daily measurement | No change – the same |
| Measurement<br>Method | Oscillometric Method | No change – the same |
| Measurement<br>Range | BP : 20 to 280 mmHg<br>Pulse : 30 to 200 pulse/min | No change – the same |
| Accuracy | BP : +/- 3mmHg or +/- 2% of<br>measured value, whichever is<br>greater<br>Pulse : +/- 5 % (pulse) | No change – the same |
| Pressurization<br>Source | Automatic internal pump | No change – the same |
| Cuff Deflation<br>Method | UA-767PBT – Standard exhaust<br>valve<br>UA-1000 family – Constant speed<br>electrical controlled exhaust valve<br>(ECEV method) | No change – the same as<br>UA-767PBT |
| Display Type | Liquid crystal display | No change – the same |
| Cuff Attachment<br>Method | By plastic hose connected to<br>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<br>Detection) | interval of all pulse intervals | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------|
| Operating<br>Environment | 50°F (10°C) to 104°F (40°C)<br>30 %RH to 85% RH | No change - the same |
| Storage<br>Environment | 14°F (-20°C) to 140°F (60°C)<br>10 %RH to 95% RH | No change - the same |
| Pressure Indicator | UA-1000 family (Yes) under USA<br>JUC VII guideline | No change - the same |
| Data Memory Size<br>with Time & Date | 90 memories for UA-1000 family<br>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<br>UA-1000 Family: 140 x 60 x 105 | 190 x 83 x 165 |
| Weight | UA-1010–265g<br>UA-1020–285g<br>UA-1030T–300g without batteries | 300g without batteries |
| Cuff Design | UA-767PBT – D-ring cuffs<br>UA-1000 family – U-shape cuffs | No change - the same as<br>UA-767PBT |
| Arm Size | UA-289 small cuff : 16 to 24 cm<br>UA-290 medium cuff : 23 to 37 cm<br>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<br>Connectivity | UA-1000 family (No), UA-<br>767PBT (Yes) | Removed |
| Personal PC<br>Analysis Software | UA-1000 family (No), UA-<br>767PBT (Yes) | Removed |

## Key Features Comparison

| Parameter | Predicate Devices<br>(UA-1000 family & UA-<br>767PBT) | Modified Devices<br>(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.