A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS

K111686 · A&D Company, Ltd. · DXN · Aug 1, 2011 · Cardiovascular

Device Facts

• Record ID: K111686
• Device Name: A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
• Applicant: A&D Company, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The A&D Medical UA-1000 family digital blood pressure monitors are intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.

Device Story

UA-1000 family digital blood pressure monitors; oscillometric measurement of systolic/diastolic blood pressure and pulse rate. Device uses inflatable arm cuff; automatic internal pump for inflation; electronic-controlled exhaust valve for deflation. Features irregular heartbeat (IHB) detection; pressure indicator; memory storage (90 measurements) with AM/PM banks; average function for consecutive measurements (UA-1020/UA-1030T); voice announcement (UA-1030T). Operated by patient in home or clinical setting. Results displayed on LCD; used by patients to monitor blood pressure trends. Benefits include non-invasive, automated blood pressure tracking.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on identical measurement technology, range, and accuracy specifications as predicate devices.

Technological Characteristics

Oscillometric measurement; automatic internal pump; electronic-controlled exhaust valve; LCD display; powered by 4 AA batteries or AC adapter. Dimensions: 140(W)x60(H)x105(D) mm. IHB detection algorithm. No wireless connectivity. Non-sterile.

Indications for Use

Indicated for adults aged 12 and older to measure systolic/diastolic blood pressure and pulse rate. Over-the-counter use.

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-787 Digital Blood Pressure Monitor (K012472)
• A&D Model UA-851THW Digital Blood Pressure Monitor (K082734)

Submission Summary (Full Text)

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K11168b

AUG - 1 2011

## Attachment (D) 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
June 13, 2011

#### Submitter's Information 2.

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

#### Device Information 3.

A&D Medical UA-1000 Family Digital Blood Pressure Monitors Proprietary Name: Common/Usual Name: Blood Pressure Monitor Non-invasive blood pressure measurement System Classification name: 21 CFR 870-1130, Class II, 74DXN.

#### 4. Predicate Devices

A&D Model UA-787 Digital Blood Pressure Monitor with 510(k) number K012472 A&D Model UA-851THW Digital Blood Pressure Monitor with 510(k) number K082734 Predicate devices are designed and manufactured by the same company and facilities as the modified devices UA-1000 family.

#### Device Description - Technological and Operaional Characteristics ട്.

UA-1000 family 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. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. There is a maximum pressure safety setting at 300mmHg. The device will not inflate the cuff higher than 300mmHg. The UA-1000 family 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. For UA-1030T, the results is also annoucment in voice. The cuff is also deflated automatically at the same time. There are two memory banks to separate the measurements in the morning time and in the evening time. UA-1020 and UA-1030T can conduct average function for 3 consecutive measurmenets automatically. The detail comparison among devices are listed below.

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| Features | UA-1010 | UA-1020 | UA-1030T |
|----------------------------------------------------|-----------|-----------|-----------|
| Powered by 4 AA size batteries and AC adaptor plug | Yes | Yes | Yes |
| Memory Size (90 measurements) | Yes | Yes | Yes |
| Time & Date | Yes | Yes | Yes |
| AM / PM Memory Banks | Yes | Yes | Yes |
| Pressure Indicator | Yes | Yes | Yes |
| Average of Measurements in Memory | Yes | Yes | Yes |
| IHB (Irregular Heartbeat Detection) | Yes | Yes | Yes |
| Outside Demission (140 w x 60 h x 105 d in mm) | The same | The same | The same |
| Talking (Voice Announcement of Measurement Result) | No | No | Yes |
| Cuff Style | Opti | Opti | Easy Fit |
| LCD size (Viewing Area in mm) | 43 × 48.5 | 62.5 × 72 | 62.5 × 72 |
| Tricheck (Average of 3 consecutive measurements) | No | Yes | Yes |

#### Intended Use 6.

The A&D Medical UA-1000 family digital blood pressure monitors are 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 UA-1000 family as described in the labeling are the same as their predicated devices, UA-787 and UA-851THW.

#### Summary of Substantial Equivalence 7.

Modifications from the predicate devices:

- Change the plastic molds so UA-1000 family has a different appearance .
- Separate the memeory into two banks so it can calculate the measurements in the . morning and in the evening separately.
- UA-1020 and UA-1030T have a tricheck capability so it can average 3 . consecutive measurement results.
- UA-1030T adds a voice anuouncemnt capability at the end of the measurement. .

| Parameter | Predicate Devices<br>(UA-787 & UA-851THW) | Modified Devices<br>(UA-1000 Family) |
|-----------------------|------------------------------------------------------------------------------------------------|--------------------------------------|
| Measurement<br>Method | Oscillometric Method | No change - the same |
| Measurement 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 greater<br>Pulse : +/- 5 % (pulse) | No change - the same |

### Product Specification Comparison

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| Pressurization Source | Automatic internal pump | No change – the same |
|-----------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Cuff Deflation<br>Method | Constant speed electrical controlled<br>exhaust valve (ECEV method) | No change – the same |
| Display Type | Liquid crystal display | No change – the same |
| Cuff Attachment<br>Method | By plastic hose connected to monitor | No change – the same |
| IHB (Irregular<br>Heartbeats Detection) | More than +/-25% to the mean<br>interval of all pulse intervals | No change – the same |
| Power Source | 6V DC, 4x1.5V AA batteries or AC<br>adapter as an option | No change – the same |
| Battery Life | 4 months with daily measurement | No change – the same |
| Operating<br>Environment | 50°F (10°C) to 104°F (40°C)<br>30 %RH to 85% RH | No change – the same |
| Storage Environment | 14°F (-20°C) to 140°F (60°C)<br>10 %RH to 95% RH | No change – the same |
| Data Memory Size<br>with Time & Date | 30, 60 or 280 rmemories for UA-787<br>51 memories for UA-851THW | 90 memories for all three<br>models of UA-1000 family |
| Dimensions | UA-787 – 163(W)×62(H)×112(D)<br>UA-851THW –<br>150(W)×156(H)×120(D) | 140(W)×60(H)×105(D) for all<br>three models of UA-1000<br>family |
| Weight | UA-787 - 920 g (2.03 lb) without<br>batteries<br>UA-851THW - 940 g (2.07 lb)<br>without batteries | UA-1010–265g<br>UA-1020–285g<br>UA-1030T–300g<br>without batteries |
| Cuff Design | UA-851THW - D-ring cuffs<br>UA-787 - U-shape cuffs | UA-1010 & UA-1020 – the<br>same as UA-851THE<br>UA-1030T – the same as UA-<br>787 |
| Arm Size | UA-787 – 19 to 36 cm<br>UA-851THW – 24 to 45 cm | UA-1030T – 23 to 37 cm<br>UA-1010 & UA-1020 – 16 to<br>45 cm |
| Clock (Time/Date) | No | UA-1000 Family –Yes |
| Talking | No | No : UA-1010 & UA-1020<br>Yes : UA-1030T (3 languages –<br>English, French, & Spanish) |
| AM/PM | No | UA-1000 Family –Yes |
| Pressure Indicator | UA-787 (No), UA-851THW (Yes) | UA-1000 Family –Yes |
| Wireless Radio<br>Connectivity | UA-787 (No), UA-851THW (Yes) | No |
| Personal PC Analysis<br>Software | UA-787 (No), UA-851THW (Yes) | No |

### Key Features Comparison

| Parameter | Predicate Devices<br>(UA-787 & UA-851THW) | Modified Devices<br>(UA-1000 Family) |
|---------------------------|-------------------------------------------|--------------------------------------|
| 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 |

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| Calibration | Not allowed in the field | No Change - the same |
|---------------------------------------------------|--------------------------|----------------------|
| Sterilization | Not needed | No Change - the same |
| Blood Pressure Reading<br>Classification Criteria | USA JNC VII | No change - the same |

### Substantial Equivalence Conclustion:

UA-1000 family digital blood pressure monitors have the following similarities to the predicate devices, UA-851THW and UA-787 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 automatic electrical controlled 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-1000 family as described in its labeling, has not changed as a result of the modifications. The fundamental scientific technology of the modified device, UA-1000 family, 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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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract bird or eagle, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

A&D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering and Quality Affairs 1756 Automation Parkway San Jose, CA 95131

AUG - 1 2011

Re: K111686

Trade/Device Name: UA-1000 Family Digital Blood Pressure Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 14, 2011 Received: July 19, 2011

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.

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

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Page 2 - Mr. Jerry Wang

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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K111686
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## Attachment B

# Indications for Use

510(k) Number (if known):_

Device Name: A&D Medical UA-1000 Family Digital Blood Pressure Monitors

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)

Signature

iovascular Devices

510(k) Number

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