ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR

K112273 · Accumed Healthcare (Shanghai), Inc. · DXN · Nov 22, 2011 · Cardiovascular

Device Facts

• Record ID: K112273
• Device Name: ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
• Applicant: Accumed Healthcare (Shanghai), Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 22, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is a noninvasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home. The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

Device Story

Accumed AAE-701 is an automatic upper arm blood pressure monitor for home use by adults. Device uses an electronic pressure sensor to measure cuff pressure variations via the oscillometric method; replaces traditional stethoscope/mercury manometer. Microprocessor analyzes electrical signals from the sensor to calculate systolic/diastolic blood pressure and pulse rate. Device features an irregular heartbeat (IHB) indicator, which triggers an LCD symbol if pulse rate deviation exceeds 25%. Users operate the device independently to monitor cardiovascular metrics; output is displayed on an integrated LCD screen. Data assists users in tracking blood pressure trends.

Clinical Evidence

Bench testing only. Device performance verified against ANSI/AAMI SP10, IEC/EN 60601-1, IEC/EN 60601-1-2, and IEC/EN 60601-1-4. Biocompatibility testing for cuff materials (cytotoxicity, sensitivity, irritation) performed per ISO 10993.

Technological Characteristics

Oscillometric measurement; semiconductor pressure sensor; microprocessor-based signal processing. Powered by batteries (implied). LCD display. Cuff materials tested for biocompatibility per ISO 10993. Standards: ANSI/AAMI SP10, IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-4.

Indications for Use

Indicated for adult patients for non-invasive measurement of systolic/diastolic blood pressure and pulse rate at home using the oscillometric method. Includes irregular heartbeat (IHB) detection.

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

• Citizen CH-101 (K100553)
• Citizen CH-609 (K100055)

Submission Summary (Full Text)

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### Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

# Accumed

510(k) Summary

| 510(k) owner's information: | Accumed Healthcare (Shanghai) Inc.<br>No. 6133, Huyi Rd., Waigang, Jiading<br>District, Shanghai, China.<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Cindy Green, Authorized Representative<br>P.O. Box 1277; Maple Valley, WA 98038<br>Tel: [phone] |
| Proprietary or Trade Name: | Accumed Upper Arm Automatic Blood<br>Pressure Monitor, Model AAE-701 |
| Common/Usual Name: | Non-Invasive Blood Pressure Monitor |
| Classification Name: | System, Measurement, Blood-Pressure,<br>Non-Invasive |
| Regulation | CFR 870.1130 |
| Product Code | DXN |
| Predicate Device: | Citizen CH-101, K100553,<br>Citizen CH-609, K100055 |
| Date Summary Prepared: | Nov 7, 2011 |

### Device Description:

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

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Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

Accumed

### Intended Use:

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is a noninvasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

### Comparison to Predicate Device

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701 is substantially equivalent to the Citizen CH-101 (K100553) and Citizen CH-609 (K100055).

The Accumed AAE-701 and the Citizen CH-101 and CH-609 predicates have the same:

- · Intended use
- · Intended use environment
- · Intended patient population
- · Display type
- · Accuracy
- · Pulse range measurement
- · Well known oscillometric method within the software algorithm used to determine the systolic and diastolic blood pressure and pulse
- · Semi-conductor pressure sensor technology used to translate the pressure variations to electrical signals that can be interpreted by the microprocessor

The Accumed AAE-701 and the Citizen CH-609 have an irregular heart beat detection function and the same memory capacity.

The subject device and the predicate devices Citizen CH-101and CH-609 are not identical with regards to arm circumference, display parameters, dimensions, and weight, The Citizen CH-609 is intended for use on the wrist; as opposed to the arm. Therefore, the Citizen CH-609 has a different pressure range measurement, operating environment, and storage environment.

The subject device is substantially equivalent to the Citizen CH-101 (K100553) and Citizen CH-609 (K100055). There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

## Accumed

### Performance Testing:

The started on the commended on the first comments of the comments of the

Bench testing was conducted to demonstrate that the device meets its Requirements Specification. The following performance tests were completed:

- ANSI/AAMI SP10 .
- . IEC/EN 60601-1
- IEC/EN 60601-1-2 .
- . IEC/EN 60601-1-4

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701 meets all applicable requirements.

### Biocompatibility

Testing was performed for in vitro cytotoxicity, sensitivity, and irritation according to ISO 10993 requirements. Test results demonstrate that there is no cytotoxicity, sensitivity, or irritation caused by the Blood Pressure Monitor Cuff.

### Conclusion;

Based on the evaluations completed there are no new safety or effectiveness issues introduced with this new medical device. Therefore, the Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is substantially equivalent to the predicate devices; Citizen CH-101 (K100553) and Citizen CH-609 (K100055).

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

NOV 2 2 2011

Accumed Healthcare (Shanghai) Inc. c/o Cindy Green Authorized Representative P.O. Box 1277; Maple Valley. WA 98038

Re: K112273 ·

Trade/Device Name: Accumed Upper Arm Automatic Blood Pressure Monitor, AAE-701 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 8, 2011 Received: November 10, 2011

Dear Ms. Green:

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 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

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Page 2 - Ms. Cindy Green

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/ucm117800.html 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" (21CFF) Page 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,

Ram D. Zutshi, M.D.

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: Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701

Indications For Use:

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

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) | |
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| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K112273 |
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