FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K121372 · Andon Health Co, Ltd. · DXN · Sep 10, 2012 · Cardiovascular

Device Facts

• Record ID: K121372
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Device Story

Fully automatic electronic blood pressure monitor; uses oscillometric principle with silicon integrated pressure sensor; inputs pressure signals from inflatable upper arm cuff (22-48cm); calculates systolic/diastolic blood pressure and pulse rate; displays results on LCD; detects irregular heartbeats; calculates averages of stored measurements from last 7 days; used by medical professionals or patients at home; output informs clinical decision-making regarding hypertension management; benefits patient through convenient, non-invasive monitoring.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1, EN 60601-1-2, and AAMI/ANSI SP10:2002 (including amendments 1 and 2) for safety, electromagnetic compatibility, and performance of electronic sphygmomanometers.

Technological Characteristics

Oscillometric measurement principle; silicon integrated pressure sensor; inflatable upper arm cuff (22-48cm); LCD display; powered by internal energy source; conforms to AAMI/ANSI SP10, IEC 60601-1, and EN 60601-1-2 standards.

Indications for Use

Indicated for adult individuals to measure systolic/diastolic blood pressure and pulse rate via non-invasive upper arm cuff (22-48cm circumference). For use by medical professionals or home users.

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

• KD-5964 Fully Automatic Electronic Blood Pressure Monitor (K102906)
• KD-556J Fully Automatic Electronic Blood Pressure Monitor (K110330)

Reference Devices

• KD-5567

Submission Summary (Full Text)

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KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

# 510(k) Summary 《ノミノシア2

SEP 10 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

# 1.0 submitter's information

| Name: |
|----------|
| Address: |

Phone number:

Fax number:

Contact:

Andon Health Co., Ltd. No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China 86-22-6052 6161. Ext. 8060 86-22-6052 6162 Liu Yi 04/27/2012 Date of Application:

# 2.0 Device information

KD-513LU Fully Automatic Electronic Blood Pressure Monitor Device name: KD-513LC Fully Automatic Electronic Blood Pressure Monitor

# 3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

.

# 4.0 Predicate device information

| 1 | <table><tr><td>Manufacturer:</td><td>Andon Health Co., Ltd.</td></tr><tr><td>Device:</td><td>KD-5964 Fully Automatic Electronic Blood Pressure Monitor</td></tr><tr><td>510(k) number:</td><td>K102906</td></tr></table> | Manufacturer: | Andon Health Co., Ltd. | Device: | KD-5964 Fully Automatic Electronic Blood Pressure Monitor | 510(k) number: | K102906 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------|---------|-----------------------------------------------------------|----------------|---------|
| Manufacturer: | Andon Health Co., Ltd. | | | | | | |
| Device: | KD-5964 Fully Automatic Electronic Blood Pressure Monitor | | | | | | |
| 510(k) number: | K102906 | | | | | | |
| 2 | <table><tr><td>Manufacturer:</td><td>Andon Health Co., Ltd.</td></tr></table> | Manufacturer: | Andon Health Co., Ltd. | | | | |
| Manufacturer: | Andon Health Co., Ltd. | | | | | | |

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KD-556J Fully Automatic Electronic Blood Pressure Monitor

510(k) number: K110330

# 5.0 Device description

Device:

KD-513LU and KD-513 LC Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the all stored measurement of the same period(example: morning or afternoon) of the last 7 days.

### 6.0 Intended use

KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

The intended use and the indication for use of KD-513LU and KD-513LC, as described in the labeling are the same as the predicate device KD-5964 and KD-5567.

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# 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |

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# 8.0 Performance summary

KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor conform to the following standards:

- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

# 9.0 Comparison to the predicate device and the conclusion

Our device KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5964 whose 510(k) number is K102906 and the Fully Automatic Electronic Blood Pressure Monitor KD-556J with the 510(k) number of K110330.

KD-513LU and KD-513LC are very similar in the intended use, the design principle, the material, the performance and the applicable standards with their predicate devices. Only their appearance and the memory times are changed.

However, appropriate test have been conducted and conform that the new devices are the same safe and effective as the predicate devices.

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#### Public Health Service

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

SEP 10 2012

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin 300190 CHINA

Re: K121372

> Trade Names: KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 9, 2012 Received: August 13, 2012

Dear Mr. Liu:

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.

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# Page 2 - Mr. Liu Yi

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/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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# Statement of Indications for Use

| 510(k) Number : | K121372 |
|-----------------|-------------------------------------------------------------------------|
| Device name: | KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor |

## Indications for use:

KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Prescription use Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use YES (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off) Division of Cardiovascular Devices 510(k) Number 5 + 6

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