FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K140121 · Andon Health Co, Ltd. · DXN · Jul 2, 2014 · Cardiovascular

Device Facts

• Record ID: K140121
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KN-550, KN-550N ,KN-520 and KD-5005 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 method with silicon-integrated pressure sensor technology. Input: pressure signals from inflatable upper arm cuff. Processing: calculates systolic/diastolic blood pressure and pulse rate; detects irregular heartbeats; computes measurement averages. Output: results displayed on LCD. Used by medical professionals or patients at home. Provides objective blood pressure data to assist in clinical monitoring and patient self-management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), and performance testing for automated non-invasive sphygmomanometers (IEC 80601-2-30).

Technological Characteristics

Oscillometric measurement principle; silicon-integrated pressure sensor. Powered by electrical source. Form factor: upper arm cuff (22-48cm). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 80601-2-30 (automated sphygmomanometers).

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive upper arm cuff (22cm-48cm circumference). Suitable 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-513LU Fully Automatic Electronic Blood Pressure Monitor (K121372)

Submission Summary (Full Text)

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### K140121

KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

# 510(k) Summary

JUL 0 2 2014

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: | Andon Health Co., Ltd. |
|----------------------|--------------------------------------------------------------------------|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin,<br>P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 12/27/2013 |

### 2.0 Device information

| Trade name: | KN-550, KN-550N, KN-520 and KD-5005 Fully Automatic<br>Electronic Blood Pressure Monitor. |
|----------------------|-------------------------------------------------------------------------------------------|
| Device name: | KN-550,KN-550N,KN-520 and KD-5005Fully Automatic<br>Electronic Blood Pressure Monitor. |
| Classification name: | Noninvasive blood pressure measurement system |

### 3.0 Classification

រូ

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

### 4.0 Predicate device information

| Manufacturer: | Andon Health Co., Ltd. |
|----------------|----------------------------------------------------------------|
| Device: | KD-513LU Fully Automatic Electronic Blood Pressure<br>Monitor. |
| 510(k) number: | K121372 |

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### K140121

#### 5.0 Intended use

KN-550, KN-520 and KD-5005 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 KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Pressure Monitor., as described in its labeling are the same as the predicate device KD-513LU .

#### 6.0 Device description

KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Monitor. is designed and manufactured Pressure according to IEC80601-2-30--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD or other display components.

| 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 |

#### 7.0 Summary comparing technological characteristics with predicate device

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### K140121

KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

#### 8.0 Discussion of non-clinical and clinical test performed

#### Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

b. Electrical safety according test to IEC 60601-1 and IEC 60601-1-1

c. Safety and performance characteristics of the test according to IEC 80601-2-30 ·

None of the test demonstrates that KN-550, KN-550N-,KN-520 and KD-5005 Blood Pressure Monitor brings new questions of safety and Fully Automatic effectiveness.

#### 9.0 Performance summary

Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

- 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical ● IEC equipment -- Part 1: General requirements for basic safety and essential performance)
- IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical
- equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests)
- · IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)

#### 10.0 Comparison to the predicate device and the conclusion

Our device KN-550, KN-520 and KD-5005Fully Automatic Electronic Blood Pressure Monitor. is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-513LU whose 510(k) number is K121372.

The five devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, and the user interface are different.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 2, 2014

Mr. Liu Yi, President Andon Health Co., Ltd. No 3, Jinping Street, Ya An Road, Nankai District Tianjin People's Republic of China 300190

K140121 Re:

Trade/Device Names: KN-550, KN-550N, KN-520 and KD-5005 Fully Automatic Electronic 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: June 6, 2014 Received: June 9, 2014

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. 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. 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 fisting (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/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/ReportalProblem/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,

forBram 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 : | K140121 |
|-----------------|----------------------------------------------------------------------------------------|
| Device name: | KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor. |

### Indications for use:

KN-550, KN-550N ,KN-520 and KD-5005 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)

Date
2014.07.02
17:27:52 -04'00'

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