Fully Automatic Electronic Blood Pressure Monitor

K162668 · Andon Health Co, Ltd. · DXN · Feb 14, 2017 · Cardiovascular

Device Facts

• Record ID: K162668
• Device Name: Fully Automatic Electronic Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 14, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-926 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

KD-926 is a fully automatic electronic blood pressure monitor; utilizes oscillometric measurement principle with silicon-integrated pressure sensor; wraps inflatable cuff around upper arm; measures systolic/diastolic blood pressure and pulse rate; detects irregular heartbeats; displays results on LCD; includes blood pressure classification indicator; intended for clinical or home use by professionals or patients; provides objective data for monitoring cardiovascular status; benefits patients through convenient, non-invasive self-monitoring of blood pressure.

Clinical Evidence

No new clinical testing performed. Clinical evidence relies on data from previously cleared devices (K102939 and K120672) which utilize the same cuff and algorithm as the subject device.

Technological Characteristics

Oscillometric measurement with silicon-integrated pressure sensor. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 80601-2-30 (automated noninvasive sphygmomanometers). Form factor: upper arm cuff (22-48cm). Features LCD display, irregular heartbeat detection, and blood pressure classification indicator.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm cuff (22-48cm circumference). Suitable for use by medical professionals or patients at home.

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-927 Fully Automatic Electronic Blood Pressure Monitor (K141984)

Reference Devices

• K102939
• K120672

Submission Summary (Full Text)

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

February 14, 2017

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

Re: K162668

Trade/Device Name: KD-926 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 15, 2016 Received: November 17, 2016

Dear Mr. Liu Yi:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Liu Yi

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Jellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K162668

Device Name

KD-926 Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

KD-926 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

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 Preparation: | 9/23/2016 |

### 2.0 Device information

Trade name: KD-926 Fully Automatic Electronic Blood Pressure Monitor

Common name: Noninvasive blood pressure measurement system

Classification name: Noninvasive blood pressure measurement system

### 3.0 Classification

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. KD-927 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K141984

### 5.0 Intended use

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KD-926 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.

The intended use and the indication for use of KD-926, as described in its labeling are the same as the predicate device KD-927 (K141984)

## 6.0 Device description

KD-926 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. 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.

### 7.0 Summary comparing technological characteristics with predicate device

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

# 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;

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

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

None of the test demonstrates that KD-926 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.

#### Clinical Tests

The cuff and algorithm of KD-926 is the same as K102939 and K120672, so we use the clinical data of K102939 and K120672 as the clinical proof of the new device.

#### 9.0 Performance summary

KD-926 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

- IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- · IEC 80601-2-30:2009 & A1:2013.Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers

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

Our device KD-926 Fully Automatic Electronic are substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-927 whose 510(k) number is K141984.

KD-926 is very similar with its predicate device in the intended use, the design principle, the memory capacity, the material, the performance and the applicable standards. Only their appearance, the data transmission mode, the memory average function, the electrical power and the MCU are different.

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