FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR

K121470 · Andon Health Co, Ltd. · DXN · Jun 14, 2012 · Cardiovascular

Device Facts

• Record ID: K121470
• Device Name: FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 14, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 wrist. The cuff circumference is limited to 13.5cm-22cm.

Device Story

The KD-972 is a non-invasive, automated wrist-worn blood pressure monitor. It utilizes an inflatable cuff and silicon-integrated pressure sensor technology to perform oscillometric measurements. Unlike traditional monitors, the device lacks an onboard display; it pairs via Bluetooth with an iPhone, iPod touch, or iPad running support software to function as a complete system. The device measures blood pressure during the cuff inflation phase. It provides systolic/diastolic pressure and pulse rate, detects irregular heartbeats, and calculates measurement averages. Data is transmitted wirelessly to the mobile device for display and user review. Used by clinicians or patients at home, the system enables remote monitoring and tracking of blood pressure trends, facilitating clinical decision-making through accessible, digitized health data.

Clinical Evidence

Bench testing only. The device conforms to IEC 60601-1, EN 60601-1-2, and IEC 80601-2-30 standards for safety, electromagnetic compatibility, and performance of automated non-invasive sphygmomanometers.

Technological Characteristics

Oscillometric measurement principle using silicon-integrated pressure sensors. Wrist cuff (13.5cm-22cm). Bluetooth connectivity for data transmission to mobile devices (iPhone/iPod/iPad). No onboard LCD. Powered by internal energy source. Complies with IEC 80601-2-30, IEC 60601-1, and EN 60601-1-2.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via wrist cuff (13.5cm-22cm 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-7964 Fully Automatic Electronic Blood Pressure Monitor (K102906)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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.

JUN 1 4 2012

K121470

\$1/3

### 1.0 submitter's information

| Name: | Andon Health Co., Ltd. |
|----------------------|------------------------------------------------------------|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| | P.R. China |
| Phone number: | 86-22-6052 6161 Ext 8060 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 05/08/2012 |

### 2.0 Device information

| Trade name: | iHealth BP7-Wireless Blood Pressure Wrist Monitor |
|----------------------|-----------------------------------------------------------------|
| Device name: | KD-972 Fully Automatic Wireless Blood Pressure Wrist<br>Monitor |
| Classification name: | Noninvasive blood pressure measurement system |

### 3.0 Classification

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

### 4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. Device: KD-7964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906

### 5.0 Device description

KD-972 Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system

{1}------------------------------------------------

intended to measure the diastolic and systolic blood pressures and pulse rate K121470 of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.

833

It is designed and manufactured according to IEC 80601-2-30- Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurement 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.

KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor achieves its function by integrate the device with an iPhone, iPod touch or iPad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod touch or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth.

#### 6.0 Intended use

KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 wrist. The cuff circumference is limited to 13.5cm-22cm.

The intended use and the indication for use of KD-972, as described in the labeling are the same as its predicate device KD-7964.

### 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |

2- 3

{2}------------------------------------------------

| Biocompatibility | Identical |
|-------------------|-----------|
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |

121470 p3/3

### 8.0 Performance summary

KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms 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.
- · IEC 80601-2-30, Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanmeters,2009.

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

Our device KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7964 whose 510(k) number is K102906.

KD-972 and KD-7964 are very similar in the intended use, the design principle, the performance and the applicable standards. Only their appearance, the memory time, the average function are different. The measure process is also changed, that is the new device will get the measurement results when the device is inflating, while KD -7964 gets the result during the deflating period. The data transfer method of the new device KD-972 is changed to Bluetooth and the data displayed on iPhone, while KD-7964 transfer the data to PC while receive available command.

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.

Public Health Service

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

JUN 1 4 2012

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

Re: K121470

> Trade/Device Name: Fully Automatic Wireless Blood Pressure Wrist Monitor, KD-972 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 14, 2012 Received: May 17, 2012

Dear Ms. 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

{4}------------------------------------------------

Page 2 - Ms. Liu Yi

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 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

{5}------------------------------------------------

## Statement of Indications for Use

### 510(k) Number :

Device name:

KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor

#### Indications for use:

KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 wrist. The cuff circumference is limited to 13.5cm-22cm.

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (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 Sign-on)
Division of Cardiovascular Devices

Page I of

510(k) Number K121470