SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909

K091739 · Andon Health Co, Ltd. · DXN · Aug 18, 2009 · Cardiovascular

Device Facts

• Record ID: K091739
• Device Name: SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-3917 and KD-3909 Semi 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

Non-invasive blood pressure monitor (KD-3917/KD-3909) uses inflatable upper arm cuff to measure systolic/diastolic pressure and pulse rate. Operates via oscillometric principle with silicon integrated pressure sensor. Device displays results on LCD; includes blood pressure classification indicator and irregular heartbeat detection. KD-3909 model features memory for 2x60 measurements and averaging of last three readings; KD-3917 features 60-measurement memory. Used by clinicians or patients at home. Output allows monitoring of cardiovascular status to inform clinical decision-making.

Clinical Evidence

Bench testing only. Device performance validated against AAMI SP10:2002 and amendments (A1:2003, A2:2006) for manual, electronic, or automated sphygmomanometers. Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) confirmed.

Technological Characteristics

Oscillometric measurement principle using silicon integrated pressure sensor. Powered by electronic interface module with LCD. Cuff circumference 22-48cm. Complies with AAMI SP10, IEC 60601-1, and IEC 60601-1-2 standards. Standalone device.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive upper arm cuff (22-48cm circumference). Suitable for use by medical professionals or 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-391 Semi Automatic Electronic Blood Pressure Monitor (K080326)

Submission Summary (Full Text)

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# 510(k) Summary

K091739
P 1/4

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

AUG 1 8 2009

| Name: | Andon Health Co., Ltd. |
|----------------------|-----------------------------------------------------------------|
| Address: | No 31, Changjiang 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: | 05/27/2009 |

#### 2.0 Device information

Semi Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:

#### 3.0 Classification

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

#### 4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-391 Semi Automatic Electronic Blood Pressure Monitor Device: K080326 510(k) number:

#### 5.0 Device description

KD-3917 and KD-3909 Semi 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.

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It is designed and manufactured according to ANSI/AAMI SP10--manual, P2/4 electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module; the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.

#### 6.0 Intended use

KD-3917 and KD-3909 Semi 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-3917 and KD-3909, as described in their labelings are the same as the predict device KD-391.

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Similar |
| 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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#### 8.0 Performance summary

KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure 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.
- · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004, Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- · 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 predict device and the conclusion

Our device KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Semi Automatic Electronic Blood Pressure Monitor KD-391 whose 510(k) number is K080326.

KD-3917 and KD-391 are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance is different. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-391. The pulse rate range is changed from 30-180 times/min to 40-180 times/min. KD-3917 also adds a new cuff.

KD-3909 and KD-391 are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance and some functions such as 2×60 times memory and averaging the last three measurements are different. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-391. The pulse rate range is changed from 30-180 times/min to 40-180 times/min, KD-3909 also adds a new cuff.

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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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianiin China 300190

## 'AUG 1 8 2009

Re: K091739

> Trade/Device Name: KD-3917, KD-3909 Semi 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: undated Received: July 21, 2009

Dear Mr. 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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Žuckerman, 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 : | K091739 |
|-----------------|----------------------------------------------------------------------|
| Device name: | KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor |

#### Indications for use:

KD-3917 and KD-3909 Semi 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)

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)

Hofstetter B Zuckerman

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

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