SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598

K083395 · Andon Health Co, Ltd. · DXN · Feb 27, 2009 · Cardiovascular

Device Facts

• Record ID: K083395
• Device Name: SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device.

Device Story

Non-invasive blood pressure monitor; uses oscillometric method with silicon integrated pressure sensor. Input: pressure signals from inflatable cuff (22-48cm circumference) wrapped around left upper arm. Device processes signals to calculate systolic/diastolic blood pressure and pulse rate. Output: results displayed on LCD. Used in clinical or home settings by medical professionals or patients. Provides objective measurements to assist in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. Device performance validated against ANSI/AAMI SP-10 standard for non-invasive blood pressure measurement systems, EN60601-1 for electrical safety, and EN60601-1-2 for electromagnetic compatibility.

Technological Characteristics

Oscillometric measurement method; silicon integrated pressure sensor; LCD display. Cuff circumference 22-48cm. Cuff pressure range 0-300mmHg. Powered by electronic interface module. Complies with ANSI/AAMI SP-10, EN60601-1, and EN60601-1-2.

Indications for Use

Indicated for adult patients for non-invasive measurement of systolic and diastolic blood pressure and pulse rate using an inflatable upper arm cuff (circumference 22cm-48cm). 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-322 (K052676)
• KD-622 (K030358)
• KD-525E (K070395)
• KD-575 (K042418)
• KD-593 (K070828)
• KD-595 (K070828)
• KD-596 (K070828)
• KD-598 (K070828)

Submission Summary (Full Text)

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# 天 津 九 安 医 疗 电 子 股 份 有 限 公 司

Andon Health Co., Ltd.

地址:天津市南开区雅安道金平路 10号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, NanKai District, Tianjin, China 郎纷(P.C.): 300190 传(Fax): 86-22-6052 6162 E-mail: [e-mail] ttt:1(Tel): 86-22-6052 6161

# 510(k) Summary

## ldentification of the submitter:

| Submitter: | Andon Health Co., Ltd. |
|----------------------|---------------------------------------------------|
| | No 31, Changjiang Road, Nankai District, Tianjin, |
| | P.R. China, 300193 |
| Telephone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 11/10/08 |

### Identification of the product:

| Device proprietary Name: | Arm Electronic Blood Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement systems |
| Classification name: | Noninvasive blood pressure measurement system<br>Class II per 21 CFR 870.1130 |

#### Marketed Devices to which equivalence is claimed:

| Device | manufacture | 510(k) number |
|---------|-----------------------|---------------|
| KD-322 | Andon Health Co., Ltd | K052676 |
| KD-622 | Andon Health Co., Ltd | K030358 |
| KD-525E | Andon Health Co., Ltd | K070395 |
| KD-575 | Andon Health Co., Ltd | K042418 |
| KD-593 | Andon Health Co., Ltd | K070828 |
| KD-595 | Andon Health Co., Ltd | K070828 |
| KD-596 | Andon Health Co., Ltd | K070828 |
| KD-598 | Andon Health Co., Ltd | K070828 |

#### Device description:

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD

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083395

#### 天 津 九 安 医 疗 电 子 股 份 有 限 公 司 Andon Health Co., Ltd.

地址:天津市南开区雅安道金平路 10号华侨创业大厦7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin, China 邮编(P.C.): 300190 传真(Fax): 86-22-6052 6162 【!】(Tel): 86-22-6052 6161 E-mail: [e-mail]

with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.

#### Intended use:

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E. KD-593. KD-595. KD-596, KD-598) is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device.

## Summary comparing technological characteristics with predicate device:

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-675, KD-525E, KD-593, KD-595, KD-596, KD-598) has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD. The modifications that were made are:

(1): Cuff size change into 22cm-48cm from 22cm-30cm.

(2): The Environmental parameters are changed.

The operational range for humidity (<90%) and the storage range for temperature ( - 20-55°C) and for humidity (<95%) of the modified device are all changed from the predict device.

(3): The Cuff Pressure Range change into 0-300mmHg from 20-300 mmHg (only for KD-322, KD-622 and KD-575).

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K083395 \$ 3/3

## 天 津 九 安 医 疗 电 子 股 份 有 限 公 司

Andon Health Co., Ltd. 地址:天津市南开区雅安道金平路 10 号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin. China 邮编(P.C.) 300190 传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-6052 6161 E-mail: [e-mail]

Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.

| FDA file reference number | Predicated Devices |
|-------------------------------|--------------------|
| Technological Characteristics | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Energy used and/or delivered | Identical |
| Where used | Similar |
| Standards met | Identical |
| Electrical safety | Identical |

#### Device testing:

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) meets the following standards:

- · ANSI/AAMI SP-10 standard
- EN60601-1 Medical electrical equipment Part 1: General requirements for safety
- · EN60601-1-2 Electromagnetic Compatibility

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 7 2009

Andon Health Co. Ltd. c/o Ms. Liu Yi No. 31, Changjiang Road, Nankai District Tianjin, P.R. China 300193

Re: K083395

Trade Name: Arm Electronic Blood Pressure Monitor, Models KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596 and KD-598

Regulation Number: 21 CFR 870.1130

Regulation Name: Noninvasive Blood Pressure Measurement System

Regulatory Class: Class II (two)

Product Code: DXN

Dated: February 4, 2009

Received: February 9, 2009

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. Ilsting 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 such 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 - Ms. 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html: --

Sincerely vours.

Mark Teller
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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#### 天 津 九 安 医 疗 电 子 股 份 有 限 公 司

Andon Health Co., Ltd.

地址:天津市南开区雅安道金平路 10号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin, China 邮编(P.C.): 300190 传真(Fax):86-22-60526162 E-mail: [e-mail] 山语(Tel): 86-22-6052 6161

# Statement of Indications for Use

510(k) Number :

083375

Applicant:

Andon Health Co., Ltd

Device name:

## Arm Electronic Blood Pressure Monitor Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598

#### indications for use:

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals 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 ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).

Prescription use Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

YES

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(Please Do Not WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|--|--------------------------------------------|
|--|--------------------------------------------|

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K083395 |