SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU

K083753 · K-Jump Health Co., Ltd. · DXN · Jun 19, 2009 · Cardiovascular

Device Facts

• Record ID: K083753
• Device Name: SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU
• Applicant: K-Jump Health Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 19, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff. The device is indicated for use with adults. The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

Device Story

Electronic arm blood pressure monitor; uses inflating cuff to measure systolic/diastolic blood pressure and pulse rate. Input: pressure oscillations detected by bellows sensor during cuff deflation. Processing: internal electronics calculate blood pressure and pulse rate; detects irregular pulse patterns. Output: LCD screen displays blood pressure, heart rate, and IPD icon. Used in home or clinical settings; operated by patient or healthcare provider. Provides objective measurements to assist in monitoring cardiovascular health.

Clinical Evidence

Clinical trial performed per AAMI/ANSI SP10 (2002/A1:2003) to verify in vivo measurement accuracy. Results demonstrate accurate measurement of blood pressure and pulse rate.

Technological Characteristics

Electronic blood pressure monitor. Components: inflating cuff, LCD display, bellows sensor, internal air pump, leakage valve, exhaust valve, battery power. Standards: AAMI/ANSI SP10, IEC 60601-1, IEC 60601-1-2, EN61000-4-2, EN61000-4-3.

Indications for Use

Indicated for use in adults to measure systolic and diastolic blood pressure and pulse rate via an arm-cuff. Includes irregular pulse detection (IPD) feature.

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

• Wristwatch BPM Blood Pressure Monitor Model KP-6210 (K-jump Health Co., Ltd.)
• Arm BPM Blood Pressure Monitor Model KP-6821 (K-jump Health Co., Ltd.)
• Arm BPM Blood Pressure Monitor Model KP-6822 (K-jump Health Co., Ltd.)
• Upper Arm Blood Pressure Monitor Model BP-3BT0-AP (MicroLife)

Submission Summary (Full Text)

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# Ko83753

# 510(k) Summary

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Mr. Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

JUN 19 2009

#### Name of Device

Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D

#### Name/Address of Sponsor

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person: Jason Cheng

#### Common or Usual Name

Arm Blood Pressure Monitor

#### Classification Name

Class II § 870.1130; System, Measurement, Blood Pressure, Non-Invasive

#### Predicate Device

- I. K jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model KP-6210.
- II. K-jump Health Co., Ltd.'s Arm BPM Blood Pressure Monitor Model KP-6821 and KP-6822.
- III. MicroLife's Upper Arm Blood Pressure Monitor Model BP-3BT0-AP.

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## Intended Use/Indications for Use

The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff. The device is indicated for use with adults.

The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

#### Technological Characteristics

The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.

#### Performance Data

The Arm Blood Pressure Monitor Model KP-7500 and KP-7500D complies with the following FDA recognized consensus standards, to the extent that these standards are applicable to this device:

- AAMI/ANSI SP10 (2002 / A1:2003); .
- IEC 60601-1 (1988); and �
- IEC 60601-1-2 (2002). .

The KP-7500 and KP-7500D also complies with the following additional

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standards:

- . EN61000-4-2 (1995); and
- EN61000-4-3 (2002). .

In accordance with AAMI/ANSI SP10, a clinical trial also was performed to verify the accuracy of in vivo measurement. The results demonstrate that the KP-7500 and KP-7500D accurately measures the patient's blood pressure and pulse rate.

#### Substantial Equivalence

The KP-7500 and KP-7500D have the same intended use and indications for use as K-Jump's Arm Blood Pressure Monitor Model KP-6210, K-Jump's Wristwatch Blood Pressure Monitor Model KP-6821 and MicroLife's Model BP-3BT0-AP.

The KP-7500 has the same technological characteristics as the KP-6210 except: (1) that the KP-7500 uses a bellows sensor; and (2) the KP-7500 is used on the upper arm rather than on the wrist.

The KP-7500D has the same technological characteristics as the KP-6821 except: (1) that the KP-7500D uses a bellows sensor; and (2) the KP-7500D displays blood pressure and heart rate on the same screen simultaneously rather than on subsequent, alternating screens.

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Microlife's Model BP-3BT0-AP also uses a bellows sensor same as the KP-7500 and KP-7500D. Both devices include an irregular pulse detection function.

Thus, the minor differences between the KP-7500, KP-7500D and the predicate devices are not new technological characteristics for arm blood pressure monitors. The modification of the device's LCD display was made for user convenience. Therefore, these minor technological differences do not raise any new questions of safety or effectiveness. Accordingly, the KP-7500 and KP-7500D are substantially equivalent to its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and professional, reflecting the department's role in public health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2009

K-jump Health Co., Ltd. c/o Mr. Jason Cheng Regulatory Affairs No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien 248 Taiwan

Re: K083753

> Trade/Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 12, 2009 Received: June 16, 2009

Dear Mr. Cheng:

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 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 - Mr. Jason Cheng

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

or 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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# Indications for Use Statement

510(k) Number (if Known): K083753

Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D

Indication for Use:

The KP-7500 and KP-7500D are intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. It is indicated for use in adults.

The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

Prescription Use -------(Per 21 C.F.R. 801.109) -Over-The-Counter-Use-X-(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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-OR-

of Cardiovascula

510(k) Number K 08373