BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211

K022916 · K-Jump Health Co., Ltd. · DXN · Nov 21, 2002 · Cardiovascular

Device Facts

• Record ID: K022916
• Device Name: BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
• Applicant: K-Jump Health Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The K-jump's SmartlogiC models KP-6210 and KP-6211 are intended to be used for the measurement of the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff that is wrapped around the wrist. The devices are indicated for use in adults.

Device Story

Electronic blood pressure monitor; wrist-worn inflating cuff; measures systolic/diastolic pressure and pulse rate. Operates during cuff inflation; data processed to determine blood pressure values; results displayed on integrated LCD screen. Used by adults in home or clinical settings. Provides objective blood pressure readings to assist users and healthcare providers in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI SP10A-1996, EN 60601-1-2 (1993), CISPR11 (1993) Class B, IEC 801-2 (1991), and IEC 801-3 (1984) standards.

Technological Characteristics

Electronic blood pressure monitor; LCD display; wrist-worn inflating cuff. Measurement principle: oscillometric (during inflation). Standards: AAMI/ANSI SP10A-1996, EN 60601-1-2, CISPR11, IEC 801-2, IEC 801-3.

Indications for Use

Indicated for use in adults for the non-invasive measurement of systolic blood pressure, diastolic blood pressure, and pulse rate using a wrist-worn inflating cuff.

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

• K-jump Health Co., Ltd. Wristwatch BPM model KP-6120
• Rossmax International Co., Ltd. SmartInflate CardioPro model 1000i and model 3000i

Submission Summary (Full Text)

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# 510(k) Summary

Kozz916

# K-JUMP'S MODELS KP-6210 AND KP-6211

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

Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan 248 Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

T.T. Lin, Director Contact Person:

September 2, 2002 Date Prepared:

## Name of Device and Name/Address of Sponsor

Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan 248 Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

# Common or Usual Name

Blood Pressure Monitor

## Classification Name

System, Measurement, Blood Pressure, Non-Invasive

## Predicate Devices

- I. K-jump Health Co., Ltd. Wristwatch BPM model KP-6120
- II. Rossmax International Co., Ltd. SmartInflate CardioPro model 1000i and model 3000i

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### Intended Use

The K-jump's SmartlogiC models KP-6210 and KP-6211 are intended to be used for the measurement of the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff that is wrapped around the wrist. The devices are indicated for use in adults.

#### Technological Characteristics

The devices are electronic blood pressure monitors with LCD displays. The devices were designed to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff. K-jump's models KP-6210 and KP-6211 have the same intended use and fundamental scientific technology as the previously cleared model KP-6120. The primary changes are: (1) the systolic, diastolic blood pressure, and pulse rate are measured during deflation of the cuff in cleared model KP-6120 and during inflation of the cuff in new models KP-6211 and KP-6210; (2) all of the readings are displayed on subsequent screens of the LCD display in cleared model KP-6120 and on one LCD screen in new models KP-6211 and KP-6210; and (3) small differences in their blood pressure measurement ranges, operational temperature and humidity, storage temperature and humidity, and number of memories.

#### Performance Data

The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 comply with EN 60601-1-2 (1993); CISPR11 (1993) Class B; IEC 801-2 (1991); IEC 801-3 (1984); and the AAMI/ANSI SP10A-1996.

#### Substantial Equivalence

The devices are substantially equivalent to K-jump's Wristwatch Blood Pressure Monitor model KP-6120 and Rossmax SmartInflate CardioPro model 1000i and model 3000i. The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 have the same intended use and similar indications and principles of operation. With the exception of small differences in their blood pressure measurement ranges, operational temperature and humidity, storage temperature and humidity, and number of memories, models KP-6211 and KP-6210 are technologically identical to their predicate devices, K-jump's Wristwatch Blood Pressure Monitor model KP-6120 and Rossmax SmartInflate CardioPro model 1000i and model 3000i. The minor technological differences do not raise any new issues of safety or effectiveness. Models KP-6120, KP-6210, and KP-6211 all share the same intended use and operate using the same fundamental technology.

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Furthermore, the devices comply with the AAMI/ANSI SP10A-1996 standard in its entirety. Thus models KP-6210 and KP-6211 are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2002

K-jump Health Co., Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth St., N.W. Washington, DC 20004-1109

Re: K022916

Trade Name: Blood Pressure Monitor SmartlogiC Models KP-6210 and KP-6211 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 24, 2002 Received: October 24, 2002

#### Dear Mr. Kahan:

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. Jonathan S. Kahan, Esq.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

L

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 Form

Ko 279 (6 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

# Device Name: Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211

Indications for Use:

The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 are intended to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff. The devices are indicated for use in adults.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | 4022916 |
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| Prescription Use<br>(Per 21 C.F.R. § 801.109) | OR | Over-The-Counter Use. <span style="text-decoration: overline;">✓</span> |
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(Optional Format 1-2-96)

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