GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100

K022926 · Genteel Technology Co., Ltd. · DXN · Jun 6, 2003 · Cardiovascular

Device Facts

• Record ID: K022926
• Device Name: GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
• Applicant: Genteel Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

GENTEEL BP-100 Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate(heart rate) by using an inflating cuff which is wrapped around the wrist. The Device is indicated for use by people over 15 age old in home use.

Device Story

Wrist-worn digital blood pressure monitor; measures systolic/diastolic blood pressure and pulse rate. Input: oscillometric pressure signals from wrist cuff inflation/deflation. Operation: automated inflation/deflation cycle; signal processing to determine blood pressure values. Output: digital display of systolic, diastolic, and pulse rate on LCD panel. Used in home setting by patients. Healthcare providers use output for monitoring blood pressure trends and clinical decision-making. Benefits: enables convenient, non-invasive self-monitoring of cardiovascular metrics.

Clinical Evidence

Clinical comparison study performed against auscultatory method. Study validated clinical repeatability of the device. Results demonstrated statistically and clinically acceptable performance.

Technological Characteristics

Wrist-worn digital blood pressure monitor. Oscillometric measurement principle. Conforms to EN-1060-3, ANSI/AAMI SP-10, and IEC 60601-1-2 standards. LCD display output. Battery-powered.

Indications for Use

Indicated for individuals over 15 years of age for home use to measure systolic and diastolic blood pressure and pulse rate via 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

• OMRON HEM-608 Wrist Blood Pressure Monitor

Reference Devices

• OMRON HEM-600 Wrist Blood Pressure Monitor

Submission Summary (Full Text)

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## K022926 S-10 K summ with the requirements of SMDA and 21 CFR §807.92

.IIIN = 6 2003

| 1.0 | Submitter's Name: | GENTEEL TECHNOLOGY CO., LTD. |
|------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 3F, No. 23, Sec. 2, Chung-Hsiao E. Rd., Taipei, Taiwan, R.O.C. |
| | Phone: | 001-886-2-23917311 |
| | Fax: | 001-886-2-23916335 |
| | Contact: | Mr. Deng-Jeng Chou, President |
| 2.0 Device Name: | | GENTEEL BP-100 Wrist Blood Pressure Monitor |
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | GENTEEL BP-100 Wrist Blood Pressure Monitor has similar<br>general design with OMRON HEM-608 Wrist Blood Pressure<br>Monitor marketed by Omron Healthcare INC. |
| 5.0 | Device Description: | GENTEEL BP-100 Wrist Blood Pressure Monitor is designed<br>to measure the systolic and diastolic blood pressure, and pulse<br>rate(heart of an individual). |
| 6.0 | Intended Use: | GENTEEL BP-100 Wrist Blood Pressure Monitor is intended to<br>measure the systolic and diastolic blood pressure, and pulse<br>rate(heart rate) by using an inflating cuff which is wrapped around<br>the wrist. The Device is indicated for use by people over 15 age old<br>in home use. |
| 7.0 | Performance Summary: | In terms of operating specification, Safety & EMC requirements, the<br>device conforms to applicable standards included EN-1060-3,<br>ANSI/AAMI SP-10 and IEC 60601-1-2 requirements<br>A comparison study with device that use auscultatory method was<br>performed to validate the performance of the GENTEEL BP-100<br>Wrist Blood Pressure Monitor. The comparison study<br>demonstrated that the clinical repeatability of GENTEEL BP-100<br>Wrist Blood Pressure Monitor is statistically and clinically<br>acceptable. |

## 8. Conclusions:

The GENTEEL BP-100 Wrist Blood Pressure Monitor have the same intended use and similar technological characteristics as OMRON HEM-600 Wrist Blood Pressure Monitor marketed by Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the GENTEEL BP-100 Wrist Blood Pressure Monitor is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

Genteel Technology Co., Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

K022926 Re:

> Trade Name: Genteel Wrist Digital Blood Pressure Monitor Model No. BP-100 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 11, 2003 Received: March 17, 2003

Dear Ms. Reich:

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.

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

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## Page 2 - Ms. Jennifer Reich

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/dsma/dsmamain.html

Sincerely yours,

DaLatTe

ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NUMBER (IF KNOWN): 510 (k)

GENTEEL BP-100 Wrist Blood Pressure Monitor DEVICE NAME: genteel technology co., Ltd.

INDICATIONS FOR USE:

The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.

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Concurrence of CDRH, Office of Device Evaluation Over-The-Counter OR Prescription Use (Optional Format) (Per 21 CFR 801.109)

510(k) Number K022926