BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR

K033216 · The Buzz Group, LLC · DXN · May 4, 2004 · Cardiovascular

Device Facts

• Record ID: K033216
• Device Name: BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
• Applicant: The Buzz Group, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: May 4, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.

Device Story

The BZ-576 is an automatic, non-invasive wrist blood pressure monitor designed for home, work, or travel use. It utilizes an oscillometric method with fuzzy arithmetic to measure systolic/diastolic blood pressure and pulse rate. The device consists of a cuff, integrated silicon pressure sensor, electronic pump, electronic valve, microcontroller, and LCD display. The user operates the device via buttons to initiate automated inflation and controlled deflation cycles. The silicon sensor detects cuff pressure and pulse wave components during deflation. The microcontroller processes these signals to calculate blood pressure and pulse values, which are displayed in mmHg or kPa. The device provides a portable, user-friendly solution for frequent self-monitoring of blood pressure, enabling patients to track their cardiovascular health outside of clinical settings.

Clinical Evidence

Bench and user/clinical testing were performed to validate the device. Results indicate the BZ-576 is as safe and effective as the predicate device.

Technological Characteristics

Oscillometric measurement principle; integrated silicon pressure sensor; electronic pump and valve for automated inflation/deflation; microcontroller-based processing; LCD display; battery-powered (4-AA); wrist-worn form factor.

Indications for Use

Indicated for adult patients with arm circumference between 5 and 15 inches for the measurement of systolic and diastolic blood pressure and pulse rate.

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-757 Automatic Blood Pressure Monitor (K001670)

Submission Summary (Full Text)

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## EXHIBIT 2 Summary of Safety and Effectiveness

# The Buzz Group, LLC 420 Lexington Avenue, Suite 2816 New York, NY 10170 Tel: [phone] Fax: [phone] Contact: David Ortiz, President

### 1. Identification of the device Proprietary-Trade Name: Model BZ-576 Automatic Blood Pressure Monitor Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Wrist blood pressure monitor/Body fat meter

#### Equivalent legally marketed devices 2.

This product is similar in function and design to the Omron HEM-757 Automatic Blood Pressure Monitor, K001670

#### 3. Indications for Use (intended use)

Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.

#### Description of the Device 4.

The Model BZ-576 Digital Blood Pressure Monitor uses the oscillometric method with Fuzzy arithmetic for measuring blood pressure, and the high accuracy and repeatability are achieved. The device is ideal for people who frequently monitor their own blood pressure, for its easy way to use at home, at work and during travel. The main components include a cuff, an integrated silicon pressure sensor, an electronic pump, an electronic valve, two buttons, a microcontroller and LCD display. The integrated silicon pressure sensor is used for detecting pressure within the cuff and the pulse wave component during the course of cuff pressure deflation, and guarantees the long period stability. The air pressure of inflation, deflation and rapid release are fully automatic by using an electronic pump and an electronic valve, and a constant deflation speed is controlled in the process of measurement for increasing the accuracy and reducing the measurement time. The blood pressure and pulse values are calculated, and are displayed with "mmHg" or "kPa" on LCD alternatively.

#### Safety and Effectiveness, comparison to predicate device క.

The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices.

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| Designation | Omron HEM-757 Automatic Blood<br>Pressure Monitor, K001670 | Buzz Group BZ-576 |
|---------------------|------------------------------------------------------------|-----------------------------------------------------------------------------|
| Operating Principle | Oscillometric automated blood<br>pressure monitoring | SAME |
| Display | LCD: Systolic, Diastolic, Pulse,<br>Low Batt. | LCD: Systolic, Diastolic, Pulse,<br>Low Batt. (SAME) PLUS date<br>and time. |
| Controls | ON/OFF<br>START<br>M (Memory) | POWER<br>START<br>MEM A<br>MEM B |
| Power supply | 4-AA batteries; AC Adaptor | SAME except no AC Adaptor<br>available |
| External dimensions | Approx. 4.5" L x 7" W x 2.8" H | Approx. 3.8" L x 5.2" W x<br>1.5" H. |
| Memory | 14 measurements | SAME |
| Weight | 19 oz, 530 g. not including<br>batteries | 10.2 oz with batteries (unit)<br>4.4 oz: cuff |
| Accessories | Arm cuff, carrying case,<br>instruction manual | SAME |

### Comparison matrix -- new vs. Predicate device 6.

#### 7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of The Buzz Group that that the "BZ-576" Automated Blood Pressure Monitor is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2004

The Buzz Group, LLC c/o Mr. Daniel Kamm Kamm & Associates PO Box 7007 Deerfield IL 60015

Re: K033216

Trade/Device Name: "BZ-576" Non-invasive Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 30, 2003 Received: October 03, 2003

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 ro(x) [remained is substantially equivalent (for the indications feterenced above and nave determined the marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated to of the Medical Device Americans, or to connineree prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). alla Cosment Act (Act) that to hot require appear a controls provisions of the Act. The You may, therefore, market the devices, bacterements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (\$60 a0070) als. Existing major regulations affecting your device can inay be subject to such additions, 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 I hat FDA has made a determination that your device complics with other requirements of the Act that I DT has made a actual regulations administered by other Federal agencies. You must

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Page 2 – Mr. Daniel Kamm

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 CI IC rate 677, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quant) by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control pro no begin (2001) (2006) 100 marketing your Section 510(k) I mis letter with and w yourse only and inding of substantial equivalence of your device to a legally premaired predicated. The PDF interessification 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 If you desire specific acritories for your as [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 other general 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,

Dma R. Lachner

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

Enclosure

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Page 4 – Mr. Daniel Kamm

Indications for Use

510(k) Number: K033216

Device Name: "BZ-576" Non-Invasive Automatic Blood Pressure Monitor

Indications For Use:

Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number LA33216

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