AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY

K033397 · Avita Corporation · DXN · Apr 9, 2004 · Cardiovascular

Device Facts

• Record ID: K033397
• Device Name: AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
• Applicant: Avita Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

AVITA BPM6 series Blood Pressure Meter is intended to measure human begins Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only.

Device Story

Device measures systolic/diastolic blood pressure and pulse rate via oscillometric method; utilizes arm cuff for data input. Operates as standalone monitor with LCD output for user. Intended for adult use; suitable for over-the-counter settings. Provides digital readout of vital signs to assist users in monitoring cardiovascular status.

Clinical Evidence

Clinical repeatability validated via comparison study against auscultatory method. Device conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Oscillometric measurement principle; LCD display; arm cuff interface. Conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2 standards.

Indications for Use

Indicated for noninvasive measurement of systolic, diastolic blood pressure, and pulse rate in adults using an arm 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-757 Blood Pressure Monitor (K001670)

Submission Summary (Full Text)

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APR - 9 2004

## 510(K) SUMMARY

K033397 p112-

This summary of 510(k) safety and effectiveness information is being submitted in accordance in with the requirements of SMDA and 21 CFR §807.92

| 1.0 | Submitter's Name: | AVITA Corp |
|-----|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County,<br>Taiwan, R.O.C. |
| | Phone: | 001-886-2-85121568 |
| | Fax: | 001-886-2-85121347 |
| | Contact: | Mr. Geo Lin, General Manager |
| 2.0 | Device Name: | AVITA BPM6 series Blood Pressure Meter(or Monitor) |
| | Model No.: | BPM6XY (X= 0 or 1 , Y=1,2 or 3)<br>The first Character (X= 0 or 1 ) represents for type of case housing.<br>The second Character (Y=1,2 or 3 ) represents for type of product specification. |
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | AVITA BPM6 series Blood Pressure Meter(or Monitor) has similar general design with OMRON HEM-757 Blood Pressure<br>Monitor(K001670) marketed by Omron Healthcare, Inc.. |
| 5.0 | Device Description: | AVITA BPM6 series Blood Pressure Meter(or Monitor) is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual). |
| 6.0 | Intended Use: | AVITA BPM6 series Blood Pressure Meter is intended to measure human begins Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only. |
| 7.0 | Performance Summary: | In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements. A comparison study with device that use auscultatory method was performed to validate the performance of the AVITA BPM6 series Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM6 series Blood Pressure Meter is statistically and clinically acceptable. |

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## Conclusions: 8.

o. "Conclusione:
The AVITA BPM6 series Blood Pressure Meter have the same intended use and similar mle AVTA Blance 21000 Bress 21000
technological characteristics as OMRON HEM-757 Blood Pressure Monitor(K001670) technological characteristions as Chitter Contained in this submission and mailkeled by Official realthours, mon more connological characteristics do
clinical testing supplied demonstrate that any differences in the same of the st cifical testing supplied demonstrate that any and the AVITA BPM6 series Blood not raiso and not is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AVITA Corporation c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

Re: K033397

Trade Name: AViTA BPM6 Series Blood Pressure Meter (Monitor) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Received: March 02, 2004

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

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/dsma/dsmamain.html

Sincerely yours,

Dana R. Lo Jones

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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Page 4 - Ms. Jennifer Reich

## Indications for Use

510(k) Number: K033397

Device Name: Avita BPM6 Series Blood Pressure Meter (or Monitor)

Indications For Use:

The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.

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)

Duna R. Lochner

(Division 3) - Jil) Division of Cardiovascular Devices

510(k) Number_K033399