AVITA WRIST TYPE BLOOD PRESSURE MONITOR

K102624 · Avita Corporation · DXN · Dec 16, 2010 · Cardiovascular

Device Facts

• Record ID: K102624
• Device Name: AVITA WRIST TYPE BLOOD PRESSURE MONITOR
• Applicant: Avita Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

Device Story

Wrist-worn oscillometric blood pressure monitor; measures systolic/diastolic pressure and pulse rate. Input: pressure oscillations detected at wrist via cuff. Processing: oscillometric algorithm calculates blood pressure values and detects irregular heartbeats. Output: digital display of blood pressure and pulse rate; irregular heartbeat indicator. Used in home setting by adult patients. Provides objective data for patient self-monitoring of cardiovascular status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; wrist-cuff form factor; battery-powered; digital display. Intended for wrist circumferences 125-210 mm.

Indications for Use

Indicated for adults with wrist circumference 125-210 mm for automatic measurement of systolic/diastolic blood pressure and pulse rate via oscillometric method. Intended for home use.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

DEC 1 6 2010

AVITA Corporation c/o Ms. Jennifer Reich Harvest Consulting Corporation 2904 N. Boldt Drive Flagstaff, AZ 86001

Re: K102624

> Trade/Device Name: AViTA BPM1x Series Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 07, 2010 Received: December 13, 2010

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 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 - A V iTA Corporation c/o 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

510(k) Number (if known): K102624

## Device Name: AViTA BPM1x series Wrist Type Blood Pressure Monitor AViTA Corporation

Indications for Use:

The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

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)

W. Wood

diovascular Devices

510(k) Number 102624

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