AVITA ARM TYPE BLOOD PRESSURE MONITOR

K112825 · Avita Corporation · DXN · Jan 18, 2012 · Cardiovascular

Device Facts

• Record ID: K112825
• Device Name: AVITA ARM TYPE BLOOD PRESSURE MONITOR
• Applicant: Avita Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 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

The AViTA BPM6x is an arm-type blood pressure monitor for home use. It utilizes an inflatable cuff and an oscillometric sensor to detect arterial pressure oscillations. The device processes these signals to calculate systolic and diastolic blood pressure and pulse rate. It includes an irregular heartbeat detection feature that displays a symbol when detected. The device is operated by the patient; results are displayed on an integrated screen for self-monitoring. The device provides a non-invasive method for tracking blood pressure trends at home, assisting users in managing their cardiovascular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive oscillometric measurement principle. Upper arm cuff (229-330 mm). Digital display. Battery-powered. Embedded firmware for signal processing and irregular heartbeat detection.

Indications for Use

Indicated for adult individuals for the non-invasive measurement of systolic and diastolic blood pressure and pulse rate using an upper arm cuff (229-330 mm circumference). 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

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

Avita (Wujiang) Co., LTD c/o: Ms. Jennifer Reich Harvest Consulting Corp. (USA) 2904 N. Boldt Drive Flagstaff, AZ 86001

JAN 1 8 2012

Re: K112825

Trade Name: Avita arm type blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN (Noninvasive blood pressure measurement system). Dated: 12/15/2011 Received: 12/16/2011

Dear Mrs. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarell by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to conninered proc to May 20, 1978) the excordance with the provisions of the Federal Food, Drug, devices that have been roomsting approval of a premarket approval application (PMA). and Cosmetion recry rece) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, as thing
adulteration. Please note: CDRH does not evaluate information related to contract liability adultcraiton. Treasonote: ODFET assess as that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (300 a0010) inse the major regulations affecting your device can be may be subject to additional controliations, 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 - 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 or any I 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 CI ic Fat 607), abouting (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 11 70 a dos://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/ReportaProblem/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 I ou may other 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.

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Sincerely yours,

Bram D. Zuckerman, M.D.

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

K112825

## Device Name: AViTA BPM6x Series Arm Type Blood Pressure Monitor AViTA Corporation

Indications for Use:

The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 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

V Over-The-Counter Use (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)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K112825 |

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