ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I

K021225 · Rossmax International , Ltd. · DXN · May 22, 2002 · Cardiovascular

Device Facts

• Record ID: K021225
• Device Name: ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")

Device Story

Rossmax Automatic Blood Pressure Monitor (CardioCare 1000i) is an oscillometric device for non-invasive blood pressure and pulse rate measurement. Intended for over-the-counter use by adult patients. Device uses an inflatable cuff to detect arterial pressure oscillations; internal processor calculates systolic/diastolic blood pressure and pulse rate from these signals. Output displayed on integrated screen for patient review. Facilitates home monitoring of cardiovascular status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; electronic automated system; intended for arm circumference 22-32 cm; Class II device (Product Code DXN).

Indications for Use

Indicated for adult consumers with arm circumference 22-32 cm for measurement of systolic/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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

d and Drug Administration 00 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Mr. Michael Yeh Managing Director Rossmax International Ltd. 12F., No. 189, Kang Chien Road Taipei 114 TAIWAN

Re: K021225

Trade Name: Rossmax Automatic Blood Pressure Monitor, Model CardioCare 1000i Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2002 Received: May 6, 2002

Dear Mr. Yeh:

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.

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## Page 2 - Mr. Michael Yeh

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dan V. Telleh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT

| Indications for Use Statement | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K021225 |
| Device Names: | Rossmax Automatic Blood Pressure Monitor, model<br>CardioCare 1000i |
| Indications For Use: | The blood pressure monitor is used to measure systolic,<br>diastolic, and pulse rates in adult consumers with arm<br>circumference between 22 cm to 32 cm (8.7" to 12.6") |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021225

Prescription Use______________________________________________________________________________________________________________________________________________________________

or

Over-the-counter use X