DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11

K014141 · Digibio Technology Corp. · DXN · Sep 13, 2002 · Cardiovascular

Device Facts

• Record ID: K014141
• Device Name: DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
• Applicant: Digibio Technology Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.

Device Story

DIGIBIO Digital Blood Pressure Monitor Model D11 is an oscillometric device for non-invasive blood pressure and pulse rate measurement. Designed for over-the-counter use, the device utilizes an inflatable arm cuff to detect arterial pressure oscillations. The internal system processes these signals to calculate systolic and diastolic blood pressure values and pulse rate, displaying results on an integrated screen. The device is intended for patient self-monitoring in home or clinical settings to assist in tracking cardiovascular health metrics.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate technology.

Technological Characteristics

Oscillometric non-invasive blood pressure measurement system. Includes inflatable arm cuff, pressure sensor, and digital display. Operates via electronic signal processing of arterial oscillations. Class II device (Product Code DXN).

Indications for Use

Indicated for noninvasive measurement of systolic and diastolic blood pressure and pulse rate in adults via 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SFP 1 3 2002

Digibio Technology Corporation c/o Eric Luo, Ph.D. 6833 Saint Lawrence Street Plano, TX 75024

Re: K014141

Trade Name: DIGIBIO Digital Blood Pressure Monitor Model D11 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 17, 2002 Received: June 18, 2002

Dear Dr. Luo:

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 – Eric Luo, Ph.D.

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,

J. Odlaten

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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510(k) Number (if known):

Device Name: DIGIBIO Digital Blood Pressure Monitor Model D11

Indications For Use:

DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

y. Oelatin
on of Cardiovascular & Respiratory Devices

Division of Cardiovascular & Respiratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)