MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR

K050040 · Mars Medical Products · DXN · Mar 30, 2005 · Cardiovascular

Device Facts

• Record ID: K050040
• Device Name: MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
• Applicant: Mars Medical Products
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate. The device is for adult use only. The device is for use at home or while traveling.

Device Story

MS-753 Mars Inflate-Read Blood Pressure Monitor; noninvasive oscillometric device. Inputs: pressure oscillations from inflatable cuff. Processing: oscillometric algorithm derives systolic/diastolic blood pressure and pulse rate. Output: digital display of BP and pulse. Used by adult patients in home or travel settings. Provides objective BP/pulse data to assist users in monitoring cardiovascular status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Noninvasive oscillometric blood pressure monitor. Uses inflatable cuff for pressure sensing. Digital display. Battery-powered. Class II device (Product Code DXN).

Indications for Use

Indicated for adult patients for noninvasive measurement of systolic and diastolic blood pressure and pulse rate using the oscillometric method. Intended for home or travel use. Over-the-counter 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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Public Health Service

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MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mars Medical Products c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K050040

Trade Name: MS-930 Mars Inflate-Read Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 14, 2005 Received: March 15, 2005

Dear Mr. Smith:

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 interstatc 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, I'DA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. E. J. Smith

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,

Bhimmer for

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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## K050040

## INDICATIONS FOR USE

Applicant: Mars Medical Products Co., Ltd.

K050040 510(k) Number (if known):

Device Name: MS-753 Mars Inflate-Read Blood Pressure Monitor

## Indications For Use:

- 1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. \ The device also measure pulse rate.
- 2. The device is for adult use only.
- The device is for use at home or while traveling. 3.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over the Counter Use__X__

For FDA Use Only

Blummenstor

vision Sign-Off) Division of Cardiovascular Devices 510(k) Number KOD DOYD