MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05

K071960 · Meditech Kft. · DXN · Aug 3, 2007 · Cardiovascular

Device Facts

• Record ID: K071960
• Device Name: MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
• Applicant: Meditech Kft.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Device Story

Meditech ABPM-05 is an ambulatory blood pressure monitor; performs automatic, sequential measurements of systolic/diastolic blood pressure and pulse rate. Device uses oscillometric method with standard upper arm cuff; operation preprogrammed via external software. Used in ambulatory settings; operated by patients under clinical guidance. Output consists of blood pressure and pulse data; used by clinicians to assess cardiovascular status and manage hypertension. Benefits include continuous monitoring outside clinical environment, providing comprehensive blood pressure profile.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Noninvasive blood pressure measurement system; oscillometric sensing principle; uses standard upper arm cuff; software-controlled sequential measurement; Class II device (Product Code DXN).

Indications for Use

Indicated for adult patients requiring ambulatory blood pressure and pulse rate monitoring. Uses standard oscillometric method via upper 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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Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three parallel lines curving upwards, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Meditech Kft. c/o Mr. Benny Arazy Arazy Group - Medical Device Consultants Industrial Park 13 M.P. Misgav 201870 Mizpe Aviv ISRAEL

Re: K071960

Trade/Device Name: Meditech Ambulatory Blood Pressure Monitor, Model ABPM-05 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 17, 2007 Received: July 17, 2007

Dear Mr. Arazy:

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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## Pagc 2 - Mr. Benny Arazy

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Blymmimmoa 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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## Attachment 2

## Indications for Use Statement

K071960

510(k) Number

Device Name Meditech ABPM-05 Ambulatory Blood Pressure Monitor

Indications for The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software.

> The -device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Bhumlema

of Cardlovascular Devices 510(k) Number

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