A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE

K992808 · A&D Medical Div. · DXN · Sep 1, 1999 · Cardiovascular

Device Facts

• Record ID: K992808
• Device Name: A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
• Applicant: A&D Medical Div.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The models TM-2430 and TM-2431 will be referred to as TM-2430/31 except where specific differences occur. The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.

Device Story

Ambulatory blood pressure monitors (TM-2430/31) designed for clinical or home use; patient-worn device. Inputs: oscillometric pressure signals from cuff. Operation: automated inflation/deflation cycles; signal processing to derive systolic/diastolic blood pressure and pulse rate. Output: digital display of blood pressure and pulse values. Healthcare providers use data for hypertension management and diagnostic assessment. Benefits: enables long-term blood pressure tracking outside clinical settings, providing comprehensive cardiovascular data for clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Oscillometric blood pressure measurement principle. Ambulatory form factor. Battery-powered. Software-based signal processing for pressure oscillation analysis.

Indications for Use

Indicated for monitoring systolic/diastolic blood pressure and pulse rate in adults aged 18 years and older using the oscillometric method.

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

Public Health Service

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## SEP 1 19999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A&D Medical Division c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K992808 A&D Medical TM-2430 and TM 2431 Ambulatory Blood Pressure Monitors Requlatory Class: II (Two) Product Code: 74 DXN Dated: Auqust 19, 1999 Received: Auqust 20, 1999

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert Mosenkis

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aug-31-99 08:28A A&D Service

K 992808 510(k) Number (if known): __

Device Name: IM-2430 and TM-2431 Ambulatory Blood Pressure Monitors

Or

## Indications for Use:

The models TM-2430 and TM-2431 will be referred to as TM-2430/31 except where specific differences occur. The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ਮ Over-The-Counter Use

(Optional Format 1-2-96)

Sue K. Campbell

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ 14992808