AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

K994423 · Vsm Medtech , Ltd. · DXN · Mar 28, 2000 · Cardiovascular

Device Facts

• Record ID: K994423
• Device Name: AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
• Applicant: Vsm Medtech , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BPM-100: - Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age. - Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.

Device Story

BPM-100 is an automated non-invasive blood pressure monitor; measures systolic/diastolic blood pressure and pulse rate. Used in clinical environments (physicians' offices, hospitals) by healthcare professionals. Device utilizes oscillometric measurement principle; processes pressure signals to derive blood pressure and heart rate values. Output displayed for clinician review to assist in patient monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Automated non-invasive blood pressure monitor; oscillometric measurement principle; intended for clinical use; dimensions/form factor not specified; software-based signal processing.

Indications for Use

Indicated for adults >18 years for measurement of systolic/diastolic blood pressure and pulse rate. Intended for use in clinical settings including physicians' offices, nursing units, and hospital patient care areas.

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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**MAR 2 8 200**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VSM Medtech Ltd. c/o Mr. Howard M. Holstein Hogan and Hartson, L.L.P. 555 13th Street NW Washington, DC 20004-1109

Re : K994423 Automated Non-Invasive Blood Pressure Monitor, Model BPM-100 Requlatory Class: II (two) Product Code: 74 DXN December 24, 1999 Dated: Received: December 29, 1999

Dear Mr. Holstein:

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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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. Howard M. Holstein

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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

for James E. Dillard III
Director

Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VSM Technology Inc.

## 2.2. INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K994423 |
|----------------|---------|
|----------------|---------|

Device Name: Automated Non-Invasive Blood Pressure Monitor

Model Name: BPM-100

Indications For Use:

The BPM-100:

- Measures systolic and diastolic blood pressure and pulse rate in adults greater than ● 18 years of age.
- ls intended for use in physicians' offices, nursing units, and patient care areas of . hospitals.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

## Over-The-Counter USE

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Aere L. Lamper Q

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

510(k) Number K994423