BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200

K023055 · Vsm Medtech , Ltd. · DXN · Oct 22, 2002 · Cardiovascular

Device Facts

• Record ID: K023055
• Device Name: BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
• Applicant: Vsm Medtech , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BpTRU BPM-200: Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older. Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.

Device Story

BpTRU BPM-200 is a portable, automated, non-invasive blood pressure monitor. Device uses upper arm cuff to measure blood pressure and pulse rate via oscillometric technique. Operates in two modes: Manual (single measurement) and Automatic (six measurements, discards first, averages remaining five). Features include internal rechargeable battery, USB connectivity, and mounting options (wall, roll-stand, tabletop). Used in clinical environments by healthcare professionals. Output displayed for clinician review to assist in patient assessment and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance similarities to the predicate device.

Technological Characteristics

Oscillometric non-invasive blood pressure measurement. Portable form factor with internal rechargeable battery and USB connectivity. Supports wall, roll-stand, or tabletop mounting. Software-controlled automated inflation/deflation cycles.

Indications for Use

Indicated for subjects 3 years of age or older for measurement of systolic/diastolic blood pressure and pulse rate in clinical settings (physicians' offices, nursing units, hospitals).

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.

Predicate Devices

• VSM Technology BpTRU™ Automated Non-Invasive Blood Pressure Monitor (Model BPM-100) (K994423, K002046, K012636)

Submission Summary (Full Text)

{0}------------------------------------------------

# 2.3. 510(K) Summary of Safety and Effectiveness

OCT 2 2 2002

#### Submitter:

VSM MedTech Ltd. 15th Floor, 675 West Hastings Street Vancouver, BC V6B 1N2 CANADA

## Company Contact:

Daryl Wisdahl Director of Regulatory Affairs and Clinical Research Phone: [phone] Fax: [phone]

#### Regulatory Identification:

| Device Name: | BpTRUTM Portable Automated Non-Invasive Blood Pressure Monitor |
|-----------------------------------------------------|----------------------------------------------------------------|
| Model Name: | BPM-200 |
| Device Classification Name: | System, measurement, blood-pressure, non-invasive |
| Device Class: | II |
| Regulation Numbers: | CFR 870.1130 |
| Panel: | Circulatory System Device Panel (74) |
| Product Code: | DXN |
| Classification Advisory Committee: | Cardiovascular |
| Establishment Registration Number (Owner/Operator): | 9034609 |

#### Predicate Device Information:

VSM Technology BpTRU™ Automated Non-Invasive Blood Pressure Monitor (Model BPM-100) as cleared by K994423, K002046 and K012636.

September 12, 2002

{1}------------------------------------------------

## Device Description:

The BpTRU Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200) is a portable automated, non-invasive blood pressure monitor designed to measure the blood pressure and pulse rate of patients using an upper arm cuff. The device uses a standard blood pressure cuff to measure the blood pressure in the upper arm. The device automatically inflates and deflates the cuff, and uses the oscillometric technique to calculate systolic and diastolic blood pressure.

The BPM-200 has two blood pressure operational modes: Manual and Automatic. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Individual readings are stored and can be reviewed in both Manual and Automatic Modes.

The BPM-200 can be operated while mounted to a wall, attached to a roll-stand or self-standing on the tabletop. The new device includes an internal rechargeable battery and features USB connectivity.

#### Description of Modification:

The BPM-200 is an extension of the BpTRU family of NIBP devices, and as such the existing BPM-100 has been modified to create the BPM-200. The modifications include the addition of battery operation, USB connectivity, and provisions for polemounted and self-standing operation.

#### Indications for Use:

The BpTRU:

- . Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older
- Is intended for use in physicians' offices, nursing units, and patient care areas . of hospitals.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that suggest the shape of a head, body, and tail.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VSM MedTech Ltd. c/o Mr. Daryl Wisdahl Director of Regulatory Affairs and Clinical Research 15th Floor, 675 West Hastings Street Vancouver, BC V6B 1N2 CANADA

Re: K023055

Trade Name: BpTRU™ Portable Automated Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 10, 2002 Received: October 11, 2002

Dear Mr. Wisdahl:

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.

{3}------------------------------------------------

## Page 2 -- Mr. Daryl Wisdahl

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,

Megan Magner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## 2.2. Indications for Use Statement

| 510(k) Number: | K02-3055 |
|----------------|----------------------------------------------------------------|
| Device Name: | BpTRUTM Portable Automated Non-Invasive Blood Pressure Monitor |
| Model Name: | BPM-200 |

Indications For Use:

# The BpTRU BPM-200:

- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- Is 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 |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

Utefane Mynul for BDZ

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K023655 |
|---------------|---------|
|---------------|---------|

September 12, 2002