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

K012636 · Vsm Technology, Inc. · DXN · Oct 26, 2001 · Cardiovascular

Device Facts

• Record ID: K012636
• Device Name: BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
• Applicant: Vsm Technology, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BpTRU: - Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older. - age of officials' offices, nursing units, and patient care areas of ● hospitals.

Device Story

BpTRU Automated Non-Invasive Blood Pressure Monitor (BPM-100) measures systolic/diastolic blood pressure and pulse rate. Device intended for use in clinical environments (hospitals, nursing units, physician offices). Operates via automated non-invasive oscillometric measurement. Provides digital output of blood pressure and pulse rate to healthcare providers for clinical assessment. Benefits include automated, standardized blood pressure monitoring in clinical settings.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor. Class II device (Product Code DXN).

Indications for Use

Indicated for measuring systolic/diastolic blood pressure and pulse rate in patients 3 years of age or older in clinical settings including hospitals, nursing units, and physician offices.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2001

Mr. Darvl Wisdahl Director of Regulatory Affairs and Clinical Research VSM MedTech Ltd. 15th Floor, 675 West Hastings Street Vancouver, BC Canada V6B 1N2

Re: K012636

Trade Name: BpTRU 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: August 10, 2001 Received: August 13, 2001

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.

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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,

Della Tek

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2.2. Indications for Use Statement

| 510(k) Number: | K012636 |
|----------------------|-----------------------------------------------------|
| Device Name: | BpTRU Automated Non-Invasive Blood Pressure Monitor |
| Model Name: | BPM-100 |
| Indications For Use: | |

The BpTRU:

- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
- age of officials' offices, nursing units, and patient care areas of ● hospitals.

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

Prescription Use (Per 21 CFR 801.109)

OR

## Over-The-Counter USE

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K02636

August 10, 2001