BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR

K023078 · Vsm Medtech , Ltd. · DXN · Mar 21, 2003 · Cardiovascular

Device Facts

• Record ID: K023078
• Device Name: BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR
• Applicant: Vsm Medtech , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BpTRU is intended to: - measure systolic and diastolic blood pressure and pulse rate in subjects - measure systolic blood pressure in the range of 60 to 250 mmHg. ● - measure diastolic blood pressure in the range of 40 to 160 mmHg. ● - measure pulse rate in the range of 40 to 200 beats per minute. . - measure temperature in the range of 28°C to 43°C (82.4°F to 109.4°F) for ● Continuous (Monitoring) Measurements and 35°C to 39°C (95.0 to 102.2°F) for Predictive (Single) Measurements. - be operated by physicians, nurses, or other qualified medical personnel. ● - be used in physicians' offices, nursing units, and patient care areas of . hospitals. - . be pole-mounted, wall-mounted or used on a table top. - be battery or mains operated. . - be connected to a PC via a USB port for data interchange. .

Device Story

BPM-300 is an automated, non-invasive vital signs monitor; measures blood pressure (BP) and pulse rate via upper arm cuff; measures temperature via oral, axillary, or rectal thermometry probes. BP measurement uses oscillometric technique; features Manual mode (single reading) and Automatic mode (six measurements, discards first, averages remaining five). Temperature measurement uses negative temperature coefficient thermistor probes; features Continuous mode (monitoring) and Predictive mode (15-second calculation). Device is portable (battery-powered) or mains-operated; includes USB port for PC data interchange. Operated by physicians, nurses, or qualified medical personnel in clinical settings. Output displayed for clinician review to support patient assessment and clinical decision-making.

Clinical Evidence

Bench testing performed for blood pressure per AAMI/ANSI SP10:1992 and continuous temperature per ASTM E1112-00. Predictive temperature feature validated via clinical study comparing predictive measurements to continuous temperature measurements, demonstrating accuracy.

Technological Characteristics

Non-invasive oscillometric BP monitor; electronic thermometry using negative temperature coefficient thermistor. Stainless steel probes with santoprene handles; ethylene methyl acrylate copolymer probe covers. Battery or mains powered; USB connectivity. Tested to AAMI/ANSI SP10:1992 and ASTM E1112-00.

Indications for Use

Indicated for measuring systolic/diastolic blood pressure, pulse rate, and temperature in subjects 3 years of age or older. Intended for use in 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.

Predicate Devices

• BpTRU Automated Non-Invasive Blood Pressure Monitor (Model BPM-100) (K994423, K002046, K012636)
• Tycos Instruments Clinical Vital Signs Monitor, Model #52STP-E (K951193)

Submission Summary (Full Text)

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

## 510(K) Summary of Safety and Effectiveness

#### Submitter:

MAR 21 2003

13

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]

K0230

### Regulatory Identification:

| Device Names: | (1) BpTRU Vital Signs Monitor<br>(2) BpTRU Portable Automated Non-Invasive Blood Pressure and<br>Temperature Monitor | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Model Name: | BPM-300 | |
| Device Classification Name: | System, measurement, blood-pressure, non-invasive<br>Thermometer, electronic, clinical | |
| Device Class: | II | |
| Regulation Numbers: | CFR 870.1130 / 880.2910 | |
| Panel: | Circulatory System Device Panel (74) / General Hospital (80) | |
| Product Code: | DXN / FLL | |
| Classification Advisory Committee: | Cardiovascular / General Hospital | |
| 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

Tycos Instruments Clinical Vital Signs Monitor, Model #52STP-E as cleared by K951193.

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

2/3

## Device Description:

The BPM-300 is an automated, non-invasive blood pressure and temperature monitor that measures the blood pressure and pulse rate of patients using an upper arm cuff and the oral, axillary and rectal temperature using thermometry probes. The device uses standard blood pressure cuffs normally used in auscultation to measure the blood pressure in the upper arm. The device also uses stainless steel temperature probes, which are similar to design to commercially available probes from YSI, to measure the temperature from the oral, axillary and rectal regions.

The BPM-300 has two blood pressure operational modes: Manual and Automatic, which are used with the oscillometric technique to calculate systolic and diastolic blood pressure. 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. Readings can be reviewed in both Manual and Automatic Modes.

The BPM-300 includes two temperature measurement modes: Predictive and Continuous. Continuous Mode is designed to be used for taking extended length, monitoring measurements from the oral, axillary or rectal regions of the body. Predictive Mode is designed to calculate a single, quick (15 second) and accurate temperature measurement from either the oral or axillary region. There are two different color-coded temperature probes available for the BPM-300: oral/axillary (blue probe) and rectal (red probe). These temperature probes, which are manufactured for VSM by Yellow Springs Inc., also include the additional safety of a disposable probe cover, manufactured for VSM by Banta Healthcare.

The BPM-300 incorporates a battery, which allows for portable operation, a polemounting feature and computer/interface connectivity feature, through a USB port.

### Indications for Use:

The BpTRU Vital Signs Monitor (Model BPM-300):

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

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

# Intended Use:

The BpTRU is intended to:

- measure systolic and diastolic blood pressure and pulse rate in subjects .
- measure systolic blood pressure in the range of 60 to 250 mmHg. ●
- measure diastolic blood pressure in the range of 40 to 160 mmHg. ●
- measure pulse rate in the range of 40 to 200 beats per minute. .
- measure temperature in the range of 28°C to 43°C (82.4°F to 109.4°F) for ● Continuous (Monitoring) Measurements and 35°C to 39°C (95.0 to 102.2°F) for Predictive (Single) Measurements.
- be operated by physicians, nurses, or other qualified medical personnel. ●
- be used in physicians' offices, nursing units, and patient care areas of . hospitals.
- . be pole-mounted, wall-mounted or used on a table top.
- be battery or mains operated. .
- be connected to a PC via a USB port for data interchange. .

# Technological Characteristics:

The blood pressure functionality of the BPM-300 has the equivalent technological characteristics as the predicate device [BpTRU Automated Non-Invasive Blood Pressure Monitor (Model BPM-100)].

The sensor used with the temperature probe is a negative temperature coefficient thermistor. The sensor is mounted within a stainless steel probe.

The temperature probes have a stainless steel shaft with a santoprene handle and a polyurethane-coated coiled cable. They are manufactured for VSM by YSI Incorporated. (Refer to Appendix B.)

The temperature probe covers are manufactured from ethylene methyl acrylate copolymer film. They are manufactured for VSM by Banta Healthcare. (Refer to Appendix C.)

# Testing:

The blood pressure feature of the BPM-300 was tested and meets the requirements of AAMI/ANSI SP10: 1992 (Electronic or automated sphygmomanometers).

The continuous temperature feature of the BPM-300 was tested and meets the requirements of ASTM E1112-00 (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature).

The predictive temperature feature of the BPM-300 was tested in a clinical validation study and the results demonstrate that the predictive measurements are accurate as compared to the continuous temperature.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

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

Re: K023078

Trade Name: BpTRUTM Vital Signs Monitor, Model BPM-300 Regulation Number: 21 CFR 870.1130 and 21 CFR 880.2910 Regulation Name: Noninvasive Blood Pressure Measurement System and Clinical Electronic Thermometer Regulatory Class: Class II (two) Product Code: DXN and FLL Dated: December 20, 2002 Received: December 23, 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.

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

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

KedarTum

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

Enclosure

{5}------------------------------------------------

## Indications for Use Statement

| 510(k) Number: | K023078 |
|----------------|----------------------------------------------------------------------------------------------------------------------|
| Device Names: | (1) BpTRU Vital Signs Monitor<br>(2) BpTRU Portable Automated Non-Invasive Blood Pressure and<br>Temperature Monitor |
| Model Name: | BPM-300 |

## Indications For Use:

The BpTRU Vital Signs Monitor:

- Measures systolic and diastolic blood pressure and pulse rate in subjects 3 . years of age or older.
- . Measures temperatures 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 | <div>✓</div> |
|----------------------|------------------------------------|
| (Per 21 CFR 801.109) | OR Over-The-Counter USE |
| | (Optional Format 1-2-96) |
| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| 510(k) Number | K023078 |