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.

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 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.

AI/ML Overview

The provided 510(k) summary (K023078) for the BpTRU Vital Signs Monitor (Model BPM-300) indicates that the device was tested against recognized standards for both blood pressure and temperature measurement. However, the document lacks detailed acceptance criteria and the comprehensive study information requested in the prompt.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Test	Acceptance Criteria	Reported Device Performance
Blood Pressure
AAMI/ANSI SP10: 1992 (Blood Pressure)	As per AAMI/ANSI SP10: 1992 standards: - Mean difference between test device and reference device for systolic blood pressure: ≤ ± 5 mmHg - Standard deviation of the differences for systolic blood pressure: ≤ 8 mmHg - Mean difference between test device and reference device for diastolic blood pressure: ≤ ± 5 mmHg - Standard deviation of the differences for diastolic blood pressure: ≤ 8 mmHg - Specific requirements for cuff size, subject population (e.g., adult, pediatric), number of subjects, and number of measurements per subject.	"The blood pressure feature of the BPM-300 was tested and meets the requirements of AAMI/ANSI SP10: 1992 (Electronic or automated sphygmomanometers)." Specific numerical performance values (mean difference, standard deviation) are not reported* in the provided document.*
Continuous Temperature
ASTM E1112-00 (Continuous Temperature)	As per ASTM E1112-00 standards: - Accuracy requirements specifying maximum permissible error within certain temperature ranges (e.g., ± 0.1 °C for certain core body temperatures, ± 0.2 °C for others). - Stability, response time, and other performance characteristics.	"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)." Specific numerical performance values are not reported* in the provided document.*
Predictive Temperature	Implied: Predictive measurements are "accurate as compared to the continuous temperature." Specific numerical criteria for this accuracy (e.g., mean difference, confidence intervals) are not provided.	"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." Specific numerical performance values are not reported* in the provided document.*

2. Sample Size Used for the Test Set and Data Provenance

Blood Pressure: The document states "The blood pressure feature of the BPM-300 was tested and meets the requirements of AAMI/ANSI SP10: 1992". While AAMI/ANSI SP10 specifies minimum sample sizes (e.g., typically at least 85 subjects for validation), the exact sample size used in the test set is not explicitly stated in the provided text.
Continuous Temperature: The document states "The continuous temperature feature of the BPM-300 was tested and meets the requirements of ASTM E1112-00". ASTM E1112-00 has specific testing protocols, but the exact sample size used and data provenance are not reported. This standard is for the device itself, likely involving laboratory testing more than clinical patient data.
Predictive Temperature: "The predictive temperature feature of the BPM-300 was tested in a clinical validation study." The sample size for this clinical study is not reported. The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Blood Pressure: For AAMI/ANSI SP10 testing, ground truth typically involves a reference method performed by trained observers (e.g., auscultatory method by two trained observers). The number and qualifications of experts are not specified in the provided text.
Continuous Temperature: For ASTM E1112-00, the "ground truth" would be established by a primary reference thermometer instrument or known temperature baths in a lab setting, not typically by human experts.
Predictive Temperature: The ground truth was "continuous temperature." This would likely involve the device's own continuous temperature measurement mode or another validated continuous temperature monitoring device. The use of human experts to establish this ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

Blood Pressure: For AAMI/ANSI SP10, if human observers were part of the reference method, an adjudication method (e.g., averaging two observers' readings or a third adjudicator if there's a discrepancy) would be standard. However, the specific adjudication method is not mentioned in the document.
Temperature: Adjudication by human experts is not applicable for temperature measurement studies described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported. This type of study is more common for diagnostic imaging devices where human readers interpret images with and without AI assistance to assess changes in diagnostic accuracy.

6. Standalone Performance

Yes, standalone performance was assessed for both blood pressure and temperature functions.

The blood pressure feature "was tested and meets the requirements of AAMI/ANSI SP10: 1992". This refers to the algorithm/device performance directly compared to a reference standard, without human intervention in the measurement process itself beyond initiating it.
The continuous temperature feature "was tested and meets the requirements of ASTM E1112-00". This is a direct assessment of the device's accuracy.
The predictive temperature feature "was tested in a clinical validation study and the results demonstrate that the predictive measurements are accurate as compared to the continuous temperature". This describes the standalone performance of the predictive algorithm against a reference (continuous temperature).

7. Type of Ground Truth Used

Blood Pressure: Ground truth was based on the requirements of AAMI/ANSI SP10: 1992. This standard typically involves comparison to a reference sphygmomanometer reading, often obtained through the auscultatory method (manual stethoscope and cuff) by trained observers.
Continuous Temperature: Ground truth was based on the requirements of ASTM E1112-00. This standard typically relies on calibrated temperature probes or reference thermometers in a controlled environment.
Predictive Temperature: Ground truth was the device's "continuous temperature" measurement, implying a comparison of the rapid predictive reading to a several-minute continuous reading from the same device or a similar validated continuous temperature monitor.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests that the device's underlying algorithms (oscillometric for BP, thermistor for temperature prediction) may be based on established physical principles and prior development, rather than a specific machine learning model that requires a distinct "training set" in the modern sense. If there was an internal algorithm for predictive temperature, the data used to develop that algorithm is not discussed.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, information on how its ground truth was established is not available.

Summary

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510(K) Summary of Safety and Effectiveness

Submitter:

MAR 21 2003

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: (604) 738-8763 Fax: (604) 738-8762

K0230

Regulatory Identification:

Device Names:	(1) BpTRU Vital Signs Monitor(2) BpTRU Portable Automated Non-Invasive Blood Pressure andTemperature Monitor
Model Name:	BPM-300
Device Classification Name:	System, measurement, blood-pressure, non-invasiveThermometer, 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.

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Device Description:

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.

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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.

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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.

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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), please contact the Office of Compliance at (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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Indications for Use Statement

510(k) Number:	K023078
Device Names:	(1) BpTRU Vital Signs Monitor(2) BpTRU Portable Automated Non-Invasive Blood Pressure andTemperature 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	✓
(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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).