The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through adult.

The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.

Device Description

The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, and printer has been updated to include an additional electronic thermometer option which uses the same technology as existing legally marketed devices. This device is designed to provide full-featured monitoring capabilities in a lightweight, transportable design. The system consists of a small tabletop NIBP monitor with a desktop charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.

AI/ML Overview

The provided text describes the BCI Mini-Torr Plus (model 6004) with a new electronic thermometer option. The study aims to demonstrate that the performance of this updated device is substantially equivalent to existing legally marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (within specified tolerances of monitors and simulators, and ±0.2°F for temperature)	Reported Device Performance (Average difference between predicate and new device)
Systolic Pressure (NIBP)	Within specified tolerances	-0.14 mmHg
Diastolic Pressure (NIBP)	Within specified tolerances	0.07 mmHg
Mean Arterial Pressure (MAP) (NIBP)	Within specified tolerances	0.07 mmHg
Heart Rate (NIBP)	Within specified tolerances	0 bpm
SpO2 (Oximetry)	Within specified tolerances	0%
Heart Rate (Oximetry)	Within specified tolerances	0 bpm
Temperature	Within specified tolerance (±0.2 °F)	-0.04 °F

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

The document does not explicitly state a specific sample size (e.g., number of patients or trials) for the comparison testing. Instead, it mentions:

NIBP and Oximetry: Measurements were made using "simulators" with settings spanning the 6004's entire specification range. This suggests comprehensive testing across various operational conditions.
Temperature: Both devices simultaneously measured temperature in a "water bath over their entire specified temperature range (84 - 108 °F)."

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in relation to the device's development, as it describes validation testing performed before seeking regulatory approval.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This study does not involve human experts to establish ground truth in the traditional sense of diagnostic interpretation. Instead, the ground truth is established by:

Predicate Devices: The performance of the predicate BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer serves as the reference or "ground truth" against which the new device's performance is compared for substantial equivalence.
Simulators: For NIBP and oximetry, simulators were used, implying their known and controlled outputs served as the reference.
Water Bath: For temperature, a water bath with a known temperature range provided the reference.

No human experts were used for adjudication of the test results themselves.

4. Adjudication Method for the Test Set

No human adjudication method (like 2+1, 3+1) was used for this study. The comparison was quantitative, directly comparing measurements from the new device against predicate devices and simulators/controlled environments.

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

No MRMC comparative effectiveness study was conducted. This study focuses on direct device performance comparison, not on evaluating human reader improvement with or without AI assistance. The device in question is a physiological monitor, not an AI-powered diagnostic tool.

6. Standalone Performance

Yes, a standalone performance assessment was effectively done. The "new 6004 with temperature option" device was tested independently and its measurements were then compared against established predicate devices and simulators. This assesses the algorithm/device's performance without human intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth for this study was established using:

Predicate Devices: The established performance and readings of the BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer.
Simulators: Controlled devices with known outputs for NIBP and Oximetry parameters.
Controlled Environment: A water bath with a defined temperature range for thermometry testing.

Essentially, the ground truth was based on known and validated performance of existing, legally marketed devices and controlled testing environments.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a medical device validation study focused on demonstrating substantial equivalence, not a machine learning model development study. Therefore, the concept of a training set as typically understood in AI/ML is not applicable here.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable. The device's design utilizes "currently available technology found in many legally marketed devices," implying established engineering principles and components rather than a data-driven learning approach.

Summary

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JAN 22 1999

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Summary of Safety and Effectiveness

Submitter:Address:	BCI International, Inc.N7 W22025 Johnson RoadWaukesha, WI 53186
Telephone:	(414) 542-3100
Contact:	VP Regulatory Affairs
Prepared:	October 2, 1998
Proprietary Name:	BCI Mini-Torr Plus (model 6004) with newelectronic thermometer option
Common/Classification Name:	Noninvasive blood pressure measurementsystem
Predicate Devices:	BCI 6004 NIBP monitorWelch Allyn 678 SureTemp Thermometer

New Device Description:

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Intended Use:

The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or inter are available. The device will provide fast, reliable NIBP measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers. It provides oral or rectal temperature information for patients neonate through adult.

Performance Data:

The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that BCI 6004 monitor would perform within the environment(s) for which it is to be marketed. Testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices and electronic thermometers. EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BCI 6004 monitor was in compliance with the guidelines and standards referenced in the reviewer's guides and that it performed within its specifications and functional requirements.

Comparison testing of the new 6004 with temperature option and the predicate 6004 was done to show that the performance of the NIBP and oximetry parameters of the two devices are the same (systolic, diastolic, and mean arterial pressures, NIBP heart rate, SpO2, and oximetry heart rate). Using simulator s, measurements were made by both devices. The tests were run with simulator settings spanning the 6004's entire specification range. The difference between measurements made by both devices (predicate - new) was calculated. The average difference between readings were -0.14 mmHg for systolic pressure, 0.07 mmHg for diastolic pressure, 0.07 mmHg for MAP, 0 bpm for heart rate measured with the NIBP parameter, 0% for SpO2 and 0 bpm for heart rate measured with the oximetry parameter. All measurements were within the specified tolerances of the monitors and simulators. These data support substantial equivalence of the NIBP and oximetry parameters of the new 6004 monitor to the original 6004 monitor.

Comparison testing of the new 6004 with temperature option and the Welch Allyn 678 SureTemp Thermometer was done to show that the performance of the temperature measurements made by the two devices is the same. Both the BCI 6004 and Welch Allyn 678 monitors were used to simultaneously measure temperature in a water bath over their

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entire specified temperature range (84 - 108 °F). The average difference (predicate - new) between measurements made with both monitor was -0.04 °F, which is within the specified tolerance (±0.2 °F).

The testing described above indicate that there is no functional difference between the operation of the new 6004 NIBP monitor with temperature option and the original 6004 NIBP monitor or Welch Allyn 678 SureTemp Thermometer. On the basis of these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Respectfully,

Donald Alexander

Donald Alexander VP Regulatory Affairs

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 1999

Mr. Donald J. Alexander VP Regulatory Affairs BCI International, Inc. N7 W22025 Johnson Road Waukesha, WI 23186

Re : K983796 6004 NIBP Monitor with Temperature Regulatory Class: II (Two) Product Code: 74 DXN October 26, 1998 Dated: October 27, 1998 Received:

Dear Mr. Alexander:

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 regulatory 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. Donald J. Alexander

This letter will allow you to begin marketing your device as Inis leccer will arrow you oo bog-arman The FDA finding acberlood in judinate of your device to a legally marketed of substantial equivated on your active for your device and predicate action redevice to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpccirre additionally 809.10 for in vitro regulation (21 Crx rare ase contact the Office of Compliance at Glaghosere devices), promoty, for questions on the promotion and (501) 594 4040. Thanksione, please contact the Office of advertibing of 701) 594-4639. Also, please note the regulation compriance at (301) by reference to premarket notification' (21 enerica, Hibbranaing eral information on your responsibilities under the Act may be obtained from the Division of Small under the may be 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 yours,

Thomas J. Callahan, Ph.D.

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

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Indications For Use

510(k) Number (if Known):__________________________________________________

Device Name: BCI Mini-Torr Plus Monitor. Model 6004, NIBP monitor with optional oximeter, electronic thermometer, and printer

Indications For Use:

Intended Use

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elixai Aleiniker

iovascular.

510(k) Number K983792

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

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).