BCI MINI-TORR PLUS, MODEL 6004 by BCI INTL., INC.

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 form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. 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 neonate through adult patients.

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 BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic thermometer, and printer has been updated to include a new neonatal NIBP mode which uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top 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), display of patient NIBP mode via an LED, 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

Here's an analysis of the acceptance criteria and study details for the BCI Mini-Torr Plus (model 6004) with new neonate NIBP mode, based on the provided text:

Acceptance Criteria and Device Performance

The primary acceptance criteria for the new neonatal NIBP mode are derived from the ANSI/AAMI SP10-1992 standard and its 1996 amendment. These standards mandate specific limits for the difference between the device's measurements and a reference standard (arterial line pressure transducer) in terms of mean difference and standard deviation.

Acceptance Criteria (ANSI/AAMI SP10)	Performance Metric	Reported Device Performance (Mean Difference vs. Arterial Line)	Reported Device Performance (Standard Deviation of Difference)
Mean difference ≤ ±5 mmHg	Systolic Pressure	-0.4 mmHg	7.6 mmHg
Mean difference ≤ ±5 mmHg	Diastolic Pressure	-0.2 mmHg	5.3 mmHg
Mean difference ≤ ±5 mmHg	Mean Arterial Pressure (MAP)	-0.6 mmHg	5.1 mmHg
Std. deviation ≤ 8 mmHg	Systolic Pressure	N/A (criteria for mean difference)	7.6 mmHg (meets criteria of ≤ 8 mmHg)
Std. deviation ≤ 8 mmHg	Diastolic Pressure	N/A (criteria for mean difference)	5.3 mmHg (meets criteria of ≤ 8 mmHg)
Std. deviation ≤ 8 mmHg	Mean Arterial Pressure (MAP)	N/A (criteria for mean difference)	5.1 mmHg (meets criteria of ≤ 8 mmHg)

Summary of Device Performance against Acceptance Criteria: The device met all stated acceptance criteria from the ANSI/AAMI SP10 standard for the neonatal NIBP mode.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of individual neonatal patients included in the clinical study is not specified, only that it was conducted on "neonates ranging in size from 0.52 to 8.60 kilograms."
- Data Provenance: The clinical testing was conducted at "two local hospitals." This indicates a prospective, multi-site clinical study. The country of origin is not explicitly stated, but given the submitter's address in Wisconsin, USA, and the referencing of American National Standards (ANSI/AAMI), it is highly probable the data is from the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the NIBP measurements was established by "measurements made from an arterial line pressure transducer." This is an objective, direct physiological measurement. The document does not mention human expert involvement in establishing this specific ground truth for the NIBP readings.
- For the overall study conduct and ethical oversight, "Institutional Review Board (IRB) approvals" were received, indicating expert review of the study protocol.
Adjudication method for the test set: Not applicable, as the ground truth for NIBP was a direct physiological measurement from an arterial line, rather than a subjective assessment requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study focuses on the accuracy of a physiological measurement device (NIBP monitor) and its algorithms, not on human reader performance with or without AI assistance for interpretation tasks.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, regarding the neonatal NIBP mode, the clinical testing involved comparing the "6004 monitor's algorithm" measurements to arterial line measurements. This represents standalone algorithm performance in the context of a medical device's automated function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The primary ground truth for the neonatal NIBP mode was invasive arterial line pressure transducer measurements. This is a highly accurate and direct physiological measurement often considered a gold standard for blood pressure.
The sample size for the training set: Not applicable. This document describes a validation study for a medical device feature, not a machine learning model that would typically have a distinct training set. The device utilizes "currently available technology" and its design was updated with "only software...changed" for the neonatal NIBP mode. The development (training) of the underlying NIBP algorithm is not detailed here.
How the ground truth for the training set was established: Not applicable, as this documentation pertains to a validation study rather than the development of an algorithm requiring a separate training set description.

Summary

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3/25/99

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Summary of Safety and Effectiveness

Submitter:	BCI International, Inc.
Address:	N7 W22025 Johnson RoadWaukesha, WI 53186
Telephone:	(414) 542-3100
Contact:	VP Regulatory Affairs
Prepared:	December 7, 1998
Proprietary Name:	BCI Mini-Torr Plus (model 6004) with newneonate NIBP mode
Common/Classification Name:	Noninvasive blood pressure measurement system
Predicate Devices:	BCI 6004 NIBP Monitor (K970801)BCI 6004 Monitor with Temperature Option,510(k) pending (K983796)BCI 6200 Vital Signs Monitor (K953415)

New Device Description:

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 integral printer

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are available. The device will provide fast, reliable NIBP measurements on patients ranging from neonate 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.

Performance Data:

The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done previously to ensure that the BCI 6004 monitor would perform within the environment(s) for which it is to be marketed (510[k] pending, K983796). As only software has changed, further environmental testing was not necessary. The previous testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices and electronic thermometers. Electromagnetic compatability (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.

Additional safety testing of the new neonatal NIBP mode was performed in accordance with IEC601-2-30: 1995. The monitor passes all of these tests and met all requirements of the standard.

Comparison testing of the 6004 with the new neonate NIBP mode and the predicate 6004 was done to show that the performance of the NIBP adult mode, oximetry, and electronic thermometry parameters of the two devices are the same (systolic, and mean arterial pressures, NIBP heart rate, SpO2, oximetry heart rate, and temperature). Using simulators, 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 1.29 mmHg for adult mode systolic pressure, 0.71 mmHg for adult mode diastolic pressure, 0.93 mmHg for adult mode MAP, 0.43 bpm for heart rate measured with the adult mode NIBP parameter, 0.04% for SpO2, 0 bpm for heart rate measured with the oximetry parameter, and -0.05 °F for oral and rectal temperature. All measurements were within the specified tolerances of the monitors and simulators. These data support substantial equivalence of the adult mode NIBP, oximetry, and electronic thermometry parameters of the new 6004 monitor to the predicate 6004 monitor.

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Finally, clinical testing of the BCI 6004 NIBP monitor with new neonatal NIBP mode demonstrated compliance to the ANSI/AAMI SP10-1992 standard (American National Standard for Electronic or automated sphygmomanometers ) and ANSI/AAMI/ISO SP10A-1996 Amendment to ANSI/AAMI SP10-1992. The SP-10 testing was conducted after receiving Institutional Review Board (IRB) approvals at two local hospitals on neonates ranging in size from 0.52 to 8.60 kilograms. Measurements of systolic, diastolic, and mean arterial blood pressures made by the 6004 monitor's algorithm were compared to measurements made from an arterial line pressure transducer. The means of these differences are: -0.4 mmHg for systolic pressures, -0.2 mmHg for diastolic pressures, and -0.6 mmHg for mean arterial pressures. These fall within the ±5 mmHg limit imposed by the SP-10 standard. The standard deviations of these differences are: 7.6 mmHg for systolic pressures, 5.3 mmHg for diastolic pressures, and 5.1 mmHg for mean arterial pressures. These fall within the 8 mmHg limit imposed by the SP-10 standard. Further testing demonstrated that the clinical software used for data acquisition and the final software for the monitor obtain the same measurements when tested using simulators.

The testing described above indicate that there is no functional difference between the operation of the 6004 NIBP monitor with new neonatal NIBP mode and the predicate 6004 NIBP monitor for adult mode NIBP, oximetry, and electronic thermometry measurements. Also, the clinical data provide information on the accuracy of the new neonatal NIBP function. 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

MAR 2 5 1999

Mr. Donald J. Alexander BCI International N7 W22025 Johnson Road Waukesha, WI 53186

Re: K984618 BCI Mini-Torr Plus Monitor, Model 6004 with Neonatal NIBP Mode Regulatory Class: II (two) 74 DXN Product Code: December 22, 1998 Dated: December 29, 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 Regulation (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 described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: K984618

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

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) of litted Shanker

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_k984

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).