The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). A 2-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI accessories.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.

Device Description

The BCI 9200 Vital Signs Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, two invasive pressure interfaces, two YSI compatible temparature interfaces, an NBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient and waveform data via a color LCD, system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, zero (IP zero), NIBP start/stop, print start/stop & alarm silence). The monitor has a serial port that is used for data communications.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed for the BCI 9200 Vital Signs Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter Tested	Acceptance Criteria	Reported Device Performance	Study Type	Notes
Oximetry (SpO2)
70% - 100% SpO2	Standard deviation ≤ 2	Standard deviation = 1.74	Clinical	R-squared = 0.91
50% - <70% SpO2	Standard deviation ≤ 3	Standard deviation = 2.77	Clinical
Respiration
Breath Rate	Accuracy ±1 bpm or ±5%, whichever is greater	Mean difference = 0.57 bpm, Standard deviation = 0.65 bpm	Clinical	Compared to BCI 9004 Capnograph
NIBP
Systolic Pressure (Clinical - Mini-study)	Mean difference ±5 mmHg, Standard deviation ≤ 8 mmHg (SP10)	Mean difference = 2.81 mmHg, Standard deviation = 2.34 mmHg	Clinical	Compared to manual readings
Diastolic Pressure (Clinical - Mini-study)	Mean difference ±5 mmHg, Standard deviation ≤ 8 mmHg (SP10)	Mean difference = 3.45 mmHg, Standard deviation = 2.54 mmHg	Clinical	Compared to manual readings
Systolic Pressure (SP10 Testing)	Mean difference ±5 mmHg, Standard deviation ≤ 8 mmHg	Mean difference = -1.8 mmHg, Standard deviation = 7.1 mmHg	Clinical	Compared to average manual readings
Diastolic Pressure (SP10 Testing)	Mean difference ±5 mmHg, Standard deviation ≤ 8 mmHg	Mean difference = -2.6 mmHg, Standard deviation = 7.6 mmHg	Clinical	Compared to average manual readings
NIBP Comparison (MicroNIBP vs. 6004)	Not explicitly stated an "acceptance criterion" but implicitly aims for minimal difference.	Largest difference of averages = 4.3 mmHg. Average difference: SYS=1.0, DIA=1.1, MAP=1.1, HR=0.	Bench	Used Dynatech Nevada CuffLink NIBP Analyzer as simulator
ECG	Adherence to ANSI/AAMI EC13-1992 requirements	Met all applicable requirements	Bench/Verification	Included labeling, operating conditions, overload protection, risk current, auxiliary output, respiration, leads-off sensing, active noise suppression, QRS detection, range & accuracy of heart rate meter, alarm system, ECG display capability.
Other Parameters (Bench Tests)	Mean differences less than one (compared to simulator setting)	All mean differences < 1	Bench	Parameters: ECG rate, Oximetry %SpO2 & rate, NIBP rate, respiration rate, temperature, IBP static pressure, systolic, diastolic & mean pressures plus pulse rate.
General Device Performance	Compliance with guidelines and standards referenced in reviewers guide, performed within specifications and functional requirements.	Device was in compliance and performed within specifications.	Various	EMC, electrical, mechanical durability, safety (operator and patient), temperature/humidity.

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

Oximetry: Not explicitly stated, though a "deep desaturation test" was run on the OEM board. It was done at the VA Medical Center in Milwaukee. The data provenance is prospective (clinical study with volunteers).
Respiration: 31 volunteers. The test was conducted at BCI. Data provenance is prospective (clinical study with volunteers).
NIBP (Mini-Study): 31 volunteers. The test was conducted at BCI. Data provenance is prospective (clinical study with volunteers).
NIBP (SP-10 Testing): Not explicitly stated, but conducted under an approved IRB. Conducted at the VA Medical Center in Milwaukee and at BCI International. Data provenance is prospective (clinical study with volunteers).
Bench Tests (all parameters): 3 devices were tested on simulators. Data provenance is internal lab testing.

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

Oximetry: Values compared to an OSM-3 co-oximeter. The co-oximeter serves as the reference standard, not human experts for ground truth.
Respiration: Values compared to a BCI 9004 Capnograph (CO2 gas monitor). The capnograph serves as the reference standard, not human experts.
NIBP (Mini-Study): A "single human observer taking a manual NIBP reading" on the same arm. The qualifications of this observer are not specified.
NIBP (SP-10 Testing): Compared to "the average of the manual readings." It is implied that multiple manual readings were taken, but the number of observers and their qualifications are not specified.
Bench Tests: Ground truth established by commercially available simulators with known settings. No human experts involved in establishing ground truth.

4. Adjudication Method for the Test Set

Oximetry, Respiration, Bench Tests: Comparison to a reference device/simulator. No human adjudication method described.
NIBP (Mini-Study): Direct comparison to a single human observer's manual reading. No adjudication described.
NIBP (SP-10 Testing): Compared to "the average of the manual readings." This averaging serves as a form of consensus/adjudication for the manual readings but no explicit adjudication process between multiple observers is detailed beyond that.

5. 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

No, an MRMC comparative effectiveness study was not done. This document describes a traditional medical device performance study, not an AI-based diagnostic tool study. Therefore, there is no mention of AI assistance or human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, portions of the testing represent standalone algorithm performance. The bench tests with simulators and the comparisons to reference devices (co-oximeter, capnograph) evaluate the device's measurement capabilities independently of human interpretation. For example, the oximetry and respiration studies assess how accurately the device itself measures these parameters.

7. The Type of Ground Truth Used

Reference Devices/Simulators: For most parameters (ECG, SpO2, Respiration, IBP, NIBP in bench tests).
Manual Observations: For NIBP (mini-study and SP10 testing), involving a single or averaged manual cuff readings.
Performance Standards: For ECG (ANSI/AAMI EC13-1992) which involves adherence to specified technical and functional requirements.

8. The Sample Size for the Training Set

Not Applicable. This device is a vital signs monitor, not a machine learning or AI algorithm in the context of this document. Therefore, there is no "training set" as understood in AI/ML development. The device design utilizes "currently available technology," implying established engineering principles and algorithms, rather than data-driven machine learning models.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the information provided.

Summary

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K982279

2 5 1998

Image /page/0/Picture/2 description: The image shows the logo for BCI International. The logo consists of a circle made of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font. Below the letters, the word "INTERNATIONAL" is written in a smaller, sans-serif font.

Summary of Safety and Effectiveness

Submitter: Address:

Telephone:

Contact:

BCI International, Inc. W238 N1650 Rockwood Drive Waukesha, WI 53188

(414) 542-3100 VP Regulatory Affairs

Prepared:

Proprietary Name: Common/Classification Name: Predicate Devices:

May 29, 1998

BCI 9200 Vital Signs Monitor Monitor, Electrocardiograph BCI 6200 Vital Signs Monitor BCI 9100 Multigas Monitor BCI 6004 NIBP Monitor Siemens SC6000 Bedside Monitor

New Device Description:

Intended Use:

The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead), impedance respiration (RSP), noninvasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and two temperature channels (Tl and T2). A 2-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI accessories.

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Performance Data:

The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that it would perform within the environment(s) for which it is to be marketed. The testing was performed in accordance with the guidelines found in the reviewers guide for respiratory devices and with international safety standards. This testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements.

Performance testing of the 9200 Vital Signs Monitor and its components were seperated into three types of testing. Bench tests using simulators were used to test each parameter. Clinical tests using volunteers were used to verify performance for respiration, NIBP and oximetry. Two performance standards were used for ECG (ANSI/AAMI EC13) and NIBP (ANSVAAMI SP10).

Bench Tests:

Three devices were tested on simulators to determine performance over the specified range. All of the simulators are commercially available. The device reading is compared to the simulator setting. The parameters tested were: ECG rate, Oximetery % SpO2 & rate, NIBP rate, respiration rate, temperature, and IBP static pressure, systolic, diastolic & mean pressures plus pulse rate. The 9200 Vital Signs Monitors very closely tracked the simulators. All of the mean differences were less than one.

Clinical Tests:

Clinical studies were done on oximetry, respiration and NIBP.

Oximetry:

A deep desaturation test was run on the Newox1P OEM oximeter board (used in the 9200) at the VA Medical Center in Milwaukee under an approved IRB. The oximeter values were compared to an OSM-3 co-oximeter. Over the SpO2 range of 70% - 100% the standard deviation was 1.74 (spec = +/- 2). Over the SpO2 range of 50% - <70% the standard deviation was 2.77 (spec = +/-3). R squared = 0.91 (measure of how true the regression line is, one being perfect).

Respiration:

The repiration values were collected from the 9200 and a BCI 9004 Capnograph (K970209) ( a CO2 gas monitor). The test was conducted at BCI. Thirty one volunteers were tested. The minimum breath rate was 5 bpm and the maximum was 33 bpm. The mean difference between the 9004 and the 9200 readings was 0.57 with a standard deviation of 0.65. The accuracy specification of the 9200 respiration is 11 bpm or ±5%, whichever is greater. The 9200 agreed very closely with the 9004 respiration rate.

NIBP

The NIBP function of the 9200 is provided by the MicroNIBP module. The actual clinical data for the MicroNIBP module is contained in the SP10 report. The summary is contained in the following performance standards section. A mini-study was conducted at BCI with a 9200 containing the MicroNIBP module. Thirty one volunteers were tested and compared to a single human observer taking a manual NIBP reading at the same time (on the same arm). The accuracy requirement of the SP10 standard is a mean difference of ±5 mmHg with a standard deviation of 8 mmHg. For the systolic readings the mean difference was 2.81 mmHg with a standard deviation of 2.34 mmHg. For the diastolic readings the mean difference was 3.45 mmHg with a standard deviation of 2.54 mmHg. The results are well within the SP10 requirements.

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Performance Standards:

Two performance standards were used. The NIBP standard is ANSI/AAMI SP10-1992 standard (American National Standard for Electronic or automated sphygmomanometers ) & ANSVAAMI/ISO SP10A-1996 Amendment to ANSV/AAMI SP10-1992. The ECG standard is ANSI/AAMI EC13-1992 standard (American National Standard for Cardiac monitors, heart rate meters and alarms).

NIBP

Performance testing for the NIBP was composed of two sections. The first part was testing to the ANSVAAMI SP10-1992 standard. This test was to determine the accuracy of the NIBP technology using the MicroNIBP module. The next test showed that the MicroNIBP module and the BCI 6004 NIBP monitor (K970801) performed the same. This is to support the accuracy of the MAP readings.

The SP-10 testing was conducted under an approved IRB at the VA Medical Center in Milwaukee and at BCI International. When the MicroNIBP measurements are compared to the average of the manual readings the mean difference is -1.8 mmHg on systolic pressures and -2.6 mmHg on diastolic pressures. This meets the SP-10 requirement for a maximum mean difference of +/- 5 mmHg. The standard deviation of the difference between the MicroNIBP yalues and the average manual values was 7.1 mmHg for systolic pressures and 7.6 mmHg for diastolic pressures. This falls within the 8 mmHg limit imposed by the SP-10 standard. The next test showed that the MicroNIBP and the 6004 NIBP monitor will give the same NIBP readings. Using the Dynatech Nevada CuffLink NIBP Analyzer as the NIBP simulator a series of readings where taken over the specification range. The largest difference (of averages) for any setting was 4.3 mmHg. The average difference of all the readings were 1.0 for SYS, 1.1 for DIA, 1.1 for MAP and 0 for HR. This shows that the MicroNIBP module (used in the 9200) and the 6004 NIBP monitor operate the same.

ECG

The 9200 was tested to the requirements of AAMI EC13-1992. These requirements included reviews or tests for labeling, operating conditions, overload protection (includes defib tests), risk current (leakage), auxiliary output, respiration, leads-off sensing, active noise suppression, ORS detection, range & accuracy of heart rate meter, alarm system and ECG display capability requirements (including pacemaker). The 9200 met all of the applicable requirements.

The 9200 passed all the tests.

On the basis of these results and the above-referenced testing it is our determination that the device is safe, effective, and performs as well as or better than 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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SEP 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald Alexander Requlatory Affairs BCI International W238 N1650 Rockwood Drive Waukesha, WI 53188

Re : K982279 ADVISOR Model #9200 Requlatory Class: II Product Code: MHX June 26, 1998 Dated: Received: June 30, 1998

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 leqally 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, qood manufacturing practice, labelinq, and prohibitions against misbrandinq 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 Requlations, 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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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 regulation (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,

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

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Indications For Use

K982279 510(k) Number (if known):

Device Name: BCI 9200 Vital Signs Monitor

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)

V. Curtis Tull

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

www.buumber.com.com.com.

Over-The Counter Use

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.