VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200

K982279 · Bci Intl., Inc. · MHX · Sep 25, 1998 · Cardiovascular

Device Facts

• Record ID: K982279
• Device Name: VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
• Applicant: Bci Intl., Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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 / 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 Story

BCI 9200 Vital Signs Monitor provides multi-parameter patient monitoring in hospital/clinical settings. Inputs: ECG (3/5 lead), impedance respiration, NIBP, SpO2, invasive blood pressure (P1/P2), and temperature (T1/T2). Device processes signals to display waveforms and numerical data on color LCD; features adjustable alarm limits with audible/visible alerts. Operated by clinicians; includes optional internal printer and battery. Output assists clinicians in real-time patient status assessment and clinical decision-making. Benefits include reliable, continuous monitoring of vital signs for pediatric and adult populations.

Clinical Evidence

Clinical studies conducted on 31 volunteers for respiration, NIBP, and oximetry. Oximetry (Newox1P board) compared to OSM-3 co-oximeter (70-100% SpO2 SD 1.74; 50-<70% SD 2.77). Respiration compared to BCI 9004 Capnograph (mean difference 0.57 bpm). NIBP compared to manual auscultation (systolic mean difference 2.81 mmHg, diastolic 3.45 mmHg). All results met ANSI/AAMI SP10 and EC13 requirements.

Technological Characteristics

Tabletop monitor; ECG (3/5 lead), impedance respiration, NIBP, SpO2, invasive pressure, temperature channels. Color LCD display, rotary control, keypad. Connectivity via serial port. Complies with ANSI/AAMI SP10-1992/1996 (NIBP) and ANSI/AAMI EC13-1992 (ECG).

Indications for Use

Indicated for pediatric and adult patients in hospital or clinical settings (ICU, CCU, OR, ER, RR, Labor and Delivery, special procedure labs) for monitoring ECG, impedance respiration, NIBP, SpO2, invasive blood pressure, and temperature. Contraindicated for home use, neonatal use, and apnea monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BCI 6200 Vital Signs Monitor
• BCI 9100 Multigas Monitor
• BCI 6004 NIBP Monitor
• Siemens SC6000 Bedside Monitor

Reference Devices

• BCI 9004 Capnograph (K970209)
• BCI 6004 NIBP monitor (K970801)

Submission Summary (Full Text)

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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

[phone] 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:

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.

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.

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.

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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

3

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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.

( 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.

OR

Over-The Counter Use