CAPNOCHECK PLUS

K970209 · Bci Intl., Inc. · CCK · Apr 18, 1997 · Anesthesiology

Device Facts

• Record ID: K970209
• Device Name: CAPNOCHECK PLUS
• Applicant: Bci Intl., Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Apr 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO₂ and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122°F (0 to 50°C).

Device Story

Capnocheck Plus (Model 9004) is a transportable, tabletop capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) monitoring. Device inputs include sidestream breath samples via gas inlet port/moisture trap, SpO2 probe signals, and FiO2 sensor data. System processes these inputs to display real-time CO2, SpO2, pulse rate, pulse strength, and FiO2 on a VFD screen. Operated by clinicians in hospitals, clinics, or during emergency transport. Provides continuous monitoring with adjustable audible/visible alarms for patient status. Serial/PC port supports data communication and analog output. Benefits include real-time physiological monitoring to assist clinical decision-making in critical care, anesthesia, and transport settings.

Clinical Evidence

Clinical evidence includes controlled desaturation studies comparing the device's SpO2 measurements to a co-oximeter (OSM-3). Results showed a standard deviation of 2.0 for the 70-100% range and 2.7 for the 50-69% range, with an R-squared value of 0.97. Extensive bench testing was also performed, covering EMC, electrical safety, mechanical durability, CO2 response time, linearity, breath rate, and FiO2 accuracy at 0%, 21%, 60%, and 100% O2 concentrations.

Technological Characteristics

Tabletop capnograph with sidestream gas sampling, moisture trap, SpO2 probe interface, and FiO2 sensor. Features VFD display, LED status indicators, and 6-key keypad. Connectivity includes serial/PC port and 3 analog output channels. Operates in 32-122°F range. Testing performed per respiratory device reviewer guidelines (EMC, electrical, mechanical, environmental).

Indications for Use

Indicated for continuous monitoring of CO2, SpO2, pulse rate, and FiO2 in pediatric to adult patients in hospital, clinical, and emergency land transport environments.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• BCI 9000 Capnograph-Oximeter
• BCI 9100 Multigas Monitor

Reference Devices

• OSM-3 co-oximeter

Submission Summary (Full Text)

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BCI INTERNATIONAL
K970209
APR 18 1997

# Summary of Safety and Effectiveness

Submitter: BCI International, Inc.
Address: W238 N1650 Rockwood Drive
Waukesha, WI 53188
Telephone: [phone]
Contact: VP Regulatory Affairs
Prepared: January 20, 1997
Proprietary Name: Capnocheck® Plus, Model 9004
Common/Classification Name: Capnograph
Predicate Devices: BCI 9000 Capnograph-Oximeter
BCI 9100 Multigas Monitor

## New Device Description:

The BCI Capnocheck Plus capnograph with optional pulse oximetry (SpO₂) and fractional inspired oxygen (FiO₂) is an updated version of existing devices legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top capnograph with a wall mount charger. The system features a gas inlet port with moisture trap for the breath sample (sidestream capnograph), an SpO₂ probe interface, the FiO₂ sensor connector, display of patient data via a VFD display (CO₂, SpO₂, Pulse Rate, Pulse Strength, FiO₂, alarm information), system status LEDs (Battery, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of six keys (STNBY/ON, WAVE/TREND, Up and Down Arrows, MENU/ENTER, & Alarm Silence). The capnograph has a serial printer / pc port that is used for data communication. Three analog output channels are supported on the same connector.

## Intended Use:

The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO₂ and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122°F (0 to 50°C).

BCI International
W238 N1650 Rockwood Drive
Waukesha, WI 53188-1199 USA

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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 and standards found in the reviewers guide for respiratory devices. 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 between the new 9004 and the predicate 9000 was done to show that the performance of the two devices is the same (CO₂, RR, SpO₂ & HR). All the results of each parameter of each device were the same or within one count of each other.

An in-house performance test of the 9004 was run. It tested CO₂ response time, accuracy & linearity with humidity & over temperature & at altitude, temperature shock, interfering gases, breath rate, contamination and water trap testing. The testing to determine how often the unit needs to be recalibrated was also completed. The FiO₂ function was tested with O₂ values of 0%, 21%, 60% and 100% oxygen. The 9004 passed all the tests.

Additionally, clinically controlled desaturation studies of the optional oximeter were done to demonstrate that the 9004 accurately displays the patient’s blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs. The results from the clinical studies support the accuracy claims of the device, with a standard deviation of 2.0 for the measurement range of 70-100% and 2.7 for the range of 50-69%. The R squared value was 0.97 over the entire range. (R squared - measure of how true the regression line is. R squared = 1 is a perfect fit.)

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
VP Regulatory Affairs