(87 days)
BCI 9000 Capnograph-Oximeter, BCI 9100 Multigas Monitor
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No
The summary describes a standard patient monitor with capnography, oximetry, and FiO2 measurement. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The summary indicates that the device is for monitoring purposes (continuous patient monitoring, displays patient data, provides SPO2 and pulse rate, etc.). There is no mention of treating or mitigating a disease or condition, which would make it a therapeutic device.
Yes
The device is described as a "Capnocheck Plus capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2)" that provides "continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals." It displays patient data such as CO2, SpO2, Pulse Rate, Pulse Strength, and FiO2, which are all diagnostic parameters. Additionally, it highlights "clinically controlled desaturation studies of the optional oximeter were done to demonstrate that the 9004 accurately displays the patient's blood oxygen level," further confirming its diagnostic function.
No
The device description clearly outlines hardware components such as a gas inlet port, SpO2 probe interface, FiO2 sensor connector, VFD display, LEDs, function keypad, and a serial printer/PC port. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the device is a "capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2)". These are devices that measure physiological parameters directly from the patient (e.g., CO2 in exhaled breath, oxygen saturation in blood via a probe, oxygen concentration in inspired air).
- Specimen Type: The device uses a "gas inlet port with moisture trap for the breath sample" and an "SpO2 probe interface". These are not specimens derived from the human body in the way that blood, tissue, or urine are used in IVDs. The breath sample is a direct measurement of exhaled gas, and the SpO2 probe is a non-invasive measurement through the skin.
- Intended Use: The intended use describes continuous patient monitoring in various clinical and transport environments. This is consistent with a patient monitoring device, not an IVD.
Therefore, the BCI Capnocheck Plus is a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 ootion 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).
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
pediatric to adults.
Intended User / Care Setting
hospital or clinical environment, and during emergency land transport.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Standard deviation of 2.0 for the measurement range of 70-100% (SpO2)
Standard deviation of 2.7 for the range of 50-69% (SpO2)
R squared value was 0.97 over the entire range (SpO2)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BCI 9000 Capnograph-Oximeter, BCI 9100 Multigas Monitor
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
APR
1 8
1997
Image /page/0/Picture/2 description: The image shows a logo for BCI International. The logo consists of a stylized circle on the left, followed by the letters "BCI" in a bold, sans-serif font. Below the letters, the word "INTERNATIONAL" is written in a smaller, sans-serif font. The logo is black and white.
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:
January 20, 1997
Proprietary Name: Common/Classification Name: Predicate Devices:
Capnocheck® Plus, Model 9004 Capnograph 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 ootion 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
1
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 Alexand
Donald Alexander VP Regulatory Affairs