(70 days)
Not Found
No
The document describes standard physiological monitoring technology (capnography and pulse oximetry) and does not mention AI, ML, or any related concepts.
No.
The device is a monitor that measures CO2, respiration rate, and SpO2. It is not intended for treatment or therapy.
Yes
This device is designed to measure physiological parameters like ETCO2, inspired CO2, respiration rate, and SpO2, which are used to assess a patient's medical condition. This assessment of the patient's condition for the purpose of diagnosis or treatment falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components such as a hand-held monitor, gas inlet/exhaust connections, SpO2 sensor interface, LCD display, keypad, LEDs, and an infrared serial port. It also mentions an optional external printer and AC powered battery eliminator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The 8400 Capnocheck II monitors physiological parameters directly from the patient:
- Capnography: Measures CO2 in exhaled breath.
- Pulse Oximetry: Measures oxygen saturation and pulse rate through a sensor placed on the skin.
- No specimen analysis: The device does not analyze any specimens taken from the body. It directly measures gases and physiological signals from the patient.
Therefore, the 8400 Capnocheck II falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It 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 ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximeter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
Product codes
73 CCK
Device Description
The BCI 8400 Capnocheck II monitor performs capnography and pulse oximetry using the same technology as existing legally marketed devices. Capnography data includes end-tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements as well as a respiration breath indicator and ETCO2 waveform. Oximetry data includes functional arterial blood oxygen saturation (%SpO2) and heart rate measurements as well as pulse strength indicator and plethysmogram. This device is designed to provide full-featured monitoring. capabilities in a lightweight, hand-held design. The system consists of a small hand held monitor with optional infrared linked printer and AC powered battery eliminator. Features include a gas inlet connection, an exhaust gas connection, an SpO2 sensor interface, Ilquid crystal display (LCD), system status LEDs, function keypad, and infrared serial port. The LCD display has an electroluminescent (EL) backlight and displays patient data, waveforms, trends, breath and pulse rate indicators, alarm limit indicators, and messages. The keypad consists of six keys: power, waveform/trend, alarm silence, up and down arrows, and menu/enter. There are three system status LEDs: alarm silence, high and medium/low priority alarms. The infrared serial port is used for data communication with the optional printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric to adult
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing was done to ensure that the BCI 8400 monitor was safe and would perform within the environment(s) for which it is to be marketed.
Safety testing was conducted in accordance with the Reviewer's Guidance for Respiratory Devices, 1993, EN60601-1, and several other international standards for medical devices. The monitor passes all of these tests and met all requirements of the standards.
Environmental testing was performed in accordance with the guidelines and standards found in the Reviewer's Guidance for Respiratory Devices, 1993 and EN60601-1-2. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BCI 8400 monitor complied with the guidelines and standards and that it performed within its specifications and functional requirements.
Testing of device performance included clinical testing of the ETCO2. respiration rate, and SpO2 measurements made by the BCI 8400 monitor. Further performance testing of the capnography parameter was also conducted in accordance with EN 864 (international standard for capnography). In addition, a human factors review and long term alarm test were performed to demonstrate overall device performance. The results demonstrated that the BCI 8400 monitor performed within its specifications.
Comparison testing of the 8400 and the predicate BCI 9000 Capnograph/Oximeter was done to show that the performance of the ETCO2, respiration rate, %SpO2, and heart rate parameters of the two devices are the same. Using simulators, measurements were made by both devices. The tests were run with simulator settings spanning the 8400's entire specification range. All measurements were within the specified tolerances of the monitors and simulators. These data support substantial equivalence of the BCI 8400 monitor to the BCI 9000 monitor.
Key Metrics
Not Found
Predicate Device(s)
BCI 8200 Capnometer (K941982), BCI 9000 Capnograph (K873856), BCI 9004 Capnograph (K970209)
Reference Device(s)
Not Found
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
Image /page/0/Picture/2 description: The image shows the logo for BCI International. The logo consists of a circle on the left side with vertical lines inside. To the right of the circle are the letters BCI in large, bold font, with the word "INTERNATIONAL" underneath in a smaller font.
Summary of Safety and Effectiveness
| Submitter:
Address: | BCI International, Inc.
N7 W22025 Johnson Road
Waukesha, WI 53186 |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Telephone: | (414) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | March 26, 1999 |
| Proprietary Name: | BCI Capnocheck® II |
| Common/Classification Name: | Capnograph with pulse oximeter and optional
printer. |
| Predicate Devices: | BCI 8200 Capnometer (K941982)
BCI 9000 Capnograph (K873856)
BCI 9004 Capnograph (K970209) |
New Device Description:
The BCI 8400 Capnocheck II monitor performs capnography and pulse oximetry using the same technology as existing legally marketed devices. Capnography data includes end-tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements as well as a respiration breath indicator and ETCO2 waveform. Oximetry data includes functional arterial blood oxygen saturation (%SpO2) and heart rate measurements as well as pulse strength indicator and plethysmogram. This device is designed to provide full-featured monitoring. capabilities in a lightweight, hand-held design. The system consists of a small hand held monitor with optional infrared linked printer and AC powered battery eliminator. Features include a gas inlet connection, an exhaust gas connection, an SpO2 sensor interface, Ilquid crystal display (LCD), system status LEDs, function keypad, and infrared serial port. The LCD display has an electroluminescent (EL) backlight and displays patient data, waveforms, trends, breath and pulse rate indicators, alarm limit indicators, and messages. The keypad consists of six keys: power, waveform/trend, alarm silence, up and down arrows, and menu/enter. There are three system status LEDs: alarm silence, high and medium/low priority alarms. The infrared serial port is used for data communication with the optional printer.
BCI International N7 W22025 Johnson Road Waukesha, WI 53186-1856 U.S.A. 414-542-3100 Fax: 414-542-3325
1
Patient data can be printed up to every 15 seconds as it is collected or trends can be printed (text only).
Intended Use:
The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It 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 ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximeter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that the BCI 8400 monitor was safe and would perform within the environment(s) for which it is to be marketed.
Safety testing was conducted in accordance with the Reviewer's Guidance for Respiratory Devices, 1993, EN60601-1, and several other international standards for medical devices. The monitor passes all of these tests and met all requirements of the standards.
Environmental testing was performed in accordance with the guidelines and standards found in the Reviewer's Guidance for Respiratory Devices, 1993 and EN60601-1-2. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BCI 8400 monitor complied with the guidelines and standards and that it performed within its specifications and functional requirements.
Testing of device performance included clinical testing of the ETCO2. respiration rate, and SpO2 measurements made by the BCI 8400 monitor. Further performance testing of the capnography parameter was also conducted in accordance with EN 864 (international standard for capnography). In addition, a human factors review and long term alarm test were performed to demonstrate overall device performance. The results demonstrated that the BCI 8400 monitor performed within its specifications.
Comparison testing of the 8400 and the predicate BCI 9000 Capnograph/Oximeter was done to show that the performance of the ETCO2, respiration rate, %SpO2, and heart rate parameters of the two devices are the same. Using simulators, measurements were made by both devices. The tests were run with simulator settings spanning the 8400's entire specification range. All measurements were within the specified tolerances of the monitors and
2
simulators. These data support substantial equivalence of the BCI 8400 monitor to the BCI 9000 monitor.
The testing described above indicate that there is no functional difference between the operation of the BCI 8400 Capnocheck II monitor and the predicate BCI 9000 Capnograph/Oximeter for ETCO2, respiration rate, SpO2, and heart rate measurements. Based on 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
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN ਰੇ
Mr. Donald J. Alexander BCI International N7 W22025 Johnson Road Waukesha, WI 53186
K991086 Re: BCI 8400 Capnocheck® II Capnograph with Pulse Oximeter and Optional External Printer Requlatory Class: II (two) Product Code: 73 CCK March 29, 1999 Dated: Received: March 31, 1999
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 requlation may result in requlatory 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 requlations.
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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 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
Enclosure
5
Indications For Use
510(k) Number (if Known): _
Device Name: BCI Capnocheck® II Monitor. Model 8400, Capnograph with Pulse Oximeter and optional external printer.
Indications For Use:
Intended Use:
The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It 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 ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Arle A. Cialowski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 991086 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use __