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.

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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific, quantifiable acceptance criteria. The performance claims are framed as meeting existing standards and matching predicate device performance.

Parameter/Criterion	Acceptance Criteria (Implicit from text)	Reported Device Performance
General Safety	Adherence to recognized medical device safety standards	"The monitor passes all of these tests and met all requirements of the standards (EN60601-1, Reviewer's Guidance for Respiratory Devices, 1993, and other international standards)."
Environmental Performance	Adherence to environmental guidelines and standards	"The results demonstrated that the BCI 8400 monitor complied with the guidelines and standards (Reviewer's Guidance for Respiratory Devices, 1993 and EN60601-1-2) and that it performed within its specifications and functional requirements."
Electromagnetic Compatibility (EMC)	Compliance with standards	Demonstrated compliance.
Electrical Safety	Compliance with standards	Demonstrated compliance.
Mechanical Durability	Compliance with standards	Demonstrated compliance.
Safety (Operator and Patient)	Compliance with standards	Demonstrated compliance.
Temperature/Humidity Performance	Compliance with standards	Demonstrated compliance.
Capnography (ETCO2, inCO2, Respiration Rate)	Performance within specifications, equivalence to predicate device. Adherence to EN 864.	"Testing of device performance included clinical testing of the ETCO2, respiration rate, and SpO2 measurements... Further performance testing of the capnography parameter was also conducted in accordance with EN 864... The results demonstrated that the BCI 8400 monitor performed within its specifications." "Comparison testing... showed that the performance of the ETCO2, respiration rate... parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators."
Pulse Oximetry (%SpO2, Heart Rate)	Performance within specifications, equivalence to predicate device	"Testing of device performance included clinical testing of the ... SpO2 measurements made by the BCI 8400 monitor... The results demonstrated that the BCI 8400 monitor performed within its specifications." "Comparison testing... showed that the performance of the ... %SpO2, and heart rate parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators."
Human Factors	Acceptable user interaction	"A human factors review... were performed to demonstrate overall device performance." (Implied satisfactory outcome)
Long Term Alarm Test	Acceptable long-term alarm functionality	"A long term alarm test were performed to demonstrate overall device performance." (Implied satisfactory outcome)

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

Sample Size: The document does not explicitly state a numerical sample size for the clinical testing of ETCO2, respiration rate, and SpO2 measurements. It mentions "clinical testing" but provides no further details on the number of patients or measurement points. For the comparison testing using simulators, it states "The tests were run with simulator settings spanning the 8400's entire specification range," but again, no specific number of test points or simulator runs is provided.
Data Provenance: Not explicitly stated. The company is based in Wisconsin, USA, but no specific country of origin for the "clinical testing" data is given. It is not specified if the data was retrospective or prospective.

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

This information is not provided in the document. The studies described are primarily technical and comparison testing against predicate devices or simulators, rather than studies requiring expert ground truth for interpretation (e.g., image analysis for pathology).

4. Adjudication Method for the Test Set:

This information is not provided as the studies are not described in a way that would necessitate an adjudication method among multiple experts. The comparison testing relies on instrument readings against known simulator settings or predicate device readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study was not done. This device (BCI Capnocheck II) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

Yes, a form of standalone performance assessment was done. The device's measurements (ETCO2, respiration rate, SpO2, heart rate) were directly compared against simulator settings and the measurements from predicate devices without human interpretation or intervention as part of the primary performance evaluation. The "clinical testing" mentioned also implies standalone performance of the device on patients, though no detailed results are given beyond "performed within its specifications."

7. The Type of Ground Truth Used:

Instrument Ground Truth / Defined Standards: For the comparison testing, the "ground truth" was established by simulator settings and the performance of legally marketed predicate devices (BCI 9000 Capnograph/Oximeter).
Compliance with Industry Standards: For general safety, environmental performance, and capnography parameters, adherence to international standards such as EN60601-1, EN864, and the Reviewer's Guidance for Respiratory Devices, 1993, served as a form of ground truth or benchmark.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The BCI Capnocheck II monitor is described as utilizing "currently available technology found in many legally marketed devices" and does not appear to be an AI/machine learning device that would typically require a training set in the conventional sense. Its design and performance are validated through direct technical testing and comparison to existing, established predicate devices, not via a learning algorithm.

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

This information is not applicable/provided for the same reasons stated in point 8.

Summary

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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 RoadWaukesha, 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 optionalprinter.
Predicate Devices:	BCI 8200 Capnometer (K941982)BCI 9000 Capnograph (K873856)BCI 9004 Capnograph (K970209)

New Device Description:

BCI International N7 W22025 Johnson Road Waukesha, WI 53186-1856 U.S.A. 414-542-3100 Fax: 414-542-3325

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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

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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

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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,

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

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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:

( 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

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use __

Regulation Number and Section

§ 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).