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). Capnography (ETCO2, inCO2, RR), a two-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 neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.

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.

Device Description

The BCI 9200 vital signs monitor has been updated to include a new capnography option. This new feature uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a table top design. The full system features an ECG cable interface, two invasive pressure interfaces, two YSI 400/700 compatible temperature interfaces, an NIBP cuff hose connection, an SpO2 sensor interface, a capnography tubing interface and filters, an internal printer, display of patient and waveform data via a color liquid crystal display (LCD), system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, IP zero, NIBP start/stop, print start/stop and alarm silence). The monitor has analog and serial output ports that are used for data communications to personal computers, printers, chart recorders, or the Life Sensing Instrument Company, Inc. HTS 820 Central Station.

AI/ML Overview

The provided text describes the BCI 9200 vital signs monitor with a new capnography option. The document is a 510(k) summary of safety and effectiveness, indicating the device's substantial equivalence to predicate devices. While it states that performance testing was conducted, it does not explicitly provide a table of acceptance criteria and reported device performance for specific metrics or a detailed study section with the requested information.

However, based on the type of device (a vital signs monitor with capnography) and the nature of the document (a 510(k) submission primarily focused on substantial equivalence), we can infer certain aspects of the testing and the kind of information that would typically be gathered for such a device, even if the specific numerical data isn't present in this summary.

Here's a breakdown of what can be gleaned and what is explicitly missing from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not include a specific table of acceptance criteria and reported device performance values (e.g., accuracy, precision, bias for ETCO2 or respiration rate). It generically states:

"The results demonstrated that the BC10 9200 vital signs monitor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements."
"The results demonstrated that the BCI® 9200 vital signs monitor performed within its specifications."

For capnography devices, typical performance metrics would include accuracy of ETCO2 measurement (e.g., ± 2 mmHg or 10% of reading, whichever is greater, within a specified range), accuracy of respiration rate (e.g., ± 1 breath per minute), rise time, and drift. While these are implied to have been met, the specific values are not presented.

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: The document mentions "clinical testing of the ETCO2 and respiration rate measurements" and "bench and clinical tests" for the capnography feature. However, it does not specify the sample size (number of patients, number of measurements) used for these clinical tests.
Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (United States), it is highly probable the clinical tests, if performed, included data from the United States, but this is not confirmed. It is a prospective study implied for the clinical testing of the new capnography option, as it's part of the premarket submission for a new feature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. For a vital signs monitor, ground truth for parameters like ETCO2 and respiration rate in clinical tests would typically be established using a reference standard device (e.g., another highly accurate and calibrated capnograph or a spirometer for respiration rate), not necessarily human experts in the same way, for direct physiological measurements. If "experts" were involved, it would likely be in setting up and validating the reference standard, or in clinical assessment, but this is not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Adjudication methods are more common in subjective assessment (e.g., image interpretation) or when there's ambiguity in ground truth. For physiological measurements like capnography, performance is usually assessed against a "gold standard" or reference device, rather than through expert adjudication of the results themselves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: An MRMC comparative effectiveness study is not applicable to this device. This type of study is relevant for diagnostic imaging interpretation where human readers (e.g., radiologists) use AI assistance to interpret images. The BCI 9200 is a vital signs monitor, and the capnography feature provides direct physiological measurements, not interpretations requiring human reader input with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, standalone performance for the device's capnography measurements (ETCO2 and respiration rate) was implicitly and explicitly done. The document states:
- "Testing of device performance included clinical testing of the ETCO2 and respiration rate measurements made by the BC10 9200 vital signs monitor."
- "Further performance testing of the capnography parameter was also conducted in accordance with EN 864 (international standard for capnography)."
- "The results demonstrated that the BCI® 9200 vital signs monitor performed within its specifications."
These statements confirm that the device's ability to measure these parameters was evaluated as an algorithm/device-only function. The "human-in-the-loop" aspect for this type of device primarily involves clinicians using the measurements, not interpreting raw data generated by the device to produce a measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the clinical and bench testing of the capnography feature would have been established using reference standard devices or methods known to be highly accurate for measuring ETCO2 and respiration rate. The document mentions "Comparison of the new capnography feature was made to BCI® 9000 monitor's capnography function using both bench and clinical tests." This suggests the predicate device (BCI 9000's capnography function) might have served as a reference standard, or another validated reference system as per EN 864 standard.

8. The sample size for the training set:

This information is not applicable and not provided. The BCI 9200 monitor with its capnography option is not described as an AI/machine learning device that requires a training set in the conventional sense. Its function is based on established physiological measurement principles and signal processing, not on learning from a large dataset to make predictions or classifications.

9. How the ground truth for the training set was established:

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

Summary

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Image /page/0/Picture/0 description: The image shows a logo with a circular design on the left and the letters 'BCI' on the right. The circular design consists of vertical lines that are closely spaced together. The letters 'BCI' are in a bold, sans-serif font, with a small dot above and to the right of the 'I'. The logo appears to be for a company or organization with the initials 'BCI'.

AUG 1 9 2003

Summary of Safety and Effectiveness

Submitter:	BCI, Inc.
Address:	N7 W22025 Johnson RoadWaukesha, WI 53186
Telephone:	(262) 542-3100
Contact:	VP Regulatory Affairs
Prepared:	January 31, 2003
Proprietary Name:	BCIT™ Advisor® vital signs monitor (model 9200) with new capnography option.
Common/Classification Name:	Vital signs monitor
Predicate Devices:	BCIT™ 9200 vital signs monitor (K982279, K010770, K011177)BCITM 9004 monitor (K970209)BCIT™ 9000 monitor (K873856)

New Device Description:

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

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Image /page/1/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle made up of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font on the right. There is a small dot to the right of the "I". The logo is black and white.

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). Capnography (ETCO2, inCO2, RR), a two-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 neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.

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.

Performance Data:

The design of this device utilizes currently available technology found in many legally marketed devices. Both hardware and software changes were made to the device. Testing was done to ensure that BC10 9200 vital signs monitor was safe and would perform within the environments for which it is to be marketed.

Testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BC10 9200 vital signs monitor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements.

Tests were performed to show substantial equivalence of the new device to the predicate devices. Comparison of the new capnography feature was made to BCI® 9000 monitor's capnography function using both bench and clinical tests. Comparisons of all other parameters were made with the previous BCI® 9200 vital signs monitor using bench tests.

Testing of device performance included clinical testing of the ETCO2 and respiration rate measurements made by the BC10 9200 vital signs 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® 9200 vital signs monitor performed within its specifications.

A full software validation test of the BC1® 9200 vital signs monitor with new capnography option was completed. These tests showed that the device modifications operate as intended and that the changes made do not compromise the overall performance of the monitor.

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Image /page/2/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle made of vertical lines on the left and the letters BCI in bold black font on the right. There is a small black dot to the right of the I.

On the basis of 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BCI, Inc. c/o Mr. Donald J. Alexander VP Regulatory Affairs N7 W22025 Johnson Road Waukesha, WI 53186

Re: K030407

Trade Name: BCI™ Advisor® Vital Signs monitor (model 9200) with new capnography option Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon-Dioxide Gas Analyzer, Gaseous-Phase Regulatory Class: Class II (two) Product Code: CCK Dated: June 6, 2003 Received: June 9, 2003

Dear Mr. Alexander:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Donald J. Alexander

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Indications For Use

K030407 510(k) Number (if known):

Device Name: BCI 9200 Vital Signs Monitor with Capnography.

Indications For Use:

Intended Use

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.

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hacerta

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K030407

Prescription Use
X
(Per 21 CFR 801.109)

Over-The Counter Use

605.000

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).