(193 days)
Not Found
No
The document describes a standard vital signs monitor with various physiological parameter measurements and does not mention any AI or ML capabilities. The testing described focuses on standard performance, safety, and equivalence to predicate devices.
No
The device is described as a vital signs monitor, intended for monitoring various physiological parameters (ECG, respiration, NIBP, SpO2, invasive pressures, temperature, capnography) and providing alarms. It does not actively treat or prevent a disease, nor does it restore, modify, or correct body function; rather, it provides information about a patient's status.
No
A vital signs monitor measures physiological parameters and provides real-time data, but it does not diagnose a medical condition.
No
The device description clearly outlines numerous hardware components including interfaces for ECG cables, pressure sensors, temperature sensors, NIBP cuffs, SpO2 sensors, capnography tubing, an internal printer, an LCD display, LEDs, a rotary control knob, and function keys. The performance studies also mention testing of electrical, mechanical, and hardware-related aspects.
Based on the provided text, the BCI 9200 vital signs monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters directly from the patient (ECG, respiration, blood pressure, SpO2, temperature, capnography). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details connections for patient sensors and interfaces, not for handling or analyzing biological specimens.
- Lack of Mention of Specimen Analysis: There is no mention of the device analyzing any type of biological sample.
Therefore, the BCI 9200 vital signs monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
CCK
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.
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
patients ranging from neonate to adults.
The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring.
Intended User / Care Setting
ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic.
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
Bench and clinical tests were used to compare the new capnography feature to the BCI 9000 monitor's capnography function.
Bench tests were used to compare all other parameters with the previous BCI 9200 vital signs monitor.
Clinical testing was performed for the ETCO2 and respiration rate measurements.
Further performance testing of the capnography parameter was conducted in accordance with EN 864.
A human factors review and long term alarm test were performed.
A full software validation test of the BC1 9200 vital signs monitor with new capnography option was completed.
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
BCIT™ 9200 vital signs monitor (K982279, K010770, K011177),BCITM 9004 monitor (K970209),BCIT™ 9000 monitor (K873856)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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 Road |
| Waukesha, 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:
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.
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
l
1
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.
2
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
3
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.
4
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
5
Indications For Use
K030407 510(k) Number (if known):
Device Name: BCI 9200 Vital Signs Monitor with Capnography.
Indications For Use:
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 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.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
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