(87 days)
None
No
The document describes a standard vital signs monitor with basic signal processing and alarm functions. There is no mention of AI, ML, or any advanced algorithms that would suggest the use of these technologies. The performance studies focus on standard accuracy metrics for vital signs measurements.
No
A vital signs monitor is a diagnostic tool, not a therapeutic device. It measures and displays physiological parameters to assist healthcare professionals in monitoring a patient's condition, but it does not treat or alleviate a disease or condition.
No
The device is a vital signs monitor that measures physiological parameters. While these measurements can contribute to a physician's diagnostic process, the device itself is not indicated to diagnose a condition, but rather to monitor established vital signs.
No
The device description explicitly details hardware components such as interfaces for ECG cables, invasive pressure, temperature, NBP cuff hose, SpO2 probe, an internal printer, a color LCD, LEDs, a rotary control knob, and a function keypad. 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 IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a vital signs monitor used for monitoring physiological parameters (ECG, respiration, NIBP, SpO2, invasive blood pressure, temperature) directly from the patient. IVD devices are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a monitor with interfaces for patient connections (ECG cables, pressure interfaces, cuff hose, SpO2 probe). It does not mention any components or processes related to handling or analyzing biological specimens.
- Performance Studies: The performance studies involve testing the device's ability to accurately measure physiological parameters from volunteers and simulators. They do not involve the analysis of biological samples.
The device is a patient monitoring device, which falls under a different regulatory category than IVD devices.
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). A 2-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 children (pediatric) to adults when using the appropriate BCI accessories.
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. The monitor is not intended for neonatal use.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The BCI 9200 Vital Signs Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, two invasive pressure interfaces, two YSI compatible temparature interfaces, an NBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient and waveform data via a color LCD, system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, zero (IP zero), NIBP start/stop, print start/stop & alarm silence). The monitor has a serial port that is used for data communications.
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
children (pediatric) to adults
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 Tests:
Three devices were tested on simulators to determine performance over the specified range. All of the simulators are commercially available. The device reading is compared to the simulator setting. The parameters tested were: ECG rate, Oximetery % SpO2 & rate, NIBP rate, respiration rate, temperature, and IBP static pressure, systolic, diastolic & mean pressures plus pulse rate.
Clinical Tests:
Oximetry: A deep desaturation test was run on the Newox1P OEM oximeter board (used in the 9200) at the VA Medical Center in Milwaukee under an approved IRB. The oximeter values were compared to an OSM-3 co-oximeter.
Respiration: The repiration values were collected from the 9200 and a BCI 9004 Capnograph (K970209) ( a CO2 gas monitor). The test was conducted at BCI. Thirty one volunteers were tested.
NIBP: A mini-study was conducted at BCI with a 9200 containing the MicroNIBP module. Thirty one volunteers were tested and compared to a single human observer taking a manual NIBP reading at the same time (on the same arm).
Performance Standards:
NIBP: Testing to the ANSVAAMI SP10-1992 standard was conducted under an approved IRB at the VA Medical Center in Milwaukee and at BCI International. Measurements were compared to the average of manual readings. To show the MicroNIBP module and the BCI 6004 NIBP monitor perform the same, the Dynatech Nevada CuffLink NIBP Analyzer as the NIBP simulator was used for a series of readings.
ECG: The 9200 was tested to the requirements of AAMI EC13-1992, including reviews or tests for labeling, operating conditions, overload protection (includes defib tests), risk current (leakage), auxiliary output, respiration, leads-off sensing, active noise suppression, ORS detection, range & accuracy of heart rate meter, alarm system and ECG display capability requirements (including pacemaker).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Testing performed in accordance with the guidelines found in the reviewers guide for respiratory devices and with international safety standards, including EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results demonstrated compliance with the guidelines and standards and that the device performed within its specifications and functional requirements.
Performance testing of the 9200 Vital Signs Monitor and its components were separated into three types of testing: Bench tests, Clinical tests, and performance standards testing.
Bench Tests:
- Three devices tested on simulators.
- All mean differences between device readings and simulator settings were less than one. The 9200 Vital Signs Monitors very closely tracked the simulators for ECG rate, Oximetery % SpO2 & rate, NIBP rate, respiration rate, temperature, and IBP static pressure, systolic, diastolic & mean pressures plus pulse rate.
Clinical Tests:
Oximetry:
- Deep desaturation test on Newox1P OEM oximeter board at VA Medical Center, Milwaukee, under approved IRB.
- Values compared to OSM-3 co-oximeter.
- SpO2 range 70% - 100%: standard deviation = 1.74 (spec = +/- 2).
- SpO2 range 50% -
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
2 5 1998
Image /page/0/Picture/2 description: The image shows the logo for BCI International. The logo consists of a circle made of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font. Below the letters, the word "INTERNATIONAL" is written in a smaller, sans-serif font.
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:
Proprietary Name: Common/Classification Name: Predicate Devices:
May 29, 1998
BCI 9200 Vital Signs Monitor Monitor, Electrocardiograph BCI 6200 Vital Signs Monitor BCI 9100 Multigas Monitor BCI 6004 NIBP Monitor Siemens SC6000 Bedside Monitor
New Device Description:
The BCI 9200 Vital Signs Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, two invasive pressure interfaces, two YSI compatible temparature interfaces, an NBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient and waveform data via a color LCD, system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, zero (IP zero), NIBP start/stop, print start/stop & alarm silence). The monitor has a serial port that is used for data communications.
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), impedance respiration (RSP), noninvasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and two temperature channels (Tl and T2). A 2-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 children (pediatric) to adults when using the appropriate BCI accessories.
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. The monitor is not intended for neonatal use.
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 found in the reviewers guide for respiratory devices and with international safety standards. 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 of the 9200 Vital Signs Monitor and its components were seperated into three types of testing. Bench tests using simulators were used to test each parameter. Clinical tests using volunteers were used to verify performance for respiration, NIBP and oximetry. Two performance standards were used for ECG (ANSI/AAMI EC13) and NIBP (ANSVAAMI SP10).
Bench Tests:
Three devices were tested on simulators to determine performance over the specified range. All of the simulators are commercially available. The device reading is compared to the simulator setting. The parameters tested were: ECG rate, Oximetery % SpO2 & rate, NIBP rate, respiration rate, temperature, and IBP static pressure, systolic, diastolic & mean pressures plus pulse rate. The 9200 Vital Signs Monitors very closely tracked the simulators. All of the mean differences were less than one.
Clinical Tests:
Clinical studies were done on oximetry, respiration and NIBP.
Oximetry:
A deep desaturation test was run on the Newox1P OEM oximeter board (used in the 9200) at the VA Medical Center in Milwaukee under an approved IRB. The oximeter values were compared to an OSM-3 co-oximeter. Over the SpO2 range of 70% - 100% the standard deviation was 1.74 (spec = +/- 2). Over the SpO2 range of 50% -