(79 days)
BCI 3304 Pulse Oximeter, BCI 3100 Oximeter / ECG Monitor, Siemens SC6000 Bedside Monitor
No
The document describes a standard vital signs monitor with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: The device is a monitor that primarily measures and displays physiological parameters (SpO2, pulse rate, respiration rate, plethysmogram, ECG waveforms) and provides alarms. It is used for diagnostic purposes and continuous monitoring, rather than directly treating a disease or condition.
Yes
The device continuously monitors and displays physiological parameters such as oxygen saturation (SpO2), pulse rate, respiration rate, and ECG waveforms, which are used to evaluate or determine a patient's health status.
No
The device description explicitly details hardware components such as an ECG cable interface, SpO2 probe interface, display, power status LED, function keypad, and a serial port. This indicates it is a physical medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BCI 3404 Monitor is a non-invasive monitoring device that measures physiological parameters directly from the patient's body (SpO2, pulse rate, respiration rate, ECG). It does not analyze samples taken from the body.
Therefore, based on the provided information, the BCI 3404 Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport.
The device will provide fast, reliable measurements on patients ranging from pediatric to adult 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
DQA
Device Description
The BCI 3404 Oximeter / ECG 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, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.
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
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.
Oximetry Clinical Tests: A deep desaturation test was run on the 3404 oximeter at the VA Medical Center in Milwaukee under an approved IRB. The oximeter values were compared to an OSM-3 co-oximeter.
Respiration Clinical Tests: The respiration values were collected from the 3404 and a BCI 9004 Capnograph (K970209) (a CO2 gas monitor). The test was conducted at BCI. Thirty volunteers were tested. Three readings were recorded from each subject; at rest, right after heavy exercise (bike) and after a cool down period.
ECG Performance Standard: The 3404 was tested to the requirements of AAMI EC13-1992. These requirements included 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)
Bench Tests:
- ECG Rates: Range 30 to 254 bpm, Mean Error 0, Standard Deviation 0. Tested 3 lead and 5 lead modes vs all leads at multiple amplitude settings spec ±2 bpm or ±2% (greater of).
- Oximetry % SpO2: Range 50 to 100%, Mean Error 0.25, Standard Deviation 0.45.
- Oximetry Pulse rate (bpm): Range 30 to 250, Mean Error 1.18, Standard Deviation 0.90. Spec oximetery ±2% SpO2 (min), rate ±2 bpm or ±2% (greater of).
- Repiration breaths per minute: Range 4 to 150, Mean Error 0, Standard Deviation 0. Spec breath rate ±1 bpm or ±5% (greater of).
Results: The 3404 monitors very closely tracked the simulators. The maximum mean differences was 1.18 for SpO2 pulse rate, all other values were less than one.
Clinical Tests:
- Oximetry: Deep desaturation test. Over the SpO2 range of 70% - 100% the standard deviation was 1.8 (spec = +/- 2). Over the SpO2 range of 50% -
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
AUG 20 1998
ATIONAL
Image /page/0/Picture/1 description: The image shows the date August 26, 1998, in a simple, sans-serif font. The text is black against a white background. Below the date is a logo that is black and white.
Summary of Safety and Effectiveness
Submitter: Address:
Telephone: Contact:
Prepared:
Proprietary Name: Common/Classification Name: Predicate Devices:
BCI International, Inc. W238 N1650 Rockwood Drive Waukesha, WI 53188
(414) 542-3100 VP Regulatory Affairs
May 29, 1998
BCI 3404 Oximeter / ECG Monitor Pulse Oximeter BCI 3304 Pulse Oximeter BCI 3100 Oximeter / ECG Monitor Siemens SC6000 Bedside Monitor
New Device Description:
The BCI 3404 Oximeter / ECG 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, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.
Intended Use:
The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport. The device will provide fast, reliable measurements on patients ranging from pediatric to adult 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 3404 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 and oximetry. A performance standard was used for ECG (ANSI/AAMI EC13).
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.
| Parameter | Range | Mean Error | Standard Deviation |
|---|---|---|---|
| ECG Rates | |||
| beats per minute | 30 to 254 | 0 | 0 |
| Tested 3 lead and 5 lead modes vs all leads at multiple amplitude settings spec ±2 bpm or ±2% (greater of) | |||
| Oximetry | |||
| % SpO2 | 50 to 100% | 0.25 | 0.45 |
| Oximetry | |||
| Pulse rate (bpm) | 30 to 250 | 1.18 | 0.90 |
| spec oximetery ±2% SpO2 (min), rate ±2 bpm or ±2% (greater of) | |||
| Repiration | |||
| breaths per minute | 4 to 150 | 0 | 0 |
| spec breath rate ±1 bpm or ±5% (greater of) |
As the tables show the 3404 monitors very closely tracked the simulators. The maximum mean differences was 1.18 for SpO2 pulse rate, all other values were less than one.
2
Clinical Tests:
Clinical studies were done on oximetry and respiration
Oximetry:
A deep desaturation test was run on the 3404 oximeter 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 1.8 (spec = +/- 2). Over the SpO2 range of 50% -