(85 days)
BCI 3301, 3302 & 3100 Oximeters
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No
The description focuses on standard pulse oximetry technology and does not mention any AI or ML components. The performance studies are based on statistical analysis of standard physiological measurements.
No.
The README states that the device "provides fast, reliable SpO2, pulse rate and pulse strength measurements" and "accurately displays the patient's blood oxygen level". This indicates that it is a diagnostic/monitoring device, not a therapeutic one.
Yes
The device measures SpO2, pulse rate, and pulse strength, which are physiological parameters used to assess a patient's health status and can indicate disease or injury. The information is used for continuous patient monitoring, allowing for the detection of abnormal conditions, which is a diagnostic function. The performance studies also involve comparing its measurements to a co-oximeter for blood oxygen levels, further supporting its diagnostic utility.
No
The device description clearly outlines hardware components such as a table top oximeter, wall mount charger, LED display, system status LEDs, and a function keypad area. It also mentions an SpO2 probe interface and various ports. This indicates it is a hardware 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 describes measuring physiological parameters (SpO2, pulse rate, pulse strength) directly from a patient. IVDs 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 a pulse oximeter that interfaces with a probe placed on the patient. It does not mention handling or analyzing biological specimens.
- Performance Studies: The performance studies involve clinical desaturation studies on human subjects, comparing the device's readings to a co-oximeter (which measures oxygen saturation in blood, but the device itself is not analyzing the blood sample). This is consistent with a non-IVD device that measures physiological parameters.
Therefore, the BCI 3304 pulse oximeter is a medical device used for patient monitoring, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104° F (0 to 40° C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals
Product codes
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Device Description
The new BCI 3304 pulse oximeter is an updated version of existing pulse oximeters legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence, Alarm Volume, Pulse Volume). The oximeter has a printer / pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
all patients from neonate to adult.
Intended User / Care Setting
hospital or clinical environment, during emergency air or land transport and in the home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Additionally, clinically controlled desaturation studies were done to demonstrate that the 3304 accurately displays the patient's blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs.
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. 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 and standards found in the reviewers guide for respiratory devices. 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.
Additionally, clinically controlled desaturation studies were done to demonstrate that the 3304 accurately displays the patient's blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs. The results from the clinical studies support the accuracy claims of the device, with a standard deviation of 1.92 for the measurement range of 70-100% and 2.31 for the range of 50-69%. The R squared value was 0.978 over the entire range. (R squared - measure of how true the regression line is. R squared = 1 is a perfect fit.) On the basis of these results and the above-referenced testing it is our determination that the device is safe, effective, and performs as well as or better than the legally marketed predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
standard deviation of 1.92 for the measurement range of 70-100% and 2.31 for the range of 50-69%. The R squared value was 0.978 over the entire range.
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.
BCI 3301, 3302 & 3100 Oximeters
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Summary of Safety and Effectiveness
| Submitter: | BCI International, Inc. |
|---|---|
| Address: | W238 N1650 Rockwood Drive |
| Waukesha, WI 53188 | |
| Telephone: | (414) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | May 31, 1996 |
| Proprietary Name: | 3304 Pulse Oximeter |
| Common/Classification Name: | Pulse Oximeter |
| Predicate Devices: | BCI 3301, 3302 & 3100 Oximeters |
New Device Description:
The new BCI 3304 pulse oximeter is an updated version of existing pulse oximeters legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence, Alarm Volume, Pulse Volume). The oximeter has a printer / pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
Intended Use:
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104° F (0 to 40° C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals
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 and standards found in the reviewers guide for respiratory devices. 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.
Additionally, clinically controlled desaturation studies were done to demonstrate that the 3304 accurately displays the patient's blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs. The results from the clinical studies support the accuracy claims of the device, with a standard deviation of 1.92 for the measurement range of 70-100% and 2.31 for the range of 50-69%. The R squared value was 0.978 over the entire range. (R squared - measure of how true the regression line is. R squared = 1 is a perfect fit.) On the basis of these results and the above-referenced testing it is our determination that the device is safe, effective, and performs as well as or better than 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 Alexand
Donald Alexander VP Regulatory Affairs