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Found 13 results
510(k) Data Aggregation
(48 days)
BCI INTL., INC.
The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO2 and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. The BCI 3402 is not designed or intended to be used as an apnea monitor.
The BCI 3402 Digital Handheld Oximeter monitor is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of an oximeter sensor interface, LED display, front and side keypads, and an infra-red LED printer output port. The device is powered by six "AA" batteries.
The BCI Digital Handheld Oximeter (model 3402) is a pulse oximeter intended for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength in various environments.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy Limits | Not explicitly stated as a separate acceptance criterion, but the performance is measured against a co-oximeter. |
| Statistical Accuracy (SpO2 70-100%) | Standard deviation of 1.49% |
| Correlation (SpO2 entire range, likely 0-100% or 70-100%) | R-squared value of 0.98 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified, but implied to be sufficient for a "clinically controlled desaturation study."
- Data Provenance: The study involved "clinically controlled desaturation studies," which are prospective in nature, as subjects are actively desaturated. The country of origin is not specified but it usually means it was done in the USA since it is submitted in the USA for FDA Approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the study used a "co-oximeter (OSM-3)" to establish the ground truth for blood oxygen levels. The co-oximeter itself serves as the reference standard, and medical professionals would operate and interpret its results, but their specific qualifications are not detailed.
4. Adjudication Method
- Adjudication Method: Not applicable. The ground truth was established by a co-oximeter, which provides objective measurements, rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this device is a standalone medical device for direct measurement, not an AI-assisted diagnostic tool that would typically involve human reader performance comparisons. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the study describes the performance of the BCI 3402 Digital Handheld Oximeter in a standalone capacity. It directly compares the device's measurements to a co-oximeter, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical desaturation studies was established using a co-oximeter (OSM-3). This is an objective laboratory reference method for measuring blood oxygen saturation.
8. Sample Size for the Training Set
- Sample Size for Training Set: This device is a traditional hardware-based pulse oximeter, not an AI/Machine Learning algorithm. Therefore, the concept of a "training set" for an algorithm to learn from is not applicable. Its performance is based on its sensor technology and signal processing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as it's not an AI/ML device. The device's design and calibration would have been based on established engineering principles and validation against reference standards during its development.
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(70 days)
BCI INTL., INC.
The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
The BCI 8400 Capnocheck II monitor performs capnography and pulse oximetry using the same technology as existing legally marketed devices. Capnography data includes end-tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements as well as a respiration breath indicator and ETCO2 waveform. Oximetry data includes functional arterial blood oxygen saturation (%SpO2) and heart rate measurements as well as pulse strength indicator and plethysmogram. This device is designed to provide full-featured monitoring. capabilities in a lightweight, hand-held design. The system consists of a small hand held monitor with optional infrared linked printer and AC powered battery eliminator. Features include a gas inlet connection, an exhaust gas connection, an SpO2 sensor interface, Ilquid crystal display (LCD), system status LEDs, function keypad, and infrared serial port. The LCD display has an electroluminescent (EL) backlight and displays patient data, waveforms, trends, breath and pulse rate indicators, alarm limit indicators, and messages. The keypad consists of six keys: power, waveform/trend, alarm silence, up and down arrows, and menu/enter. There are three system status LEDs: alarm silence, high and medium/low priority alarms. The infrared serial port is used for data communication with the optional printer.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific, quantifiable acceptance criteria. The performance claims are framed as meeting existing standards and matching predicate device performance.
| Parameter/Criterion | Acceptance Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| General Safety | Adherence to recognized medical device safety standards | "The monitor passes all of these tests and met all requirements of the standards (EN60601-1, Reviewer's Guidance for Respiratory Devices, 1993, and other international standards)." |
| Environmental Performance | Adherence to environmental guidelines and standards | "The results demonstrated that the BCI 8400 monitor complied with the guidelines and standards (Reviewer's Guidance for Respiratory Devices, 1993 and EN60601-1-2) and that it performed within its specifications and functional requirements." |
| Electromagnetic Compatibility (EMC) | Compliance with standards | Demonstrated compliance. |
| Electrical Safety | Compliance with standards | Demonstrated compliance. |
| Mechanical Durability | Compliance with standards | Demonstrated compliance. |
| Safety (Operator and Patient) | Compliance with standards | Demonstrated compliance. |
| Temperature/Humidity Performance | Compliance with standards | Demonstrated compliance. |
| Capnography (ETCO2, inCO2, Respiration Rate) | Performance within specifications, equivalence to predicate device. Adherence to EN 864. | "Testing of device performance included clinical testing of the ETCO2, respiration rate, and SpO2 measurements... Further performance testing of the capnography parameter was also conducted in accordance with EN 864... The results demonstrated that the BCI 8400 monitor performed within its specifications." |
| "Comparison testing... showed that the performance of the ETCO2, respiration rate... parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators." | ||
| Pulse Oximetry (%SpO2, Heart Rate) | Performance within specifications, equivalence to predicate device | "Testing of device performance included clinical testing of the ... SpO2 measurements made by the BCI 8400 monitor... The results demonstrated that the BCI 8400 monitor performed within its specifications." |
| "Comparison testing... showed that the performance of the ... %SpO2, and heart rate parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators." | ||
| Human Factors | Acceptable user interaction | "A human factors review... were performed to demonstrate overall device performance." (Implied satisfactory outcome) |
| Long Term Alarm Test | Acceptable long-term alarm functionality | "A long term alarm test were performed to demonstrate overall device performance." (Implied satisfactory outcome) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a numerical sample size for the clinical testing of ETCO2, respiration rate, and SpO2 measurements. It mentions "clinical testing" but provides no further details on the number of patients or measurement points. For the comparison testing using simulators, it states "The tests were run with simulator settings spanning the 8400's entire specification range," but again, no specific number of test points or simulator runs is provided.
- Data Provenance: Not explicitly stated. The company is based in Wisconsin, USA, but no specific country of origin for the "clinical testing" data is given. It is not specified if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are primarily technical and comparison testing against predicate devices or simulators, rather than studies requiring expert ground truth for interpretation (e.g., image analysis for pathology).
4. Adjudication Method for the Test Set:
This information is not provided as the studies are not described in a way that would necessitate an adjudication method among multiple experts. The comparison testing relies on instrument readings against known simulator settings or predicate device readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
An MRMC comparative effectiveness study was not done. This device (BCI Capnocheck II) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a form of standalone performance assessment was done. The device's measurements (ETCO2, respiration rate, SpO2, heart rate) were directly compared against simulator settings and the measurements from predicate devices without human interpretation or intervention as part of the primary performance evaluation. The "clinical testing" mentioned also implies standalone performance of the device on patients, though no detailed results are given beyond "performed within its specifications."
7. The Type of Ground Truth Used:
- Instrument Ground Truth / Defined Standards: For the comparison testing, the "ground truth" was established by simulator settings and the performance of legally marketed predicate devices (BCI 9000 Capnograph/Oximeter).
- Compliance with Industry Standards: For general safety, environmental performance, and capnography parameters, adherence to international standards such as EN60601-1, EN864, and the Reviewer's Guidance for Respiratory Devices, 1993, served as a form of ground truth or benchmark.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The BCI Capnocheck II monitor is described as utilizing "currently available technology found in many legally marketed devices" and does not appear to be an AI/machine learning device that would typically require a training set in the conventional sense. Its design and performance are validated through direct technical testing and comparison to existing, established predicate devices, not via a learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reasons stated in point 8.
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(86 days)
BCI INTL., INC.
The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers, and provides oral or rectal temperature information for neonate through adult patients.
The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.
The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic thermometer, and printer has been updated to include a new neonatal NIBP mode which uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), display of patient NIBP mode via an LED, system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
Here's an analysis of the acceptance criteria and study details for the BCI Mini-Torr Plus (model 6004) with new neonate NIBP mode, based on the provided text:
Acceptance Criteria and Device Performance
The primary acceptance criteria for the new neonatal NIBP mode are derived from the ANSI/AAMI SP10-1992 standard and its 1996 amendment. These standards mandate specific limits for the difference between the device's measurements and a reference standard (arterial line pressure transducer) in terms of mean difference and standard deviation.
| Acceptance Criteria (ANSI/AAMI SP10) | Performance Metric | Reported Device Performance (Mean Difference vs. Arterial Line) | Reported Device Performance (Standard Deviation of Difference) |
|---|---|---|---|
| Mean difference ≤ ±5 mmHg | Systolic Pressure | -0.4 mmHg | 7.6 mmHg |
| Mean difference ≤ ±5 mmHg | Diastolic Pressure | -0.2 mmHg | 5.3 mmHg |
| Mean difference ≤ ±5 mmHg | Mean Arterial Pressure (MAP) | -0.6 mmHg | 5.1 mmHg |
| Std. deviation ≤ 8 mmHg | Systolic Pressure | N/A (criteria for mean difference) | 7.6 mmHg (meets criteria of ≤ 8 mmHg) |
| Std. deviation ≤ 8 mmHg | Diastolic Pressure | N/A (criteria for mean difference) | 5.3 mmHg (meets criteria of ≤ 8 mmHg) |
| Std. deviation ≤ 8 mmHg | Mean Arterial Pressure (MAP) | N/A (criteria for mean difference) | 5.1 mmHg (meets criteria of ≤ 8 mmHg) |
Summary of Device Performance against Acceptance Criteria: The device met all stated acceptance criteria from the ANSI/AAMI SP10 standard for the neonatal NIBP mode.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of individual neonatal patients included in the clinical study is not specified, only that it was conducted on "neonates ranging in size from 0.52 to 8.60 kilograms."
- Data Provenance: The clinical testing was conducted at "two local hospitals." This indicates a prospective, multi-site clinical study. The country of origin is not explicitly stated, but given the submitter's address in Wisconsin, USA, and the referencing of American National Standards (ANSI/AAMI), it is highly probable the data is from the USA.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the NIBP measurements was established by "measurements made from an arterial line pressure transducer." This is an objective, direct physiological measurement. The document does not mention human expert involvement in establishing this specific ground truth for the NIBP readings.
- For the overall study conduct and ethical oversight, "Institutional Review Board (IRB) approvals" were received, indicating expert review of the study protocol.
-
Adjudication method for the test set: Not applicable, as the ground truth for NIBP was a direct physiological measurement from an arterial line, rather than a subjective assessment requiring adjudication.
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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: Not applicable. This study focuses on the accuracy of a physiological measurement device (NIBP monitor) and its algorithms, not on human reader performance with or without AI assistance for interpretation tasks.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, regarding the neonatal NIBP mode, the clinical testing involved comparing the "6004 monitor's algorithm" measurements to arterial line measurements. This represents standalone algorithm performance in the context of a medical device's automated function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The primary ground truth for the neonatal NIBP mode was invasive arterial line pressure transducer measurements. This is a highly accurate and direct physiological measurement often considered a gold standard for blood pressure.
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The sample size for the training set: Not applicable. This document describes a validation study for a medical device feature, not a machine learning model that would typically have a distinct training set. The device utilizes "currently available technology" and its design was updated with "only software...changed" for the neonatal NIBP mode. The development (training) of the underlying NIBP algorithm is not detailed here.
-
How the ground truth for the training set was established: Not applicable, as this documentation pertains to a validation study rather than the development of an algorithm requiring a separate training set description.
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(87 days)
BCI INTL., INC.
The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through adult.
The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.
The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, and printer has been updated to include an additional electronic thermometer option which uses the same technology as existing legally marketed devices. This device is designed to provide full-featured monitoring capabilities in a lightweight, transportable design. The system consists of a small tabletop NIBP monitor with a desktop charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
The provided text describes the BCI Mini-Torr Plus (model 6004) with a new electronic thermometer option. The study aims to demonstrate that the performance of this updated device is substantially equivalent to existing legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (within specified tolerances of monitors and simulators, and ±0.2°F for temperature) | Reported Device Performance (Average difference between predicate and new device) |
|---|---|---|
| Systolic Pressure (NIBP) | Within specified tolerances | -0.14 mmHg |
| Diastolic Pressure (NIBP) | Within specified tolerances | 0.07 mmHg |
| Mean Arterial Pressure (MAP) (NIBP) | Within specified tolerances | 0.07 mmHg |
| Heart Rate (NIBP) | Within specified tolerances | 0 bpm |
| SpO2 (Oximetry) | Within specified tolerances | 0% |
| Heart Rate (Oximetry) | Within specified tolerances | 0 bpm |
| Temperature | Within specified tolerance (±0.2 °F) | -0.04 °F |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size (e.g., number of patients or trials) for the comparison testing. Instead, it mentions:
- NIBP and Oximetry: Measurements were made using "simulators" with settings spanning the 6004's entire specification range. This suggests comprehensive testing across various operational conditions.
- Temperature: Both devices simultaneously measured temperature in a "water bath over their entire specified temperature range (84 - 108 °F)."
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in relation to the device's development, as it describes validation testing performed before seeking regulatory approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This study does not involve human experts to establish ground truth in the traditional sense of diagnostic interpretation. Instead, the ground truth is established by:
- Predicate Devices: The performance of the predicate BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer serves as the reference or "ground truth" against which the new device's performance is compared for substantial equivalence.
- Simulators: For NIBP and oximetry, simulators were used, implying their known and controlled outputs served as the reference.
- Water Bath: For temperature, a water bath with a known temperature range provided the reference.
No human experts were used for adjudication of the test results themselves.
4. Adjudication Method for the Test Set
No human adjudication method (like 2+1, 3+1) was used for this study. The comparison was quantitative, directly comparing measurements from the new device against predicate devices and simulators/controlled environments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This study focuses on direct device performance comparison, not on evaluating human reader improvement with or without AI assistance. The device in question is a physiological monitor, not an AI-powered diagnostic tool.
6. Standalone Performance
Yes, a standalone performance assessment was effectively done. The "new 6004 with temperature option" device was tested independently and its measurements were then compared against established predicate devices and simulators. This assesses the algorithm/device's performance without human intervention in the measurement process.
7. Type of Ground Truth Used
The ground truth for this study was established using:
- Predicate Devices: The established performance and readings of the BCI 6004 NIBP monitor and the Welch Allyn 678 SureTemp Thermometer.
- Simulators: Controlled devices with known outputs for NIBP and Oximetry parameters.
- Controlled Environment: A water bath with a defined temperature range for thermometry testing.
Essentially, the ground truth was based on known and validated performance of existing, legally marketed devices and controlled testing environments.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a medical device validation study focused on demonstrating substantial equivalence, not a machine learning model development study. Therefore, the concept of a training set as typically understood in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, this question is not applicable. The device's design utilizes "currently available technology found in many legally marketed devices," implying established engineering principles and components rather than a data-driven learning approach.
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(87 days)
BCI INTL., INC.
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.
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.
Here's a breakdown of the acceptance criteria and the studies performed for the BCI 9200 Vital Signs Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter Tested | Acceptance Criteria | Reported Device Performance | Study Type | Notes |
|---|---|---|---|---|
| Oximetry (SpO2) | ||||
| 70% - 100% SpO2 | Standard deviation ≤ 2 | Standard deviation = 1.74 | Clinical | R-squared = 0.91 |
| 50% - |
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(79 days)
BCI INTL., INC.
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.
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.
Here's a breakdown of the acceptance criteria and study details for the BCI 3404 Oximeter / ECG Monitor, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Mean Error ± SD) |
|---|---|---|
| Bench Tests | ||
| ECG Rates (beats per minute) | ±2 bpm or ±2% (greater of) | 0 bpm ± 0 bpm |
| Oximetry % SpO2 | ±2% SpO2 (min) | 0.25% ± 0.45% |
| Oximetry Pulse Rate (bpm) | ±2 bpm or ±2% (greater of) | 1.18 bpm ± 0.90 bpm |
| Respiration (breaths per minute) | ±1 bpm or ±5% (greater of) | 0 bpm ± 0 bpm |
| Clinical Tests (Oximetry) | ||
| SpO2 (70% - 100%) | Standard Deviation ≤ 2.0% | 1.8% (Standard Deviation) |
| SpO2 (50% - |
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(29 days)
BCI INTL., INC.
The BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended monitoring of SpO2, pulse rate and pulse strength. The 3401 is a battery powered pulse oximeter with an optional built-in printer. It may be used in the hospital or clinical environment, and during emergency land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult. This device is not intended for continuous patient monitoring. There are no audible or visable patient alarms. The device is not intended for home use.
The BCI 3401 Handheld Pulse Oximeter is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of two major elements. The first is the oximeter featuring the oximeter sensor interface, the LED display, and the keypad. The second element is the optional internal printer. The device is powered by four "AA" batteries.
Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the BCI 3401 Handheld Pulse Oximeter:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of blood oxygen level (SpO2) within a specified range compared to a co-oximeter. | Standard deviation of 1.97% for the measurement range of 70-100%. |
| R-squared value for the accuracy comparison. | R-squared value of 0.96 over the entire measurement range (70-100%). |
| Compliance with established guidelines and standards for respiratory devices (e.g., EMC, electrical, mechanical durability, safety, 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." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinically controlled desaturation studies" and "data collected from the studies," implying a sufficient number of subjects were involved to produce statistically significant results, but no specific human subject count is provided.
- Data Provenance: Prospective. The studies were "clinically controlled desaturation studies," indicating they were conducted specifically to test the device's performance. The location of the studies is not specified (e.g., country of origin).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The ground truth was established by a co-oximeter (OSM-3), which itself is a medical device, not human experts in this context.
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Adjudication method for the test set:
- Not applicable as the ground truth was established by a co-oximeter, not human adjudicators.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The study focused on the device's accuracy against a reference device (co-oximeter), not on comparing human reader performance with and without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is a standalone evaluation of the pulse oximeter's accuracy in measuring SpO2 compared to a co-oximeter. There is no mention of a human-in-the-loop component for the accuracy assessment.
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The type of ground truth used:
- Reference Device/Instrumental: The ground truth for SpO2 measurements was established by a co-oximeter (OSM-3), which is considered a more accurate and reliable method for blood oxygen analysis.
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The sample size for the training set:
- Not applicable. This device is a pulse oximeter that uses established physiological principles and signal processing, not a machine learning model that typically requires a distinct training set. The performance data refers to validation/testing, not training.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning model. The device's operation is based on physical principles, not on "learning" from a dataset in the modern AI sense.
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(85 days)
BCI INTL., INC.
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
This submission describes the BCI 3444 Reusable Finger Sensor, an updated version of an existing finger sensor (BCI 3044), designed to work with BCI oximeters for noninvasive measurement of oxygen saturation (SpO2), pulse rate, and plethysmographic pulse waves.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|
| Standard deviation for SpO2 measurement range of 70-100% ≤ 2 | 1.73 |
| Standard deviation for SpO2 measurement range of 50-69% ≤ 3 | 2.50 |
| Sensor intensity (Red & IR light) | Passed (Performed the same as predicate device) |
| Drop test | Passed |
| 4 kV Hi-Pot test | Passed |
| Surface temperature test | Passed |
| Operational test at extreme temperatures (0°F & 140°F) | Passed |
| Maximum difference in readings when compared to predicate device (3044) | A count of one (maximum difference between 89 sets of measurements) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes two main clinical/comparison studies for the test set:
- Clinically controlled desaturation studies: The sample size for these studies is not explicitly stated as a number of subjects. It mentions "data collected from the studies" but does not quantify the number of subjects or measurements.
- Comparison with predicate device (3044): 89 sets of measurements were compared on subjects. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated, but the context of "clinically controlled desaturation studies" suggests a prospective, controlled clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the clinical studies. Instead, it relies on a co-oximeter (OSM-3) as the reference standard for blood oxygen level measurements during the controlled desaturation studies. Therefore, this section is not applicable as expert review was not the method for ground truth.
4. Adjudication Method for the Test Set
Since a co-oximeter was used as the reference standard and there's no mention of expert review, there was no adjudication method described for the test set. The comparison was statistical against the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's accuracy against a reference standard and its equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The clinical desaturation studies and the comparison with the predicate device represent a standalone assessment of the BCI 3444 sensor (in conjunction with a BCI oximeter). The performance metrics (standard deviation) are for the device system's accuracy as compared to a co-oximeter, without human intervention in interpreting the output of the device under test beyond standard clinical usage.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical desaturation studies was measurement from a co-oximeter (OSM-3), which is a gold standard for blood gas analysis. This is a form of direct physiological measurement providing objective outcome data.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set. This is a medical device submission for an updated sensor, not an AI or machine learning algorithm. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here. The performance evaluation relies on comparing the new device against a predicate and a reference standard.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set (as this is not an AI/ML device), this section is not applicable.
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(253 days)
BCI INTL., INC.
The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer 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 light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.
Here's a breakdown of the acceptance criteria and the study details for the BCI 6004 NIBP Monitor, extracted from the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy (70% - 100% saturation range): Standard deviation of 2.0% or less compared to a co-oximeter. | Standard deviation = 2.0%. |
| **SpO2 Accuracy (50% - |
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(87 days)
BCI INTL., INC.
The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry ootion works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults.
The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122° F (0 to 50° C).
The BCI Capnocheck Plus capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) is an updated version of existing devices 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 capnograph with a wall mount charger. The system features a gas inlet port with moisture trap for the breath sample (sidestream capnograph), an SpO2 probe interface, the FiO2 sensor connector, display of patient data via a VFD display (CO2, SpO2, Pulse Rate, Pulse Strength, FiO2, alarm information), system status LEDs (Battery, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of six keys (STNBY/ON, WAVE/TREND, Up and Down Arrows, MENU/ENTER, & Alarm Silence). The capnograph has a serial printer / pc port that is used for data communication. Three analog output channels are supported on the same connector.
The document describes the BCI Capnocheck® Plus, Model 9004, a capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) monitoring capabilities.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it broadly states that the device was tested to "perform within its specifications and functional requirements" and "in compliance with the guidelines and standards referenced in the reviewers guide for respiratory devices."
However, specific performance claims and results are mentioned, particularly for the oximetry function. These can be inferred as de facto acceptance criteria.
Inferred Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | Perform within specifications and functional requirements. | "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." |
| In compliance with guidelines and standards (EMC, electrical, mechanical durability, safety, temperature/humidity) from the reviewers guide for respiratory 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..." | |
| CO2, RR, SpO2 & HR | Performance comparable to the predicate device (BCI 9000). | "Performance testing between the new 9004 and the predicate 9000 was done to show that the performance of the two devices is the same (CO2, RR, SpO2 & HR). All the results of each parameter of each device were the same or within one count of each other." (This implies a very close match, likely within typical measurement variability). |
| Capnography (CO2) | Accurate response time, accuracy & linearity with humidity, over temperature & at altitude. Resistant to temperature shock, interfering gases. Proper breath rate, contamination, and water trap testing. Appropriate recalibration interval. | "An in-house performance test of the 9004 was run. It tested CO2 response time, accuracy & linearity with humidity & over temperature & at altitude, temperature shock, interfering gases, breath rate, contamination and water trap testing. The testing to determine how often the unit needs to be recalibrated was also completed. The 9004 passed all the tests." (This indicates successful performance across these conditions). |
| FiO2 Function | Accurate over a range of O2 values. | "The FiO2 function was tested with O2 values of 0%, 21%, 60% and 100% oxygen. The 9004 passed all the tests." |
| Pulse Oximetry (SpO2) | Accurately displays patient's blood oxygen level within accuracy limits compared to a co-oximeter. | "Statistically significant accuracy claims," specifically: |
- Standard Deviation (SD) for 70-100% SpO2 range: 2.0
- Standard Deviation (SD) for 50-69% SpO2 range: 2.7
- R-squared value over the entire range: 0.97 (indicating a strong correlation with the co-oximeter) |
Study Details for SpO2 Performance
The most detailed performance study described is for the optional pulse oximetry (SpO2) function.
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Sample Size used for the test set and the data provenance:
- The document states "clinically controlled desaturation studies of the optional oximeter were done." It does not specify the exact sample size (number of subjects).
- The data provenance is clinical, though the specific country of origin is not explicitly stated. The context implies it was likely conducted in the US, given the submission to the FDA. It was a prospective study ("controlled subject desaturation runs").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number of experts or their qualifications for establishing ground truth.
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Adjudication method for the test set:
- The document does not describe an adjudication method. The ground truth seems to be established by the co-oximeter.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study involving human readers comparing AI vs. no-AI assistance was not done. This device is a medical monitoring instrument, not an AI diagnostic tool that assists human readers with interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance study for the SpO2 function (and other parameters) describes the device's standalone performance compared to a reference standard (co-oximeter for SpO2).
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The type of ground truth used:
- For the SpO2 accuracy, the ground truth was comparison to a co-oximeter (OSM-3) during controlled desaturation studies. This is a common and accepted clinical reference standard for blood oxygen saturation.
- For other parameters (CO2, RR, HR, FiO2), the ground truth appears to be based on "in-house performance tests" and comparison to a "predicate 9000" device, implying established laboratory standards and a legally marketed reference device.
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The sample size for the training set:
- This information is not provided. As this is a medical device for monitoring physiological parameters, not a machine learning model, the concept of a "training set" in the context of AI is not directly applicable. The device's algorithms would have been developed and refined through engineering and calibration processes, not data training in the AI sense.
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device in the modern sense of a "training set." Device calibration and algorithm development would typically rely on established physical principles, engineering standards, and potentially in-house testing against known reference values or predicate devices, rather than a "ground truth" derived from a separate dataset for training.
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