(644 days)
The BTNeo System is indicated for measurement of a neonate's brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature.
The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.
The BrainTemp Neonate (BTNeo) System is an external brain temperature measurement system that measures temperature at a depth of approximately 2.0 cm below the forehead sensor. The device system consists of the following components:
- . Sensor: Used to measure temperature of the brain beneath the sensor. Single-use and affixed to the patient's forehead via medical grade adhesive.
- 0 Sensor Connector: Connects the system to the disposable sensor.
- Cable with In-line Radiometer with Switch Module: Converts sensor readings to brain . temperature measurements via a proprietary algorithm.
- . Display Interface: Connected to the Radiometer and displays brain temperature data and warning lights. There is an optional connection to a compatible vital sign monitor for display of brain temperature data in comparison to core body temperature.
The provided text describes the BTNeo System, a brain temperature measurement device for neonates, and the studies conducted to support its De Novo classification. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BTNeo System are primarily outlined under the "Special Controls" section, which details the performance requirements for such a device. The "Performance Testing - Bench" and "Performance Testing - Animal" sections describe the studies conducted to meet these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Study Description |
|---|---|---|
| In vivo performance | Device performs as intended for anticipated conditions of use and can accurately and reliably measure brain temperature compared to a ground truth measurement. | A Good Laboratory Practices (GLP) animal study using a weanling porcine model (n=3 piglets) was conducted. The device's performance was compared to an invasive brain temperature probe inserted approximately 2 cm below the skin surface in a cerebral hemisphere. The study involved warming and cooling procedures to demonstrate accurate measurement of brain temperature changes. The correlation between the invasive brain probe and the device was 0.97. |
| Non-clinical performance | Device can accurately measure changes in brain temperature under simulated conditions of use. Testing must assess repeatability within pre-specified, clinically relevant parameters. Technical specifications of hardware and software must be fully characterized. | Testing was conducted in accordance with IEC 80601-2-56: 2017. This involved evaluation across the operating temperature range (low, middle, high) and over a 24-hour use period using a phantom model (adult human scapula covered with synthetic pediatric skin) and an antenna simulator. The running average of measurements met the criteria of accuracy within ± 0.3 °C per Clause 201.101.2 of the standard for each test run. |
| Electrical Safety | Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility (EMC) testing must be performed. | The system was tested and passed according to ANSI/AAMI ES 60601-1-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 61000-4-39:2017, and IEC 60601-1-8/AMD1:2012. |
| Software Documentation | Software documentation must include a detailed technical description of the algorithm(s) and be accompanied by verification and validation testing to ensure device and algorithm functionality, as informed by software requirements and hazard analysis. | Software verification and validation testing and documentation were provided according to FDA guidance. The device was determined to have a moderate level of concern. Documentation confirmed proper operation, and hazard analysis addressed potential risks. Cybersecurity documentation was also provided and included hazard analysis and mitigation. |
| Biocompatibility | The tissue-contacting device components must be demonstrated to be biocompatible. | Cytotoxicity testing (ISO 10993-5) and sensitization and irritation testing (ISO 10993-10) were conducted for the sensor component, which contacts intact skin for a prolonged duration. |
| Usability Evaluation | Usability evaluation must demonstrate that the intended user(s) can safely and correctly use the device, based solely on reading the directions for use. | Testing and evaluation conformed to IEC 60601-1-6: 2010+A1:2013, covering key use characteristics like sensor placement and re-application. All defined success criteria were met, supporting basic safety and essential performance. Peer-reviewed literature also supported the use of silicone adhesive on neonates. |
| Labeling | Labeling must include instructions for use, warnings (e.g., not for core temp, conditions impacting accuracy, skin injury risk, limitations for diagnosis/therapy), and summaries of in vivo testing (description of device outputs, study population/environment, data collection methods, observed adverse events/complications). | The labeling was deemed sufficient, satisfying 21 CFR 801.109. It includes device description, indications, contraindications, warnings (including those specified in the acceptance criteria, such as not for core temp, not for diagnosis/therapy, and skin integrity), precautions, and instructions for use. Summaries of the animal study findings are also included. |
Study Details for Device Performance
2. Sample Size and Data Provenance
- Test Set Sample Size: 3 weanling piglets (animal study).
- Data Provenance: The animal study was a prospective GLP (Good Laboratory Practices) study conducted in an animal model (weanling porcine). The country of origin for the study is not explicitly stated in the provided text, but it's an animal study rather than human clinical data.
3. Number of Experts and Qualifications for Ground Truth
- The ground truth for the animal study (invasive brain temperature probe) was established by direct physical measurement using a thermocouple inserted approximately 2 cm below the skin surface into a cerebral hemisphere. This method inherently serves as the expert-established ground truth for brain temperature within that model.
- The text does not mention the need for or involvement of "experts" in the traditional sense (e.g., radiologists) to interpret images or reach a consensus for ground truth determination, as this was a direct physical measurement study. The expertise would lie in the veterinary and research staff conducting the GLP animal study. Their specific qualifications are not detailed beyond the study being GLP-compliant.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1) was applicable or mentioned, as the ground truth was established by direct physical measurement (invasive thermocouple) in the animal model, not through expert review or consensus of subjective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study involving human readers comparing AI-assisted vs. non-AI-assisted performance was done or mentioned. The device is a direct measurement system, not an AI-driven image analysis or diagnostic aid that would typically involve human reader studies.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance evaluation of the device's accuracy was a primary objective of both the bench testing and the animal study.
- Bench testing: The device's running average met the criteria of ± 0.3 °C deviation from the reference temperature in the phantom model.
- Animal study: The device's output (YSI Out) was directly compared to the invasive thermocouple, demonstrating a correlation of 0.97. This shows the algorithm's ability to measure brain temperature independently.
7. Type of Ground Truth Used
- Bench Study: The ground truth was a precisely controlled and known temperature established by the testing apparatus in the phantom model, adhering to an international standard (IEC 80601-2-56: 2017).
- Animal Study: The ground truth was invasive direct measurement using a thermocouple placed approximately 2 cm below the skin surface into a cerebral hemisphere in a live animal model. This serves as the "gold standard" or "outcome data" for brain temperature in that experimental setup.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning model development. This device likely relies on a physics-based or empirically derived algorithm rather than a machine learning model that would require a separate training dataset. The "training" of the device's performance would have occurred through the calibration and development process, which is not detailed as a separate data set in this
document.
9. How Ground Truth for Training Set Was Established
- As indicated in point 8, a distinct "training set" with ground truth in the context of machine learning is not described. The device's algorithm would have been developed and refined through engineering and calibration processes, likely based on scientific principles and empirical data from laboratory experiments (similar to the described bench studies) and potentially early animal model work, but this is not presented as a specific "training set" with corresponding ground truth establishment details.
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DE NOVO CLASSIFICATION REQUEST FOR BRAINTEMP NEONATE SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Brain temperature measurement system. A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
NEW REGULATION NUMBER: 21 CFR 882.1565
CLASSIFICATION: Class II
PRODUCT CODE: QSL
BACKGROUND
DEVICE NAME: BrainTemp Neonate (BTNeo) System
SUBMISSION NUMBER: DEN200042
DATE DE NOVO RECEIVED: June 26, 2020
SPONSOR INFORMATION:
BrainTemp Inc. P.O. Box 823 Bryn Mawr, PA 19010
INDICATIONS FOR USE
The BTNeo System is indicated for measurement of a neonate's brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature.
The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
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The safety and effectiveness of the BTNeo System to inform diagnosis or therapy has not been evaluated.
The device is not intended for use in neonates less than 35 weeks gestational age.
The device is not intended for use in neonates that do not have intact skin for sensor placement.
The device is not intended to measure core body temperature.
Sensor accuracy may be reduced if the sensor or radiometer are placed in direct contact with an active temperature management device.
Sensor accuracy may be reduced if there is anything (e.g., hair, tape) between the sensor and the skin.
The device has been validated in a laboratory study to measure the brain temperature at a depth of approximately 2 cm below the external forehead sensor. The safety and effectiveness of the device measurement at other depths of the brain has not been evaluated or demonstrated.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The BrainTemp Neonate (BTNeo) System is an external brain temperature measurement system that measures temperature at a depth of approximately 2.0 cm below the forehead sensor. The device system consists of the following components:
- . Sensor: Used to measure temperature of the brain beneath the sensor. Single-use and affixed to the patient's forehead via medical grade adhesive.
- 0 Sensor Connector: Connects the system to the disposable sensor.
- Cable with In-line Radiometer with Switch Module: Converts sensor readings to brain . temperature measurements via a proprietary algorithm.
- . Display Interface: Connected to the Radiometer and displays brain temperature data and warning lights. There is an optional connection to a compatible vital sign monitor for display of brain temperature data in comparison to core body temperature.
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Image /page/2/Figure/0 description: The image shows a medical device with several components labeled. There is a "Sensor Connector" attached to a cable, a "Disposable Sensor", a "Display Interface" showing the number 37.0, and a "Radiometer". The device appears to be a type of medical sensor or monitoring equipment.
Figure 1: BTNeo System Components
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY
The sensor component of the BTNeo System is a surface device contacting intact skin for a prolonged duration (> 24 hours to 30 days) based on cumulative use. The following testing was conducted to assess the biocompatibility of the tissue-contacting components of the device:
- . Cytotoxicity testing in accordance with ISO 10993-5, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity."
- Sensitization and irritation testing in accordance with ISO 10993-10, "Biological . evaluation of medical devices - Part 10: Tests for irritation and skin sensitization."
ELECTROMAGNETIC COMPATIBILITY (EMC) AND ELECTRICAL SAFETY
The BTNeo System was tested in accordance with the following consensus standards and passed the following EMC, immunity, electrical, mechanical, and thermal safety tests.
| Standard | Name |
|---|---|
| ANSI/AAMI ES 60601-1-1:2005/(R)2012 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Section 2:Collateral Standard: Electromagnetic |
Table 1. EMC and Electrical Safety Testing Completed for the BTNeo System
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| Standard | Name |
|---|---|
| IEC 61000-4-39:2017 | Compatibility - Requirements and TestsMedical Electrical Equipment - Part 4-39: Testingand Measurement Techniques - Radiated Fields inClose Proximity, Magnetic Field, 10-150 kHz |
| IEC 60601-1-8/AMD1:2012 | Medical Electrical Equipment - Part 1-8: GeneralRequirements for Safety - Section 8:Collateral Standard: General Requirements, Tests,and Guidance for Alarm Systems in MedicalElectrical Equipment and Medical ElectricalSystems |
SOFTWARE/CYBERSECURITY
Software verification and validation testing and documentation was provided according to the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Per this guidance, the BTNeo System was determined to have a moderate level of concern. Documentation describing the firmware, software specifications, architecture design, software development environment, traceability, revision level history, and unresolved anomalies conclude that the software will operate in the manner described in the specifications. The hazard analysis characterized software and cybersecurity risks. including device malfunction, measurement-related errors. sensor, cable and other hardware failures, and unauthorized access by malicious end users during manufacturing. The submission describes verification and validation testing to address the potential hazards with satisfactory results.
The cybersecurity documentation included all the recommended information from the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." This includes a cybersecurity hazard analysis and mitigation information, an upgrade and maintenance plan, other information for safeguarding the device during manufacturing and upon commercial distribution, and warning and precaution information in the product labeling.
HUMAN FACTORS-USABILITY
Testing and evaluation was conducted in conformance with the IEC 60601-1-6: 2010+A1:2013 standard for "Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Section 6: Collateral Standard: Usability," which included establishing procedures for identifying potential hazards, evaluating key use characteristics such as sensor placement, sensor re-application, basic cleaning instructions, and optional connection to a compatible vital signs monitor, and evaluating labeling instructions and use by anticipated users. The testing passed all defined success criteria in support of the basic safety and essential performance of the device given risks associated with use. Additionally, peer-reviewed literature evaluating the placement, application, and adhesion of other commercially available devices with similar physical designs was provided to support use of silicone adhesive to attach the sensor component
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of the device to the neonatal population for the intended duration. This testing and associated evaluation of similar devices informed corresponding warning and precaution statements and other use instructions in the product labeling regarding application and positioning of the sensor component to prevent thermal, pressure or other injuries that may cause trauma to the patient's skin.
PERFORMANCE TESTING - BENCH
Testing to demonstrate the accuracy of the BTNeo System was conducted in accordance with Clause 201.101.2 of the IEC 80601-2-56: 2017 standard for "Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement." This involved evaluation of the device performance across the operating temperature range, using a phantom model consisting of adult human scapula covered with synthetic pediatric skin, intended to simulate neonatal use, and an antenna simulator intended to simulate the BTNeo System and calibrate the skin temperature function. Separate testing sessions were performed at constant temperatures at different parts of the operating temperature range (low, middle, and high) and over the 24-hour use period (middle of operating range). To evaluate at a constant temperature, the device was placed on top of the phantom apparatus, which was then placed inside a ======================================================================================================================== and (0)(4) to allow for representation of the (b)(4) dielectric and flow properties of cerebrospinal fluid. For evaluation over the 24-hour period, the sensor was placed in a = = = = = = = = = = to ensure that any water loss of the phantom due to evaporation over the test period did not impact the accuracy of the device performance. The running average was evaluated for accuracy within ± 0.3 ℃. Results indicated that the running average met the criteria per Clause 201.101.2 of the IEC 80601-2-56 standard for each test run across the operating temperature range and over a 24-hour period.
PERFORMANCE TESTING - ANIMAL
Objective
A Good Laboratory Practices (GLP) animal study was conducted to evaluate the performance of the final, finished version of the device in comparison to a brain temperature probe inserted approximately 2 cm below the skin surface in a weanling porcine model. This evaluation served as the primary basis for the device performance validation.
Study Design
Three (n=3), 4-week-old piglets were assessed under general anesthesia. The following temperature signals were measured: rectal, esophageal, and brain via thermocouple; the device when placed on the forehead; skin temperature (obtained from the device); and air temperature delivered into the nasal cavity. The brain temperature was measured by placing a thermocouple approximately 2 cm below the skin surface into a cerebral hemisphere. Animals then underwent several warming and cooling procedures, with the objective of demonstrating that the device accurately measured changes in brain temperature in comparison to measurements made using the invasive thermocouple.
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| Piglet | Weight | SkinThickness | Skull Thickness | Probe Placementdepth into BrainTissue |
|---|---|---|---|---|
| #1 | 7.6kg | .37cm | .42cm | 1.73cm |
| #2 | 8.0kg | .37cm | .34cm | 1.73cm |
| #3 | 7.8kg | .36cm | .35cm | 1.74cm |
Table 2. Piglet Physical Characteristics
Methods
Each animal underwent the following procedures:
-
- Recording started when both the brain and device temperature (the 2 key temperatures) were stable between 38 and 39 °C (± 0.2 °C) for at least two minutes. A heating blanket was set to 42 °C and animals were warmed, with whole-body heating being maintained . until either the two key temperatures stabilized (± 0.2 °C) for at least two minutes, rectal temperature reached 42 ℃, or 30 minutes had elapsed.
-
- When the first procedure concluded, the second procedure started immediately. Some heat sources were removed, and 15 mL/min air flow was introduced to the nasal passages to induce selective brain/head cooling. Dry air was supplemented with saline pumped into the nasal cavity. Selective cooling was maintained until either the two key temperatures stabilized (± 0.2 ℃) for at least two minutes, or when 45 minutes had elapsed. At this point, nasal air flow was turned off and heating blankets set at 42 ℃ were used to return the animal to its pre-experimental brain temperature of 38 ℃ (± 1 °C).
-
- Once the piglet's brain temperature returned to approximately 38 °C or 45 minutes had passed, the blanket settings were changed to 10 ℃ to cool the piglet to induce wholebody hypothermia until the two key temperatures stabilized (± 2 °C) for at least two minutes, the rectal temperature fell to 34 ℃, or 45 minutes had elapsed. Once the procedures were concluded, the animals were euthanized.
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Results
Image /page/6/Figure/1 description: The image is a line graph titled "All Recorded Temperatures Across Time PIG=1". The graph shows temperature on the y-axis from 30 to 40 degrees and clock time on the x-axis from 9:00 to 12:00. There are four different lines on the graph, representing skin temperature, esophagus thermocouple, rectal thermocouple, YSI OUT, and 2CM thermocouple. The graph also includes labels for "Whole-body Hyperthermia", "Brain Hypothermia", and "Whole-body Hypothermia".
Figure 2: Experimental Temperature Data of Pig 1
Figure 2 shows the temperature data for Pig 1 comparing the invasive brain probe (2 cm Thermocouple), the test device (YSI Out), core temperatures (rectal and esophagus thermocouple), and skin temperature, with the vertical dotted lines dividing the different experimental procedures. For whole body hyperthermia, all temperatures trended downward, then upward. For brain hypothermia, the brain, skin and device temperatures decreased rapidly while the core body temperatures (rectal and esophageal) decreased more gradually. All probes trended upward when nasal cooling stopped and warming was initiated. For whole body hypothermia, temperatures trended downward for all probes, with skin temperature consistently being less than the brain or core body temperatures.
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Image /page/7/Figure/0 description: The image is a graph titled "All Recorded Temperatures Across Time PIG=2". The graph shows temperature on the y-axis and clock time on the x-axis. There are multiple lines on the graph, representing skin temperature, esophagus thermocouple, rectal thermocouple, YSI OUT, and 2CM thermocouple. The graph also includes labels for "Warm-up", "Experiment 4", "Whole-body Hyperthermia", and "Brain Hypothermia".
Figure 3: Experimental Temperature Data of Pig 2
Figure 3 shows the temperature data for Pig 2. As with Pig 1, core (esophageal and rectal) thermocouples, brain and the device temperatures trended in the same direction. When selective head/brain cooling was applied (brain hypothermia), the brain and device probes decreased more rapidly in comparison to the core (esophageal and rectal) probes. Additionally, skin temperature was consistently less than brain or core temperatures.
Image /page/7/Figure/3 description: The image is a line graph titled "All Recorded Temperatures Across Time PIG=3". The graph shows temperature on the y-axis and clock time on the x-axis. There are 5 different lines on the graph, representing skin temperature, YSI OUT, ESOPHAGUS THERMOCOUPLE, RECTAL THERMOCOUPLE, and 2CM THERMOCOUPLE. The graph is divided into three sections: Hyperthermia, Brain Hypothermia, and Whole-body Hypothermia.
Figure 4: Experimental Temperature Data of Pig 3
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Figure 4 shows temperature data for Pig 3. For this animal, the brain, device, and esophageal temperatures had similar rates of temperature change, including during selective head cooling. The rectal thermocouple shows a more gradual decrease in temperature during the brain hypothermia procedure. Skin temperature was consistently less than brain or core temperatures.
Image /page/8/Figure/1 description: This image is a scatter plot titled "Scatter Plot With 95% Prediction Ellipse". The y-axis is labeled "YSIOUT" and the x-axis is labeled "2CM THERMOCOUPLE". The plot shows a positive correlation between the two variables. The text in the upper left corner indicates that there are 37702 observations and a correlation of 0.0764.
Figure 5: Point-to-point Comparison of Brain Probes for All Animals
Figure 5 shows the invasive brain probe (2 cm Thermocouple) and the test device (YSI Out) of all animals. The correlation between the temperature probes was 0.97. The dips at the top right of the graph indicate the occurrence of animal movement during recording.
LABELING
The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 for prescription devices.
The labeling includes a detailed description of the device, a description of the patient population for which the device is indicated for use, contraindications, warnings, precautions, and instructions for use. The labeling also includes summary information about the animal studies performed to validate the device measures.
The labeling includes information regarding appropriate use and placement of the sensor component, reliability of the device output based on sensor application site, instructions to monitor skin integrity for duration of use, and a discussion of the limitations that the device is not intended to inform diagnosis or therapy, is not intended for use in patients less than 35 weeks gestational age, and is not intended for use in patients who do not have intact skin for sensor application.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of a brain temperature measurement system and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Inaccurate measurement made by thedevice, resulting in misuse ormisinterpretation of device output | In vivo performance testingNon-clinical performance testingSoftware verification, validation, and hazard analysisUsability evaluationLabeling |
| Equipment malfunction leading to injuryto user/patient (e.g., shock, burn,interference) | Electrical, mechanical and thermal safety testingElectromagnetic compatibility (EMC) testingLabeling |
| Adverse tissue reaction, includingthermal or pressure injuries | Biocompatibility evaluationUsability evaluationLabeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the brain temperature measurement system is subject to the following special controls:
- (1) In vivo performance testing must demonstrate that the device performs as intended for its anticipated conditions of use and can accurately and reliably measure brain temperature compared to a ground truth measurement.
- (2) Non-clinical performance testing must demonstrate that the device can accurately measure changes in brain temperature under simulated conditions of use. Testing must assess repeatability within pre-specified, clinically relevant parameters. The technical specifications of the device's hardware and software must be fully characterized.
- (3) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility (EMC) testing must be performed.
- (4) Software documentation must include a detailed technical description of the algorithm(s) used to generate the device output(s), and be accompanied by verification and validation testing to ensure device and algorithm functionality as informed by the software requirements and hazard analysis.
- (5) The tissue contacting device components must be demonstrated to be biocompatible.
- (6) Usability evaluation must demonstrate that the intended user(s) can safely and correctly use the device, based solely on reading the directions for use.
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- (7) Labeling must include:
- (i) Instructions for use, including a detailed description of the device and explanation of all device outputs.
- (ii) The following warnings:
- (A) A statement that the device is not intended to measure core body temperature, and to use an independent thermometer to measure core body temperature.
- (B) Conditions of use that may impact the accuracy and reliability of the device measurement.
- (C) Conditions of use that may affect skin integrity or cause skin injury, such as extended wear duration or placement of the device on damaged or compromised skin, skin lesions, or open wounds.
- (D) Limitations of device use to inform diagnosis or therapy.
- (iii) Summaries of in vivo testing conducted to demonstrate how the device functions as intended. The summary must include the following:
- (A) A description of each device output.
- (B) A description of the study population and the use environment.
- (C) The methods used to collect temperature data.
- (D) Any observed adverse events and complications.
BENEFIT-RISK DETERMINATION
Risks associated with use of the device are related to biocompatibility, electrical safety, electromagnetic compatibility (EMC), software verification, usability, pressure on the skin, and the sensor adhesive. Risks include inaccurate measurement, inappropriate use of the device to inform diagnostic and therapeutic decisions based on its output, and injury to the skin.
The safety testing and hazard analysis performed, in conjunction with the device technical alerts regarding device malfunction and labeling contraindications, warnings, and precautions mitigate the risks presented. The product labeling also states that the safety and effectiveness of the device to inform diagnosis or therapy has not been evaluated. Use of the device is limited to patients under care in the neonatal neurocritical care environment.
The probable benefits of the device are based on bench and animal studies demonstrating the accuracy of the measurements made by the device. The BTNeo System is an externally placed device that provides an estimated measure of brain temperature below the sensor. This device allows qualified healthcare professionals to measure brain temperature, which is intended to be displayed along with core temperature.
Additional factors to be considered in determining probable risks and benefits for the BTNeo System include:
- Brain temperature is a physiological measurement that is currently not typically included . in the clinical evaluation of the target population. Utility for diagnosis or making treatment decisions of this additional physiological data has not been established.
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- . Other methods to measure brain tissue temperature are not practical in the neonatal intensive care or are invasive.
For the reasons described above, the probable benefits of the BTNeo System outweigh the probable risks.
Patient Perspectives
This submission did not include specific information on patient or parent perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement,
"The BTNeo System is indicated for measurement of a neonate's brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature.
The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms,"
the probable benefits outweigh the probable risks for the BTNeo System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the BTNeo System is granted and the device is classified as follows:
Product Code: OSL Device Type: Brain temperature measurement system Regulation Number: 21 CFR 882.1565 Class: II
N/A