The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cvcle. The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.

Device Description

As described above, the BrainPulse, Model 1100 (BrainPulse) is designed to measure skull motion caused by pulsatile blood flow. The BrainPulse measures these cranial pulsatile movements via an array of accelerometers placed on the scalp. The system consists of three main components: a headset, data collector, and computer.

The headset contains a forehead photoplethysmograph (PPG) sensor that measures the patient's pulse rate, a Sound Pressure Level (SPL) sensor for detecting ambient environment noise, and six accelerometers to detect the acceleration of the skull at six selected locations. These acceleration measurements typically fall in the range of 0.001 - 0.03 g.

The data collector converts the analog signals from the headset sensors and provides a digital data stream via Ethernet cable to the computer. The computer is loaded with software that allows for the user to initiate and end recordings and to manage saved data files. The BrainPulse software is not capable of displaying the recorded data from the headset; rather the data are saved in multiple file formats that can be readily displayed using other third-party software for post-hoc review.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the BrainPulse, Model 1100 meets these criteria, based on the provided text.

Based on the provided text, the BrainPulse, Model 1100 is a Class II device intended to non-invasively detect, amplify, and capture skull motion caused by pulsatile flow from the cardiac cycle. It is not intended for diagnostic purposes. Therefore, the "acceptance criteria" for this device are primarily focused on its ability to accurately, precisely, stably, and repeatably measure cranial motion, and its safety, rather than diagnostic performance metrics like sensitivity, specificity, or AUC.

The information provided describes the assessment of the device against a set of standards and performance expectations, rather than a single "study" with a specific test set, ground truth, and expert adjudication as might be seen for a diagnostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a measurement tool, not a diagnostic one), the "acceptance criteria" are derived from the "Special Controls" and the objectives of the various non-clinical and clinical performance tests.

Acceptance Criteria Category	Specific Acceptance Criteria (from Special Controls/Test Purpose)	Reported Device Performance / Study Finding
I. Biocompatibility	Patient-contacting components must be demonstrated to be biocompatible (Special Control #2).	Passed: Cytotoxicity Evaluation (Non-cytotoxic), Kligman Maximization Test (Sensitization rate = 0%, grade "Weak"), Primary Skin Irritation Test (No signs of erythema or edema, Negligible Irritant), Intracutaneous Injection Test (No difference between test and control). Biocompatibility evaluation deemed adequate.
II. Electrical/Thermal/Mechanical Safety & EMC	Device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC) (Special Control #3).	Passed: Complied with IEC60601-1: 2005 +AM1: 2012 (Medical Electrical Equipment; Part 1: General Requirements for Safety) and IEC60601-1-2: 2007 (EMC).
III. Software Performance	Software hardware specifications must be provided, with V&V and hazard analysis. Software must be described in SRS/SDS, with V&V and hazard analysis (Special Control #1a, 1b).	Passed: Software consistent with 'MODERATE' level of concern. Appropriate documentation (V&V, hazard analysis) provided as part of de novo request.
IV. Performance Testing (Bench)	Accelerometer Measurement Stability and Repeatability: Measurements are stable within a typical recording session and repeatable across multiple sessions/operators.	Passed: All within-session recording segments demonstrated stable correlation with a baseline recording. ANOVA results did not demonstrate variation across multiple sessions or operators.
	Accelerometer Resolution: Expected changes in acceleration are adequately resolved and above the observed noise floor.	Passed: Frequency analysis and visual inspection demonstrate signals of interest are resolved above the observed noise floor, confirming accelerometer specifications.
	PPG Sensor Accuracy and Precision: Device accurately and precisely measures heart rate based on changes in blood flow.	Passed: Visual comparison to concurrent SpO2 sensor recordings demonstrate adequate PPG sensor performance.
	Hardware Verification: Accelerometers adequately measure across the range of expected values; SPL sensor adequately measures ambient noise; Data Collector battery charges/discharges; Tablet interfaces with Data Collector and records sensor data.	Passed: Accelerometer calibration confirmed operation. Successful SPL measurement of test signals. Battery operates according to specification. Tablet passed all functional requirements.
V. Clinical Performance	Clinical performance testing must demonstrate accuracy, precision, stability, and repeatability of measuring cranial motion per intended use in the intended environment (Special Control #4).	Demonstrated: 616 successful recordings from 273 patients across 6 clinical studies (4 completed/terminated, 2 ongoing). All studies demonstrated the measured skull motion correlated with a regular pulse related to the cardiac cycle. No major variations in within-patient recordings reported. Supports stability and repeatability.
VI. Labeling	Labeling must include intended use, instruction for technicians, and information on variability (Special Control #5).	Confirmed: User manual consistent with performance data, covers hazards and clinical information. Satisfies 21 CFR § 801.109. Includes intended use, technician instructions, and information allowing clinicians to understand potential sources of variability.
VII. Risk Mitigation	Risks (Adverse Tissue Reaction, Equipment Malfunction, Inaccurate Measurement, Use Error) must be mitigated.	Mitigated: Biocompatibility, Electrical/Mechanical/Thermal Safety, EMC, Clinical Performance Testing, Hardware/Software V&V, Hazard Analysis, and Labeling were used to mitigate identified risks. Probability of adverse events deemed low.

2. Sample Size Used for the Test Set and Data Provenance

As this device is a measurement tool and not a diagnostic AI, there isn't a dedicated "test set" in the sense of a validation dataset for a diagnostic algorithm. Instead, its performance was assessed through various bench and clinical evaluations.

Clinical Performance Data: 616 successful recordings from 273 patients across six clinical studies.
Data Provenance: Studies were conducted "both at centers within and outside the United States." The text also mentions that summaries of these studies were "supplied to support a determination of a reasonable assurance of the safety and effectiveness." It is not specified whether these were specifically prospective or retrospective studies for the purpose of regulatory submission, but rather they appear to be existing clinical studies from which data was leveraged.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For a device like BrainPulse, which measures a physical phenomenon (skull motion due to pulsatile flow), the concept of "ground truth" for a diagnostic outcome established by human experts is not directly applicable.

Ground Truth for Measurement Performance: The "ground truth" for evaluating the measurement capabilities of the accelerometers and PPG sensor would have been established by:
- Reference Measurement Devices: For accelerometer resolution and SPL sensor accuracy tests, comparison to "reference measurement device" was used.
- Known Physical Inputs/Conditions: Accelerometer stability/repeatability and hardware verification would likely involve known mechanical inputs or environmental conditions to test the device's output.
- Physiological Correlation: For the PPG sensor, performance was evaluated by "visual comparison to concurrent SpO2 (blood oxygen saturation) sensor recordings." The "ground truth" here is the expected physiological correlation between blood flow and pulse.
- Clinical Correlation: In clinical studies, the "ground truth" for the device's intended function was the correlation of measured skull motion with a regular pulse related to the cardiac cycle. This is an observable physiological phenomenon.
Experts: No specific number or qualifications of "experts" are mentioned for establishing this type of ground truth, as it relies on physical and physiological principles and comparisons to established reference measurements.

4. Adjudication Method for the Test Set

Not applicable in the context of this device's performance evaluation. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human experts are making qualitative or subjective assessments that need to be aggregated into a "ground truth" for a diagnostic label. Here, the performance is based on quantifiable physical measurements and their correlation with physiological events.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted and was not necessary for this device.

Reasoning: An MRMC study assesses the impact of AI assistance on human reader performance, typically for diagnostic tasks (e.g., radiologists reading images with or without AI). The BrainPulse is a measurement device, not a diagnostic aid that assists a human reader in interpreting complex clinical data. Its output (skull motion data) is intended to be incorporated into a clinician's overall assessment paradigm, but the device itself doesn't offer a diagnostic interpretation or classification that a human "reader" would be evaluating. The submission explicitly states: "Consequently, a demonstration of clinical diagnostic utility in specific patient populations was not required."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the core of the performance evaluation for BrainPulse, Model 1100, is essentially its standalone (algorithm/hardware-only) performance in measuring cranial motion.

Measurement Accuracy and Reliability: The bench performance tests (accelerometer stability, repeatability, resolution, PPG accuracy, hardware verification) evaluate the device's ability to accurately and reliably capture the intended data independently.
Clinical Correlation: The clinical studies confirmed that the device's measurements (algorithm's output) correlated with the cardiac cycle, which is its primary intended function. While clinicians use the data, the device is evaluated on its ability to produce the measurement correctly, not on a human's ability to interpret that measurement for a specific diagnostic outcome.

7. The Type of Ground Truth Used

The "ground truth" for the BrainPulse's evaluation was primarily:

Physical/Engineering Specifications: For bench testing, this often meant comparing the device's output to known physical inputs or outputs from calibrated reference instruments (e.g., "reference measurement device" for SPL sensor, "accelerometer specifications" for resolution).
Physiological Correlation: For the PPG sensor, the ground truth was the expected physiological correlation with SpO2 readings (though "visual comparison" suggests a qualitative assessment of this correlation rather than quantitative comparison to a gold standard).
Observable Physiological Events: In clinical studies, the ground truth for validating the device's intended use was the "regular pulse related to the cardiac cycle," an established physiological event which the device's skull motion measurements were expected to correlate with.
Absence of Adverse Events: Safety ground truth relied on patient reporting of discomfort or adverse events.

This is distinct from "expert consensus" or "pathology" which are typically ground truths for diagnostic tasks. Outcomes data might be relevant for clinical utility, which was explicitly not assessed.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning (ML) or Artificial Intelligence (AI) model that would require a distinct training set. The device appears to be based on direct physical measurements using accelerometers and a PPG sensor. Its "software" is described as managing recordings and saving data, consistent with traditional software, not an ML/AI algorithm that learns from data.

If there were internal algorithms for signal processing or noise reduction, the document does not specify if these were "trained" on data or if they were designed based on known physics and engineering principles. Given the de novo nature from 2014, it's highly likely that any signal processing would be deterministic rather than AI/ML-based.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or specific ML/AI model is described.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR BRAINPULSE, MODEL 1100

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Cranial Motion Measurement Device. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.

NEW REGULATION NUMBER: 21 CFR 882.1630

CLASSIFICATION: CLASS II

PRODUCT CODE: POP

BACKGROUND

DEVICE NAME: BRAINPULSE, MODEL 1100

SUBMISSION NUMBER: DEN140040

DATE OF DE NOVO: DECEMBER 23, 2014

CONTACT: JAN MEDICAL, INC 110 Pioneer Way SUITE L MOUNTAIN VIEW, CA 94041

REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II

INDICATIONS FOR USE

LIMITATIONS

For prescription use only.

The BrainPulse is not indicated for use on patients with a wound close to a sensor location.

The position of the subject has an impact on the BrainPulse recording. The recording may

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be affected by whether the subject is sitting upright or is supine, whether the head is facing forward or to the side. Changes to the position cause changes to blood flow and this changes brain motion. As a result, if multiple recordings are obtained from the same subject, a consistent position between recordings will lead to more comparable recordings.

Patient respiration rate, heart rate, and head and body motion also may cause variation in the recording. The presence of atrial fibrillation, premature ventricular contractions, stroke, aneurysms, or intracranial bleeding in patients may also cause variations in the recording.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

Figure 1. BrainPulse system consisting of the data collector and battery, headset containing sensors, and computer.

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Image /page/2/Figure/0 description: The image shows three diagrams of a human skull. The first diagram shows a frontal view of the skull with green markers on the forehead and top of the head. The second diagram shows a side view of the skull with a red marker on the forehead and behind the ear. The third diagram shows a side view of the skull with the brain and blood vessels visible, and a blue marker on the back of the head.

Figure 2. BrainPulse accelerometer placement.

Image /page/2/Picture/2 description: The image shows two views of a white helmet on a white stand with a brown base. The helmet is round and has several attachments on the sides and top. The left view shows the side of the helmet, while the right view shows the back. The helmet appears to be made of plastic and has a smooth surface.

Figure 3. BrainPulse headset viewed from the front (left panel) and from the right (right panel).

Image /page/2/Picture/4 description: In the image, a person is wearing a white plastic headset. The headset has multiple adjustable straps and components that appear to be for medical or research purposes. The person's hair is dark and wet, and the headset is positioned on the back of their head. The background is a room with a desk and some equipment.

Figure 4. BrainPulse headset worn on a patient's head.

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Image /page/3/Figure/0 description: The image shows a graph with two lines, one red and one green, plotted against each other. The x-axis is labeled 'points' and ranges from 0 to 4000, while the y-axis is labeled with a greater than sign '>'. The red and green lines oscillate, with the red line initially dipping below zero and the green line rising above zero. As the 'points' value increases, the oscillations of both lines dampen and converge towards zero.

Figure 5. Sample plot of accelerometer data recording from the left and right temple accelerometers for a single heartbeat. This waveform is an average of data recorded across 45 heartbeats.

SUMMARY OF NONCLINICAL/BENCH STUDIES

The sponsor conducted a series of bench testing to demonstrate that the BrainPulse would perform as anticipated. Please refer to the sub-sections below for a discussion of each nonclinical test performed.

BIOCOMPATIBILITY/MATERIALS

The BrainPulse contacts the patient's skin for typically no longer than a 30-minute recording session. The BrainPulse is categorized as a surface-contacting device with a limited duration of contact (less than 24 hours). In accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a Risk Management Process, the following biocompatibility testing was conducted on the BrainPulse. The biocompatibility evaluation was deemed adequate.

Test	Purpose	Results
Cytotoxicity Evaluation – L929MEM Elution Test/L929 NeutralRed Uptake Test	To assess the biological activityof L-929 mouse fibroblast cells(grown in culture) after exposureto extracts prepared from thecompleted BrainPulse system	Non-cytotoxic
Kligman Maximization Test	To estimate the potential forsensitization of the BrainPulsesystem extract using the guineapig as an animal model	Sensitization rate = 0%Sensitization grade = “Weak”
Primary Skin Irritation Test	To estimate the potential toproduce primary skin irritationafter a single topical exposure tothe skin of New Zealand WhiteRabbits	No signs of erythema or edemaConsidered a Negligible Irritant

		Table 1. Biocompatibility testing completed for the BrainPulse

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Test	Purpose	Results
Intracutaneous Injection Test	To assess the irritating potentialof extracts of the BrainPulsesystem to cause irritation to theexposed part of the body	No difference between mean testarticle score and mean controlscore

SHELF LIFE/STERILITY

The BrainPulse is not provided sterile nor are any of the components to be sterilized by the end user. Cleaning and maintenance instructions are included in the device labeling.

The BrainPulse and its components do not have a stated shelf life as the products are not provided sterile. However, the device labeling states that the device has an expected service life of 5 years, which is typical for general electronic devices. Based on the nature of the system components, this estimation of product life is acceptable.

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The BrainPulse was tested in accordance with the following consensus standards and passed the following electromagnetic compatibility (EMC), electrical, mechanical, and thermal safety tests:

Standard	Name
IEC60601-1: 2005 +AM1: 2012	Medical Electrical Equipment; Part 1: General Requirements for Safety
IEC60601-1-2: 2007	Medical Electrical Equipment; Part 1-2: General Requirements for Safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and tests.

Table 2. EMC and electrical safety testing completed for the BrainPulse

SOFTWARE

Software for the device consisted of proprietary software. The software is consistent with a 'MODERATE' level of concern, as discussed in the FDA document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. Appropriate documentation was provided as part of the de novo request.

PERFORMANCE TESTING - BENCH

The BrainPulse was subjected to a series of bench tests to assess its functional performance. These tests were performed on a final manufactured product. Table 3 summarizes the testing performed:

						Table 3. Bench testing completed for the BrainPulse
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Test	Purpose	Results
Accelerometer MeasurementStability and Repeatability	To ensure accelerationmeasurements made by theBrainPulse device are stablewithin a typical recording session	Passed; all within-sessionrecording segments demonstratedstable correlation with a baselinerecording. ANOVA results did

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Test	Purpose	Results
Accelerometer Resolution	and are repeatable across multiplerecording sessions and multipleoperatorsTo ensure the expected changesin acceleration measured by theBrainPulse device are adequatelyresolved by the BrainPulse andare above the observed noisefloor	not demonstrate variation in therecordings across multiplesessions or operatorsPassed; frequency analysis andvisual inspection demonstratesignals of interest are resolvedabove the observed noise floorthat confirms accelerometerspecifications
PPG Sensor Accuracy andPrecision	To ensure the BrainPulse deviceaccurately and precisely measuresheartrate based upon changes inblood flow	Passed; visual comparison toconcurrent SpO2 (blood oxygensaturation) sensor recordingsdemonstrate adequate PPG sensorperformance
Hardware Verification	To ensure the accelerometersadequately measure accelerationacross the range of expectedvalues during intended use of theBrainPulse deviceTo ensure the Sound PressureLevel (SPL) sensor adequatelymeasures ambient noise across afrequency range relevant to theBrainPulse device and in theintended use environment of theBrainPulse deviceTo ensure the Data Collectorbattery charges and dischargesaccording to specificationTo ensure the tablet systemproperly interfaces with the DataCollector and properly recordssensor data	Passed; calibration ofaccelerometers confirmsoperation according tospecificationPassed; successful measurementof test signals in intended useenvironment, compared toreference measurement devicePassed; battery operatesaccording to specificationPassed; tablet passed allfunctional requirements

SUMMARY OF CLINICAL INFORMATION

Summaries of six (6) clinical studies (4 completed or terminated, and 2 ongoing) were supplied to support a determination of a reasonable assurance of the safety and effectiveness of the BrainPulse. These studies were conducted both at centers within and outside the United States. While these clinical studies were performed on a wide variety of patient populations with varying neurological conditions, the BrainPulse has only been evaluated in the context of the indications for use; that is, the device's ability to measure cranial motion due to the pulsatile flow from the cardiac cycle.

In total, 616 successful recordings were evaluated from 273 patients across all six of the studies. All studies demonstrated the measured skull motion correlated with a regular pulse related to the cardiac cycle. Only some of the studies obtained multiple recordings per patient; however, no major variations in within-patient recordings were reported. These results were supported by the

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stability and repeatability testing summarized in the "Performance Testing – Bench" section above.

Two patients from one of the studies complained of discomfort when wearing the headset. No other adverse events, complaints, or device issues or malfunctions were reported.

LABELING

The user manual is consistent with the performance data and covers all the hazards and other clinically relevant information that may impact use of the device. The labeling satisfies the requirements of 21 CFR § 801.109 Prescription devices. The labeling for the BrainPulse includes:

1. The intended use population and the intended use environment.
1. Instructions technicians should convey to patients regarding the collection of cranial motion data.
1. Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

Because cranial motion data are currently not typically included in the clinical evaluation of patients, clinicians utilizing the measurement data provided by the BrainPulse should be physicians who have familiarized themselves with the labeling of the BrainPulse.

RISKS TO HEALTH

Table 4 below identifies the risks to health that may be associated with use of Cranial Motion Measurement Device and the measures necessary to mitigate these risks.

Identified Risk	Mitigation Measure
Adverse Tissue Reaction	Biocompatibility EvaluationLabeling
Equipment Malfunction Leading to Injury toUser or Patient	Electrical, Mechanical and Thermal SafetyTestingElectromagnetic Compatibility TestingLabeling
Inaccurate Measurement	Clinical Performance TestingHardware and Software verification, validationand hazard analysisElectromagnetic Compatibility TestingLabeling
Use Error	Hardware and Software verification, validationand hazard analysisLabeling

Table 4. Identified Risks to Health and Mitigation Measures

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SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the Cranial Motion Measurement Device is subject to the following special controls:

1. The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
- a. Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.
- b. Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.
1. The patient-contacting components of the device must be demonstrated to be biocompatible.
1. The device must be designed and tested for electrical, thermal and mechanical safety and electromagnetic compatibility (EMC).
1. Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.
1. The labeling must include:
- The intended use population and the intended use environment. a.
- b. Any instructions technicians should convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.
- c. Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

BENEFIT/RISK DETERMINATION

While the summaries of 6 completed, terminated, or ongoing clinical studies were provided, no formal clinical study was provided, requested, or deemed necessary for the BrainPulse based on the risks for the current indications for use. The probable risks of the device are based on risk analysis, bench and clinical testing that included assessments of accuracy and precision, as well as the stability and repeatability studies described above. Probable device-related adverse events include adverse tissue reaction, equipment malfunction leading to injury of the user or patient, inaccurate measurement, and use error leading to inaccurate measurement or patient discomfort. Based on the nonclinical and clinical information provided, the probability of each of these adverse events is low.

The probable benefits of the device are also based on the clinical summaries, bench testing, as well as the stability and repeatability studies described above. The BrainPulse measures skull motion correlated with the cardiac cycle. This measurement is stable and repeatable under

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controlled procedures and in a controlled environment, allowing clinicians to observe notable differences or changes in the measurement that may be incorporated into their clinical assessment paradigm. It should be noted that the clinical data were only reviewed in the context of the indications for use; that is, the device's ability to measure skull motion due to the pulsatile flow from the cardiac cycle. Consequently, a demonstration of clinical diagnostic utility in specific patient populations was not required.

Additional factors to be considered in determining probable risks and benefits for the BrainPulse include:

. Skull motion is a physiological measurement that is currently not typically included in the clinical evaluation of patients. Diagnostic utility of this additional physiological data has not been established for specific patient populations.
. Patient respiration rate, heart rate, and head and body motion also may cause variation in the recording. The presence of atrial fibrillation, premature ventricular contractions, stroke, aneurysms or intracranial bleeding in patients may also cause variations in the recording. These sources of variation have been identified through risk analyses and preliminary clinical use; however, additional sources of variability remain unknown.
Feedback from centers using the device in preliminary clinical studies has been positive in terms of ease of use.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

In conclusion, given the available information above, the data support that for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle, the probable benefits outweigh the probable risks for the BrainPulse. The device provides benefit, and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The de novo request for the BrainPulse, Model 1100 is granted and the device is classified under the following:

Product Code: POP Device Type: Cranial Motion Measurement Device Class: Class II Regulation: 21 CFR 882.1630

Regulation Number and Section

§ 882.1630 Cranial motion measurement device.

(a)
Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.
(ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.
(5) The labeling must include:
(i) The intended use population and the intended use environment.
(ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.
(iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.