(448 days)
BcSs-PICNI-2000, K182073
No
The document describes signal processing and analysis of strain gauge data to produce surrogate ICP waveforms and parameters. There is no mention of AI, ML, or related techniques in the device description, intended use, or performance study summaries. The analysis focuses on correlation and agreement metrics, not typical AI/ML performance indicators.
No
The device is intended for monitoring and providing information for interpretation related to intracranial pressure, not for direct treatment or therapy.
No
Explanation: The "Summary of Performance Studies" section explicitly states, "The B4C System is not intended to be a standalone diagnostic tool." Its purpose is for monitoring variations in ICP, not to provide a definitive diagnosis.
No
The device description explicitly states that the B4C System consists of hardware components including a sensor with Bluetooth wireless module, headband, receiver, external battery pack and charger, in addition to the software components.
Based on the provided information, the B4C System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the monitoring of variation in intracranial pressure and changes in intracranial compliance by providing surrogate waveforms and parameters. It explicitly states it does not measure absolute ICP values and does not substitute methods when absolute ICP measurement is required for clinical decisions.
- Device Description: The device description details a non-invasive system that uses strain gauges to detect variations in skull deformation. This is a physical measurement, not a test performed on biological samples in vitro.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The B4C System does not analyze any biological samples.
- Focus on Physical Measurement: The core technology relies on detecting physical changes in the skull, which are then processed to provide surrogate information about ICP.
Therefore, the B4C System falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.
Product codes
GWM
Device Description
The B4C System is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, external battery pack and charger, as well as processing and analytical software. The sensor contains four strain gauges situated on a metal bar that detects variations in skull deformation through tension and compression of the metal bar in response to changes in intracranial pressure. These resistance measures are converted to a digital signal using a high-resolution ADC (Analog to Digital Converter) in the sensor that is transmitted to software components for viewing, processing and analysis. The proposed device does not measure absolute intracranial pressure values, but produces surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.
The sensor component is supported on a plastic headband worn by the patient, such that the sensor is in contact with the scalp and is perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane. Slight pressure is applied so that the sensor pin maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired data to the B4C analytical and processing software, and back to the mobile device application or to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability via a paired receiver. Data is transferred wireless via Bluetooth connection between sensor and mobile application and HTTPs protocol between mobile application and analytics software. The clinician may view the visualized waveform on the mobile device along with an intermediate or final report of surrogate waveform and associated parameters including surrogate waveform trend line, average waveform per minute and estimated P2/P1 ratio, normalized time-to-peak, as well as derived useful ICP pulses and cardiac pulses. Alternatively, the paired monitor's inherent software interprets the signal received from the B4C System's sensor and displays a surrogate waveform that allows for viewing the same ICP waveform on the monitor's display. Clinicians review the B4C System outputs to assess patients with suspected intracranial hypertension or changes in intracranial compliance based on the characteristic Percussion (P1), Tidal (P2), and Dicrotic (P3) peaks of the waveform morphology and associated parameters.
The B4C System is not intended to be a standalone diagnostic tool. The surrogate waveform and associated parameter outputs do not replace a comprehensive clinical evaluation, but only provide an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
The B4C System is intended for use for adult patients ages 18 and older.
Intended User / Care Setting
Clinician; neurointensive care unit
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Dataset Description
Total number of centers: 4
Total number of subjects: 123 enrolled, 107 after device label check, 85 after data quality check (78 adults, 7 pediatric)
Collected data: ICP Surrogate Waveform (BcSs-PICNI-2000 (K182073) or B4C System); Invasive Arterial Blood Pressure, Invasive ICP Waveform (EVD or Bolt)
Range of acquisition sessions time: 5 min to 3.5 hours
Total number of monitoring sessions that passed quality check: 159
Total acquisition time that passed quality check: 4800 (98% adult, 2% pediatric)
Analyzed participants
Seventy eight adults (18+) who met all eligibility criteria and were admitted to the neurointensive care unit and underwent invasive ICP monitoring and invasive arterial blood pressure monitoring were considered in the dataset. Due to the reduced quantity of pediatric subjects, the analysis could only demonstrate statistically relevant performance for the adult population.
Total number of analyzed subjects: 78 adults
Total acquisition time analyzed: 4695 minutes
Age of analyzed subjects: 52.7+/-19.4
Gender of analyzed subjects: 47% female ; 53% male
Study Procedures
All centers used Braincare's non-invasive sensors with identical principles of operations (3 centers are with BcSs-PICNI-2000 sensor (K182073), 1 with B4C System wireless sensor). The sensors at each site were positioned according to the same protocols, i.e., temporal region avoiding arteries and adjustment to the point that an acceptable waveform appears, a procedure that represents real case usage. Patients at all sites had invasive, non invasive and ABP waveforms captured.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: combined prospective, multi-center, observational study
Sample size: 78 adults (18+)
Key Results:
- Correlation analysis:
- For the normalized time to peak, the Spearman correlation was 0.318 [0.291, 0.345], p0.2.
- While the mean difference in P2/P1 between our device and invasive ICP is not significantly different from zero, we observed instances where P2/P1 measured by the device differed from that measured by invasive ICP by >0.7.
- Both classes of analysis, Bland-Altman / Deming Regression which evaluate agreement, and Normalized Mutual Information / Spearman which evaluate correlation presented statistically meaningful results.
Safety: No adverse events were reported.
Study Conclusion: Results of this study demonstrated a statistically significant correlation in the ICP signal and waveform parameters between the B4C System and the gold standard invasive ICP monitoring device measured over time. The study outcomes demonstrate comparable effectiveness between the Braincare device and commonly used invasive ICP devices for use in monitoring and assessing variations in ICP waveform associated parameters over time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BcSs-PICNI-2000 Sensor K182073
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 8, 2021
Braincare Desenvolvimento e Inovacao Tecnologica S.A. % Connie Oiu Regulatory Consultant M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York, New York 10001
Re: K201989
Trade/Device Name: B4C System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: September 9, 2021 Received: September 10, 2021
Dear Connie Qiu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201989
Device Name B4C System
Indications for Use (Describe)
The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.
Refer to device labeling for more information regarding the derivation of the output of the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
B4C System
| Sponsor: | Braincare desenvolvimento e Inovacao Tecnologica S.A.
Avenida Bruno Ruggiero Filho, 971
São Carlos, SP - Brazil
13562-420 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Connie Qiu
M Squared Associates, Inc.
127 West 30th Street, 9th Floor
New York, New York 10001
Ph. 703-562-9800
Fax. 703-562-9797 |
| Date Prepared: | October 8, 2021 |
| Proprietary Name: | B4C System |
| Common Name: | Intracranial pressure monitoring device |
| Regulatory Class: | II |
| Regulation: | 21 CFR 882.1620 |
| Product Code: | GWM |
| Predicate Device(s): | BcSs-PICNI-2000 Sensor K182073 |
Device Description
The B4C System is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, external battery pack and charger, as well as processing and analytical software. The sensor contains four strain gauges situated on a metal bar that detects variations in skull deformation through tension and compression of the metal bar in response to changes in intracranial pressure. These resistance measures are converted to a digital signal using a high-resolution ADC (Analog to Digital Converter) in the sensor that is transmitted to software components for viewing, processing and analysis. The proposed device does not measure absolute intracranial pressure values, but produces surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.
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K201989, Page 2 of 12
The sensor component is supported on a plastic headband worn by the patient, such that the sensor is in contact with the scalp and is perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane. Slight pressure is applied so that the sensor pin maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired data to the B4C analytical and processing software, and back to the mobile device application or to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability via a paired receiver. Data is transferred wireless via Bluetooth connection between sensor and mobile application and HTTPs protocol between mobile application and analytics software. The clinician may view the visualized waveform on the mobile device along with an intermediate or final report of surrogate waveform and associated parameters including surrogate waveform trend line, average waveform per minute and estimated P2/P1 ratio, normalized time-to-peak, as well as derived useful ICP pulses and cardiac pulses. Alternatively, the paired monitor's inherent software interprets the signal received from the B4C System's sensor and displays a surrogate waveform that allows for viewing the same ICP waveform on the monitor's display. Clinicians review the B4C System outputs to assess patients with suspected intracranial hypertension or changes in intracranial compliance based on the characteristic Percussion (P1), Tidal (P2), and Dicrotic (P3) peaks of the waveform morphology and associated parameters.
The B4C System is not intended to be a standalone diagnostic tool. The surrogate waveform and associated parameter outputs do not replace a comprehensive clinical evaluation, but only provide an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.
The B4C System is intended for use for adult patients ages 18 and older.
Indications for Use: The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Timeto-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.
Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.
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Comparison to Predicate Device
The B4C System is an evolution of the first iteration, BcSs-PICNI-2000 Sensor (K182073). Comparison of technological characteristics between the B4C System to the predicate device, BcSs-PICNI-2000 Sensor is presented in Table 1. The differences compared to the currently marketed device do not affect the intended use and do not raise new questions of safety and effectiveness.
| | B4C System | Braincare BcSs-PICNI-
2000 Sensor | Substantial Equivalence |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K201989 | K182073 | Not applicable |
| Product Code | GWM | GWM | Same |
| Indication for Use | The B4C System is
intended for the
monitoring of variation
in intracranial pressure
in patients with
suspected alteration of
intracranial pressure
(ICP) or change in
intracranial compliance,
by providing surrogate
ICP waveforms and
associated parameters
(estimated P2/P1 ratio,
normalized Time-to-
Peak, derived useful ICP
pulses and cardiac pulse)
for interpretation.
Refer to device labeling
for more information
regarding the derivation
and interpretation of the
output of the device. | The BcSs-PICNI-2000
Sensor is intended for the
monitoring of variation in
intracranial pressure in
patients with suspected
alteration of intracranial
pressure (ICP) or change
in brain compliance, by
providing ICP waveforms
for interpretation. | Same intended use.
Similar indications for use.
Brain compliance is replaced to
intracranial compliance for
consistency with medical
terminology. Otherwise, the
only difference in the
indications for use is that the
subject device is intended to
provide some associated
parameters about the ICP
waveform characteristics in
addition to the visualized
surrogate waveform. However,
these do not change the
intended use, intended user, or
clinical utility compared to the
originally cleared device. This
difference does not raise new
questions of safety or
effectiveness. |
| Prescription Device | Yes | Yes | Same |
| Device
Description | Non-invasive ICP
monitoring device
consisting of strain
gauge pressure sensors
supported on a headband
to detect skull
deformations in response
to ICP changes. System
wirelessly transmits
acquired signal for | Non-invasive ICP
monitoring device
consisting of strain gauge
pressure sensors supported
on a headband to detect
skull deformations in
response to ICP changes.
System requires a wired
connection to a compatible
patient monitor to view | Similar
The operating principle of the
sensor remains the same. This
510(k) introduces
modifications primarily
consisting of software
components that include:
Bluetooth module and
firmware embedded in sensor |
| Table 1 Comparison of B4C System to BcSs-PICNI-2000 Sensor | |||||
|---|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------ | -- | -- | -- |
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| System outputs surrogate ICP waveform and report of waveform's associated parameters on mobile device application and web portal. ICP waveform may also be viewed on compatible monitor via paired wireless receiver. | transmission, ability to view the surrogate ICP waveform on a mobile device application, wireless transmission of acquired signal to compatible monitor, and reports with associated waveform parameters. Neither the subject nor the predicate devices produce absolute value of ICP, and neither is intended to be used as a standalone diagnostic tool. Performance testing demonstrate that the modified device does not raise new questions of safety and effectiveness. | ||
|---|---|---|---|
| Clinical Application | Non-invasive application of a sensor on the scalp perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane | Non-invasive application of a sensor on the scalp perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane | Same |
| Contraindications | The B4C System is contraindicated for use in patients who have: | ||
| Undergone decompressive craniectomy or craniotomy; Cranial defects (portion of skull missing); Any other conditions that the health practitioner deems to be unsuitable for use of this device. | The BcSs-PICNI-2000 Sensor is contraindicated for use in patients who have: | ||
| Undergone decompressive craniectomy or craniotomy; Cranial defects (portion of skull missing); Any other conditions that the health practitioner deems to be unsuitable for use of this device. | Same | ||
| Device Materials | Polycarbonate sensor casing and contact pin Silicone base around sensor Polypropylene headband | Polyoxymethylene sensor and headband. Adaptor cable: TPU (thermoplastic polyurethane) and ABS (Acrylonitrile butadiene styrene) case. | Different |
| While there are differences in specific device materials, the patient contacting surfaces continue to be comprised of materials that are commonly used in medical devices. Both | |||
| devices have satisfied | |||
| biocompatibility testing for the | |||
| patient contacting surfaces. The | |||
| difference in materials do not | |||
| raise new questions in terms of | |||
| safety or effectiveness. | |||
| MRI Claim | MR Unsafe | MR Unsafe | Same |
| Sterilization | Not applicable | Not applicable | Same |
| Device dimensions | Sensor case: 75.6 X 51.5 | ||
| X 27.7 mm |
Receiver case: 94 X 17.5
X 15 mm
Receiver cable and
connector length: 20 cm | Sensor case: 18.7 x 18.5 x
66.5 mm
Sensor pin length: 18mm
Sensor pin diameter: 7.5
mm
Sensor cable length: 200
cm. | The differences in dimension
do not raise new questions of
safety or effectiveness. |
| | Headband size with
turnbuckle :
XXS: 49.5 cm, XS: 52
cm, S: 54.5 cm, M: 57
cm, L: 59.5 cm, XL: 52
cm, XXL: 64.5 cm | Headband Perimeter:
Extra Small: 50-55cm,
Small: 52.5-57.5 cm,
Medium: 55-60 cm,
Large: 57.5-62.5 cm.
Adaptor cable length: 180
cm. | |
| Biocompatibility | Limited duration contact
(≤24) with intact skin
Non-cytotoxic
Non-sensitizing
Non-irritating | Prolonged contact (>24
hours but within ≤30 days)
with intact skin
Non-cytotoxic
Non-sensitizing
Non-irritating | Similar
The device continues to be
intended only for contact with
intact skin. While the predicate
device was assessed for
prolonged contact as a
conservative risk management
approach, it is expected that the
device will only be applied for
limited duration (≤24 hours) in
actual use. Biocompatibility
evaluation demonstrate that thi
difference does not raise new
questions of safety and
effectiveness. |
| Energy modality | Sensor contains internal
rechargeable battery and
external rechargeable
battery pack | 5 volts DC when
connected to ICP
monitoring device | Different
The modified device introduces
internal and external batteries,
while the predicate device had
power supplied by the
connected patient monitor.
Battery safety, electrical safety,
and electromagnetic
compatibility testing |
| ICP Waveform
Outputs | Waveform displayed on
compatible patient
monitor
Analytical software also
produces the following
associated parameters
about the surrogate ICP
waveform displayed in a
report and on the
accompanying mobile
medical application:
• Surrogate
Waveform
• Waveform
Trend line
• Average
waveform
• Estimated P2:P1
ratio
• Normalized
Time-to-Peak
• Derived useful
ICP pulses
• Derived Cardiac
Pulse
These associated
parameters are derived
based on well-
established principles in
scientific literature and
clinical practice. | Waveform displayed on
compatible patient
monitor | demonstrate that these
technological differences do
not raise new questions of
safety and effectiveness.
Similar
Both the subject and predicate
device produce display of ICP
waveforms in real-time. The
modified device also provides
associated parameters of the
surrogate waveform that may
be viewed in a convenient
report on the accompanying
mobile medical application or
web portal as an alternative to a
compatible multiparameter
monitor. The surrogate
waveform and associated
parameters continue to be
interpreted by the clinician per
standard clinical practice and
with other clinical evaluations
and parameters as deemed
necessary by the clinician.
Performance testing
demonstrates that the
differences in displayed
information do not raise new
questions of safety and
effectiveness. |
| Sensing element | Strain gauge | Strain gauge | Same |
| Functional pressure
range | Not applicable as it does
not provide absolute
values of pressure | Not applicable as it does
not provide absolute
values of pressure | Same |
| Functional over
pressure range
without damage | Not applicable as it does
not provide absolute
values of pressure, and
does not have a specified
functional pressure
range. | Not applicable as it does
not provide absolute
values of pressure, and
does not have a specified
functional pressure range. | Same |
| Input/ Output
Impedance | The wireless sensor is
not physically connected
to any device and has an
internal resistive bridge | 350 ohms nominal | The differences in input/output
impedance do not raise new
questions of safety or
effectiveness. |
| | with input and output
impedance of 1000
Ohms. | | |
| Output signal
(sensitivity) | Not applicable for the
wireless sensor since it is
not physically connected
to any device.
The receiver can output
a maximum signal of
25mV and minimum of -
2.5mV. | 10mV | The differences do not raise
new questions of safety or
effectiveness. |
| Zero Drift | Not applicable for the
sensor as it does not
provide absolute values
and brain4care aApp
performs auto scale so
that the waveform is
always visible.
The receiver is also
capable of automatically
readjusting the signal
offset level so that the
waveform is always
visible on the monitor. | The Adaptor cable can be
used to adjust offset
$\pm$ 20mV. | The differences do not raise
new questions of safety or
effectiveness. |
| Electrical Safety | Complies with IEC
60601-1 | Complies with IEC
60601-1 | Same |
| Electromagnetic
Compatibility | Complies with IEC
60601-1-2 | Complies with IEC
60601-1-2 | Same |
| Software | This device modification
introduces a mobile
device application,
firmware, analytical and
processing software, and
administrative software
components. | None | Different
While the predicate did not
contain software, the modified
device introduces several
software components.
The new software components
are used to analyze the input
ICP sensor data, view, store,
and transfer device output.
Software verification and
validation met acceptance
criteria. There is no change to
the intended use of the device.
This difference does not raise
new questions in terms of
safety and effectiveness. |
| Sensor Connection to
Monitor | Wireless
Bluetooth connection to
a receiver or micro-USB
connection specific to
compatible patient | Wired
Adaptor Cable with
adaptor plug specific to
compatible patient
monitors | Different
While the predicate utilizes a
wired connection to display the
acquired waveform on the
compatible patient monitor, the |
| | monitors | | modified device is able to
transmit the signal to the
patient monitor wirelessly via a
Bluetooth connection and
receiver on the monitor.
Performance testing
demonstrate that this difference
does not raise new questions of
safety and effectiveness. |
| Wireless Module | Bluetooth | None | Different
The modified device introduces
a Bluetooth module to facilitate
wireless transmission of the
acquired ICP waveform signal
to a mobile device and receiver
to display the waveform on a
connected monitor, and to view
the waveform and related
parameters on a mobile device.
Addition of wireless capability
does not change the intended
use, intended user, or intended
use environment compared to
the predicate. Performance data
demonstrate that these
technological differences do
not raise new questions of
safety and effectiveness. |
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Differences from Predicate
Compared to the predicate device, the B4C System converts the analog signal to a digital signal, transfers the acquired signal wirelessly over Bluetooth and HTTPs connection rather than a cable, operates by battery, processes and analyzes the acquired signal to produce the surrogate ICP waveform and associated parameters, and allows the user to view the waveform on either a compatible patient monitor or a mobile application and the associated waveform parameters on either the mobile application or web portal. There are also some minor technological differences with respect to materials and dimensions. Despite these differences, the subject and predicate device share common intended use, sensor technology, operating principle, and clinical utility, and demonstrate comparable device performance.
Discussion of Performance Data
The following performance data in Table 2 are provided in support of the substantial equivalence determination between the proposed device, B4C System, and predicate device, BcSs-PICNI-2000 Sensor
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(K182073).
| TEST | TITLE/TEST METHOD SUMMARY | RESULTS |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: | |
| Tests for in vitro cytotoxicity | Pass | |
| Non-cytotoxic | ||
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: | |
| Tests for irritation and skin sensitization | Pass | |
| Non-sensitizing | ||
| Non-irritating | ||
| Electrical Safety and Electromagnetic Compatibility | ||
| IEC 60601-1 | Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential | ||
| performance | Pass | |
| ANSI AAMI ES | ||
| 60601-1 | Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential | ||
| performance | Pass | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General | |
| requirements for basic safety and essential | ||
| performance - Collateral | Pass | |
| AAMI TIR69 | Risk management of radio-frequency wireless | |
| coexistence for medical devices and systems | Testing not required | |
| based on risk | ||
| assessment | ||
| Disinfection | ||
| Disinfection | ||
| Validation | Validation of Low-Level disinfection method using | |
| 70% ethanol. | Pass |
6-log microbial
reduction |
| Bench Testing | | |
| Monitor Compatibility | Demonstration of compatibility for use with patient
monitors. | Pass |
| Stability and
Reproducibility | Demonstration of stability, repeatability, and
reproducibility between the ICP waveform outputs of
the wireless and wired sensors. | Pass |
| Software | | |
| Software Verification
and Validation | Demonstrate that all software requirements were
appropriately implemented in the software. | Pass |
Table 2 Summary of Non-Clinical Performance Data
Performance test results demonstrate that the subject device and predicate device, BcSs-PICNI-2000 Sensor (K182073), are substantially equivalent with respect to biocompatibility, electrical safety, electromagnetic compatibility, disinfection, monitor compatibility, and reproducibility for their shared intended use in monitoring of suspected variation in ICP and brain compliance.
Discussion of Clinical Testing
Braincare conducted a combined prospective, multi-center, observational study to assess the comparison of the acquired ICP waveform signal and parameters between the B4C System and standard of care invasive ICP monitoring methods. The study device consisted of the B4C processing and analytical software used with the wired sensor (K182073). Although the wired sensor was used in the
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study, the results reflect the performance of the B4C System.
Dataset Description
- Total number of centers: 4 ●
- Total number of subjects: 123 enrolled, 107 after device label check, 85 after data quality check ● (78 adults, 7 pediatric)
- Collected data: ICP Surrogate Waveform (BcSs-PICNI-2000 (K182073) or B4C System); ● Invasive Arterial Blood Pressure, Invasive ICP Waveform (EVD or Bolt)
- Range of acquisition sessions time: 5 min to 3.5 hours
- Total number of monitoring sessions that passed quality check: 159 ●
- Total acquisition time that passed quality check: 4800 (98% adult, 2% pediatric)
Analyzed participants
Seventy eight adults (18+) who met all eligibility criteria and were admitted to the neurointensive care unit and underwent invasive ICP monitoring and invasive arterial blood pressure monitoring were considered in the dataset. Due to the reduced quantity of pediatric subjects, the analysis could only demonstrate statistically relevant performance for the adult population.
- Total number of analyzed subjects: 78 adults ●
- Total acquisition time analyzed: 4695 minutes
- Age of analyzed subjects: 52.7±19.4 ●
- Gender of analyzed subjects: 47% female ; 53% male ●
Study Objective
The goal of the analysis was to verify whether the new medical device developed by Braincare demonstrated a consistent correlation between its recorded waveform with the invasive devices waveform that are currently used in clinical practice. The objective was to evaluate the reliability and accuracy of the correlation between the Braincare device in monitoring ICP waveform in comparison to gold standard invasive ICP monitoring methods such as the external ventricular drain or intraparenchymal micro transducers that are currently used in clinical practice, and utilized in the target population in different centers and medical settings.
Study Procedures
All centers used Braincare's non-invasive sensors with identical principles of operations (3 centers are with BcSs-PICNI-2000 sensor (K182073), 1 with B4C System wireless sensor). The sensors at each site were positioned according to the same protocols, i.e., temporal region avoiding arteries and adjustment to the point that an acceptable waveform appears, a procedure that represents real case usage. Patients at all sites had invasive, non invasive and ABP waveforms captured.
Study Outcomes
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The primary objective was to compare the ICP curve morphology obtained with the Braincare and invasive ICP sensors, with focus on the characteristics of peaks P1, P2, P3 amplitudes and their ratios, among other characteristics of the ICP pulse waveform including lags between wave peaks (time to peak) and the absolute curvature of the peaks to determine relative changes and trends over time in ICP and brain compliance.
The analysis aimed evaluate the reliability and accuracy of the Braincare device in assessing ICP waveform in comparison to gold standard invasive ICP monitoring methods such as the external ventricular drain or intraparenchymal micro transducers as well as the ability to monitor relative changes in ICP as well as trends over time. The study hypothesis was that the ICP pulse morphology (waveform) detected by the Braincare noninvasive device presented a statistically significant correlation with the ICP pulse morphology (waveform) detected by the gold standard invasive method(s).
Bland-Altman plots and Deming regression analyses were used to quantify agreement between the invasive ICP waveform and Braincare surrogate ICP waveform parameters - estimated P2/P1 ratio and normalized time to peak (TTP), estimating the differences between the respective averages per minute. Additionally, spearman and normalized mutual information methods were utilized to assess non-linear behavior between waveforms. Considering the differences in positioning of the invasive and non-invasive sensors (inside the ventricle compared to outside the skull), strong agreement between the signals was not expected. Nevertheless, a relatively large region of agreement and presented correlation between the parameters was observed and demonstrated statistical significance confirmed by additional statistical tests.
- Correlation analysis: ●
Spearman correlation and normalized mutual information were used to assess statistical dependence on the ICP waveform parameters between the Braincare sensor and invasive sensor. For the normalized time to peak, the Spearman correlation was 0.318 [0.291, 0.345], p0.2. Additionally, while the mean difference in P2/P1 between our device and invasive ICP is not significantly different from zero, we observed instances where P2/P1 measured by the device differed from that measured by invasive ICP by >0.7.
Both classes of analysis, Bland-Altman / Deming Regression which evaluate agreement, and Normalized Mutual Information / Spearman which evaluate correlation presented statistically meaningful results.
Safety
No adverse events were reported.
Study Conclusion
Results of this study demonstrated a statistically significant correlation in the ICP signal and waveform parameters between the B4C System and the gold standard invasive ICP monitoring device measured over time. The study outcomes demonstrate comparable effectiveness between the Braincare device and commonly used invasive ICP devices for use in monitoring and assessing variations in ICP waveform associated parameters over time.
Conclusion
Based on the results of the performance testing and substantial equivalence comparison, the B4C System has the same intended use as the predicate device. The presented information is sufficient to determine that the B4C System is substantially equivalent to the legally marketed predicate device.