B4C System

K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · GWM · Oct 8, 2021 · Neurology

Device Facts

• Record ID: K201989
• Device Name: B4C System
• Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
• Product Code: GWM · Neurology
• Decision Date: Oct 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended 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.

Device Story

Non-invasive ICP monitoring system; uses scalp-mounted strain gauge sensor on headband to detect skull deformation; converts mechanical tension/compression to digital signals via high-resolution ADC. System processes signals to generate surrogate ICP waveforms, trend lines, and parameters (P2/P1 ratio, normalized Time-to-Peak, pulse metrics). Data transmitted via Bluetooth to mobile app or compatible multi-parameter monitor. Used in clinical settings (e.g., neuro-ICU) by clinicians to assess intracranial hypertension or compliance changes. Not a standalone diagnostic tool; does not provide absolute ICP values. Complements clinical evaluation; aids in preliminary assessment of ICP trends.

Clinical Evidence

Prospective, multi-center, observational study (n=78 adults). Compared B4C surrogate ICP waveform/parameters (P2/P1 ratio, Time-to-Peak) against invasive gold standard (EVD/Bolt). Spearman correlation for P2/P1 ratio was 0.495 (p<.0001) and for Time-to-Peak was 0.318 (p<.0001). Normalized mutual information was 0.561 and 0.612 respectively. Bland-Altman analysis showed mean bias of 0.019 for P2/P1 and 0.031 for Time-to-Peak. Results confirm statistically significant correlation between B4C surrogate morphology and invasive ICP monitoring.

Technological Characteristics

Non-invasive strain gauge sensor; polycarbonate casing, silicone contact pin, polypropylene headband. Wireless connectivity via Bluetooth; HTTPs protocol for cloud/app data transfer. Powered by internal/external rechargeable batteries. Software-based signal processing and analysis. MR Unsafe. Disinfection via 70% ethanol. Complies with IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult patients (18+) with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. Contraindicated for patients who have undergone decompressive craniectomy or craniotomy, have cranial defects (missing skull portion), or other conditions deemed unsuitable by a health practitioner.

Regulatory Classification

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.

Predicate Devices

• BcSs-PICNI-2000 Sensor (K182073)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

# B4C System

| Sponsor: | Braincare desenvolvimento e Inovacao Tecnologica S.A.<br>Avenida Bruno Ruggiero Filho, 971<br>São Carlos, SP - Brazil<br>13562-420 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Connie Qiu<br>M Squared Associates, Inc.<br>127 West 30th Street, 9th Floor<br>New York, New York 10001<br>Ph. 703-562-9800<br>Fax. [phone] |
| 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-<br>2000 Sensor | Substantial Equivalence |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K201989 | K182073 | Not applicable |
| Product Code | GWM | GWM | Same |
| Indication for Use | The B4C System is<br>intended for the<br>monitoring of variation<br>in intracranial pressure<br>in patients with<br>suspected alteration of<br>intracranial pressure<br>(ICP) or change in<br>intracranial compliance,<br>by providing surrogate<br>ICP waveforms and<br>associated parameters<br>(estimated P2/P1 ratio,<br>normalized Time-to-<br>Peak, derived useful ICP<br>pulses and cardiac pulse)<br>for interpretation.<br><br>Refer to device labeling<br>for more information<br>regarding the derivation<br>and interpretation of the<br>output of the device. | The BcSs-PICNI-2000<br>Sensor is intended for the<br>monitoring of variation in<br>intracranial pressure in<br>patients with suspected<br>alteration of intracranial<br>pressure (ICP) or change<br>in brain compliance, by<br>providing ICP waveforms<br>for interpretation. | Same intended use.<br><br>Similar indications for use.<br>Brain compliance is replaced to<br>intracranial compliance for<br>consistency with medical<br>terminology. Otherwise, the<br>only difference in the<br>indications for use is that the<br>subject device is intended to<br>provide some associated<br>parameters about the ICP<br>waveform characteristics in<br>addition to the visualized<br>surrogate waveform. However,<br>these do not change the<br>intended use, intended user, or<br>clinical utility compared to the<br>originally cleared device. This<br>difference does not raise new<br>questions of safety or<br>effectiveness. |
| Prescription Device | Yes | Yes | Same |
| Device<br>Description | Non-invasive ICP<br>monitoring device<br>consisting of strain<br>gauge pressure sensors<br>supported on a headband<br>to detect skull<br>deformations in response<br>to ICP changes. System<br>wirelessly transmits<br>acquired signal for | Non-invasive ICP<br>monitoring device<br>consisting of strain gauge<br>pressure sensors supported<br>on a headband to detect<br>skull deformations in<br>response to ICP changes.<br>System requires a wired<br>connection to a compatible<br>patient monitor to view | Similar<br><br>The operating principle of the<br>sensor remains the same. This<br>510(k) introduces<br>modifications primarily<br>consisting of software<br>components that include:<br>Bluetooth module and<br>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:<br>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:<br>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<br>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<br>biocompatibility testing for the<br>patient contacting surfaces. The<br>difference in materials do not<br>raise new questions in terms of<br>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<br>X 27.7 mm<br><br>Receiver case: 94 X 17.5<br>X 15 mm<br><br>Receiver cable and<br>connector length: 20 cm | Sensor case: 18.7 x 18.5 x<br>66.5 mm<br><br>Sensor pin length: 18mm<br>Sensor pin diameter: 7.5<br>mm<br><br>Sensor cable length: 200<br>cm. | The differences in dimension<br>do not raise new questions of<br>safety or effectiveness. |
| | Headband size with<br>turnbuckle :<br>XXS: 49.5 cm, XS: 52<br>cm, S: 54.5 cm, M: 57<br>cm, L: 59.5 cm, XL: 52<br>cm, XXL: 64.5 cm | Headband Perimeter:<br>Extra Small: 50-55cm,<br>Small: 52.5-57.5 cm,<br>Medium: 55-60 cm,<br>Large: 57.5-62.5 cm.<br><br>Adaptor cable length: 180<br>cm. | |
| Biocompatibility | Limited duration contact<br>(≤24) with intact skin<br><br>Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Prolonged contact (>24<br>hours but within ≤30 days)<br>with intact skin<br><br>Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Similar<br>The device continues to be<br>intended only for contact with<br>intact skin. While the predicate<br>device was assessed for<br>prolonged contact as a<br>conservative risk management<br>approach, it is expected that the<br>device will only be applied for<br>limited duration (≤24 hours) in<br>actual use. Biocompatibility<br>evaluation demonstrate that thi<br>difference does not raise new<br>questions of safety and<br>effectiveness. |
| Energy modality | Sensor contains internal<br>rechargeable battery and<br>external rechargeable<br>battery pack | 5 volts DC when<br>connected to ICP<br>monitoring device | Different<br>The modified device introduces<br>internal and external batteries,<br>while the predicate device had<br>power supplied by the<br>connected patient monitor.<br>Battery safety, electrical safety,<br>and electromagnetic<br>compatibility testing |
| ICP Waveform<br>Outputs | Waveform displayed on<br>compatible patient<br>monitor<br>Analytical software also<br>produces the following<br>associated parameters<br>about the surrogate ICP<br>waveform displayed in a<br>report and on the<br>accompanying mobile<br>medical application:<br>• Surrogate<br>Waveform<br>• Waveform<br>Trend line<br>• Average<br>waveform<br>• Estimated P2:P1<br>ratio<br>• Normalized<br>Time-to-Peak<br>• Derived useful<br>ICP pulses<br>• Derived Cardiac<br>Pulse<br>These associated<br>parameters are derived<br>based on well-<br>established principles in<br>scientific literature and<br>clinical practice. | Waveform displayed on<br>compatible patient<br>monitor | demonstrate that these<br>technological differences do<br>not raise new questions of<br>safety and effectiveness.<br>Similar<br>Both the subject and predicate<br>device produce display of ICP<br>waveforms in real-time. The<br>modified device also provides<br>associated parameters of the<br>surrogate waveform that may<br>be viewed in a convenient<br>report on the accompanying<br>mobile medical application or<br>web portal as an alternative to a<br>compatible multiparameter<br>monitor. The surrogate<br>waveform and associated<br>parameters continue to be<br>interpreted by the clinician per<br>standard clinical practice and<br>with other clinical evaluations<br>and parameters as deemed<br>necessary by the clinician.<br>Performance testing<br>demonstrates that the<br>differences in displayed<br>information do not raise new<br>questions of safety and<br>effectiveness. |
| Sensing element | Strain gauge | Strain gauge | Same |
| Functional pressure<br>range | Not applicable as it does<br>not provide absolute<br>values of pressure | Not applicable as it does<br>not provide absolute<br>values of pressure | Same |
| Functional over<br>pressure range<br>without damage | Not applicable as it does<br>not provide absolute<br>values of pressure, and<br>does not have a specified<br>functional pressure<br>range. | Not applicable as it does<br>not provide absolute<br>values of pressure, and<br>does not have a specified<br>functional pressure range. | Same |
| Input/ Output<br>Impedance | The wireless sensor is<br>not physically connected<br>to any device and has an<br>internal resistive bridge | 350 ohms nominal | The differences in input/output<br>impedance do not raise new<br>questions of safety or<br>effectiveness. |
| | with input and output<br>impedance of 1000<br>Ohms. | | |
| Output signal<br>(sensitivity) | Not applicable for the<br>wireless sensor since it is<br>not physically connected<br>to any device.<br>The receiver can output<br>a maximum signal of<br>25mV and minimum of -<br>2.5mV. | 10mV | The differences do not raise<br>new questions of safety or<br>effectiveness. |
| Zero Drift | Not applicable for the<br>sensor as it does not<br>provide absolute values<br>and brain4care aApp<br>performs auto scale so<br>that the waveform is<br>always visible.<br>The receiver is also<br>capable of automatically<br>readjusting the signal<br>offset level so that the<br>waveform is always<br>visible on the monitor. | The Adaptor cable can be<br>used to adjust offset<br>$\pm$ 20mV. | The differences do not raise<br>new questions of safety or<br>effectiveness. |
| Electrical Safety | Complies with IEC<br>60601-1 | Complies with IEC<br>60601-1 | Same |
| Electromagnetic<br>Compatibility | Complies with IEC<br>60601-1-2 | Complies with IEC<br>60601-1-2 | Same |
| Software | This device modification<br>introduces a mobile<br>device application,<br>firmware, analytical and<br>processing software, and<br>administrative software<br>components. | None | Different<br>While the predicate did not<br>contain software, the modified<br>device introduces several<br>software components.<br>The new software components<br>are used to analyze the input<br>ICP sensor data, view, store,<br>and transfer device output.<br>Software verification and<br>validation met acceptance<br>criteria. There is no change to<br>the intended use of the device.<br>This difference does not raise<br>new questions in terms of<br>safety and effectiveness. |
| Sensor Connection to<br>Monitor | Wireless<br>Bluetooth connection to<br>a receiver or micro-USB<br>connection specific to<br>compatible patient | Wired<br>Adaptor Cable with<br>adaptor plug specific to<br>compatible patient<br>monitors | Different<br>While the predicate utilizes a<br>wired connection to display the<br>acquired waveform on the<br>compatible patient monitor, the |
| | monitors | | modified device is able to<br>transmit the signal to the<br>patient monitor wirelessly via a<br>Bluetooth connection and<br>receiver on the monitor.<br>Performance testing<br>demonstrate that this difference<br>does not raise new questions of<br>safety and effectiveness. |
| Wireless Module | Bluetooth | None | Different<br>The modified device introduces<br>a Bluetooth module to facilitate<br>wireless transmission of the<br>acquired ICP waveform signal<br>to a mobile device and receiver<br>to display the waveform on a<br>connected monitor, and to view<br>the waveform and related<br>parameters on a mobile device.<br>Addition of wireless capability<br>does not change the intended<br>use, intended user, or intended<br>use environment compared to<br>the predicate. Performance data<br>demonstrate that these<br>technological differences do<br>not raise new questions of<br>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:<br>Tests for in vitro cytotoxicity | Pass<br>Non-cytotoxic |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | Pass<br>Non-sensitizing<br>Non-irritating |
| Electrical Safety and Electromagnetic Compatibility | | |
| IEC 60601-1 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | Pass |
| ANSI AAMI ES<br>60601-1 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | Pass |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral | Pass |
| AAMI TIR69 | Risk management of radio-frequency wireless<br>coexistence for medical devices and systems | Testing not required<br>based on risk<br>assessment |
| Disinfection | | |
| Disinfection<br>Validation | Validation of Low-Level disinfection method using<br>70% ethanol. | Pass<br>>6-log microbial<br>reduction |
| Bench Testing | | |
| Monitor Compatibility | Demonstration of compatibility for use with patient<br>monitors. | Pass |
| Stability and<br>Reproducibility | Demonstration of stability, repeatability, and<br>reproducibility between the ICP waveform outputs of<br>the wireless and wired sensors. | Pass |
| Software | | |
| Software Verification<br>and Validation | Demonstrate that all software requirements were<br>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…