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 Description

The B4C System is a non-invasive device intended for 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, charger, as well as processing and analytical software. The subject of this 510(k) is to introduce an additional sensor, model BcSs-PICNIW-2000, that is compatible with the existing B4C System (K201989). The BcSs-PICNIW-2000 sensor consists of a piezoelectric fixed on a circular base that is supported on a headband placed over the patient's head. The skull pulsation is sensed by the fixed piezoelectric. Users may use either the existing sensor with the B4C System. During monitoring sessions, either sensor continuously transmits the Mobile App via Bluetooth connection and then to the analytical software component, Physio Core, to perform signal processing. The processed information is then sent back to the Mobile App in the form of minute graphs of waveform derived parameters as well as a report with additional waveform information. Like the predicate sensor, the proposed sensor does not measure absolute intracranial pressure values, but continues to produce 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 is supported on a 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 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 wirelessly 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 real-time waveform, minute graphs, intermediate, or final reports 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, with a supplied dongle, a paired patient 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 characteristics 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the B4C System, with a new sensor model (BcSs-PICNIW-2000). The focus of this submission is to demonstrate substantial equivalence to the existing B4C System (K201989). The document primarily outlines the comparison between the new sensor and the predicate device, and the non-clinical performance data to support this claim.

Based on the provided text, there is no information regarding acceptance criteria outlined as specific metrics (e.g., sensitivity, specificity, accuracy) for the device's performance in a clinical study setting. The document emphasizes non-clinical performance data to demonstrate a new sensor model is substantially equivalent to a previously cleared device.

Therefore, for the purpose of answering your request, I will extract the information related to the non-clinical performance data which serves as the "study" proving the device meets the "acceptance criteria" for substantial equivalence. The acceptance criteria here are implicitly showing that the new sensor performs comparably to the predicate device and meets established safety and performance standards.

Here's the breakdown of the information based on your request, extracted from the provided text:

Acceptance Criteria and Device Performance for New Sensor (BcSs-PICNIW-2000)

The "acceptance criteria" in this context are primarily derived from demonstrating that the new BcSs-PICNIW-2000 sensor, when integrated into the B4C System, maintains comparable performance, safety, and effectiveness to its predicate device (B4C System K201989). This is achieved through non-clinical testing, ensuring the differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Non-Clinical)
Biocompatibility: Device materials are safe for patient contact.	The BcSs-PICNIW-2000 is comprised of the same materials as the predicate device sensor. A biological risk assessment was provided in lieu of repeating testing. (Implies acceptance based on predicate's known safety)
Electrical Safety: Device meets electrical safety standards.	IEC 60601-1 / ANSI AAMI ES 60601-1: Pass
Electromagnetic Compatibility (EMC): Device operates without interference and is not susceptible to interference.	IEC 60601-1-2: PassAAMI TIR69: Testing not required based on risk assessment (Implies acceptance based on risk assessment, indicating no new EMC concerns).
Disinfection: Device can be reprocessed safely and effectively.	The BcSs-PICNIW-2000 is intended to be reprocessed according to the same methods as the predicate device sensor. Reprocessing validation was not required. (Implies acceptance based on predicate's established reprocessing methods).
Monitor Compatibility: New sensor works with existing monitor/receiver.	There are no changes to the predicate device receiver and wireless communication protocol. Monitor compatibility testing was not repeated. (Implies acceptance as existing compatibility is maintained).
Stability and Reproducibility: Device provides stable and consistent ICP waveform outputs.	Demonstration of stability, repeatability, and reproducibility: Pass (This is the most direct "performance" metric mentioned for the new sensor's output comparable to the predicate's wired sensor).
Software Verification and Validation: Software meets all requirements.	Demonstrate that all software requirements were appropriately implemented in the software. Pass. (Implies acceptance that the minor software updates do not negatively impact functionality, aligning with existing system software performance).
Overall substantial equivalence: Differences do not raise new questions of safety or effectiveness.	The document concludes: "Based on results of the performance testing and substantial equivalence comparison, the B4C System maintains the same intended use as the predicate device and the information presented is sufficient to determine that the subject device is substantially equivalent to the predicate device." (Overall acceptance).

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a "sample size" in terms of patient data for a clinical test set. The reported "performance data" is non-clinical bench testing and verification/validation.
Data Provenance: The data provenance for these non-clinical tests is not explicitly stated (e.g., country of origin, retrospective/prospective). However, such testing is typically controlled laboratory or engineering testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As the reported data is non-clinical bench testing and verification/validation, it does not involve human experts establishing "ground truth" for patient data in the way a clinical study would. The "ground truth" for these tests would be defined by engineering specifications and regulatory standards (e.g., IEC standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No human adjudication method is described as the data pertains to non-clinical tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No such study was done or reported. The device is an intracranial pressure monitoring device, and the submission is for a new sensor model. It is not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The information provided primarily focuses on the technical validation of the hardware (sensor) and its integration with the existing B4C System software and receiver. Specifically, it mentions "Software Verification and Validation" demonstrating that "all software requirements were appropriately implemented."
While the device outputs parameters for "interpretation," the assessment here is on the technical functionality and equivalence of the new sensor's output, not a standalone diagnostic algorithm's performance. The device is explicitly stated as not a standalone diagnostic tool, but provides information for clinician interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable in the traditional clinical sense. For the non-clinical bench testing and verification/validation, the "ground truth" refers to established engineering specifications, regulatory standards (e.g., IEC 60601-1), or the known performance of the predicate device against which the new sensor's outputs ("stability, repeatability, and reproducibility of ICP waveform outputs") are compared.

8. The sample size for the training set:

Not Applicable. The document describes a 510(k) submission for a new sensor model and its non-clinical performance and equivalence to a predicate. It does not refer to an AI/ML algorithm that would require a "training set" in the common sense of machine learning. The B4C System contains "analytical and processing software," but the submission does not detail its development or "training" data.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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July 18, 2024

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Braincare Desenvolvimento e Inovação Tecnológica S.A. % Cherita James Official Correspondent ProPharma MedTech 1129 20th Street NW, Ste 600 Washington, District of Columbia 20036

Re: K240821

Trade/Device Name: B4C System with BcSs-PICNIW-2000 sensor model Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: March 21, 2024 Received: March 25, 2024

Dear Cherita James:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Patrick Antkowiak -S

for

Jay Gupta, MS Assistant Director DHT5A: Division of Neurosurgical,

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240821

Device Name

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

Indications for Use (Describe)

Refer to device labeling for more information regarding the derivation and interpretation 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

B4C System - Addition of BcSs-PICNIW-2000 Sensor

Sponsor:	Braincare Desenvolvimento e Inovacao Tecnologica S.AAvenida Bruno Ruggiero Filho, 971São Carlos, SP – Brazil13562-420
Contact:	Connie QiuProPharma MedTech1129 20th Street NW, Suite 600Washington, DC 20036connie.qiu@propharmagroup.comPh. 347-954-0411
Date Prepared:	March 6, 2024
Proprietary Name:	B4C System (Addition of BcSs-PICNIW-2000 Sensor)
Common Name:	Intracranial pressure monitoring device
Regulatory Class:	II
Regulation:	882.1620
Product Code:	GWM
Predicate Device(s):	B4C System K201989

Device Description

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sensor, the proposed sensor does not measure absolute intracranial pressure values, but continues to produce 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 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

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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.

Comparison to Predicate Device

The subject of this 510(k) is to introduce the additional BcSs-PICNIW-2000 sensor to the existing B4C System that is marketed under K201989. A comparison of the subject and predicate devices 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 SystemAddition of SensorBcSs-PICNIW-2000	B4C System K201989	SubstantialEquivalence
Product Code	GWM	GWM	Same
Indications for Use	The B4C System isintended for the monitoringof variation in intracranialpressure in patients withsuspected alteration ofintracranial pressure (ICP)or change in intracranialcompliance, by providingsurrogate ICP waveformsand associated parameters(estimated P2/P1 ratio,normalized Time-to-Peak,derived useful ICP pulsesand cardiac pulse) forinterpretation.Refer to device labeling formore information regardingthe derivation andinterpretation of the outputof the device.	The B4C System is intendedfor the monitoring ofvariation in intracranialpressure in patients withsuspected alteration ofintracranial pressure (ICP) orchange in intracranialcompliance, by providingsurrogate ICP waveforms andassociated parameters(estimated P2/P1 ratio,normalized Time-to-Peak,derived useful ICP pulses andcardiac pulse) forinterpretation.Refer to device labeling formore information regardingthe derivation andinterpretation of the output ofthe device.	Same
Prescription Device	Yes	Yes	Same
DeviceDescription	Non-invasive ICPmonitoring deviceconsisting of pressuresensors supported on aheadband to detect skull	Non-invasive ICP monitoringdevice consisting of straingauge pressure sensorssupported on a headband todetect skull deformations in	Similar. The maindifference compared tothe predicate is that anadditional sensor isintroduced as an option
	deformations in response to ICP changes. System wirelessly transmits acquired signal for processing and analytics. 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. This 510(k) introduces an additional piezoelectric pressure sensor available for use with the existing B4C System in addition to a strain gauge pressure sensor.	response to ICP changes. System wirelessly transmits acquired signal for processing and analytics. 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.	to the user with the existing B4C System. The B4C System's software components have also undergone minor software updates.
ClinicalApplication	Non-invasive application ofa sensor on the scalpperpendicularly positionedin the temporoparietaltransition, 2 inches (5-6cm) above the entrance ofthe external auditory canalon the coronal plane	Non-invasive application of asensor on the scalpperpendicularly positioned inthe temporoparietaltransition, 2 inches (5-6 cm)above the entrance of theexternal auditory canal on thecoronal plane	Same
Contraindications	The B4C System iscontraindicated for use inpatients who have:• Undergonedecompressivecraniectomy orcraniotomy;• Cranial defects (portionof skull missing);Any other conditions thatthe health practitionerdeems to be unsuitable foruse of this device.	The B4C System iscontraindicated for use inpatients who have:• Undergone decompressivecraniectomy orcraniotomy:• Cranial defects (portion ofskull missing);Any other conditions that thehealth practitioner deems tobe unsuitable for use of thisdevice.	Same
Device Materials	• Silicone andpolycarbonate/ABSsensor casing• Polypropyleneheadband	• Polycarbonate sensorcasing and contact pin• Silicone base aroundsensor• Polypropylene headband	Same materials
MRI Claim	MR Unsafe	MR Unsafe	Same
Sterilization	Not applicable	Not applicable	Same
Device dimensions	Sensor case: 250 x 40 x 34 mmReceiver case: 94 x 17.5 x 15 mmHeadband size with turnbuckle:340 x 32 x 20 mm (smallest)460 x 32 x 20 mm (largest)	Sensor case: 75.6 X 51.5 X 27.7 mmReceiver case: 94 X 17.5 X 15 mmReceiver cable and connector length: 20 cmHeadband 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	Similar.Differences in dimensions do not raise new questions of safety or effectiveness.
Biocompatibility	Limited duration contact (≤24) with intact skinNon-cytotoxicNon-sensitizingNon-irritating	Limited duration contact (≤24) with intact skinNon-cytotoxicNon-sensitizingNon-irritating	Same
Energy modality	Sensor contains internal rechargeable battery	Sensor contains internal rechargeable battery and external rechargeable battery pack	SimilarBoth subject and predicate sensors contain internal rechargeable batteries. The subject sensor does not include an external rechargeable battery pack. This difference does not raise new questions of safety and effectiveness.
ICP WaveformOutputs	Waveform displayed on compatible patient monitorAnalytical 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	Waveform displayed on compatible patient monitorAnalytical 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	Same
	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.	Derived Cardiac Pulse These associated parameters are derived based on well-established principles in scientific literature and clinical practice.
Sensing element	Piezoelectric	Strain gauge	DifferentThe subject sensor utilizes a piezoelectric while the predicate sensor is strain gauge based. Both sensors follow the same operating principle of detecting changes in ICP through small variations in skull deformation based on well-understood principles of ICP waveform morphology. Performance data demonstrate that this difference does not raise new questions of safety and effectiveness.
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 of 3000 Ohms (typical values). It also uses a piezoelectric disc that does not require a power supply to generate electric charges, with	The wireless sensor is not physically connected to any device and has an internal resistive bridge with input and output impedance of 1000 Ohms.	Similar.Differences do not raise new questions of safety and effectiveness.
	magnitude of 14.5 nF.
Output signal(sensitivity)	Not applicable for thewireless sensor since it isnot physically connected toany device.The receiver can output amaximum signal of 25mVand minimum of -2.5mV.	Not applicable for thewireless sensor since it is notphysically connected to anydevice.The receiver can output amaximum signal of 25mVand minimum of -2.5mV.	Same
Zero Drift	Not applicable for thesensor as it does notprovide absolute values andbrain4care App performsauto scale so that thewaveform is always visible.The receiver is also capableof automatically readjustingthe signal offset level sothat the waveform is alwaysvisible on the monitor.	Not applicable for the sensoras it does not provideabsolute values andbrain4care App performsauto scale so that thewaveform is always visible.The receiver is also capableof automatically readjustingthe signal offset level so thatthe waveform is alwaysvisible on the monitor.	Same
Electrical Safety	Complies with IEC 60601-1	Complies with IEC 60601-1	Same
ElectromagneticCompatibility	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2	Same
Software	The B4C System includes amobile device application,firmware, analytical andprocessing software, andadministrative softwarecomponents.	The B4C System includes amobile device application,firmware, analytical andprocessing software, andadministrative softwarecomponents.	Same
Sensor Connectionto Monitor	WirelessBluetooth connection to areceiver or micro-USBconnection specific tocompatible patient monitors	WirelessBluetooth connection to areceiver or micro-USBconnection specific tocompatible patient monitors	Same
Wireless Module	Bluetooth	Bluetooth	Same

Table 1 Comparison of Subject and Predicate Devices

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Differences from Predicate

This 510(k) introduces the addition of the BcSs-PICNIW-2000 sensor to the existing B4C System, the predicate device K201989. The main difference is an additional sensor that uses a piezoelectric based sensor compared to the existing strain gauge based sensor. The B4C System continues to maintain the same indications for use, operating principle of detecting small variations in skull deformation, and clinical utility. There are no significant changes to the B4C System software.

Discussion of Performance Data

The following performance data in Table 2 are provided in support of demonstrating substantial

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equivalence between the subject and predicate devices.

Table 2 Summary of Non-Clinical Performance Data
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TEST	TITLE/TEST METHOD SUMMARY	RESULTS
Biocompatibility	The BcSs-PICNIW-2000 is comprised of the same materials as the predicate device sensor. A biologicalrisk assessment was provided in lieu of repeating testing.
Electrical Safety and Electromagnetic Compatibility
IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance	Pass
ANSI AAMI ES60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance	Pass
IEC 60601-1-2	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral	Pass
AAMI TIR69	Risk management of radio-frequency wirelesscoexistence for medical devices and systems	Testing not requiredbased on riskassessment
Disinfection	The BcSs-PICNIW-2000 is intended to be reprocessed according to the same methods as the predicatedevice sensor. Reprocessing validation was not required.
Bench Testing
Monitor Compatibility	There are no changes to the predicate device receiver and wirelesscommunication protocol. Monitor compatibility testing was not repeated.
Stability andReproducibility	Demonstration of stability, repeatability, andreproducibility between the ICP waveform outputs ofthe wireless and wired sensors.	Pass
Software
Software Verificationand Validation	Demonstrate that all software requirements wereappropriately implemented in the software.	Pass

Non-clinical performance data is sufficient to demonstrate substantial equivalence.

Conclusion

Based on results of the performance testing and substantial equivalence comparison, the B4C System maintains the same intended use as the predicate device and the information presented is sufficient to determine that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).