(115 days)
Not Found
No
The document describes signal processing and analysis but does not mention AI or ML technologies.
No.
The device is described as a non-invasive monitoring system that provides surrogate intracranial pressure (ICP) waveforms and associated parameters for interpretation. Its intended use is for monitoring, not for providing therapy or treatment. The device does not deliver any substance or energy to the patient for therapeutic purposes.
No
The device description explicitly states, "The B4C System is not intended to be a standalone diagnostic tool." It also mentions that "The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis." While it aids in assessing suspected alterations, it doesn't provide a definitive diagnosis on its own.
No
The device description explicitly lists hardware components including a sensor with Bluetooth wireless module, headband, receiver, and charger, in addition to the software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Function: The B4C System is a non-invasive device that monitors variations in intracranial pressure by sensing skull pulsations. It does not collect or analyze specimens from the human body.
- Intended Use: The intended use is for monitoring variations in intracranial pressure and providing surrogate waveforms and parameters for interpretation. This is a physiological monitoring function, not an in vitro diagnostic test.
The device operates externally to the body and analyzes physical signals (skull pulsations) rather than biological samples.
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.
Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Temporoparietal transition of the head/scalp
Indicated Patient Age Range
adult patients ages 18 and older.
Intended User / Care Setting
Clinician; Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data included:
- Biocompatibility: 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.
- Electrical Safety and Electromagnetic Compatibility:
- IEC 60601-1: Pass
- ANSI AAMI ES 60601-1: Pass
- IEC 60601-1-2: Pass
- AAMI TIR69: Testing not required based on risk assessment
- Disinfection: The BcSs-PICNIW-2000 is intended to be reprocessed according to the same methods as the predicate device sensor. Reprocessing validation was not required.
- Bench Testing:
- Monitor Compatibility: There are no changes to the predicate device receiver and wireless communication protocol. Monitor compatibility testing was not repeated.
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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"
1
(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,
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
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 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."
4
510(k) Summary
B4C System - Addition of BcSs-PICNIW-2000 Sensor
| Sponsor: | Braincare Desenvolvimento e Inovacao Tecnologica S.A
Avenida Bruno Ruggiero Filho, 971
São Carlos, SP – Brazil
13562-420 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Connie Qiu
ProPharma MedTech
1129 20th Street NW, Suite 600
Washington, DC 20036
connie.qiu@propharmagroup.com
Ph. 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
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
5
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.
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
6
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 System
Addition of Sensor
BcSs-PICNIW-2000 | B4C System K201989 | Substantial
Equivalence |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GWM | GWM | Same |
| 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 pulse) for
interpretation.
Refer to device labeling for
more information regarding
the derivation and
interpretation of the output
of the device. | 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. | Same |
| Prescription Device | Yes | Yes | Same |
| Device
Description | Non-invasive ICP
monitoring device
consisting of pressure
sensors supported on a
headband to detect skull | Non-invasive ICP monitoring
device consisting of strain
gauge pressure sensors
supported on a headband to
detect skull deformations in | Similar. The main
difference compared to
the predicate is that an
additional sensor is
introduced 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. |
| 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 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. | Same |
| Device Materials | • Silicone and
polycarbonate/ABS
sensor casing
• Polypropylene
headband | • Polycarbonate sensor
casing and contact pin
• Silicone base around
sensor
• 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 mm
Receiver case: 94 x 17.5 x 15 mm
Headband 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 mm
Receiver case: 94 X 17.5 X 15 mm
Receiver cable and connector length: 20 cm
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 | Similar.
Differences in dimensions do not raise new questions of safety or effectiveness. |
| Biocompatibility | Limited duration contact (≤24) with intact skin
Non-cytotoxic
Non-sensitizing
Non-irritating | Limited duration contact (≤24) with intact skin
Non-cytotoxic
Non-sensitizing
Non-irritating | Same |
| Energy modality | Sensor contains internal rechargeable battery | Sensor contains internal rechargeable battery and external rechargeable battery pack | Similar
Both 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 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 | 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 | 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 | Different
The 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 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. | 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. | Same |
| Zero Drift | Not applicable for the
sensor as it does not
provide absolute values and
brain4care App 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. | Not applicable for the sensor
as it does not provide
absolute values and
brain4care App 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. | Same |
| 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 | The B4C System includes a
mobile device application,
firmware, analytical and
processing software, and
administrative software
components. | The B4C System includes a
mobile device application,
firmware, analytical and
processing software, and
administrative software
components. | Same |
| Sensor Connection
to Monitor | Wireless
Bluetooth connection to a
receiver or micro-USB
connection specific to
compatible patient monitors | Wireless
Bluetooth connection to a
receiver or micro-USB
connection specific to
compatible patient monitors | Same |
| Wireless Module | Bluetooth | Bluetooth | Same |
Table 1 Comparison of Subject and Predicate Devices
7
8
9
10
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
11
equivalence between the subject and predicate devices.
| Table 2 Summary of Non-Clinical Performance Data |
|---|
| -------------------------------------------------- |
| TEST | TITLE/TEST METHOD SUMMARY | RESULTS |
|---|---|---|
| Biocompatibility | 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. | ||
| 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 | The BcSs-PICNIW-2000 is intended to be reprocessed according to the same methods as the predicate | |
| device sensor. Reprocessing validation was not required. | ||
| Bench Testing | ||
| Monitor Compatibility | There are no changes to the predicate device receiver and wireless | |
| communication protocol. Monitor compatibility testing was not repeated. | ||
| 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 |
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.