BcSs-PICNI-2000 Sensor
Device Facts
| Record ID | K182073 |
|---|---|
| Device Name | BcSs-PICNI-2000 Sensor |
| Applicant | Braincare Desenvolvimento E Inovacao Tecnologica S.A. |
| Product Code | GWM · Neurology |
| Decision Date | Oct 17, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1620 |
| Device Class | Class 2 |
Intended Use
The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.
Device Story
Non-invasive sensor; headband-mounted; placed on temporoparietal transition. Contains four strain gauges on metal bar; detects skull deformation via tension/compression from ICP changes. Transfers signals via adapter cable to multi-parameter monitor. Monitor displays ICP waveform morphology (P1, P2, P3 peaks). Used in neurointensive care units; operated by clinicians. Provides qualitative assessment of ICP trends/brain compliance; does not measure absolute ICP. Complements clinical evaluation; does not replace standard diagnostic tools. Benefits include non-invasive monitoring; avoids risks of invasive ICP monitoring (infection, hemorrhage, tissue damage).
Clinical Evidence
Two studies: 1) Case study (n=1) of HIV-associated cryptococcal meningitis; waveform morphology (P1/P2/P3) correlated with clinical status pre/post lumbar puncture. 2) Prospective study (n=7) in neuro-ICU; compared subject device (nICP) to predicate (iICP). Primary endpoint: waveform morphology similarity via Euclidean distance of power spectral densities. Results showed statistically significant similarity between nICP and iICP (p<0.05) compared to arterial blood pressure. No adverse events reported.
Technological Characteristics
Non-invasive strain gauge sensor; polyoxymethylene construction. Headband-mounted. Dimensions: 18.7x18.5x66.5 mm. Energy: 5V DC via monitor. Connectivity: Wired adapter cable to multi-parameter monitor. MR Unsafe. Disinfection: 70% ethanol. Complies with IEC 60601-1, IEC 60601-1-2.
Indications for Use
Indicated for patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance. Contraindicated for patients who have undergone decompressive craniectomy or craniotomy, or have cranial defects (missing skull portion).
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
- Codman® Microsensor Basic Kit (K153347)
Reference Devices
- BrainPulse, Model 1100 (DEN140040)
Related Devices
- K201989 — B4C System · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 8, 2021
- K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) · Braincare Desenvolvimento E Inovação Tecnológica S.A. · Jul 18, 2024
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit · Codman & Shurtleff, Inc. · Nov 8, 2017
- K062584 — PRESSIO ICP MONITORING SYSTEM · Sophysa SA · Jul 5, 2007
- K003759 — AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR · Aesculap, Inc. · Jun 28, 2001
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Braincare desenvolvimento e Inovacao Tecnologica S.A. % Ms. Connie Oiu Regulatory Consultant M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, New York 10018
Re: K182073
Trade/Device Name: BcSs-PICNI-2000 Sensor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: September 16, 2019 Received: September 17, 2019
Dear Ms. 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 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
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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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.
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) K182073
Device Name BcSs-PICNI-2000 Sensor
Indications for Use (Describe)
The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary
# BcSs-PICNI-2000 Sensor
- Sponsor: Braincare desenvolvimento e Inovacao Tecnologica S.A. Rua Cid Silva Cesar, 600 sala 6 Parque Jardim Santa Felicia Sao Carlos, 13562-400 Brazil
- Contact: Connie Qiu M Squared Associates, Inc. 575 8Th Ave., Suite 1212 New York, New York 10018 Ph. 703-562-9800 Fax. 703-562-9797
| Date Prepared: | September 16, 2019 |
|-------------------|-----------------------------------------|
| Proprietary Name: | BcSs-PICNI-2000 Sensor |
| Common Name: | Intracranial pressure monitoring device |
| Regulatory Class: | II |
| Regulation: | 882.1620 |
| Product Code: | GWM |
| Predicate Device: | Codman® Microsensor Basic Kit K153347 |
| Reference Device: | BrainPulse, Model 1100 DEN140040 |
## Device Description
The BcSs-PICNI-2000 Sensor ("the Braincare Sensor") 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 brain compliance. It consists of a sensor, headband, and adapter cable. 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. The proposed device does not measure absolute intracranial pressure values, but produces waveform morphology and its trend reflecting changes in ICP. The BcSs-PICNI-2000 Sensor and waveform output 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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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 signals through an adapter cable to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability. The multi-parameter monitor's inherent software interprets the signal received from the BcSs-PICNI-2000 Sensor and displays a waveform that allows for assessment of suspected intracranial hypertension or changes in brain compliance based on the characteristic Percussion (P1), Tidal (P2), and Dicrotic (P3) peaks of the ICP waveform morphology.
The BcSs-PICNI-2000 Sensor is not intended to be a standalone diagnostic tool. The waveform output does not replace a comprehensive clinical evaluation, but only provides an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.
Intended Use: The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.
## Comparison to Predicate Device
Comparison of technological characteristics between the BcSs-PICNI-2000 Sensor to the predicate device, Codman® Microsensor Basic Kit (K153347), is presented in Table 1. The differences between the two devices do not affect the intended use, and do not raise new questions of safety and effectiveness.
| | Braincare BcSs-PICNI-<br>2000 Sensor | Codman<br>Microsensor Basic<br>Kit Refs. 62-6631 | Substantial Equivalence |
|--------------------|---------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------|
| 510k # | K182073 | K153347 | Not applicable |
| Product Code | GWM | GWM | All devices are Intracranial<br>Pressure Monitoring<br>devices. |
| Indication for Use | The BcSs-PICNI-2000<br>Sensor is intended for the<br>monitoring of variation in | Use of the<br>CODMAN<br>MICROSENSOR | Both the BcSs-PICNI-2000<br>Sensor and the Codman ® |
| | | | Table 1 Comparison of BcSs-PICNI-2000 Sensor to Codman® Microsensor Basic Kit | |
|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | | |
| | | | | |
| Prescription device | Yes | Yes | Both devices are intended<br>for prescription use only. | |
| Device Description | Non-invasive ICP<br>monitoring device<br>consisting of strain gauge<br>pressure sensors<br>supported on a headband<br>to detect skull<br>deformations in response<br>to ICP changes. | ICP Transducer<br>consist of a<br>miniature strain<br>gauge pressure<br>sensor mounted in a<br>titanium case at the<br>tip of a 100cm 3<br>french flexible<br>nylon tube. | Both devices utilize strain<br>gauge sensors and are used<br>in real-time ICP<br>monitoring. | |
| Clinical<br>Application | Non-invasive application<br>of a sensor on the scalp<br>perpendicularly<br>positioned in the<br>temporoparietal<br>transition, 2 inches (5-6<br>cm) above the entrance of<br>the external auditory<br>canal on the coronal plane | Subdural and<br>intraparenchymal<br>implantation. | Braincare Sensor is applied<br>non-invasively, while the<br>Codman® Microsensor<br>requires subdural and<br>intraparenchymal<br>implantation. Both devices<br>share the same intended<br>use, and have satisfied<br>biocompatibility and<br>performance testing. The<br>potential differences for<br>patient application is<br>restricted to the non-<br>invasiveness nature of the<br>BcSs-PICNI-2000 Sensor,<br>which is similar to the<br>Reference Device;<br>therefore it does not raise<br>new questions in terms of<br>safety and effectiveness. | |
| Contraindications | The BcSs-PICNI-2000<br>Sensor is contraindicated<br>for use in patients who<br>have:<br>•<br>Undergone<br>decompressive<br>craniectomy or<br>craniotomy; | This kit is not<br>designed, sold or<br>intended for any use<br>except as indicated.<br><br>This kit is not<br>designed, sold or<br>intended for use as a<br>therapeutic device. | Both the subject and<br>predicate devices are<br>designed and intended only<br>for the use as indicated.<br>The Braincare device<br>carries additional<br>contraindications specific<br>to its use as a non-invasive<br>ICP monitoring device. | |
| Cranial defects (portion of skull missing); Any other conditions that the health practitioner deems to be unsuitable for use of this device. | However, these additional contraindications do not introduce new risks compared to the predicate device. The difference in contraindications do not raise new questions in terms of safety and effectiveness. | | | |
| Device Materials | Polyoxymethylene sensor and headband. Adapter cable: TPU (thermoplastic polyurethane) and ABS (Acrylonitrile butadiene styrene) case. | PCB in plastic connector housing, solder wire, resistor in plastic housing, epoxy glue Silicone Catheter strain relief Ti case Silicone membrane | The Braincare Sensor and Codman® Microsensor devices are comprised of different patient contacting materials. Both devices have satisfied biocompatibility testing. The difference in materials do not raise new questions in terms of safety or effectiveness. | |
| MRI Claim | MR Unsafe | 1.5T and 3T Conditional | Braincare sensor is MR Unsafe. The difference in MR compatibility does not raise new questions in terms of safety and effectiveness. | |
| Sterilization | Not applicable | Ethylene Oxide | Not applicable as the Braincare Sensor is a non-invasive device and is not provided sterile. The subject device contacts intact skin, and is to be disinfected between use with standard Ethanol 70%. Disinfection method of the Braincare device has been validated and does not raise new questions in terms of safety and effectiveness. | |
| Shelf Life | Not applicable | 2 years | | |
| Device dimensions | Sensor case: 18,7 x 18,5 x 66,5 mm<br>Sensor pin length: 18mm<br>Sensor pin diameter: 7.5 mm | Microsensor:<br>Length: 100cm nominal<br>Tip diameter: 1.3mm max | The Braincare Sensor and Codman® Microsensor have different dimensions due to the nature of the patient application and | |
| | 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>Adaptor cable length: 180<br>cm. | Catheter length<br>(ventricular kit):<br>38cm<br>nominal<br>Catheter diameter<br>(ventricular kit):<br>3.5mm<br>max | differences in dimension do<br>not raise new questions of<br>safety or effectiveness. | |
| Biocompatibility | Prolonged contact (>24<br>days but within ≤30 days)<br>Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Prolonged contact<br>(>24 days but<br>within ≤30 days)<br>Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Both the Braincare Sensor<br>and Codman® Microsensor<br>are categorized as<br>prolonged contact (>24<br>days but within ≤30 days).<br>Both devices were<br>demonstrated to be non-<br>cytotoxic, non-sensitizing,<br>and non-irritating. | |
| Energy modality | 5 volts DC when<br>connected to ICP<br>monitoring device | 5 volts DC when<br>connected to ICP<br>monitoring device | Both the Braincare Sensor<br>and Codman® Microsensor<br>share the same energy<br>modality. | |
| Pressure output<br>display parameters | Waveform | Millimeters of<br>Mercury (mmHg)<br>Waveform | The Braincare Sensor does<br>not provide direct pressure<br>measurement, as opposed<br>to the Codman®<br>Microsensor. However,<br>both devices use strain<br>gauge sensors and generate<br>waveform outputs in<br>response to mechanical<br>waves generated by blood<br>flow in the brain. Animal<br>and clinical study data have<br>shown similarities in the<br>outputs of both devices in<br>real-time ICP monitoring.<br>The difference in pressure<br>output display parameters<br>does not raise new<br>questions in terms of safety<br>and effectiveness. | |
| Sensing element | Strain gauge | Strain gauge silicon<br>microchip | Both devices utilize a strain<br>gauge in the sensing<br>element. | |
| Functional pressure<br>range | Not applicable, does not<br>measure absolute values<br>of pressure. | -50 mmHg to 250<br>mmHg | The Braincare Sensor does<br>not have a limit in<br>functional pressure range.<br>Comparable performance to<br>the predicate device has | |
| Functional over<br>pressure range<br>without damage | Not applicable, does not<br>provide absolute values of<br>pressure, and does not<br>have a specified<br>functional pressure range. | -700 mmHg to 1250<br>mmHg | been demonstrated in<br>animal and clinical studies.<br>This difference does not<br>raise new questions in<br>terms of safety and<br>effectiveness.<br>The Braincare Sensor does<br>not have a limit in<br>functional pressure range.<br>Comparable performance to<br>the predicate device has<br>been demonstrated in<br>animal and clinical studies.<br>This difference does not<br>raise new questions in<br>terms of safety and<br>effectiveness. | |
| Input/ Output<br>Impedance | 350 ohms nominal | 1000 ohms nominal | The Braincare Sensor and<br>Codman® Microsensor<br>differ in input/output<br>impedance based on the<br>differences in the devices'<br>operating principles in<br>monitoring ICP and their<br>technical build. Both<br>devices are designed to<br>meet acceptable safety and<br>effectiveness parameters,<br>and present similar ICP<br>morphology (waveforms)<br>information on the<br>connected patient monitor.<br>Comparable performance to<br>the predicate device has<br>been demonstrated in<br>animal and clinical studies.<br>This difference does not<br>raise new questions in<br>terms of safety or<br>effectiveness. | |
| Output signal<br>(sensitivity) | 10 mV | 7.5 mV absolute<br>voltage span<br>(Calculated based<br>on Microsensor<br>device's functional<br>pressure range of -<br>50 to 250 mmHg,<br>5V when connected<br>to ICP monitor, and<br>output signal | The two devices differ in<br>sensitivity due to<br>differences in their<br>principle of operation of<br>monitoring changes in ICP.<br>Both devices are<br>compatible for use with<br>commercially available<br>patient monitoring devices.<br>Comparable performance to<br>the predicate device has | |
| | | sensitivity 5 uV/V/mmHg) | been demonstrated in animal and clinical studies. This difference does not raise new questions in terms of safety or effectiveness. | |
| Zero Drift | The Adapter cable can be used to adjust offset ±20 mV. | No greater than 5 mmHg over 30 days | The Braincare Sensor generates output in mV and the signal is interpreted by the user in the form of waveform morphology, while the Codman® Microsensor directly measures and provides absolute ICP values in mmHg. Offset functionality for both devices have been defined based on their respective principle of operation. Comparable performance to the predicate device has been demonstrated in animal and clinical studies. This difference does not raise new questions in terms of safety and effectiveness. | |
| Electrical Safety | Complies with IEC 60601-1 | Not Known | Predicate device 510(k) summary does not provide electrical safety information for comparison. | |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 | Not Known | Predicate device 510(k) summary does not provide EMC information for comparison. | |
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## Differences from Predicate:
The BcSs-PICNI-2000 Sensor has minor technological differences from the predicate. The subject device is applied over the scalp to non-invasively capture a signal that is processed to generate a waveform output for qualitative evaluation by the clinician. However, there are other neurological devices that include similar technological characteristics.
The following table provides a comparison of the technological characteristics between the BcSs-PICNI-
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2000 Sensor and Reference Device BrainPulse (DEN140040).
| | Braincare BcSs-PICNI-<br>2000 Sensor | Reference Device:<br>BrainPulse<br>(DEN140040) | Remarks |
|-------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------|
| Clinical Application | Non-invasive<br>application to scalp | Non-invasive<br>application to scalp | Same as Reference<br>Device |
| Sensor operating<br>principle | Strain gauge sensor<br>detects skull<br>deformation resulting<br>from ICP changes | Accelerometer detects<br>skull motion | Similar to Reference<br>Device |
| Device output | Signal is processed to<br>display waveform for<br>qualitative assessment | Signal is processed to<br>display waveform for<br>qualitative assessment | Similar to Reference<br>Device |
Table 2 Technological Comparison to Reference Device
## Discussion of Performance Data
The following performance data in Table 3 are provided in support of the substantial equivalence determination between the proposed device, BcSs-PICNI-2000 Sensor, and predicate device, Codman® Microsensor Basic Kit (K153347).
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| TEST | TITLE/TEST METHOD SUMMARY | RESULTS |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | | |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass<br>Non-cytotoxic |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass<br>Non-sensitizing<br>Non-irritating |
| Electrical Safety and Electromagnetic Compatibility | | |
| IEC 60601-1<br>ANSI AAMI ES 60601-1 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and essential performance | Pass |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance - Collateral | Pass |
| Disinfection | | |
| Disinfection<br>Validation | Validation of Low-Level disinfection method using 70% ethanol. | Pass<br>6-log microbial reduction |
| Bench Testing | | |
| Monitor<br>Compatibility | Demonstration of compatibility for use with patient monitors. | Pass |
| Stability and<br>Reproducibility | Demonstration of stability of device output waveform for a patient throughout a single monitoring session, and reproducibility across multiple monitoring sessions including reapplication of device by different practitioners. | Determined estimated range of variability in waveform characteristics with respect to stability and reproducibility. Results indicate excellent stability and some variance in reproducibility. |
| Animal Studies | | |
| Direct<br>Comparison<br>Study in Rat<br>Animal Model | Simultaneous intracranial pressure monitoring with the proposed device and predicate device were applied to 7 rats that received saline injected into the spinal channel to produce dynamic ICP changes. The objective was to measure the linear correlation between the two ICP monitoring devices' outputs. | Pearson's correlation coefficient $r = 0.8\pm0.2$ indicates a positive correlation between the ICP monitoring outputs of the proposed and predicate devices. |
| Direct<br>Comparison<br>Study in Swine<br>Animal Model | Simultaneous intracranial pressure monitoring with the proposed device and predicate device were applied to a swine animal model that underwent saline injected into the spinal channel to produce dynamic ICP changes. The objective was to measure the monotonic correlation between the two ICP monitoring devices' outputs | Spearman's correlation coefficient $r= 0.81 \pm 0.24$ indicates positive correlation between the ICP monitoring outputs of the proposed and predicate devices. |
## Table 3 Summary of Non-Clinical Performance Data
Performance test results demonstrate that the BcSs-PICNI-2000 Sensor and predicate device, Codman® Microsensor Basic Kit (K153347), are substantially equivalent with respect to biocompatibility, and
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intended use in continuous intracranial pressure monitoring in two comparative animal studies. Additional non-clinical testing verified device performance characteristics that differed from the predicate.
#### Discussion of Clinical Testing
Braincare conducted two clinical studies during validation of the BcSs-PICNI-2000 Sensor. An overview of each study is provided below:
## Non-Invasive ICP Monitoring for HIV-associated Cryptococcal Meningitis
#### Participants
A critically ill adult patient diagnosed with human immunodeficiency virus-associated cryptococcal meningitis underwent real-time ICP monitoring.
## Dataset Description
Four non-invasive ICP monitoring sessions were conducted at defined time points before and after treatment to yield four ICP curves for assessment.
#### Study Objective
The goal of this early study was to evaluate the ability of the BcSs-PICNI-2000 Sensor to non-invasively monitor changes in ICP for a patient with suspected intracranial hypertension such that morphological changes are consistent with the patient's clinical status.
#### Study Procedures
The patient underwent standard treatment for cryptococcal meningitis over thirty-four (34) days. During this period, non-invasive ICP monitoring was performed on Day 12 and Day 34 prior to and following a programmed lumbar puncture procedure. Monitoring produced ICP waveforms at 4 timepoints. Waveform morphology of the ICP curves at these time points was visually assessed with other recorded clinical parameters to determine whether the waveforms were indicative of the clinical status of the patient.
#### Study Outcomes
The pulsatile waveform from ICP monitoring on Day 12 before lumbar puncture revealed P2>P1, amplitude of tidal wave greater than that of percussion wave, reflecting characteristics of relative peak height consistent with the presence of neurological symptoms. P1<P2 after lumbar puncture, demonstrating improvement towards the characteristic P1>P2>P3, where P3 is dicrotic wave, as expected with reduction in ICP post-treatment. Morphology of the waveforms obtained from Day 34 were more closely representing
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normal brain compliance (P1>P2>P3), which is consistent with reduction in ICP following the series of treatment and discharge that same day.
## Study Conclusions
Results of this study demonstrated that the BcSs-PICNI-2000 Sensor is able to continuously monitor ICP changes to acquire signals consistent with the patient's clinical status.
## Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury
## Participants
Seven adult patients who were admitted to the neurointensive care unit and presented with severe or moderate brain injury with secondary neurological deterioration intubation and mechanical ventilation were enrolled in the study.
## Dataset Description
Total number of subjects: 7 patients
Range of acquisition time: 68-282 hours
Total acquisition time: 608 hours
Total acquisition time analyzed: 337 hours
Collected data: Simultaneous and continuous recordings of invasive ICP (iICP), noninvasive intracranial pressure (nICP), arterial blood pressure (ABP).
## Study Objective
The objective of the study was to verify the similarities between the iICP (predicate device) and nICP waveforms. This assessment sought to provide evidence for the noninvasive sensor as an alternative to invasive ICP assessments in situations where the waveform can provide supplementary clinical information. In addition, the noninvasive intracranial pressure and arterial blood pressure (ABP) waveforms were compared to verify the possible influence of the extracranial peripheral circulation into the noninvasive intracranial pressure signal, acknowledged as a potential limitation of the Braincare BcSs-PICNI-2000 sensor.
#### Study Procedures
Each patient underwent continuous ICP monitoring using both the predicate and subject devices concurrently from point of admittance throughout their stay in the neurointensive care unit, with acquisition time ranging from 68-282 hours. ABP measurement directly through the radial artery and partial pressure
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of carbon dioxide (PaCO2) were also recorded simultaneously during the monitoring sessions. Approximately 337 total hours of recordings were analyzed.
## Study Outcomes
The primary endpoint was the comparison of ICP waveform morphology obtained with the nICP and iICP sensors. A secondary endpoint was the comparison of the nICP waveforms. Waveforms were compared in a lower dimensional space constructed based on signals in the frequency domain. Similarity between the two devices' signals was inferred from the Euclidean distance between the non-linear projection in a lower dimensional space of the window power spectral densities (PSD) of the respective signals, in which PSD was calculated using the short-term Fourier transform. Intraindividual statistical comparisons were performed using the non-parametric Mann-Whitney U test for not normally distributed data points with a significance level set at p<0.05. Measurement of similarities are presented in the following table.
| Patient ID | | | | | | | |
|--------------|-------|------|------|------|------|-------|------|
| Similarities | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| iICP-niICP | 35.0 | 27.2 | 26.9 | 16.9 | 36.3 | 54.7 | 30.3 |
| ABP-nICP | 117.3 | 86.6 | 86.9 | 77.9 | 78.1 | 106.6 | 76.3 |
Table 4 - Measure of similarities between i-ICP, nICP and ABP
The difference between the iICP-nICP and nICP-ABP was found to be statistically significant for all seven patients, p<0.05, using the Mann-Whitney U test.
## Study Conclusions
The study results demonstrate that a greater similarity exists between the waveforms generated from the signals of the subject and predicate device, than between the subject device and ABP measurements. Although the study had a limited sample size, the intra-individual similarities of the invasive and noninvasive ICP signals as functions of time suggest comparable effectiveness of ICP monitoring between the Braincare Sensor and the invasive Codman Microsensor ICP (K153347), which is representative of the standard of care. Additionally, no adverse events related to use of the Braincare sensor were reported,
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supporting that the noninvasive device does not raise new questions of safety.
## Benefit Risk Assessment
The main technological differences between the BcSs-PICNI-2000 Sensor and predicate device, Codman® Microsensor Basic Kit (K153347), are that the subject device noninvasively monitors ICP variation without measuring absolute ICP and outputs only the ICP waveform for qualitative review by the clinician. As such, the subject device presents reduced benefit by not offering the ICP value in addition to the waveform, but offers the clinician a method to initially assess patients with suspected variation in ICP or brain compliance to then determine the additional clinical assessments and parameters necessary to make an informed decision. Clinicians continue to use compatible patient monitors to view the ICP waveform and interpret and utilize the waveform in the same manner whether it is captured with the subject or predicate devices.
The subject device design and noninvasive application present reduced risk compared to the predicate by eliminating some known serious risks associated with invasive ICP monitoring devices such as infection, vascular complications, tissue lesions, device occlusion, and device migration. Accordingly, the device may be suitable for use to monitor some patients for whom benefits of monitoring with the predicate device, or similar invasive ICP monitoring devices, do not outweigh the potential risks.
The magnitude of benefits offered by the subject device is high. Foreseable potential risks are of low severity with high detectability, temporary duration in nature, and low uncertainty. Non-clinical testing data showed that the device satisfied all performance criteria to support its intended use and context including electrical safety, electromagnetic compatibility, monitor compatibility, stability and reproducibility of the device output, and effective mitigation of risks to acceptable levels. Animal and clinical studies directly compared performance of the subject device to the predicate, demonstrating that both devices effectively provide continuous waveform morphology consistent with the patient's clinical state, and revealed no occurrence of adverse events when using the subject device. As is true with utilization of the predicate device's output, the clinician is expected to have appropriate knowledge to assess the suitability of the output and to review the waveform together with other clinical parameters to make decisions. The sponsor thus concluded that the benefits of the subject device outweigh the potential risks and that the device is at least as safe and effective as the predicate device when used to monitor variation in ICP by providing waveforms for clinician interpretation.
## Conclusion
In summary, the BcSs-PICNI-2000 Sensor and predicate device, Codman® Microsensor Basic Kit
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(K153347), are substantially equivalent with respect to intended use, biocompatibility, and performance. Non-clinical and clinical testing results support that the subject device and predicate device are equivalent in function for use in continuous intracranial pressure monitoring to produce waveform morphology reflective of alteration in ICP and changes in brain compliance. The differences between the two devices do not raise new questions regarding safety and effectiveness.
