(442 days)
BrainPulse, Model 1100 DEN140040
No
The device description and performance studies focus on signal acquisition, waveform generation, and comparison to predicate devices and other physiological measurements. There is no mention of AI/ML algorithms being used for interpretation, diagnosis, or any other function. The interpretation of the waveform is explicitly stated to be done by the multi-parameter monitor's inherent software and the clinician.
No.
The device is described as a non-invasive monitoring device for intracranial pressure and does not provide any therapeutic intervention.
No
The device is explicitly stated not to be a standalone diagnostic tool and its output does not replace a comprehensive clinical evaluation. While it provides ICP waveforms for interpretation that can aid in preliminary assessment, the clinician is responsible for making a diagnosis with additional clinical information.
No
The device description explicitly states it consists of a sensor, headband, and adapter cable, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The BcSs-PICNI-2000 Sensor is a non-invasive device that monitors variations in intracranial pressure by detecting skull deformation. It does not analyze any biological specimens taken from the patient.
- Intended Use: The intended use is for monitoring variations in intracranial pressure and providing waveforms for interpretation, not for analyzing in vitro samples.
Therefore, the BcSs-PICNI-2000 Sensor falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GWM
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinicians, neurointensive care unit
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-Invasive ICP Monitoring for HIV-associated Cryptococcal Meningitis (Clinical Study 1):
- Participants: A critically ill adult patient diagnosed with human immunodeficiency virus-associated cryptococcal meningitis.
- 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 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.
Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury (Clinical Study 2):
- 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 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 of carbon dioxide (PaCO2) were also recorded simultaneously during the monitoring sessions. Approximately 337 total hours of recordings were analyzed.
Summary of Performance Studies
Non-Clinical Performance Data:
- Biocompatibility: ISO 10993-5 (in vitro cytotoxicity): Pass (Non-cytotoxic). ISO 10993-10 (irritation and skin sensitization): Pass (Non-sensitizing, Non-irritating).
- Electrical Safety and Electromagnetic Compatibility: IEC 60601-1 / ANSI AAMI ES 60601-1: Pass. IEC 60601-1-2: Pass.
- Disinfection: Validation of Low-Level disinfection method using 70% ethanol: Pass (6-log microbial reduction).
- Bench Testing:
- Monitor Compatibility: Pass.
- Stability and Reproducibility: 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 Comparison Study in Rat Animal Model (7 rats): Simultaneous ICP monitoring with proposed device and predicate device. Objective: measure linear correlation. Results: Pearson's correlation coefficient r = 0.8±0.2 indicates a positive correlation.
- Direct Comparison Study in Swine Animal Model: Simultaneous ICP monitoring with proposed device and predicate device. Objective: measure monotonic correlation. Results: Spearman's correlation coefficient r = 0.81 ± 0.24 indicates positive correlation.
Clinical Performance Data:
-
Study 1: Non-Invasive ICP Monitoring for HIV-associated Cryptococcal Meningitis:
- Study Type: Case study/Observational in a critically ill adult patient.
- Sample Size: 1 participant.
- Key Results: Waveforms from Day 12 showed P2>P1 (neurological symptoms), P1P2>P3), consistent with ICP reduction.
- Study Conclusions: Demonstrated ability to continuously monitor ICP changes and acquire signals consistent with patient's clinical status.
-
Study 2: Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury:
- Study Type: Observational/Comparison study.
- Sample Size: 7 adult patients.
- Study Objective: Verify similarities between iICP (predicate device) and nICP waveforms. Compare nICP and ABP waveforms to check for extracranial peripheral circulation influence.
- Key Results: The difference between iICP-nICP and nICP-ABP was statistically significant for all seven patients (p
§ 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
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
1
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
2
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) | |
|---|---|
| ☑ 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."
3
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.
4
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-
2000 Sensor | Codman
Microsensor Basic
Kit Refs. 62-6631 | Substantial Equivalence |
|--------------------|---------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------|
| 510k # | K182073 | K153347 | Not applicable |
| Product Code | GWM | GWM | All devices are Intracranial
Pressure Monitoring
devices. |
| Indication for Use | The BcSs-PICNI-2000
Sensor is intended for the
monitoring of variation in | Use of the
CODMAN
MICROSENSOR | Both the BcSs-PICNI-2000
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 | |
| for prescription use only. | ||||
| Device Description | Non-invasive ICP | |||
| monitoring device | ||||
| consisting of strain gauge | ||||
| pressure sensors | ||||
| supported on a headband | ||||
| to detect skull | ||||
| deformations in response | ||||
| to ICP changes. | ICP Transducer | |||
| consist of a | ||||
| miniature strain | ||||
| gauge pressure | ||||
| sensor mounted in a | ||||
| titanium case at the | ||||
| tip of a 100cm 3 | ||||
| french flexible | ||||
| nylon tube. | Both devices utilize strain | |||
| gauge sensors and are used | ||||
| in real-time ICP | ||||
| monitoring. | ||||
| 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 | Subdural and | |||
| intraparenchymal | ||||
| implantation. | Braincare Sensor is applied | |||
| non-invasively, while the | ||||
| Codman® Microsensor | ||||
| requires subdural and | ||||
| intraparenchymal | ||||
| implantation. Both devices | ||||
| share the same intended | ||||
| use, and have satisfied | ||||
| biocompatibility and | ||||
| performance testing. The | ||||
| potential differences for | ||||
| patient application is | ||||
| restricted to the non- | ||||
| invasiveness nature of the | ||||
| BcSs-PICNI-2000 Sensor, | ||||
| which is similar to the | ||||
| Reference Device; | ||||
| therefore it does not raise | ||||
| new questions in terms of | ||||
| safety and effectiveness. | ||||
| Contraindications | The BcSs-PICNI-2000 | |||
| Sensor is contraindicated | ||||
| for use in patients who | ||||
| have: | ||||
| • | ||||
| Undergone | ||||
| decompressive | ||||
| craniectomy or | ||||
| craniotomy; | This kit is not | |||
| designed, sold or | ||||
| intended for any use | ||||
| except as indicated. |
This kit is not
designed, sold or
intended for use as a
therapeutic device. | Both the subject and
predicate devices are
designed and intended only
for the use as indicated.
The Braincare device
carries additional
contraindications specific
to its use as a non-invasive
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
Sensor pin length: 18mm
Sensor pin diameter: 7.5 mm | Microsensor:
Length: 100cm nominal
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:
Extra Small: 50-55cm,
Small: 52.5-57.5 cm,
Medium: 55-60 cm,
Large: 57.5-62.5 cm.
Adaptor cable length: 180
cm. | Catheter length
(ventricular kit):
38cm
nominal
Catheter diameter
(ventricular kit):
3.5mm
max | differences in dimension do
not raise new questions of
safety or effectiveness. | |
| Biocompatibility | Prolonged contact (>24
days but within ≤30 days)
Non-cytotoxic
Non-sensitizing
Non-irritating | Prolonged contact
(>24 days but
within ≤30 days)
Non-cytotoxic
Non-sensitizing
Non-irritating | Both the Braincare Sensor
and Codman® Microsensor
are categorized as
prolonged contact (>24
days but within ≤30 days).
Both devices were
demonstrated to be non-
cytotoxic, non-sensitizing,
and non-irritating. | |
| Energy modality | 5 volts DC when
connected to ICP
monitoring device | 5 volts DC when
connected to ICP
monitoring device | Both the Braincare Sensor
and Codman® Microsensor
share the same energy
modality. | |
| Pressure output
display parameters | Waveform | Millimeters of
Mercury (mmHg)
Waveform | The Braincare Sensor does
not provide direct pressure
measurement, as opposed
to the Codman®
Microsensor. However,
both devices use strain
gauge sensors and generate
waveform outputs in
response to mechanical
waves generated by blood
flow in the brain. Animal
and clinical study data have
shown similarities in the
outputs of both devices in
real-time ICP monitoring.
The difference in pressure
output display parameters
does not raise new
questions in terms of safety
and effectiveness. | |
| Sensing element | Strain gauge | Strain gauge silicon
microchip | Both devices utilize a strain
gauge in the sensing
element. | |
| Functional pressure
range | Not applicable, does not
measure absolute values
of pressure. | -50 mmHg to 250
mmHg | The Braincare Sensor does
not have a limit in
functional pressure range.
Comparable performance to
the predicate device has | |
| Functional over
pressure range
without damage | Not applicable, does not
provide absolute values of
pressure, and does not
have a specified
functional pressure range. | -700 mmHg to 1250
mmHg | been demonstrated in
animal and clinical studies.
This difference does not
raise new questions in
terms of safety and
effectiveness.
The Braincare Sensor does
not have a limit in
functional pressure range.
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. | |
| Input/ Output
Impedance | 350 ohms nominal | 1000 ohms nominal | The Braincare Sensor and
Codman® Microsensor
differ in input/output
impedance based on the
differences in the devices'
operating principles in
monitoring ICP and their
technical build. Both
devices are designed to
meet acceptable safety and
effectiveness parameters,
and present similar ICP
morphology (waveforms)
information on the
connected patient monitor.
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 or
effectiveness. | |
| Output signal
(sensitivity) | 10 mV | 7.5 mV absolute
voltage span
(Calculated based
on Microsensor
device's functional
pressure range of -
50 to 250 mmHg,
5V when connected
to ICP monitor, and
output signal | The two devices differ in
sensitivity due to
differences in their
principle of operation of
monitoring changes in ICP.
Both devices are
compatible for use with
commercially available
patient monitoring devices.
Comparable performance to
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. | |
5
6
7
8
9
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-
10
2000 Sensor and Reference Device BrainPulse (DEN140040).
| | Braincare BcSs-PICNI-
2000 Sensor | Reference Device:
BrainPulse
(DEN140040) | Remarks |
|-------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------|
| Clinical Application | Non-invasive
application to scalp | Non-invasive
application to scalp | Same as Reference
Device |
| Sensor operating
principle | Strain gauge sensor
detects skull
deformation resulting
from ICP changes | Accelerometer detects
skull motion | Similar to Reference
Device |
| Device output | Signal is processed to
display waveform for
qualitative assessment | Signal is processed to
display waveform for
qualitative assessment | Similar to Reference
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).
11
| TEST | TITLE/TEST METHOD SUMMARY | RESULTS |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Non-cytotoxic | ||
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Non-sensitizing | ||
| Non-irritating | ||
| Electrical Safety and Electromagnetic Compatibility | ||
| IEC 60601-1 | ||
| 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 | |
| Disinfection | ||
| Disinfection | ||
| Validation | Validation of Low-Level disinfection method using 70% ethanol. | Pass |
| 6-log microbial reduction | ||
| Bench Testing | ||
| Monitor | ||
| Compatibility | Demonstration of compatibility for use with patient monitors. | Pass |
| Stability and | ||
| Reproducibility | Demonstration of stability 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 | ||
| Comparison | ||
| Study in Rat | ||
| 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 | ||
| Comparison | ||
| Study in Swine | ||
| 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
12
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. P1P2>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
13
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
14
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