(37 days)
K202334 - Neuronaute
K860210 Elefix
No
The summary explicitly states that the device "do not provide any diagnostics conclusions or automated alerts of an adverse clinical event" and "is not intended to replace direct communication with healthcare providers." It focuses on data acquisition, display, storage, and transmission, which are not inherently AI/ML functions. There is no mention of AI, ML, DNN, or any related concepts in the provided text.
No.
The device is intended to acquire, display, store, archive, and periodically transmit EEG signals to assist in the diagnosis of neurological disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders."
No
The device description explicitly lists hardware components such as the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, and Bioadapter.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The Neuronaute system acquires EEG signals directly from the brain in vivo (within the body).
- The intended use is to acquire, display, store, archive, and transmit EEG signals. While this data is used to assist in the diagnosis of neurological disorders, the device itself is not performing a diagnostic test on a biological sample. It's a system for collecting physiological data.
- The device description focuses on the hardware for acquiring electrical signals from the brain. It doesn't mention any reagents, assays, or procedures for analyzing biological samples.
Therefore, the Neuronaute system falls under the category of a medical device that collects physiological data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.
Product codes
GWQ, GXY
Device Description
Neuronaute with IceCap 2 & IceCap 2 Small is a full-montage standard electroencephalograph system. The system consists of the Neuronaute Head Module (CE marked and FDA 510(k) cleared) and the new generation IceCap 2 and IceCap 2 Small electrodes.
The IceCap 2 and IceCap 2 Small are medical devices composed of a single-piece flexible printed circuit headset. They include 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. These electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. Each electrode has a central hole (diameter of 4.3 mm) for the application of marketed EEG conductive pastes (e.g., Elefix paste). These electrodes are designed to continuously measure multiple-lead EEG signals for up to 72 hours.
The system acquires, records, stores, transmits, and displays EEG signals. Remote access is facilitated by the Neuronaute N-CLOUD, which receives EEG signals from the Neuronaute Head Module. The system also includes an optional video system composed of N-way and N-Deo.
The IceCap 2 is designed for head circumferences between 53 and 60 cm, and the IceCap 2 Small for head circumferences between 43 and 53 cm. The system uses a 10/20 System montage. It supports up to 24 EEG channels, with data in EDF format, and sampling rates of 250 or 500 Hz. The recorder component has wireless output via WiFi 2.4GHz and Bluetooth 2.4GHz/BLE. Electrical characteristics include an input dynamic range and differential offset voltage of ±400mV, 24 bits ADC Resolution, > 105 dB ADC Common Mode Rejection Rate (CMRR), > 1Gohm Input Impedance, and
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
January 12, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Bioserenity Madubuike Okafor Director of QMS & Regulatory Affairs for US Medical Devices 47 Boulevard De L Hopital ICM-IPEPS -Hopital Pitie Salpetriere - CS 21414 Paris, Ile-De-France 75013 France
Re: K223644
Trade/Device Name: Neuronaute with IceCap 2 & IceCap 2 Small Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GXY Dated: July 25, 2022 Received: December 6, 2022
Dear Madubuike Okafor:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223644
Device Name Neuronaute with IceCap 2 & IceCap 2 Small
Indications for Use (Describe)
Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud.
Neuronaute and its associated software are intended to assist in the diagnosis of neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.
| 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) |
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3
Special 510(k): Neuronaute with IceCap 2 & lceCap 2 Small
510(k) Summarv
From 21 CFR Part 807.92:
(a) (1) - (3)
Device Common Name: Full-Montage Standard Electroencephalograph
Device Proprietary Name: Neuronaute with IceCap 2 & IceCap 2 Small
Establishment Registration Number: 3014027738
Submitter:
BIOSERENITY 47 BOULEVARD DE L HOPITAL ICM-IPEPS - HOPITAL PITIE SALPETRIERE - CS 21414 PARIS CEDEX 13 Ile-De-France, FR 75013
Owner/Operator Number: 10057285
Contact: Madubuike Okafor madubuike.okafor@bioserenity.com
Date Prepared: January, 11 2023
Classification Regulation: 21 CFR Part 882.1400
Class: Class II
Panel: Neurology
4
Product Code: GWQ Subsequent Product Code: GXY
Predicate Device: K202334 - Neuronaute
(4) BioSerenity owns the 510(k) for the predicate: Neuronaute (K202334). The Neuronaute with IceCap 2 & IceCap 2 Small (current submission) only contains the next generation of lceCap electrodes. These new "IceCap 2" electrodes come in two different sizes, regular for adult patients (IceCap 2), and small for pediatric patients above 5 years old (IceCap 2 small). The rest of the components of the Neuronaute system remain unchanged.
The function of the system and the connection of the different elements remain the same. The lceCap 2 / 2 small replaces the IceCap to be connected to the head module, battery, and Bioadapter with the IceAdapter.
The necessary information related to the records are available in the mobile app and the cloud. The video system composed by N-way and N-Deo is optional.
As the description of all the components is provided in the previous 510(k) submission for the Neuronaute system (K202334), the focus in the current submission is only on the description of the new generation of IceCap, namely IceCap 2 & IceCap 2 Small. lceCap 2/ IceCap 2 Small Description:
lceCap 2 and IceCap 2 Small are medical devices composed of a single-piece flexible printed circuit headset compatible with the Neuronaute Head Module (CE marked and FDA 510(k) cleared. It includes 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors (Figure 1). IceCap 2 is a modification of the Neuronaute IceCap headset from which it differs in material and electrode types. It enables the analysis of potential neurological disorders via the recording of EEG signals.
The IceCap 2 and IceCap 2 Small electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The center hole of each electrode (diameter of 4.3 mm) allows the application of several marketed EEG conductive pastes (such as the Elefix paste) before positioning the device on the head. These conductive and adhesive pastes are CE marked and FDA 510(k) cleared; they are not produced by BioSerenity and they are to be bought separately as consumable material to facilitate good performance of the medical device.
The conductive electrolyte paste put in the central hole of each electrode, was cleared in K860210 Elefix.
The size chart for the IceCap 2 is:
Horizontal: 209 mm -
5
Vertical: 292mm -
The size chart for the IceCap 2 small is:
- Horizontal: 209 mm ー
- -Vertical: 246 mm
The packaging size for both IceCap 2 and IceCap 2 small is:
- Horizontal: 246 mm -
- Vertical: 350 mm ।
lceCap 2 and IceCap 2 Small electrodes are medical devices for patient above 5 years old, used as EEG electrodes. They are used by Healthcare Professionals for the diagnosis of neurological disorders using long-term EEG records (up to 72h). When connected to a compatible EEG system, they are designed to continuously measure multiple-lead EEG signals to enable review at a physician's office, hospital or other remote locations.
The IceCap 2 and IceCap 2 Small are intended to be used in the following environments:
- Hospital
- . Doctor's practice
- Private hospital
- Research environment
- . Home
- . Temperature between 5° and 40°C with relative humidity between 5% and 95% and Atmospheric pressure between 700 hPa ~ 1060 hPa.
(5) Intended use
Neuronaute including IceCap 2 / 2 Small enables the acquisition, recording, storage, transmission, and display of an electroencephalogram (EEG) in order to assist neurological disorders diagnosis.
Indication for use
Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.
6
Comparison with the predicate device intended use statement
The intended use statement is the same between the subject device and its predicate, although, in the indication for use, the targeted population is expanded (to target both adult and pediatric patients) compared to the initial indication for use of the Neuronaute submitted in prior 510(k). The change presented here (introduction of IceCap 2 & IceCap 2 Small) supports the expansion of the targeted population of the actual Neuronaute to improve the size fit of IceCap electrode range to a larger pediatric population.
The IceCap 2 electrodes have been adapted by design to be able to transmit EEG signals for children and adults as it is provided in two different sizes:
- •
- lceCap 2 Small .
Each size is adapted to a range of head size circumferences to cover the population from children (at least 5 years old) to adults.
Therefore, the Neuronaute with IceCap 2 & IceCap 2 Small is demonstrated to be substantially equivalent to the Neuronaute, as it supports the safety and effectiveness of the Neuronaute system in the expanded targeted population.
(6) Comparison of the predicate's device technical characteristics
The only change in technical characteristics consists of the materials composition of the electrodes. For IceCap, polyimide is in direct contact with the patient skin. It is superseded by polyethylene terephthalate (PET) for the IceCap 2 & IceCap 2 Small, but this component for lceCap 2 & lceCap 2 Small is no longer in direct contact with the patient's skin. Silicone adhesive and dielectric ink are in direct contact with the patient skin for the IceCap 2 Small. EEG pastes remain the same for both generations of IceCap.
The duration of use for the initial IceCap was limited to 12 and half hours due to copper migration across the silver layer when EEG paste was applied on the electrodes. For the IceCap 2 & IceCap 2 Small, the polyimide is superseded by PET (polyethylene terephthalate), widely used in the medical field. With this technology, the IceCap 2 Small can be used for several days recording (up to 72h). The previous IceCap electrodes were made of copper covered with a layer of silver, whereas the IceCap 2 & IceCap 2 Small are made of Ag/AgCl , which are widely used in medical industry for several days of recording.
The Neuronaute with IceCap 2 & IceCap 2 Small electrodes' material have been assessed by consensus standard for biocompatibility testing, as previously done with its predicate Neuronaute. Therefore, the Neuronaute with IceCap 2 Small is demonstrated to be substantially equivalent to the Neuronaute, as all tests done supports the effectiveness and the safety of the Neuronaute with IceCap 2 & IceCap 2 Small system.
7
Substantial Equivalence Comparison Table:
| Substantial | Neuronaute with IceCap 2 & | Neuronaute | Significant Differences |
|---|---|---|---|
| Equivalence Topic | IceCap 2 Small | ||
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| Establishment Name | BioSerenity SAS | BioSerenity SAS | N/A |
| Owner/Operator | 10057285 | 10057285 | N/A |
| Device Classification | Full-Montage Standard | Full-Montage Standard | None |
| Name | Electroencephalograph | Electroencephalograph | |
| Review Panel | Neurology | Neurology | None |
| Regulation Number | 882.1400 | 882.1400 | None |
| Product Codes | GWQ, GXY | GWQ, GXY | None |
| Device Class | II | II | None |
| Indications For Use | Neuronaute with IceCap 2 & IceCap 2 Small | ||
| is a system intended to acquire, display, | |||
| store, archive, and periodically transmit EEG | |||
| signals from the brain using a full montage | |||
| array to enable review at a physician's | |||
| office, hospital, or other remote locations. It | |||
| allows remote access by users via the | |||
| Neuronaute N-CLOUD which receives EEG | |||
| signals from Neuronaute Head Module | |||
| which sends transmissions to the cloud. |
Neuronaute and its associated software are
intended to assist in the diagnosis of | Neuronaute is a system intended to acquire,
display, store, archive, and periodically
transmit EEG signals from the brain using a
full montage array to enable review at a
physician's office, hospital, or other remote
locations. It allows remote access by users
via the Neuronaute N-CLOUD which receives
EEG signals from Neuronaute Head Module
which sends transmissions to the cloud.
Neuronaute and its associated software are
intended to assist in the diagnosis of
neurological disorders. Neuronaute and its | The targeted population is expanded
compared to the initial indication for
use of the Neuronaute to target both
adult and pediatric patients. However
this change was already implemented
by a change that did not need a 510(k)
submission to demonstrate the
conformity of the Neuronaute
acquisition system (Recorder,
BioAdapter, Battery) to medical
guidelines for EEG recordings on
children. |
| Substantial | Neuronaute with IceCap 2 & | Neuronaute | Significant Differences |
| Equivalence Topic | IceCap 2 Small | | |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| | neurological disorders. Neuronaute and its
components do not provide any diagnostics
conclusions or automated alerts of an
adverse clinical event about a patient's
clinical condition.
The device is for use by trained medical
professionals for patients under medical
supervision. The device is intended for use
on adults and pediatrics. Neuronaute is not
intended to replace direct communication
with healthcare providers. The system data
should not be used alone but should be
used along with all other clinical data and
exams to come to a diagnosis. | components do not provide any diagnostics
conclusions or automated alerts of an
adverse clinical event about a patient's
clinical condition.
The device is for use by trained medical
professionals for patients under medical
supervision. The device is intended for use
on adults (ages 18 and above). Neuronaute
is not intended to replace direct
communication with healthcare providers.
The system data should not be used alone
but should be used along with all other
clinical data and exams to come to a
diagnosis. | The change presented here
(introduction of IceCap 2 & IceCap 2
Small) supports the expansion of the
targeted population of the actual
Neuronaute to improve the size fit of
IceCap electrode range to a larger
pediatric population.
The IceCap 2 electrodes have been
adapted by design to be able to
transmit EEG signals for children and
adults as it is provided in two different
sizes:
IceCap 2
IceCap 2 Small
Each size is adapted to a range of head
size circumferences to cover the
population from children (at least 5
years old) to adults.
However, the Neuronaute IceCap 2 &
IceCap 2 Small is demonstrated to be
substantially equivalent to the
Neuronaute. |
| Substantial
Equivalence Topic
Relationship | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| 510(k) # | TBD | K202334 | N/A |
| Prescription or OTC
Use | Prescription | Prescription | None |
| Intended User(s) | Trained healthcare
professionals: doctors,
polysomnogram
technicians, and
nurses | Trained healthcare
professionals: doctors,
polysomnogram
technicians, and
nurses | None |
| Intend patient
population
demographics | Adult and pediatric patients 5 years of age
and older. | Adult patients ages 18 years of age and
older. | The patient demographic has been
expanded to include pediatric
patients. |
| Environment of use | Physician's office,
hospital or other
remote locations
under medical
supervision. | Physician's office,
hospital or other
remote locations
under medical
supervision. | None |
| Video | Optional; The subject
device includes a
component video
camera called N-DEO | Optional; The subject
device includes a
component video
camera called N-DEO | None |
| Electrode Components | | | |
| Type of components
in contact with the
patient | - Silicone adhesive
- Dielectric ink
- EEG Conductive pastes | - Polyimide substrate
- EEG conductive paste | For IceCap, polyimide is in direct
contact with the patient skin. It is
superseded by polyethylene
terephthalate (PET) for the IceCap 2 /
2 Small, but this component for IceCap |
| Substantial
Equivalence Topic | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| | | | 2 / 2 Small is no longer in direct
contact with the patient skin. |
| | | | Silicone adhesive and dielectric ink are
in direct contact with the patient skin
for the IceCap 2 / 2 small.
EEG pastes remain the same for both
generations of IceCap. |
| | | | IceCap 2 / 2 Small electrodes material
has been assessed by consensus
standard for biocompatibility testing,
as previously done with its predicate
Neuronaute including IceCap. |
| Electrodes | Up to 21 electrodes:
• 19 EEG electrodes
• 1 electrode (Fpz) used for
ground connection
• 1 electrode (Oz)
used as a
reference for EEG
Calculation | Up to 21 electrodes:
• 19 EEG electrodes
• 1 electrode (Fpz) used for
ground connection
• 1electrode (Oz) is
used as a
reference for EEG
Calculation | None |
| Substantial
Equivalence Topic | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| Material
Composition | - Polyethylene terephthalate (PET) - Silver and Silver/Silver chloride
conductive inks - Insulation inks
- Stiff PETG film
- Skin adhesive
- Graphical ink
- Silicone adhesive | - Polyimide
- Copper covered with a layer of silver | The duration of use for the initial
IceCap was limited to 12 and half
hours due to copper migration across
the silver layer when EEG paste was
applied on the electrodes.
For the IceCap 2 / 2 Small, the
polyimide is superseded by PET
(polyethylene terephthalate), widely
used in the medical field
Due to this technology, the IceCap 2/
2 Small can be used for several days
recording (up to 72h)
The previous IceCap electrodes were
made of copper covered with a layer
of silver, whereas IceCap 2 / 2 small
are made of Ag/AgCl , which are
widely used in medical industry for
several days of recording.
The Neuronaute with IceCap 2 &
IceCap 2 Small electrodes' material |
| Substantial
Equivalence Topic | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A
standard for biocompatibility testing,
as previously done with its predicate
Neuronaute including IceCap. |
| Electrodes; single or
reusable? | Single use, non-sterile | Single use, non-sterile | None |
| Montage | 10/20 System | 10/20 System | None |
| Able to
accommodate
different patient
head sizes | The material of the Neuronaute with IceCap
2 & IceCap 2 Small stretches to fit the
patient's head.
It's provided in two sizes depending on the
head circumference of the patient:
- Head circumferences between 43
and 53 cm: use the IceCap 2 Small - Head circumference between 53
and 60 cm: use the IceCap 2
The IceCap 2 is used when the patient is
between 2 sizes. | The material of the Neuronaute IceCap
stretches such that it
can fits on the patient's head, similar
to a sock.
The unique cap size fits to at least 90% of
the population | The device has been improved from a
single size to an extended use in a
pediatric population by including the
IceCap 2 Small and defining the head
circumferences for each use (adults
and children).
IceCap 2 electrodes have
implemented a new size range for
pediatrics although materials and
technical specifications are similar
between IceCap 2 and IceCap 2 Small.
However, the Neuronaute IceCap 2 &
IceCap 2 Small is demonstrated to be
substantially equivalent to the
Neuronaute. |
| Conductive | Conductive electrolyte paste put | Conductive electrolyte paste put | None |
| Substantial | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| Equivalence Topic | | | |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| Electrolyte gel | in the central hole of each electrode,
cleared in K860210
Elefix. | in the central hole of each electrode,
cleared in K860210
Elefix. | |
| EEG channels | Up to 24 channels | Up to 24 channels | None |
| Data format | EDF | EDF | None |
| Sampling Rate | 250 or 500 Hz | 250 or 500 Hz | None |
| Component
dimensions | IceCap2 - Height: 11.50 inches (292 mm)
- Width: 8.23 inches (209 mm)
- Sensor area: 0.11 inches ^2 (74.7 mm^2)
IceCap2 Small - Height: 9.69inches (246 mm)
- Width: 8.23 inches (209 mm)
- Sensor area: 0.11 inches^2 (74.7 mm^2) | - Height: 14.96 inches (379 mm)
- Width: 8.07 inches (205 mm)
- Sensor area: 0.24 inches ^2 (152 mm^2) | Height: IceCap 2 and IceCap 2 Small are shorter in height to ease their storage.
Width: equivalent
Sensor area: sensor areas on IceCap 2 and IceCap 2 Small are shorter due to the change on component material (from Copper to Silver/Silver Chloride) |
| Recorder Component | | | |
| Wireless Output | WiFi 2.4GHz
Bluetooth 2.4GHz
WiFi 2.412 GHz ~ 2.484 GHz (2.4 GHz ISM Band)
BLE 2.402 and 2.480 GHz | WiFi 2.4GHz
Bluetooth 2.4GHz
WiFi 2.412 GHz ~ 2.484 GHz (2.4 GHz ISM Band)
BLE 2.402 and 2.480 GHz | None |
| Substantial | Neuronaute with IceCap 2 &
IceCap 2 Small | Neuronaute | Significant Differences |
| Equivalence Topic | | | |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| Input dynamic range
and differential
offset
voltage | ±400mV | ±400mV | None |
| ADC Resolution | 24 bits | 24 bits | None |
| ADC Common
Mode Rejection
Rate
(CMRR) | > 105 dB | > 105 dB | None |
| Input Impedance | > 1Gohm | > 1Gohm | None |
| Input noise |