(37 days)
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.
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. The system includes the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, Bioadapter with the IceAdapter, mobile app, and the Neuronaute N-CLOUD. The IceCap 2 and IceCap 2 Small are single-piece flexible printed circuit headsets with 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. The electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The system allows remote access by users via the Neuronaute N-CLOUD. An optional video system composed by N-way and N-Deo is available.
The provided text describes the Neuronaute with IceCap 2 & IceCap 2 Small system, an electroencephalograph device. However, it does not contain a detailed study proving the device meets specific acceptance criteria for diagnostic performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neuronaute, K202334) through a comparison of technical characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Neuronaute with IceCap 2 & IceCap 2 Small. The comparison table focuses on technical specifications and material changes relative to the predicate device.
| Acceptance Criterion (Implicitly compared to predicate) | Reported Device Performance (Relative to Predicate) |
|---|---|
| Ability to acquire, display, store, archive, and periodically transmit EEG signals | Equivalent: "The function of the system and the connection of the different elements remain the same." |
| Target population (Adults and Pediatrics 5 years and older) | Expanded: Subject device includes pediatric patients (5 years and older) due to two sizes of IceCap 2. Predicate was adults (18+). |
| Electrode material (Ag/AgCl) | Improved: Subject device uses Ag/AgCl for longer recording (up to 72h) compared to predicate's copper covered with silver (12.5h limitation due to copper migration). |
| Biocompatibility | Equivalent: "IceCap 2 / 2 Small electrodes material has been assessed by consensus standard for biocompatibility testing, as previously done with its predicate Neuronaute." |
| Electrical safety | Equivalent: Nonclinical tests demonstrated "safe" performance. |
| Performance (General) | Equivalent: Nonclinical tests demonstrated "as effective, and performs as well as the legally marketed predicate device." |
| Number of electrodes (19 EEG, 1 reference, 1 ground) | Equivalent: "Up to 21 electrodes" with the same distribution. |
| Montage (10/20 System) | Equivalent: Both use 10/20 System. |
| Head size accommodation | Improved: Subject device offers two sizes to accommodate head circumferences from 43 to 60 cm (including pediatric). Predicate had one size for "at least 90% of the population." |
| Conductive electrolyte paste | Equivalent: Both use "Elefix" paste. |
| EEG channels (Up to 24) | Equivalent: Both have up to 24 channels. |
| Data format (EDF) | Equivalent: Both use EDF. |
| Sampling Rate (250 or 500 Hz) | Equivalent: Both support 250 or 500 Hz. |
| Wireless Output (WiFi 2.4GHz, Bluetooth 2.4GHz) | Equivalent: Same wireless specifications. |
| Input dynamic range and differential offset voltage (±400mV) | Equivalent: Same specifications. |
| ADC Resolution (24 bits) | Equivalent: Same specifications. |
| ADC Common Mode Rejection Rate (CMRR) (> 105 dB) | Equivalent: Same specifications. |
| Input Impedance (> 1 Gohm) | Equivalent: Same specifications. |
| Input noise (< 6μVp-p over 0.1-50Hz) | Equivalent: Same specifications. |
| Electrode impedance check | Equivalent: Both perform electrode impedance check. |
| Power source (Rechargeable LiPo 3.7V, 2.4 Ah battery) | Equivalent: Same battery specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set related to diagnostic accuracy or clinical performance. It refers to "nonclinical tests" (biocompatibility, performance, electrical safety) but does not provide details on the test subjects or data used for these. Given that a clinical study was not required, there is no clinical "test set" and thus no data provenance for such a set.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. No clinical test set with ground truth established by experts is described in the document.
4. Adjudication Method:
Not applicable. As no clinical test set requiring ground truth establishment by experts is described, no adjudication method would have been used for that purpose.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "N/A Clinical Testing was not required." Therefore, no MRMC study was conducted or reported.
6. Standalone Performance Study:
No. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and non-clinical testing. It does not describe a standalone performance study in terms of diagnostic accuracy or clinical outcomes. The device is intended to "assist in the diagnosis" and "should not be used alone."
7. Type of Ground Truth Used:
Not applicable for clinical performance. For the non-clinical tests (biocompatibility, performance, electrical safety), the ground truth would be based on established engineering and safety standards, but not clinical ground truth in the diagnostic sense.
8. Sample Size for the Training Set:
Not applicable. The document does not describe any machine learning or AI component that would require a "training set" in the context of diagnostic performance studies. The device is an EEG acquisition system and associated software, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set for AI/ML is mentioned.
{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) |
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}------------------------------------------------
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 Smallis a system intended to acquire, display,store, archive, and periodically transmit EEGsignals from the brain using a full montagearray to enable review at a physician'soffice, hospital, or other remote locations. Itallows remote access by users via theNeuronaute N-CLOUD which receives EEGsignals from Neuronaute Head Modulewhich sends transmissions to the cloud.Neuronaute and its associated software areintended to assist in the diagnosis of | Neuronaute is a system intended to acquire,display, store, archive, and periodicallytransmit EEG signals from the brain using afull montage array to enable review at aphysician's office, hospital, or other remotelocations. It allows remote access by usersvia the Neuronaute N-CLOUD which receivesEEG signals from Neuronaute Head Modulewhich sends transmissions to the cloud.Neuronaute and its associated software areintended to assist in the diagnosis ofneurological disorders. Neuronaute and its | The targeted population is expandedcompared to the initial indication foruse of the Neuronaute to target bothadult and pediatric patients. Howeverthis change was already implementedby a change that did not need a 510(k)submission to demonstrate theconformity of the Neuronauteacquisition system (Recorder,BioAdapter, Battery) to medicalguidelines for EEG recordings onchildren. |
| 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 itscomponents do not provide any diagnosticsconclusions or automated alerts of anadverse clinical event about a patient'sclinical condition.The device is for use by trained medicalprofessionals for patients under medicalsupervision. The device is intended for useon adults and pediatrics. Neuronaute is notintended to replace direct communicationwith healthcare providers. The system datashould not be used alone but should beused along with all other clinical data andexams to come to a diagnosis. | components do not provide any diagnosticsconclusions or automated alerts of anadverse clinical event about a patient'sclinical condition.The device is for use by trained medicalprofessionals for patients under medicalsupervision. The device is intended for useon adults (ages 18 and above). Neuronauteis not intended to replace directcommunication with healthcare providers.The system data should not be used alonebut should be used along with all otherclinical data and exams to come to adiagnosis. | The change presented here(introduction of IceCap 2 & IceCap 2Small) supports the expansion of thetargeted population of the actualNeuronaute to improve the size fit ofIceCap electrode range to a largerpediatric population.The IceCap 2 electrodes have beenadapted by design to be able totransmit EEG signals for children andadults as it is provided in two differentsizes:IceCap 2IceCap 2 SmallEach size is adapted to a range of headsize circumferences to cover thepopulation from children (at least 5years old) to adults.However, the Neuronaute IceCap 2 &IceCap 2 Small is demonstrated to besubstantially equivalent to theNeuronaute. | |
| SubstantialEquivalence TopicRelationship | Neuronaute with IceCap 2 &IceCap 2 Small | Neuronaute | Significant Differences |
| 510(k) # | TBD | K202334 | N/A |
| Prescription or OTCUse | Prescription | Prescription | None |
| Intended User(s) | Trained healthcareprofessionals: doctors,polysomnogramtechnicians, andnurses | Trained healthcareprofessionals: doctors,polysomnogramtechnicians, andnurses | None |
| Intend patientpopulationdemographics | Adult and pediatric patients 5 years of ageand older. | Adult patients ages 18 years of age andolder. | The patient demographic has beenexpanded to include pediatricpatients. |
| Environment of use | Physician's office,hospital or otherremote locationsunder medicalsupervision. | Physician's office,hospital or otherremote locationsunder medicalsupervision. | None |
| Video | Optional; The subjectdevice includes acomponent videocamera called N-DEO | Optional; The subjectdevice includes acomponent videocamera called N-DEO | None |
| Electrode Components | |||
| Type of componentsin contact with thepatient | - Silicone adhesive- Dielectric ink- EEG Conductive pastes | - Polyimide substrate- EEG conductive paste | For IceCap, polyimide is in directcontact with the patient skin. It issuperseded by polyethyleneterephthalate (PET) for the IceCap 2 /2 Small, but this component for IceCap |
| SubstantialEquivalence 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 directcontact with the patient skin. | |||
| Silicone adhesive and dielectric ink arein direct contact with the patient skinfor the IceCap 2 / 2 small.EEG pastes remain the same for bothgenerations of IceCap. | |||
| IceCap 2 / 2 Small electrodes materialhas been assessed by consensusstandard for biocompatibility testing,as previously done with its predicateNeuronaute including IceCap. | |||
| Electrodes | Up to 21 electrodes:• 19 EEG electrodes• 1 electrode (Fpz) used forground connection• 1 electrode (Oz)used as areference for EEGCalculation | Up to 21 electrodes:• 19 EEG electrodes• 1 electrode (Fpz) used forground connection• 1electrode (Oz) isused as areference for EEGCalculation | None |
| SubstantialEquivalence Topic | Neuronaute with IceCap 2 &IceCap 2 Small | Neuronaute | Significant Differences |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/A |
| MaterialComposition | - Polyethylene terephthalate (PET)- Silver and Silver/Silver chlorideconductive 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 initialIceCap was limited to 12 and halfhours due to copper migration acrossthe silver layer when EEG paste wasapplied on the electrodes.For the IceCap 2 / 2 Small, thepolyimide is superseded by PET(polyethylene terephthalate), widelyused in the medical fieldDue to this technology, the IceCap 2/2 Small can be used for several daysrecording (up to 72h)The previous IceCap electrodes weremade of copper covered with a layerof silver, whereas IceCap 2 / 2 smallare made of Ag/AgCl , which arewidely used in medical industry forseveral days of recording.The Neuronaute with IceCap 2 &IceCap 2 Small electrodes' material |
| SubstantialEquivalence Topic | Neuronaute with IceCap 2 &IceCap 2 Small | Neuronaute | Significant Differences |
| Relationship | Subject device | Predicate device | N/A |
| 510(k) # | TBD | K202334 | N/Astandard for biocompatibility testing,as previously done with its predicateNeuronaute including IceCap. |
| Electrodes; single orreusable? | Single use, non-sterile | Single use, non-sterile | None |
| Montage | 10/20 System | 10/20 System | None |
| Able toaccommodatedifferent patienthead sizes | The material of the Neuronaute with IceCap2 & IceCap 2 Small stretches to fit thepatient's head.It's provided in two sizes depending on thehead circumference of the patient:- Head circumferences between 43and 53 cm: use the IceCap 2 Small- Head circumference between 53and 60 cm: use the IceCap 2The IceCap 2 is used when the patient isbetween 2 sizes. | The material of the Neuronaute IceCapstretches such that itcan fits on the patient's head, similarto a sock.The unique cap size fits to at least 90% ofthe population | The device has been improved from asingle size to an extended use in apediatric population by including theIceCap 2 Small and defining the headcircumferences for each use (adultsand children).IceCap 2 electrodes haveimplemented a new size range forpediatrics although materials andtechnical specifications are similarbetween IceCap 2 and IceCap 2 Small.However, the Neuronaute IceCap 2 &IceCap 2 Small is demonstrated to besubstantially equivalent to theNeuronaute. |
| 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 K860210Elefix. | in the central hole of each electrode,cleared in K860210Elefix. | |
| 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 |
| Componentdimensions | 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: equivalentSensor 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 2.4GHzBluetooth 2.4GHzWiFi 2.412 GHz ~ 2.484 GHz (2.4 GHz ISM Band)BLE 2.402 and 2.480 GHz | WiFi 2.4GHzBluetooth 2.4GHzWiFi 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 rangeand differentialoffsetvoltage | ±400mV | ±400mV | None |
| ADC Resolution | 24 bits | 24 bits | None |
| ADC CommonMode RejectionRate(CMRR) | > 105 dB | > 105 dB | None |
| Input Impedance | > 1Gohm | > 1Gohm | None |
| Input noise | < 6μVp-p over 0.1-50Hz | < 6μVp-p over 0.1- 50 Hz | None |
| Electrodeimpedancecheck | Yes | Yes | None |
| General System Characteristics | |||
| Power source | Battery | Battery | None |
| Type of battery | Rechargeable LiPo(Lithium Polymer)3.7-volt, 2.4 Ah | Rechargeable LiPo(Lithium Polymer)3.7-volt, 2.4 Ah | None |
| Battery dimensions | Neuronaute HighCapacity Batterymodule: 199.5 x170.6 x 27.2 mm | Neuronaute HighCapacity Batterymodule: 199.5 x170.6 x 27.2 mm | None |
| 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 |
| Weight | Neuronaute High | Neuronaute High | None |
| Capacity Battery | Capacity Battery | ||
| module: 147 g | module: 147 g |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
Figure 1. Substantial equivalence table
{16}------------------------------------------------
- (b) (1) In order to demonstrate the substantial equivalent of Neuronaute, biocompatibility validation, performance, and electrical safety were conducted in order to ensure that it safely and effectively performs as intended.
(2) N/A Clinical Testing was not required
(3) The conclusion drawn from the nonclinical tests demonstrate that Neuronaute with IceCap 2 & IceCap 2 Small is a safe, as effective, and performs as well as the legally marketed predicate device. The verification and validation tests were all evaluated thoroughly, and passed successfully.
§ 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).