Neuronaute with IceCap 2 & IceCap 2 Small

{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. 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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) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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 Small<br>is a system intended to acquire, display,<br>store, archive, and periodically transmit EEG<br>signals from the brain using a full montage<br>array to enable review at a physician's<br>office, hospital, or other remote locations. It<br>allows remote access by users via the<br>Neuronaute N-CLOUD which receives EEG<br>signals from Neuronaute Head Module<br>which sends transmissions to the cloud.<br><br>Neuronaute and its associated software are<br>intended to assist in the diagnosis of | Neuronaute is a system intended to acquire,<br>display, store, archive, and periodically<br>transmit EEG signals from the brain using a<br>full montage array to enable review at a<br>physician's office, hospital, or other remote<br>locations. It allows remote access by users<br>via the Neuronaute N-CLOUD which receives<br>EEG signals from Neuronaute Head Module<br>which sends transmissions to the cloud.<br><br>Neuronaute and its associated software are<br>intended to assist in the diagnosis of<br>neurological disorders. Neuronaute and its | The targeted population is expanded<br>compared to the initial indication for<br>use of the Neuronaute to target both<br>adult and pediatric patients. However<br>this change was already implemented<br>by a change that did not need a 510(k)<br>submission to demonstrate the<br>conformity of the Neuronaute<br>acquisition system (Recorder,<br>BioAdapter, Battery) to medical<br>guidelines for EEG recordings on<br>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<br>components do not provide any diagnostics<br>conclusions or automated alerts of an<br>adverse clinical event about a patient's<br>clinical condition.<br>The device is for use by trained medical<br>professionals for patients under medical<br>supervision. The device is intended for use<br>on adults and pediatrics. Neuronaute is not<br>intended to replace direct communication<br>with healthcare providers. The system data<br>should not be used alone but should be<br>used along with all other clinical data and<br>exams to come to a diagnosis. | components do not provide any diagnostics<br>conclusions or automated alerts of an<br>adverse clinical event about a patient's<br>clinical condition.<br>The device is for use by trained medical<br>professionals for patients under medical<br>supervision. The device is intended for use<br>on adults (ages 18 and above). Neuronaute<br>is not intended to replace direct<br>communication with healthcare providers.<br>The system data should not be used alone<br>but should be used along with all other<br>clinical data and exams to come to a<br>diagnosis. | The change presented here<br>(introduction of IceCap 2 & IceCap 2<br>Small) supports the expansion of the<br>targeted population of the actual<br>Neuronaute to improve the size fit of<br>IceCap electrode range to a larger<br>pediatric population.<br>The IceCap 2 electrodes have been<br>adapted by design to be able to<br>transmit EEG signals for children and<br>adults as it is provided in two different<br>sizes:<br>IceCap 2<br>IceCap 2 Small<br>Each size is adapted to a range of head<br>size circumferences to cover the<br>population from children (at least 5<br>years old) to adults.<br>However, the Neuronaute IceCap 2 &<br>IceCap 2 Small is demonstrated to be<br>substantially equivalent to the<br>Neuronaute. | | Substantial<br>Equivalence Topic<br>Relationship | Neuronaute with IceCap 2 &<br>IceCap 2 Small | Neuronaute | Significant Differences | | 510(k) # | TBD | K202334 | N/A | | Prescription or OTC<br>Use | Prescription | Prescription | None | | Intended User(s) | Trained healthcare<br>professionals: doctors,<br>polysomnogram<br>technicians, and<br>nurses | Trained healthcare<br>professionals: doctors,<br>polysomnogram<br>technicians, and<br>nurses | None | | Intend patient<br>population<br>demographics | Adult and pediatric patients 5 years of age<br>and older. | Adult patients ages 18 years of age and<br>older. | The patient demographic has been<br>expanded to include pediatric<br>patients. | | Environment of use | Physician's office,<br>hospital or other<br>remote locations<br>under medical<br>supervision. | Physician's office,<br>hospital or other<br>remote locations<br>under medical<br>supervision. | None | | Video | Optional; The subject<br>device includes a<br>component video<br>camera called N-DEO | Optional; The subject<br>device includes a<br>component video<br>camera called N-DEO | None | | Electrode Components | | | | | Type of components<br>in contact with the<br>patient | - Silicone adhesive<br>- Dielectric ink<br>- EEG Conductive pastes | - Polyimide substrate<br>- EEG conductive paste | For IceCap, polyimide is in direct<br>contact with the patient skin. It is<br>superseded by polyethylene<br>terephthalate (PET) for the IceCap 2 /<br>2 Small, but this component for IceCap | | Substantial<br>Equivalence Topic | Neuronaute with IceCap 2 &<br>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<br>contact with the patient skin. | | | | | Silicone adhesive and dielectric ink are<br>in direct contact with the patient skin<br>for the IceCap 2 / 2 small.<br>EEG pastes remain the same for both<br>generations of IceCap.…