IceCap product line

K243788 · Bioserenity Medical Devices Group · GXY · Mar 13, 2025 · Neurology

Device Facts

• Record ID: K243788
• Device Name: IceCap product line
• Applicant: Bioserenity Medical Devices Group
• Product Code: GXY · Neurology
• Decision Date: Mar 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

Device Story

IceCap product line consists of single-use, non-sterile EEG electrode caps; used by healthcare professionals in hospitals, clinics, or remote locations. Input: electrophysiological signals from patient scalp; conductive tracks on flexible printed circuit transmit signals to EEG recorders via IceAdapter or Touchproof adapter. Output: raw EEG signals for clinical review. Device facilitates neurological disorder diagnosis by enabling EEG recording up to 72 hours. Benefits: provides standardized electrode placement (10/20 system) and adaptable fit for diverse patient head sizes (neonate to adult).

Clinical Evidence

No clinical data necessary; substantial equivalence supported by non-clinical bench testing, including compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment).

Technological Characteristics

Materials: PET, Ag/AgCl conductive inks, insulation inks, PETG film, silicone/acrylic adhesives, polyolefin foam. Sensing: EEG electrodes (10/20 system). Connectivity: Wired via IceAdapter/Touchproof adapter to EEG recorders. Form factor: Flexible cap with varying electrode counts (9-21). Sterilization: Non-sterile. Standards: ISO 10993-1 (biocompatibility), IEC 60601 series.

Indications for Use

Indicated for patients with neurological disorders requiring short or long-term EEG monitoring (up to 72 hours). IceCap 2 is for patients ≥10 kg and head circumference >43 cm. IceCap Neonate is for babies, newborns, and premature babies.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Neon EEG (K151576)
• Neuronaute with IceCap 2 & IceCap 2 Small (K223644)

Submission Summary (Full Text)

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March 13, 2025

Bioserenity Medical Devices Group Melanie Renaud-Samiri Head of Regulatory and Quality Affairs 20. rue Berbier du Mets Paris Cedex 13 lle-de-France Paris. 75013 France

Re: K243788

Trade/Device Name: IceCap product line Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 14, 2025 Received: February 14, 2025

Dear Melanie Renaud-Samiri:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Tushar Bansal -S

for Heather Dean, PhD

Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

Submission Number (if known)

K243788

Device Name

IceCap product line (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M))

Indications for Use (Describe)

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours).

lceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).

IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

Type of Use (Select one or both, as applicable)

cription Use (Part 21 CFR 801 Subpart D)

Counter Use (21 CFR 801 Subpart C)

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| 510(k) #: | K243788 | | 510(k) Summary | | Prepared on: 2025-03-12 |
|-----------|---------|--|----------------|--|-------------------------|
|-----------|---------|--|----------------|--|-------------------------|

| Contact Details | | | | 21 CFR 807.92(a)(1) |
|-----------------------------|--------------------------------------------------------------------------------------|--|--|---------------------|
| Applicant Name | BIOSERENITY MEDICAL DEVICES GROUP | | | |
| Applicant Address | 20, rue Berbier du Mets PARIS CEDEX 13 Ile-de-France, FR 75013<br>PARIS 75013 France | | | |
| Applicant Contact Telephone | 33-682581979 | | | |
| Applicant Contact | Mrs. Aude Gourgues | | | |
| Applicant Contact Email | [e-mail] | | | |

| Device Name | | | 21 CFR 807.92(a)(2) |
|---------------------|----------------------|--|---------------------|
| Device Trade Name | IceCap product line | | |
| Common Name | Cutaneous electrode | | |
| Classification Name | Electrode, Cutaneous | | |
| Regulation Number | 882.1320 | | |
| Product Code(s) | GXY | | |

| Legally Marketed Predicate Devices | | | 21 CFR 807.92(a)(3) |
|------------------------------------|----------------------------------------------------------|--|---------------------|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | Product Code |
| K151576 | Neon EEG | | GXY |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | | GWQ |

| Device Description Summary | | | 21 CFR 807.92(a)(4) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------|
| | The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. | | |
| | The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter. | | |
| | The electrodes placement in IceCap Product line is done accordingly to the 10/20 system.<br>The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors. | | |
| | IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).<br>IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies. | | |

| Intended Use/Indications for Use | | | 21 CFR 807.92(a)(5) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------|
| | The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by<br>Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). | | |

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lceCap Neonate shall be placed on the head of babies, newborns and premature babies.

### Indications for Use Comparison 21 CFR 807.92(a)(5) The IceCap product line and two predicate devices share similar indication for use. They are intended to be used as EEG electrodes. The only difference is the duration of use for predicate Neon EEG (K151576) is 12 hours whereas, 72 hours for lceCap product line. This duration is the same as already cleared predicate Neuronaute with Icecap 2 small (K223644). Technological Comparison 21 CFR 807.92(a)(6) The lceCap product line and two predicate devices share the similar intended use, principle of operation and same main technological characteristics. They just differ in number of electrode array. This difference is due to adaptability of the head circumference of the patients. The minor differences between the lceCap product line and two predicate devices raise no new issues of safety or effectiveness. The performance data demonstrate that the is safe and effective in use. Therefore, it is substantially equivalent. Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b) IceCap product line was tested and conformed to following standards: IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601- 1:2005/AMD2:2020 IEC 60601-1-2: 2014 + A1 (2020) IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005/ AMD 1:2012, IEC 60601-1:2005/AMD2:2020 The clinical data were not necessary to determine substantial equivalence. Hence, this section is not applicable. As demonstrated in the Substantial Equivalence Comparison Table the maintains most of the features of the predicate device. IceCap product line does new risks compared to its predicate devices. Any differences were minor and will not prevent a healthcare professional from being able to arrive at a clinical diagnosis, and there is no impact on safety and effectiveness. Based on the similarities and differences concerning the indications for use, operation, and design, the conclusion established that lceCap product line is as safe, effective, and performs as well as both predicate device. The information presented in the premarket notification is complete and supports a substantial equivalence .

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## Substantial Equivalence Comparison Table:

| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2<br>& IceCap 2 small | Significant Differences |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Topic | | | | |
| Relationship | Subject device | Predicate device (1) | Predicate device (2) | N/A |
| 510(k) # | K243788 | K151576 | K223644 | N/A |
| Establishment Name | BioSerenity Medical Devices<br>Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| Device Classification Name | electrode, cutaneous | electrode, cutaneous | full-montage standard<br>electroencephalograph | Predicate device (2) is approved<br>as part of a full<br>electroencephalograph system<br>however, subject device and<br>Predicate device (1) are only<br>electrodes with their adapters. |
| Review Panel | Neurology | Neurology | Neurology | None |
| Regulation Number | 882.1320 | 882.1320 | 882.1400 | Predicate device (2) is approved<br>as part of a full<br>electroencephalograph system<br>however, subject device and<br>Predicate device (1) are only<br>electrodes with their adapters. |
| Product Codes | GXY | GXY | GWQ /GXY | Predicate device (2) is approved<br>as part of a full<br>electroencephalograph system.<br>Therefore additional classification<br>code is used. however, subject<br>device and Predicate device (1)<br>are only electrodes with their<br>adapters. |
| Device Class | II | II | II | None |
| Intended use/Indications For Use | The IceCaps are medical devices<br>used as EEG electrodes. They are<br>used by Healthcare Professionals<br>on a patient in case of<br>neurological disorders with a short<br>or long-term EEG record (up to 72<br>hours).<br>IceCap 2 shall be placed on | The NEON EEG is intended to be<br>applied directly to the patient's<br>scalp to enable recordings of<br>electrophysiological signals (such<br>as EEG) on infants from birth.<br>The NEON EEG is indicated for<br>single use only and should be<br>replaced after 12 hours of use.<br>The NEON EEG is not indicated for | Neuronaute with IceCap 2 &<br>lceCap 2 Small is a system<br>intended to acquire, display,<br>store, archive, and periodically<br>transmit EEG signals from the<br>brain using a full montage array<br>to enable review at a physician's<br>office, hospital, or other remote<br>locations. It allows remote access | The indication for use is similar.<br>They are intended to be used as<br>EEG electrodes.<br>The predicate device (1) is<br>indicated for 12 hours of use only<br>whereas, subject device can be<br>used up to 72 hours of use, which<br>is same as predicate device (2). |
| | patients weighing at least 10 kg | use with electro stimulation<br>equipment | by users via the Neuronaute N-<br>CLOUD which receives EEG signals | |
| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2<br>& IceCap 2 small | Significant Differences |
| Topic | | | | |
| Relationship | Subject device | Predicate device (1) | Predicate device (2) | N/A |
| 510(k) # | K243788 | K151576 | K223644 | N/A |
| Establishment Name | BioSerenity Medical Devices<br>Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| | and having a head circumference<br>above 43 cm.<br>IceCap Neonate shall be placed on<br>the head of babies, newborns and<br>premature babies. | | from Neuronaute Head Module<br>which sends transmissions to the<br>cloud.<br><br>Neuronaute and its associated<br>software are intended to assist in<br>the diagnosis of neurological<br>disorders. Neuronaute and its<br>components do not provide any<br>diagnostics conclusions or<br>automated alerts of an adverse<br>clinical event about a patient's<br>clinical condition.<br><br>The device is for use by trained<br>medical professionals for patients<br>under medical supervision. The<br>device is intended for use on<br>adults and pediatrics. Neuronaute<br>is not intended to replace direct<br>communication with healthcare<br>providers. The system data should<br>not be used alone but should be<br>used along with all other clinical<br>data and exams to come to a<br>diagnosis. | The verification test for IceCap<br>product line qualifies 72 hours of<br>use. This duration of use does not<br>raise any new concern for safety<br>and effectiveness. |
| Prescription or OTC Use | Prescription | Prescription | Prescription | None |
| Intended User(s) | Trained Healthcare professionals | Trained Healthcare professionals | Trained Healthcare professionals | None |
| Environment of use | Physician's office, hospital or<br>other remote locations under<br>medical supervision. | Not indicated | Physician's office, hospital or<br>other remote locations under<br>medical supervision. | None |
| Type of components in contact<br>with the patient | IceCap 2 & 2 small:<br>Silicone adhesive<br>Dielectric ink<br>EEG conductive paste | - Ag/AgCl ink<br>- adhesive (material unknown)<br>- EEG conductive paste | IceCap 2 & 2 small:<br>Silicone adhesive<br>Dielectric ink<br>EEG conductive paste | The material of adhesive used for<br>Predicate (1) is unknown.<br>However, the subject devices are<br>biocompatible and compliant |
| Substantial Equivalence<br>Topic | IceCap Product line | Neon EEG | Neuronaute with IceCap 2<br>& IceCap 2 small | Significant Differences |
| Relationship | Subject device | Predicate device (1) | Predicate device (2) | N/A |
| 510(k) # | K243788 | K151576 | K223644 | N/A…