(94 days)
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.
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.
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).
IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.
The IceCap product line does not perform comparative effectiveness studies with human readers or standalone algorithm performance studies. The device is a cutaneous electrode, and its evaluation focuses on safety and performance according to relevant standards, not on AI-driven diagnostic accuracy.
Here's a breakdown of the acceptance criteria and supporting studies for the IceCap product line:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Topic | Description/Standard | Device Performance (IceCap product line) |
|---|---|---|
| Indications for Use | For use as EEG electrodes by Healthcare Professionals on patients with neurological disorders for short or long-term EEG record (up to 72 hours). Specific weight and head circumference ranges for IceCap 2 and IceCap Neonate. | Meets stated indications for use, including up to 72 hours of use, matching predicate device (2). |
| Safety Standards | Compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). | Conforms to 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. |
| Biocompatibility | Materials in contact with the patient must be biocompatible (ISO 10993-1). | Biocompatible and compliant with ISO 10993-1 Fifth edition 2018-08. |
| Duration of Use | Up to 72 hours of continuous use. | Qualifies for 72 hours of use. |
| Fit to Form and Usability | Ability to accommodate different head sizes and proper installation. | Qualified via fit to form test and usability test for installation. |
| Signal Quality (Implied) | The number of electrodes and material composition should not negatively impact the quality of EEG signal. | Qualified via impedance test and general quality of signal. |
| Material Composition | Specific materials used for electrodes and adhesives. | Materials listed (PET, Ag/AgCl inks, insulation inks, stiff PETG film, skin/silicone adhesive, graphical ink, protective polyolefin foam on acrylic adhesive) are biocompatible. |
| Storage Life | Expected shelf life of the device. | 12 months. (Matches predicate 2, but shorter than predicate 1. This difference does not affect safety and effectiveness.) |
| Single Use/Sterility | Non-sterile, single-use device. | Single use, non-sterile. |
| Montage System | Conforms to the 10/20 System for electrode placement. | 10/20 System. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for specific test sets (e.g., for fit-to-form, impedance, or usability tests). It mentions that the "clinical data were not necessary to determine substantial equivalence," indicating that animal or human subject testing for diagnostic or comparative effectiveness was not performed as a primary means of establishing substantial equivalence for this type of device.
The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective. The studies primarily involve non-clinical performance and safety testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As this device is an EEG electrode, the primary "ground truth" for its performance is its ability to meet electrical and biocompatibility standards, and to effectively acquire EEG signals as confirmed by non-clinical tests. There is no mention of human experts being used to establish a ground truth for a diagnostic outcome, as the device itself does not provide diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. The evaluation performed is based on compliance with harmonized standards and engineering tests, not on human-based adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The IceCap product line is an EEG electrode, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers are not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware component (EEG electrode) and does not involve a standalone algorithm for performance evaluation in a diagnostic context.
7. The type of ground truth used
The ground truth used for evaluating the IceCap product line is based on established engineering standards and regulatory requirements for medical devices, particularly for cutaneous electrodes. This includes:
- Performance standards: e.g., electrical impedance, signal integrity (implied by "general quality of signal").
- Safety standards: e.g., electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability for medical electrical equipment in the home healthcare environment (IEC 60601-1-11).
- Biocompatibility standards: (ISO 10993-1) for materials in contact with the patient.
- Functional tests: Fit-to-form, usability for installation.
The "truth" is whether the device meets these specified, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set or ground truth for training.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 75013PARIS 75013 France | |||
| Applicant Contact Telephone | 33-682581979 | |||
| Applicant Contact | Mrs. Aude Gourgues | |||
| Applicant Contact Email | aude.gourgues@bioserenity.com |
| 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.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).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 byHealthcare 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& 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 DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| Device Classification Name | electrode, cutaneous | electrode, cutaneous | full-montage standardelectroencephalograph | Predicate device (2) is approvedas part of a fullelectroencephalograph systemhowever, subject device andPredicate device (1) are onlyelectrodes with their adapters. |
| Review Panel | Neurology | Neurology | Neurology | None |
| Regulation Number | 882.1320 | 882.1320 | 882.1400 | Predicate device (2) is approvedas part of a fullelectroencephalograph systemhowever, subject device andPredicate device (1) are onlyelectrodes with their adapters. |
| Product Codes | GXY | GXY | GWQ /GXY | Predicate device (2) is approvedas part of a fullelectroencephalograph system.Therefore additional classificationcode is used. however, subjectdevice and Predicate device (1)are only electrodes with theiradapters. |
| Device Class | II | II | II | None |
| Intended use/Indications For Use | The IceCaps are medical devicesused as EEG electrodes. They areused by Healthcare Professionalson a patient in case ofneurological disorders with a shortor long-term EEG record (up to 72hours).IceCap 2 shall be placed on | The NEON EEG is intended to beapplied directly to the patient'sscalp to enable recordings ofelectrophysiological signals (suchas EEG) on infants from birth.The NEON EEG is indicated forsingle use only and should bereplaced after 12 hours of use.The NEON EEG is not indicated for | Neuronaute with IceCap 2 &lceCap 2 Small is a systemintended to acquire, display,store, archive, and periodicallytransmit EEG signals from thebrain using a full montage arrayto enable review at a physician'soffice, hospital, or other remotelocations. It allows remote access | The indication for use is similar.They are intended to be used asEEG electrodes.The predicate device (1) isindicated for 12 hours of use onlywhereas, subject device can beused up to 72 hours of use, whichis same as predicate device (2). |
| patients weighing at least 10 kg | use with electro stimulationequipment | by users via the Neuronaute N-CLOUD which receives EEG signals | ||
| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2& 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 DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| and having a head circumferenceabove 43 cm.IceCap Neonate shall be placed onthe head of babies, newborns andpremature babies. | from Neuronaute Head Modulewhich sends transmissions to thecloud.Neuronaute and its associatedsoftware are intended to assist inthe diagnosis of neurologicaldisorders. Neuronaute and itscomponents do not provide anydiagnostics conclusions orautomated alerts of an adverseclinical event about a patient'sclinical condition.The device is for use by trainedmedical professionals for patientsunder medical supervision. Thedevice is intended for use onadults and pediatrics. Neuronauteis not intended to replace directcommunication with healthcareproviders. The system data shouldnot be used alone but should beused along with all other clinicaldata and exams to come to adiagnosis. | The verification test for IceCapproduct line qualifies 72 hours ofuse. This duration of use does notraise any new concern for safetyand 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 orother remote locations undermedical supervision. | Not indicated | Physician's office, hospital orother remote locations undermedical supervision. | None |
| Type of components in contactwith the patient | IceCap 2 & 2 small:Silicone adhesiveDielectric inkEEG conductive paste | - Ag/AgCl ink- adhesive (material unknown)- EEG conductive paste | IceCap 2 & 2 small:Silicone adhesiveDielectric inkEEG conductive paste | The material of adhesive used forPredicate (1) is unknown.However, the subject devices arebiocompatible and compliant |
| Substantial EquivalenceTopic | IceCap Product line | Neon EEG | Neuronaute with IceCap 2& IceCap 2 small | Significant Differences |
| Relationship | Subject device | Predicate device (1) | Predicate device (2) | N/A |
| 510(k) # | K243788 | K151576 | K223644 | N/A |
| Establishment Name | BioSerenity Medical DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/Awith standard ISO 10993-1 Fifthedition 2018-08The difference does not affect thesafety and the effectiveness.Therefore, IceCap product line issubstantially equivalent to itspredicate devices. |
| Neonate:- Ag/AgCl ink- Polyolefin foam on acrylicadhesive | ||||
| Storage life | 12 months | 20 months | 12 months | The predicate device (1) indicates20 months storage life whereas,subject device indicates 12months of storage life, which issame as predicate device (2).The difference does not affect thesafety and the effectiveness.Therefore, IceCap product line issubstantially equivalent to itspredicate devices. |
| Electrodes | IceCap 2 & 2 small:Up to 21 electrodes:• 19 EEG electrodes• 1 electrode (Fpz) used asreference for EEG calculation• 1 electrode (Oz) used for groundconnectionNeonate:• 11 EEG electrodes (size M)Or9 EEG electrodes (size XS, S)• 1 ground connection• 1 reference for EEG calculation | 6 EEG electrodesOr10 EEG electrodes• 1 ground connection• 1 reference for EEG calculation | IceCap 2 & 2 small:Up to 21 electrodes:• 19 EEG electrodes• 1 electrode (Fpz) used asreference for EEG calculation• 1 electrode (Oz) used forground connection | The subject devices and predicatedevice (1) and (2) have 1 groundand 1 reference connection.The number of electrodes isdifferent to accommodatedifferent head circumference ofthe patient.Number of electrodes does notimpact quality of signal as thesubject device is qualified via fitto form test, impedance test andgeneral quality of signal. Thesubject device does not raise any |
| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2& 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 DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/Anew risk that can affect the safetyand the effectiveness.Therefore, IceCap product line issubstantially equivalent to itspredicate devices. |
| MaterialComposition | IceCap 2 & 2 small:- Polyethylene terephthalate (PET)- Silver and Silver/Silver chlorideconductive inks- Insulation inks- Stiff PETG film- Skin adhesive- Graphical ink- Silicone adhesiveNeonate:- Polyethylene terephthalate (PET)- Silver and Silver/Silver chlorideconductive inks- Insulation inks- Stiff PETG film- Protective polyolefin foam onacrylic adhesive- Graphical ink | - Ag/AgCl ink-adhesive (material unknown)- EEG conductive paste- other materials unknown | IceCap 2 & 2 small:- Polyethylene terephthalate(PET) - Silver and Silver/Silverchloride conductive inks- Insulation inks- Stiff PETG film- Skin adhesive- Graphical ink- Silicone adhesive | The subject devices arebiocompatible and compliantwith standard ISO 10993-1 Fifthedition 2018-08.The difference does not affect thesafety and the effectiveness.Therefore, IceCap product line issubstantially equivalent to itspredicate devices. |
| Electrodes; single or reusable? | Single use, non-sterile | Single use, non-sterile | Single use, non-sterile | None |
| Montage | 10/20 System | 10/20 System | 10/20 System | None |
| Able toaccommodatedifferent patienthead sizes | The material of the Neuronautewith IceCap 2 & IceCap 2 Smallstretches to fit the patient's head.It's provided in two sizesdepending on the headcircumference of the patient: -Head circumferences between 43and 53 cm: use the IceCap 2 Small- Head circumference between 53 | Neon EEG comes in two sizes :Neon 8: indicated to be used onpatients having headcircumferences less than 32 cmNeon 12: indicated to be used onpatients having headcircumferences more than 32 cm | The material of the Neuronautewith IceCap 2 & IceCap 2 Smallstretches to fit the patient's head.It's provided in two sizesdepending on the headcircumference of the patient: -Head circumferences between 43and 53 cm: use the IceCap 2 Small- Head circumference between 53 | The subject and predicate devicescover different range of patienthead size.The subject device is qualified viafit to form test and usability testfor installation. The subject devicedoes not raise any new risk thatcan affect the safety and the |
| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2& 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 DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| and 60 cm: use the IceCap 2 TheIceCap 2 is used when the patientis between 2 sizes.IceCap Neonate is provided inthree sizes and intended to beused on patients having headcircumferences at least 23 cm until51 cm. | and 60 cm: use the IceCap 2 TheIceCap 2 is used when the patientis between 2 sizes. | effectiveness. Therefore, IceCapproduct line is substantiallyequivalent to its predicatedevices. | ||
| ConductiveElectrolyte gel | Conductive gel | Conductive gel | Conductive gel | None |
| Component dimensions | IceCap2 –Height: 11.50 inches (292 mm)- Width: 8.23 inches (209 mm)- Sensor area: 0.11 inches ^2 (74.7mm^2)IceCap2 Small- Height: 9.69inches (246 mm)- Width: 8.23 inches (209 mm)- Sensor area: 0.11 inches^2 (74.7mm^2)IceCap Neonate M- Height: 10.38inches (263,8 mm)- Width: 8.33 inches (211,5 mm)- Sensor diameter: 0.64 inches(16,3 mm)IceCap Neonate S- Height: 11.32inches (287,5 mm)- Width: 8.34 inches (211,9 mm)- Sensor diameter: 0.60 inches(15,3 mm) | Neon 8:97mm x 208mm x 6mmNeon 12:178mm x 240mm x 9mm | 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 (74.7mm^2) | The subject and predicate devicesvary in dimension due todifference in number ofelectrodes. The number ofelectrodes is different toaccommodate different headcircumference of the patient.The subject device is qualified viafit to form test and does not raiseany new risk that can affect thesafety and the effectiveness.The subject device has more sizesavailable compared to predicate(1) to provide precise fitting forintended patient population.Therefore, IceCap product line issubstantially equivalent to itspredicate devices. |
| Substantial Equivalence | IceCap Product line | Neon EEG | Neuronaute with IceCap 2& 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 DevicesGroup | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| IceCap Neonate XS- Height: 10.28inches (261,1 mm)- Width: 8.34 inches (211,9 mm)- Sensor diameter: 0.060 inches(15,3 mm) | ||||
| Accessories to connect withrecorders on market | Touchproof AdapterIceAdapter via DB25 cable | Universal Connectivity (1.5mmTouchproof and D-typeconnectors) | Touchproof AdapterIceAdapter via DB25 cable | None |
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§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).