Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes the device as EEG electrodes and a single-use cap for signal acquisition, with no mention of AI or ML for analysis or interpretation.

Therapeutic

No
The device is described as an EEG electrode used to record neurological activity, not to treat any condition.

Diagnostic

Yes
The device is used as EEG electrodes for a "short or long-term EEG record (up to 72 hours)" in cases of "neurological disorders," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the IceCaps are "single use cap which connects to the marketed EEG recorders" and utilize "conductive tracks of the Flexible Printed Circuit" to conduct signals. This indicates a physical hardware component (the cap with electrodes and circuitry) is the primary medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
IceCaps Function: The IceCaps are EEG electrodes. They are placed on the patient's head to measure electrical activity of the brain. This is a form of in vivo (within the living body) measurement, not in vitro testing of a specimen.

The description clearly states the device is used as EEG electrodes placed on the patient's head to record electrical signals. This falls under the category of a medical device used for physiological measurement, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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). lceCap Neonate shall be placed on the head of babies, newborns and premature babies.

Product codes

GXY

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's scalp, head

Indicated Patient Age Range

babies, newborns, premature babies, patients weighing at least 10 kg and having a head circumference above 43 cm

Intended User / Care Setting

Healthcare Professionals, Physician's office, hospital or other remote locations under medical supervision.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. The performance data demonstrate that the is safe and effective in use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151576, K223644

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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
PARIS 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 by
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
& 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
Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| Device Classification Name | electrode, cutaneous | electrode, cutaneous | full-montage standard
electroencephalograph | Predicate device (2) is approved
as part of a full
electroencephalograph system
however, subject device and
Predicate device (1) are only
electrodes with their adapters. |
| Review Panel | Neurology | Neurology | Neurology | None |
| Regulation Number | 882.1320 | 882.1320 | 882.1400 | Predicate device (2) is approved
as part of a full
electroencephalograph system
however, subject device and
Predicate device (1) are only
electrodes with their adapters. |
| Product Codes | GXY | GXY | GWQ /GXY | Predicate device (2) is approved
as part of a full
electroencephalograph system.
Therefore additional classification
code is used. however, subject
device and Predicate device (1)
are only electrodes with their
adapters. |
| Device Class | II | II | II | None |
| Intended use/Indications For Use | 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).
IceCap 2 shall be placed on | The NEON EEG is intended to be
applied directly to the patient's
scalp to enable recordings of
electrophysiological signals (such
as EEG) on infants from birth.
The NEON EEG is indicated for
single use only and should be
replaced after 12 hours of use.
The NEON EEG is not indicated for | Neuronaute with IceCap 2 &
lceCap 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 | The indication for use is similar.
They are intended to be used as
EEG electrodes.
The predicate device (1) is
indicated for 12 hours of use only
whereas, subject device can be
used up to 72 hours of use, which
is same as predicate device (2). |
| | patients weighing at least 10 kg | use with electro stimulation
equipment | 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 Devices
Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A |
| | and having a head circumference
above 43 cm.
IceCap Neonate shall be placed on
the head of babies, newborns and
premature babies. | | 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. | The verification test for IceCap
product line qualifies 72 hours of
use. This duration of use does not
raise any new concern for safety
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
other remote locations under
medical supervision. | Not indicated | Physician's office, hospital or
other remote locations under
medical supervision. | None |
| Type of components in contact
with the patient | IceCap 2 & 2 small:
Silicone adhesive
Dielectric ink
EEG conductive paste | - Ag/AgCl ink

adhesive (material unknown)
EEG conductive paste | IceCap 2 & 2 small:
Silicone adhesive
Dielectric ink
EEG conductive paste | The material of adhesive used for
Predicate (1) is unknown.
However, the subject devices are
biocompatible and compliant |
| Substantial Equivalence
Topic | 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 Devices
Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A
with standard ISO 10993-1 Fifth
edition 2018-08
The difference does not affect the
safety and the effectiveness.
Therefore, IceCap product line is
substantially equivalent to its
predicate devices. |
| | Neonate:
Ag/AgCl ink
Polyolefin foam on acrylic
adhesive | | | |
| Storage life | 12 months | 20 months | 12 months | The predicate device (1) indicates
20 months storage life whereas,
subject device indicates 12
months of storage life, which is
same as predicate device (2).
The difference does not affect the
safety and the effectiveness.
Therefore, IceCap product line is
substantially equivalent to its
predicate devices. |
| Electrodes | IceCap 2 & 2 small:
Up to 21 electrodes:
• 19 EEG electrodes
• 1 electrode (Fpz) used as
reference for EEG calculation
• 1 electrode (Oz) used for ground
connection
Neonate:
• 11 EEG electrodes (size M)
Or
9 EEG electrodes (size XS, S)
• 1 ground connection
• 1 reference for EEG calculation | 6 EEG electrodes
Or
10 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 as
reference for EEG calculation
• 1 electrode (Oz) used for
ground connection | The subject devices and predicate
device (1) and (2) have 1 ground
and 1 reference connection.
The number of electrodes is
different to accommodate
different head circumference of
the patient.
Number of electrodes does not
impact quality of signal as the
subject device is qualified via fit
to form test, impedance test and
general quality of signal. The
subject 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 Devices
Group | INCEREB LTD | Bioserenity | N/A |
| Owner/Operator | 10089585 | 10051067 | 10057285 | N/A
new risk that can affect the safety
and the effectiveness.
Therefore, IceCap product line is
substantially equivalent to its
predicate devices. |
| Material
Composition | IceCap 2 & 2 small:
Polyethylene terephthalate (PET)
Silver and Silver/Silver chloride
conductive inks
Insulation inks
Stiff PETG film
Skin adhesive
Graphical ink
Silicone adhesive
Neonate:
Polyethylene terephthalate (PET)
Silver and Silver/Silver chloride
conductive inks
Insulation inks
Stiff PETG film
Protective polyolefin foam on
acrylic 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/Silver
chloride conductive inks
Insulation inks
Stiff PETG film
Skin adhesive
Graphical ink
Silicone adhesive | The subject devices are
biocompatible and compliant
with standard ISO 10993-1 Fifth
edition 2018-08.
The difference does not affect the
safety and the effectiveness.
Therefore, IceCap product line is
substantially equivalent to its
predicate 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 to
accommodate
different patient
head sizes | The material of the Neuronaute
with IceCap 2 & IceCap 2 Small
stretches to fit the patient's head.
It's provided in two sizes
depending on the head
circumference of the patient: -
Head circumferences between 43
and 53 cm: use the IceCap 2 Small
Head circumference between 53 | Neon EEG comes in two sizes :

Neon 8: indicated to be used on
patients having head
circumferences less than 32 cm
Neon 12: indicated to be used on
patients having head
circumferences more than 32 cm | The material of the Neuronaute
with IceCap 2 & IceCap 2 Small
stretches to fit the patient's head.
It's provided in two sizes
depending on the head
circumference of the patient: -
Head circumferences between 43
and 53 cm: use the IceCap 2 Small

Head circumference between 53 | The subject and predicate devices
cover different range of patient
head size.

IceCap Neonate is provided in
three sizes and intended to be
used on patients having head
circumferences at least 23 cm until
51 cm. | | and 60 cm: use the IceCap 2 The
IceCap 2 is used when the patient
is between 2 sizes. | effectiveness. Therefore, IceCap
product line is substantially
equivalent to its predicate
devices. |
| Conductive
Electrolyte 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 (74.7
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)

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 6mm

Neon 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 (74.7
mm^2) | The subject and predicate devices
vary in dimension due to
difference in number of
electrodes. The number of
electrodes is different to
accommodate different head
circumference of the patient.
The subject device is qualified via
fit to form test and does not raise
any new risk that can affect the
safety and the effectiveness.
The subject device has more sizes
available compared to predicate
(1) to provide precise fitting for
intended patient population.
Therefore, IceCap product line is
substantially equivalent to its
predicate 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 Devices
Group | 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 with
recorders on market | Touchproof Adapter
IceAdapter via DB25 cable | Universal Connectivity (1.5mm
Touchproof and D-type
connectors) | Touchproof Adapter
IceAdapter via DB25 cable | None |

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