(56 days)
No
The description focuses on signal acquisition, storage, and visual presentation of EEG data for trained medical staff to interpret. There is no mention of automated analysis, diagnostic conclusions, or any terms related to AI/ML.
No
The device is described as an EEG recording and display system to assist in diagnosis, not for therapeutic intervention.
Yes
The device records and displays EEG signals to "assist trained medical staff in making neurological diagnoses." While it doesn't provide automatic diagnoses, the intent is for the output to be used by trained professionals in the diagnostic process.
No
The device description explicitly lists multiple hardware components including a headband with electrodes, an amplifier, a tablet, and gel pods, in addition to the software (mobile application and EEG viewer software).
Based on the provided text, the Natus BrainWatch System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Natus BrainWatch Function: The Natus BrainWatch System records and stores EEG signals directly from the patient's head. This is a measurement of electrical activity within the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states it records and stores EEG signals to assist trained medical staff in making neurological diagnoses. It does not involve the analysis of biological samples.
Therefore, the Natus BrainWatch System falls under the category of a medical device that measures physiological signals in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older.
The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.
Product codes (comma separated list FDA assigned to the subject device)
OMC, GXY
Device Description
The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients.
The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier.
The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application:
- · Touchscreen Tablet with charger
- Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, . Medium, and Large) containing:
- · Hydroflex patch with 2 built-in electrodes
- · 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4
- · Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth™
- IV pole handle that holds the tablet for a hands-free experience .
- Gels pods attach to the electrodes to improve impedance levels .
The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back.
EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks ® EEG software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's head/scalp
Indicated Patient Age Range
patients aged 2 years and older.
Intended User / Care Setting
trained medical staff in making neurological diagnoses in patients.
professional healthcare facility or clinical research environment.
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)
Electrical Safety:
Verified in accordance with:
- IEC 60601-1-6:2010/AMD2:2020 (Usability)
- EC 60601-1:2005/AMD2:2020 (Basic safety and essential performance)
- IEC 80601-2-26: 2019 (Basic safety and essential performance of electroencephalographs)
Electromagnetic Compatibility:
Verified in accordance with:
- IEC 60601-1-2 Ed 4.1 (Electromagnetic Disturbances – Requirements and tests)
Packaging and Handling Verification:
Successfully passed packaging and handling verification as per ASTM D4169-22
Performance Testing - Bench Verification & Validation:
Successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level.
Bench testing confirmed device meets functional and performance characteristics.
Tests included:
- Requirements for the basic safety and essential performance of electroencephalographs per IEC 80601-2-26
- Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements of IEC 60601-1 and IEC 60601-1-2
- Battery Safety Testing per IEC 62133
- Shipping/distribution and vibration testing per ASTM D4169-22
- Biocompatibility of patient contacting components verified with Cytotoxicity, Irritation, and Sensitization testing per ISO 10993-5:2009, ISO 10993-23:2021, and ISO 10993-10:2021
- Performance Criteria of FDA Guidance titled Cutaneous Electrodes for Recording Purposes -Performance Criteria for Safety and Performance Based Pathway, issued on August 14, 2020.
- Wireless Coexistence per ANSI C63.27-2021
- Shelf-life testing
Results indicate that the Natus BrainWatch System complies with its predetermined specifications and the applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
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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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2024
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242930
Trade/Device Name: Natus BrainWatch System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: November 12, 2024 Received: November 12, 2024
Dear Prithul Bom:
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
1
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" (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 QS 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 Rule"). 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 medical devices and radiation-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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Natus BrainWatch System (Natus BrainWatch System)
Indications for Use (Describe)
The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older.
The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary
Date: November 5, 2024
Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Contact Person: Behsa Khoshnevis Senior Regulatory Affairs Specialist Natus Medical Incorporated Tel.: (905) 287 5055 Fax.: (905) 829-5304 E-mail: behsa.khoshnevis@natus.com
Proprietary Name: Natus BrainWatch™ System
Common Name: Electroencephalograph
Regulation Number: 21 CFR 882.1400
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Classification Name: Reduced montage standard electroencephalograph
Product code: OMC, GXY
Device Class: II
Predicate Device: Ceribell Pocket EEG Device (K170363), Ceribell Instant EEG Headband (210805)
Description:
Overview: Natus BrainWatch System
The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients.
The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier.
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Image /page/6/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and appears to be a company logo. The word is in all lowercase letters and has a registered trademark symbol after the "s".
The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application:
- · Touchscreen Tablet with charger
- Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, . Medium, and Large) containing:
- · Hydroflex patch with 2 built-in electrodes
- · 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4
- · Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth™
- IV pole handle that holds the tablet for a hands-free experience 。
- Gels pods attach to the electrodes to improve impedance levels .
The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back.
EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks ® EEG software.
Note: The network must support WiFi Protected Access (WPA/WPA2) security.
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Operating Principle of Natus BrainWatch System
The device is a portable, 10-channel EEG monitoring system. The device connects to a headband consisting of 10 patient electrodes which are used to form the 10 channels and may be used with any scalp EEG electrodes.
The system acquires the EEG signals of a patient and presents the EEG signals in visual formats in real time. The EEG recordings are displayed on a computer or tablet using an EEG viewer software. The visual signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event.
Micro-USB cable is used to connect the Natus BrainWatch System to power adapter for charging. Bluetooth is used to connect amplifier with tablet to transfer EEG recording files. When the Natus BrainWatch System is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
Natus BrainWatch System Features
- · Rapid Setup: The Natus BrainWatch system can be set up quickly, typically within minutes.
- Portability: The device features an integrated electrode headband and a compact amplifier that connects wirelessly to a tablet, ensuring high portability and convenience for bedside use.
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System Setup Overview
The Natus BrainWatch System setup involves several steps to ensure proper operation and accurate data capture. First, power on the tablet, followed by turning on the amplifier to the tablet via Bluetooth. Prepare the amplifier and headband by attaching the amplifier to the headband and placing the headband on the patient's head. Adjust the electrodes until the green light is displayed on the Electrode Page, indicating proper electrode placement. Enter patient demographic information into the system to ensure accurate data association. Once setup is complete, the system is ready for recording and monitoring EEG signals. When finished, stop the recording to conclude the session.
Device-patient interaction Accessories List:
The Headband will be in contact with the hair and skin of the patient's head throughout the study.
Accessories:
| Item | Model Number |
|---|---|
| Hanger Assembly (Tablet | |
| Hanger) | 045276 |
| Carry Case | 046863 |
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Image /page/9/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are evenly spaced. There is a small circle with an R inside of it to the right of the "s".
Indications for Use
The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older.
The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility. The Natus BrainWatch Headband is intended for singlepatient use.
Comparison to the Predicate Device:
There are 2 predicates: Ceribell Pocket EEG Device (K170363) and Ceribell Instant EEG Headband (K210805)
There is one reference device; CGX Quick (K203331) which is used for referring wireless amplifier technology. Both the subject device and the reference device use Bluetooth 5.9 technology.
The SE comparison table below is provided to compare the similarities and differences in the indications for use (intended use environment, intended use population) and the technological characteristics of the subject device and the predicates.
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | Class II | Class II | Same as
predicate |
| Device Code | OMC, GXY | OMC | GXY | Same as
predicate |
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
| Class Name | Reduced montage
standard
electroencephalograph,
Cutaneous Electrode | Reduced montage
standard
electroencephalograph, | Cutaneous electrode | Same as
predicate |
| Classifying
Regulation | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.1320 | Same as
Predicate |
| Indications for Use | The BrainWatch
System including the
BrainWatch Headband,
is intended to record
and store EEG signals
and present these
signals visually to assist
trained medical staff in
making neurological
diagnoses in patients
aged 2 years and older.
The device does not
provide any diagnostic
conclusions about the
subject's condition and
does not provide any
automated alerts of an
adverse clinical event.
The Natus BrainWatch
System is intended for
use within a
professional healthcare
facility. The Natus
BrainWatch Headband | The Ceribell Pocket
EEG Device is intended
to record and store
EEG signals, and to
present the EEG
signals in visual and
audible formats in real
time. The visual and
audible signals assist
trained medical staff to
make neurological
diagnoses. The Pocket
EEG Device does not
provide any diagnostic
conclusion about the
subject's condition and
does not provide.
any automated alerts of
an adverse clinical
event. The Pocket EEG
Device is intended to be
used in a professional
healthcare facility
environment. | The Ceribell Instant
EEG Headband is an
electroencephalogram
(EEG) electrode array
intended for single
patient use in the
recording of EEGs in
patients of 2 years and
older. The Instant EEG
Headband is intended
for prescription use in
the home, healthcare
facility, or clinical
research | Similar to
predicate but
equivalent in
safety and
effectiveness
The subject
device indications
for use statement
is more
descriptive and
clearer. The
clinical purpose of
the predicate and
subject devices is
same. |
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
| | is intended for single-
patient use. | | | |
| Where used | Professional healthcare
facility. | Professional healthcare
facility | Professional
healthcare facility, in
the home or clinical
research | Same as
predicate |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same as
predicate |
| DC Channel | All (10) channels are
referential | 8 Differential only | N/A | Similar to
predicate but
equivalent in
safety and
effectiveness.
Identical
electrode
numbers and
contact positions.
Equivalent or
better in
effectiveness, as
the subject device
can capture either
10 channels of
referential signals
or 8 channels of
differential
signals. |
| A/D Conversion | 24-Bit Delta-Sigma | 24-Bit Delta-Sigma | N/A | Same as
predicate |
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
| Sampling Rate | 250 Hz | 250 Hz | N/A | Same as
predicate |
| Battery
charging
power adapter | 100-240V AC power
adapter | 100-240V AC power
adapter | N/A | Same as
predicate |
| Bedside Unit-PC
Interface | Bedside unit to
computer using WiFi | Bedside unit to
computer using WiFi or
Micro-USB cable | N/A | Similar to
predicate but
equivalent in
safety and
effectiveness.
Predicate device
has a Micro-USB
cable as an
alternate option. |
| WiFi
frequency/standard | 2.4 GHz IEEE 802.11
b/g/n | 2.4 GHz IEEE 802.11
b/g/n | N/A | Same as
predicate |
| Type of Applied Part | BF | BF | N/A | Same as
predicate |
| Type of Patient
Contact | Contacts patient scalp | N/A | Contacts patient scalp | Same as
predicate |
| Type of Use | Single use, non-sterile,
disposable | N/A | Single use, non-sterile,
disposable | Same as
predicate |
| Available Sizes | Small 45-51 cm
Medium 50-56 cm
Large 55-62 cm | N/A | Small 45-51 cm
Medium 50-56 cm
Large 55-62 cm | Same as
predicate |
| Number of
Electrodes | 12 (Locations: Fp1, F7,
T3,T5, O1, Fp2, F8, T4,
T6, O2, Reference,
Ground) | 10 (Locations: Fp1, F7,
T3, T5, O1, Fp2, F8,
T4, T6, O2) | 10 (Locations: Fp1, F7,
T3, T5, O1, Fp2, F8,
T4, T6, O2) | Similar to
predicate but
equivalent in
safety and
effectiveness. |
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
| | | | | The subject
device has 12
electrodes
compared to 10
electrodes on the
predicate device.
The locations are
identical
according to the
10-20 system,
with the reference
and ground being
the 2 additional
electrodes. |
| Type of Electrodes | Passive Ag/AgCl | N/A | Passive Ag/AgCl | Same as
predicate |
| Conductive
Electrolyte Gel | Conductive electrolyte
gel is included in sealed
gel pods integrated into
each electrode
assembly. User is also
able to add additional
electrolyte gel when
needed using another
gel pod. | N/A | Conductive electrolyte
gel is included in
sealed gel packets
integrated into each
electrode assembly.
User is also able to
add additional
electrolyte gel when
needed using a
syringe. | Similar to
predicate but
equivalent in
safety and
effectiveness.
To add additional
gel to the subject
device, a new,
fully filled gel pod
can be replaced.
For the predicate
device, additional
gel is applied
using a syringe. |
| Feature | Subject Device
Natus BrainWatch
Sytem | Predicate 1
Ceribell Pocket EEG
Device, K170363 | Predicate 2
Ceribell Instant EEG
HeadbandK210805 | Comments |
| Biocompatibility | Biocompatibility of
patient contacting
components verified
with Irritation,
Sensitization and
Cytotoxicity testing per
ISO 10993-5:2009, ISO
10993-23:2021 and ISO
10993-10:2021 | Biocompatibility of
patient contacting
components verified
with Irritation,
Sensitization and
Cytotoxicity testing per
ISO 10993-5:2009 and ISO 10993-
10:2010 | Biocompatibility of
patient contacting
components verified
with Irritation,
Sensitization and
Cytotoxicity testing per
testing per ISO 10993-
5:2009 and ISO
10993-10:2010 | Subject device
and predicate
device use
conductive
electrolyte gel to
form an electrical
connection
between the
patient scalp and
the Ag/AgCl
electrodes.
Similar to
predicate but
equivalent to
safety and
effectiveness.
Testing was
performed to
current standards. |
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Image /page/13/Picture/1 description: The image shows the word "natus." in a teal color. The font is sans-serif and the letters are lowercase. The word is followed by a small circle with an R inside, indicating a registered trademark.
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Image /page/14/Picture/1 description: The image shows the word "natus." in a teal color. The font is sans-serif and the letters are lowercase. There is a small registered trademark symbol to the right of the "s".
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Image /page/15/Picture/1 description: The image shows the logo for Natus Medical Incorporated. The logo is in a teal color and features the word "natus" in a sans-serif font. A small registration mark is visible to the right of the letter "s".
| Feature | Subject Device
Natus BrainWatch System | Reference Device
CGX Quick-20m (K203331) |
|---------------------------|------------------------------------------------------------------------|------------------------------------------------|
| Device Class | Class II | Class II |
| Device Code | OMC, GXY | GWL, GXY |
| Class Name | Reduced montage standard
electroencephalograph, Cutaneous Electrode | Physiological Signal Amplifier |
| Classifying
Regulation | 21 CFR 882.1400, 21 CFR 882.1320 | 21 CFR 882.1835, 21 CFR 882.1320 |
| Wireless | Amplifier to Tablet using Bluetooth 5.0 | Amplifier to receiver (PC) using Bluetooth 5.0 |
Reference device for wireless amplifier technology:
Subject device is similar to Reference device but equivalent to safety and effectiveness. The Subject device and Reference device both use Bluetooth 5.0 technology. While the specific modules may differ in aspects such as power consumption, antenna design, or firmware capabilities, these differences are minor and do not impact the overall performance or safety of the devices.
The Subject device has been tested and certified under FCC Part 15 regulations. Additionally, the Subject device has undergone EMC compliance testing per IEC 60601-1-2 and Wireless Coexistence testing per ANSI C63.27-2021. These tests ensure that the Subject device's wireless amplifier does not interfere with other electronic devices and can coexist with them in a typical medical environment.
The Natus BrainWatch System and its predicates are substantially equivalent in features and technical characteristics. There are no major differences that significantly alter the intended use or raise new issues of safety or effectiveness.
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Image /page/16/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and appears to be a custom font. The word is all lowercase, and there is a small registered trademark symbol to the right of the "s".
Brief Summary of Performance Testing
Electrical Safety
The Natus BrainWatch System was verified for performance in accordance with the following standard:
- IEC 60601-1-6:2010/AMD2:2020, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · EC 60601-1:2005/AMD2:2020-Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- · IEC 80601-2-26: 2019- Particular requirements for the basic safety and essential performance of electroencephalographs
Electromagnetic Compatibility
The Natus BrainWatch System was verified for performance in accordance with the following standard:
- IEC 60601-1-2 Ed 4.1 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic Disturbances – Requirements and tests.
Packaging and Handling Verification
The packaged Natus BrainWatch System components have successfully passed packaging and handling verification as per ASTM D4169-22
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Image /page/17/Picture/1 description: The image shows the word "natus." in a teal color. The font is sans-serif and the letters are lowercase. There is a registered trademark symbol after the "s".
Performance Testing - Bench Verification & Validation
The Natus BrainWatch System has successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level.
The Bench testing verification and validation was performed to confirm device meets the functional and performance characteristics.
Additionally, Natus BrainWatch System has been tested and met defined acceptance criteria. The tests included:
- · Requirements for the basic safety and essential performance of electroencephalographs per IEC 80601-2-26
- · Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements of IEC 60601-1 and IEC 60601-1-2
- · Battery Safety Testing per IEC 62133
- · Shipping/distribution and vibration testing per ASTM D4169-22
- · Biocompatibility of patient contacting components verified with Cytotoxicity, Irritation, and Sensitization testing per ISO 10993-5:2009, ISO 10993-23:2021, and ISO 10993-10:2021
- · Performance Criteria of FDA Guidance titled Cutaneous Electrodes for Recording Purposes -Performance Criteria for Safety and Performance Based Pathway, issued on August 14, 2020.
- · Wireless Coexistence per ANSI C63.27-2021
- · Shelf-life testing
Results indicate that the Natus BrainWatch System complies with its predetermined specifications and the applicable standards.
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Image /page/18/Picture/1 description: The image shows the word "natus." in a teal color. The font is sans-serif and the letters are rounded. The word is written in lowercase letters and there is a trademark symbol after the "s".
Conclusions
The intended use and technology of the Natus BrainWatch System is similar to that of the predicate devices Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the Natus BrainWatch System is as safe, as effective, and performs as well as or better than the predicate device