(90 days)
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition.
The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above). (Rx Only)
The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps.
With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver.
The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information.
The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions.
The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.
The provided text describes a 510(k) premarket notification for the Nihon Kohden AE-120A EEG Head Set. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing and comparison of technological characteristics, rather than a clinical study evaluating diagnostic accuracy or human-in-the-loop improvement. Therefore, many aspects of a traditional clinical study (e.g., sample size for test set, adjudication methods, MRMC studies, effect size of human readers, ground truth establishment) are not relevant or described in this type of submission.
The document details performance testing related to electrical safety, biocompatibility, and electrode performance, but not a study to prove improved diagnostic accuracy for neurological disorders.
Here's an analysis of the provided information, focusing on what is described in the 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document describes several performance tests and their outcomes, which can be interpreted as demonstrating the device meets implicit acceptance criteria for safety and performance in its intended function. Explicit acceptance criteria values are stated for electrode performance testing.
| Acceptance Criteria Category | Specific Criteria (Implicitly Accepted by Conformance or Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Electrode Performance (ANSI AAMI EC12:2000/(R)2015) | ||
| Electrode Impedance | Applicable standard clauses for disposable electrodes (5.2.2.1) | 164.72-188.2Ω (Met pre-specified acceptance criteria) |
| Electrode DC Offset Voltage | Applicable standard clauses (5.2.2.2) | -0.7 mV to 0.1 mV (Met pre-specified acceptance criteria) |
| Combined Offset Instability & Internal Noise | Applicable standard clauses (5.2.2.3) | 13.1μV to 43.6μV (Met pre-specified acceptance criteria) |
| Biocompatibility (ISO 10993-X Series) | ||
| Cytotoxicity | Conformance to ISO 10993-5 criteria | Established biological safety |
| Sensitization | Conformance to ISO 10993-10 criteria | Established biological safety |
| Irritation | Conformance to ISO 10993-10 criteria | Established biological safety |
| Software Verification & Validation | Conformance to FDA Guidance for Software Contained in Medical Devices (Moderate LOC) | Software verified and validated |
| Electrical Safety & EMC (IEC 60601-X Series, CISPR 11) | Conformance to relevant standards (listed in document) | Tested and demonstrated conformance to listed standards |
| Input Dynamic Range | IEC 60601-2-26 Clause 201.12.1.101.2 requirement | 1 mVp-p (Complies) |
| Input Noise | IEC 60601-2-26 Clause 201.12.1.101.3 requirement | 5 µ Vp-p or less (0.53 to 60 Hz) (Complies) |
| ADC Resolution | Minimum 12 bit (ECRI 2017 review) | 12 bit (Meets minimum) |
| ADC Common Mode Rejection Rate (CMRR) | IEC 60601-2-26 Clause 201.12.1.101.5 requirement | > 90 dB (Complies) |
2. Sample sized used for the test set and the data provenance
- Electrode Performance Test: "Twelve (12) electrode pairs were tested." The data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Other tests (Software, Electrical Safety, Biocompatibility): These refer to verification and validation activities against standards and internal requirements, not studies on patient data. Thus, there isn't a "test set sample size" in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because the submission describes device performance testing (e.g., electrical, mechanical, software functionality) rather than a clinical study requiring expert-established ground truth for diagnostic accuracy. The device "assists in the diagnosis of neurological disorders" for "review by a trained medical professional" but does not provide diagnostic conclusions or automated alerts itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring 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
No such study was conducted or described. This device is an EEG headset that amplifies, captures, and transmits raw electrical brain activity. It does not incorporate AI for interpretation or diagnostic assistance, nor does it claim to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device's function is to acquire and transmit data for human review. It does not have a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described:
- Electrode Performance: Ground truth was based on measurements against the specified criteria of the ANSI AAMI EC12:2000 standard, as measured by testing equipment.
- Biocompatibility: Ground truth was established by adherence to ISO 10993 series standards, verified through laboratory testing.
- Software, Electrical Safety & EMC: Ground truth was established by adherence to recognized national and international standards (e.g., IEC 60601 series, FDA guidances) through testing and verification/validation processes.
No clinical ground truth (e.g., expert consensus on neurological disorders, pathology, patient outcomes) was necessary for this 510(k) submission, as the device doesn't provide a diagnostic output.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. To the right of that is the FDA U.S. Food & Drug Administration logo.
March 19, 2019
Nihon Kohden Corporation % Natalie Kennel Quality & Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129
Re: K183529
Trade/Device Name: AE-120A EEG Head Set Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: December 17, 2018 Received: December 19, 2018
Dear Natalie Kennel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183529
Device Name AE-120A EEG Head Set
Indications for Use (Describe)
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition.
The device is intended for use by trained medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K183529 Traditional 510(k) Summary
| Submitter | Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560(949) 680-9048 (Thomas Bento) |
|---|---|
| Contact Person | Natalie KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129Phone: (858) 705-0350Fax: (858) 764-9739Email: nkennel@njkconsulting.com |
| Date Prepared | March 19, 2019 |
| Subject Device | |
| Device Name | AE-120A EEG Head Set |
| Common Name | Electroencephalograph (EEG) |
| Device Class | Class II |
| Product Code & Regulation | OMC (Primary); Reduced- Montage Standard Electroencephalograph21 CFR 882.1400; Class II; ElectroencephalographGXY (Secondary); Cutaneous Electrode21 CFR 882.1320; Class II; Cutaneous Electrode |
| Review Panel | Neurology: Diagnostic Devices |
Intended Use
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a medical professional using the following Nihon Kohden specified electroencephalograph system to assist in the diagnosis of neurological disorders, as the subject device's components, accessories, and software operate as a system with the following devices that have been previously cleared: K011204 -- Neurofax Models EEG-9100 K080546 – EEG-1200A series
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The above EEG systems are compatible with the subject device they have been updated or can be updated to include newly developed EEG Software needed to operate with the subject device headset.
Device Description for the Subject Device: AE-120A EEG Head Set
The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps.
With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver.
The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information.
The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions.
The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.
Indications for Use
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition.
The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above). (Rx Only)
Predicate Devices
The AE-120A EEG Head Set is substantially equivalent to the Ceribell Pocket EEG with the Ceribell Instant EEG Headband. Table 1, below, lists the primary predicate device, K170363 (headbox, processing unit, basic software needed to display, store, and archive EEG and allow user-only annotation and marking; does NOT include electrodes, more complex software used to
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analyze EEG or automatically detect events). The secondary predicate device, K171459, is intended to cover the cutaneous electrode component of system, which is necessary to achieve the intended use and does not change the intended use as compared to the primary predicate EEG device, K170363.
Table 1 – List of Predicate Devices to which AE-120A EEG Head Set K183529 Claims Substantial Equivalence; Lower 2 Rows Include Reference Devices for Wireless EEG Data Transmission Characteristics of the Subject Device
| Purpose | 510(k)Number | Regulation Name | Device Name | Submitter |
|---|---|---|---|---|
| ReducedMontageStandardEEG(PrimaryPredicate) | K170363 | Reduced- MontageStandardElectroencephalograph | Ceribell Pocket EEGDevice | Ceribell, Inc |
| ElectrodeComponent(SecondaryPredicate) | K171459 | Cutaneous Electrode | Ceribell Instant EEGHeadband | Ceribell, Inc |
| ReferenceDevices (NotIntended asPredicates) | K131944 | Reduced- MontageStandardElectroencephalograph | iEEG | JordanNeuroScience, Inc. |
| Devices (NotIntended asPredicates) | K082886 | Non-NormalizingQuantitativeElectroencephalographSoftware | BrainScope Z-100 | BrainScopeCompany Inc. |
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Technological Characteristics as Compared to Predicate Devices
Table 2, belov, includes a comparison of the AE-120A EEG Head Set and its predicates K170363 Ceribell Pocket EEG & K171459 Ceribell Instant EEG Headband. Where is also a comparison to two legally marketed reference devices to support the scientific methodology of wireless transmission of EEG data transfer at decision point 5a of the 510(k) flowchart ("Are the methods acceptable?") to help determine substantial equivalence for the subject device.
| Characteristic | AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment |
|---|---|---|---|
| Intended Use | The AE-120A EEG Head Set is intendedto amplify, capture, and wirelesslytransmit electrical activity of the brainfor review by a trained medicalprofessional using the Nihon Kohdenelectroencephalograph systems clearedin K080546 and K011204 to assist in thediagnosis of neurological disorders. | K171459: A single-use disposableheadpiece with an integrated array of 10passive cutaneous electrodes, that areapplied to the patient's head to record EEGsignals when connected to an EEGrecording device.K170363: Device intended to record andstore EEG signals, and to present EEGsignals to medical staff. | Similar intended use. The combination ofthe 2 Ceribell devices together provide thesame intended use. The combination ofthe subject device and a Nihon Kohdenspecific EEG system provides the sameintended use: assisting in the diagnosis ofneurological disorders by amplifying,capturing, and sending electrical activityof the brain and patient data for review bya medical professional. |
| AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment | |
| Characteristic | |||
| Indications for Use | The AE-120A EEG Head Set is intended toamplify, capture, and wirelessly transmit electricalactivity of the brain for review by a trained medicalprofessional using the previously cleared andvalidated Nihon Kohden electroencephalographsystems (EEG-1200A series and EEG-9100) toassist in the diagnosis of neurological disorders.The AE-120A EEG Head Set and its associatedEEG Software do not provide any diagnosticconclusion or automated alerts of an adverseclinical event about a patient's condition.The device is intended for use by trained medicalprofessionals in a medical facility such as aphysician's office, laboratory, or clinic. The deviceis intended for use on adults (ages 18 and above).(Rx only) | The Ceribell Pocket EEGDevice is intended torecord and store EEGsignals, and to present theEEG signals in visual andaudible formats in realtime. The visual andaudible signals assisttrained medical staff tomake neurologicaldiagnoses.The Pocket EEG Devicedoes not provide anydiagnostic conclusionabout the subject'scondition and does notprovideany automated alerts ofan adverse clinical event.The Pocket EEG Deviceis intended to be used in aprofessionalhealthcare facilityenvironment. (Rx only)The Ceribell Instant EEGHeadband is anelectroencephalogram | Similar; The combination of the 2 Ceribelldevices provides the same intended use. Thecombination of the subject device and a NihonKohden specific EEG system provides thesame intended use: assisting in the diagnosis ofneurological disorders by amplifying,capturing, and sending electrical activity of thebrain and patient data for review by a medicalprofessional. (Rx only) |
| Device Class &Regulation | Class II per 21 CFR 882.1400Electroencephalograph (Head Set)Class II per 21 CFR 882.1320 (forelectrodes within headset) | Class II per 21 CFR 882.1400Electroencephalograph (EEG Device)Class II per 21 CFR 882.1320 (Instant EEGHeadband - cutaneous electrodes) | Same |
| Product Code(s) | Primary Proposed: OMCSecondary Proposed: GXY | K170363 cleared under: OMCK171459 cleared under: GXY | Same |
| Modalities | EEG | EEG | Same |
| Type of patientcontact | Electrodes and gel contact patient's scalp | Electrodes and gel contact patient's scalp | Same |
| Characteristic | AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment |
| Electrodes | 10 passive Ag/AgCl electrodes | 10 passive Ag/AgCl electrodes | SameSubject device EEG disk electrode of Agcleared in K171124 but with differentlength of lead. |
| Type of use -Electrodes | Single use, non-sterile, disposable | Single use, non-sterile, disposable | Same |
| Type of use - EEGdevice | AE-120A EEG Head set is reusable andnon-patient contacting.Belts are patient contacting and reusable(they can be cleaned & disinfected butare recommended for single patient use) | Ceribell Pocket EEG Device is reusable andnon-patient contacting.Ceribell Instant EEG headband is single use,patient contacting and disposable. | Subject device is reusable whereaspredicate is single use disposable.However, this difference does not raisedifferent questions of safety andeffectiveness. |
| EEG channels | 8 | 8 | Same |
| Montage | 10/20 System1 | 10/202 | Same |
| Electrical Safety &EMC | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26 | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26IEC 62133 | Same:Refer to performance testing section ofthis Summary for details on the standardsto which the subject device claimsconformance and other performancetesting. Note: IEC 62133 does not applyto AE-120A because the subject device ispowered by alkaline batteries. |
| Characteristic | AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment |
| Input dynamic range | 1 mVp-p | Unknown (presumed to be same as it meetsIEC 60601-2-26) | Similar;AE-120A complies with the requirementof the input dynamic range specified inclause 201.12.1.101.2, IEC 60601-2-26 |
| Input noise | 5 µ Vp-p or less (0.53 to 60 Hz) | Unknown (presumed to be same as it meetsIEC 60601-2-26) | SimilarAE-120A complies with the requirementof the input noise specified in clause201.12.1.101.3, IEC 60601-2-26 |
| Transfer of data toEEG | Bluetooth 2.4 GHz | Micro-USB cable | Whereas the subject device transmits thedata wirelessly in real time via Bluetoothto the compatible EEG system, theCeribell Pocket EEG Device transmits thedata via a cable after collection.The following two legally marketedreference devices are cited to support thisscientific methodology of wirelesstransmission of EEG data transfer asacceptable for the intended use. Thereference devices are: iEEG (K131944)and BrainScope Z-100 (K082886). |
| Power source | Battery powered | Battery powered | Same |
| Type of battery | 2 AA (LR6) alkaline batteries(not rechargeable) | Lithium ion batteries -rechargeable with100-240 V AC power adapter (Device doesnot work when connected to AC torecharge) | Similar;The differences do not raise any differentquestions of safety or effectiveness |
| Data format | Nihon Kohden original format | Edf | Similar;Since the AE-120A EEG Head Setprovides the data to only Nihon Kohdenspecified EEG's, this difference does notraise any different questions of safety oreffectiveness. |
| Characteristic | AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment |
| Compatibility | Works only with Nihon Kohdenspecified EEG's:EEG-1200A series (K080546)EEG-9100 (K011204) | Ceribell Instant EEG Headband works onlywith Ceribell Pocket EEG Device | Similar;Both subject and predicate device areintended to be connected to external EEGrecording devices. The differences in EEGrecording compatibility does not raise anydifferent questions of safety oreffectiveness |
| EEG Software | AE-120A EEG Head Set comes withEEG software to be placed on thecompatible EEG for interaction with andviewing of EEG data | Ceribell Pocket EEG Device comes withEEG Recording Viewer Software | Similar.Both devices come with software forviewing the EEG data collected with thedevice. The AE-120A EEG Head Setsoftware for the associated Nihon KohdenEEG allows the user to interact with thehead set and review and interpret the dataon the EEG. |
| Connector | Single connector of electrodes to AE-120A Head Set | Integrated single cable connector in CeribellInstant EEG Headband to connect to EEGrecording device | Same |
| Able to accommodatedifferent patient headsizes | AE-120A EEG Head Set has flexiblearms that are adjusted to fit differentadult patient head sizes along withadjustments from the belts/ straps (chin) | Ceribell Instant EEG Headband comes inthree sizesSmall (48.4 - 53.6 cm)Medium (53.3 -56.5 cm)Large (55.5 - 62 cm) | Similar;Both subject and predicate devices canaccommodate different patient sizes. AE-120A is limited to adults only to be surethat its flexibility is adequate for the rangeof head sets |
| ConductiveElectrolyte Material | Conductive electrolyte paste is includedin a packet gel reservoir integrated intoeach electrode. User inserts electrodeinto the electrode attachment position inHead Set with paste. | Conductive electrolyte gel is included in apacket gel reservoir integrated into eachelectrode assembly. User is also able to addadditional electrolyte gel when needed usinga syringe | Same |
| Characteristic | AE-120A EEG Head SetK183529 | Ceribell Pocket EEG DeviceK170363 and Ceribell InstantEEG Headband K171459 | Comment |
| Biocompatibility | Patient contacting components verifiedwith Cytotoxicity, Sensitization, andIrritation per ISO 10993-5and ISO10993-10 (or previous clearance orprevious use of material/processing forsame patient contact and duration).These components include: electrodes,electrode gel, paste | Patient contacting components verified withCytotoxicity, Sensitization, and Irritationper ISO 10993-5and ISO 10993-10 | Similar;All patient contacting componentsevaluated according to ISO 10993-1 andassociated FDA guidance |
| Additional electrodes | Two additional optional electrode setscan be used (NE-090S1 and NE-091S7) | N/A | The subject device includes twoadditional electrodes that can be added tothe headset's occipital region; these havebeen tested for performance since theywere not previously cleared under 21 CFR882.1400 like the other electrodes; thisdifference does not raise differentquestions of safety or effectiveness;This electrode is the same as NM-317Y3cleared in K120397 (882.1870 Evokedresponse electrical stimulator) but is notused for the purpose of evokedstimulation; it is only used for recording. |
Table 2 - Comparison of the AE-120A EEG Head Set to Predicates K170363 & K171459
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1 AE-120A EEG Head Set approximates the 10/20 montage but may deviate slightly depending on the patient's head shape
² Ceribell Pocket EEG Device and Ceribell Instant EEG Headband also approximates a 10/20 montage
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Table 3 – Comparison to Reference Devices
| Characteristic | AE-120A EEG HeadSet K183529 | Reference Device #1iEEG K131944 | Reference Device #2BrainScope Z-100K082886 | Comment |
|---|---|---|---|---|
| Modalities | EEG | EEG | EEG | Same |
| EEG Channels | 8 | 8 | 8 | Same |
| Montage | 10/20 system | 10/20 system | 10/20 system | Same |
| Wireless Output | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Same |
| Sampling Rate | 200 Hz | 250 Hz | 200 Hz | Subject device same assecond reference device.Both meet the minimum of200Hz recommended byECRI 2017 |
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| Characteristic | AE-120A EEG HeadSet K183529 | Reference Device #1iEEG K131944 | Reference Device #2BrainScope Z-100K082886 | Comment |
|---|---|---|---|---|
| ADC Resolution | 12 bit | 16 bit | 16 bit | Subject device is lower thanreference devices but 12 bitstill provides more than 4000levels of resolution & meetsthe minimum of 12 bitaccording to ECRI 2017review. |
| ADC Common ModeRejection Rate (CMRR) | > 90 dB | > 115 dB | > 100 dB | Substantially equivalent tothe predicates. Subjectdevice is slightly lower butcomplies with therequirement of the inputnoise specified in clause201.12.1.101.5, IEC60601-2-26 |
| Input Impedance | 1200 Mohms | 10 Mohms | 10 Mohms | Subject device is improvedcompared to the predicates |
| Electrode impedance check | Yes | Yes | Yes | Same |
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PERFORMANCE TESTING
Electrode Performance Testing
- ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes for NE-091S7 electrodes
This study verified the performance of the NE-091S7 electrodes using the standard ANSI/AAMI EC12:2000 because portions of this test protocol are appropriate and suitable for the subject device since they are also disposable electrodes. Only clauses 5.2.2.1 (electrode impedance), 5.2.2.2 (Electrode DC Offset Voltage), and 5.2.2.3 (Combined Offset Instability and Internal Noise) were applicable as this standard is primarily intended for electrodes for Electro-cardiographs (ECG), not EEG. Thus, some aspects of the standard cannot be applied due to the difference in anatomical region and difference in the intended use of the subject device. Twelve (12) electrode pairs were tested. The NE-091S7 met all pre-specified acceptance criteria demonstrating the acceptable performance of the electrodes related to electrode pair impedance characteristics (164.72-188.2Ω), electrode pair voltage (-0.7 mV to 0.1 mV), and offset variation and internal noise (13.1μV to 43.6μV).
NE-118A EEG disk electrodes were previously cleared in K171124, a 510(k) held by the sponsor of the subject device 510(k) and these electrodes identical materials but are of different length lead.
BIOCOMPATIBILITY
The patient-contacting components of the subject device fall within category A - limited (< 24 hours) - according to FDA's Guidance entitled "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued on June 16, 2016. Therefore, the biological endpoints included cytotoxicity, sensitization, and irritation.
The evaluation of each patient-contacting accessory and component involved the testing of the finished device testing and where applicable, use in previously cleared devices (e.g., previously cleared electrodes). This biocompatibility evaluation established the biological safety for all patient contacting device components and accessories of the AE-120A EEG Head Set System by applying the pre-specified acceptance criteria to each test article. The test battery included:
- . ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices Part 10: ● Tests for irritation and skin sensitization
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SOFTWARE
The software in the AE-120A EEG Head Set System including both the firmware on the physical headset device and the associated application to be used on the EEG computer monitor, separate from the headset, has been verified and validated. Software documentation up to a moderate level of concern (LOC) as required by the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005 was included in this submission based on the device type, and the totality of software documentation shall be retained for reference.
ELECTRICAL SAFETY & EMC
The AE-120A EEG Head Set was tested and demonstrated to conform to the following electrical safety and electromagnetic compatibility standards. The rationale in choosing the 3rd edition of the non-FDA recognized standards with respect to EMC below is due to the fact that the wireless reference devices and the two predicates claimed conformance to these versions of this standard. The sponsor also performed wireless coexistence testing on the headset in addition to providing a comparison and discussion of the differences between the 4th and 3rd editions of the standard (i.e., FDA-recognized vs. non-FDA-recognized version of the standard) to demonstrate how differences were covered in the 510(k) submission.
| Standard Developing Organization andDesignation Number & Date | Title of Standard |
|---|---|
| 1. AAMI/ANSI ES60601-1:2005/(R)2012 & A1:2012,C1:2009/(R)2012,A2:2010/(R)2012-Pt 1 (Ed 3.1) | Medical Electrical Equipment, Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005Ed 3 +AM1:2012Ed 3.1 with USDeviations due to portions that were notapplicable due to device design elements) |
| 2. IEC60601-1:2005 + A1:2012 | Medical Electrical Equipment, Part 1:General requirements for basic safety andessential performance |
| 3. IEC 60601-1-2: 2007 | Medical electrical equipment – Part 1-2:General requirements for basic safety andessential performance – CollateralStandard: Electromagnetic Compatibility– Requirements and tests |
| Standard Developing Organization andDesignation Number & Date | Title of Standard |
| 4. IEC 60601-1-6:2010 + A1:2013 | Medical electrical equipment, Part 1-6:General requirements for safety,Collateral Standard – Usability |
| 5. IEC-60601-2-26:2012 | Medical electrical equipment - Part 2-26:Particular requirements for the basicsafety and essential performance ofelectroencephalographs. |
| 6. CISPR 11:2009 + A1:2010 | Industrial, scientific and medicalequipment -Radio-frequency disturbancecharacteristics -Limits and methods ofmeasurement |
| 7. IEC 61000-4-2: 2008 | Electromagnetic compatibility – Part 4-2:Testing and measurement techniques -Electrostatic discharge immunity test |
| 8. IEC 61000-4-3: 2006 + A1:2007 +A2:2010 | Electromagnetic compatibility – Part 4-3:Testing and measurement techniques –Radiated, radio-frequency,electromagnetic field immunity test |
| 9. IEC 61000-4-6:2008 | Electromagnetic compatibility – Part 4-6:Testing and measurement techniques –Immunity to conducted disturbances,induced by radio-frequency fields |
| 10. IEC 61000-4-8:2009 | Electromagnetic compatibility – Part 4-8:Testing and measurement techniques –Power frequency magnetic field immunitytest |
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CONCLUSION
The subject device is substantially equivalent to the predicate based on the technological characteristics, intended use, and conclusions drawn from the nonclinical tests that demonstrate that the device is as safe and effective as the legally marketed predicate devices.
§ 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).