Who is the manufacturer of AE-120A EEG Head Set?

Nihon Kohden Corporation filed the 510(k) submission for AE-120A EEG Head Set (K183529).

What is the FDA product code for AE-120A EEG Head Set?

OMC. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for AE-120A EEG Head Set?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AE-120A EEG Head Set?

Ceribell Pocket EEG Device (K170363); Ceribell Instant EEG Headband (K171459).

Who can help prepare an FDA 510(k) submission like AE-120A EEG Head Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AE-120A EEG Head Set

K183529 · Nihon Kohden Corporation · OMC · Mar 19, 2019 · Neurology

Device Facts

Record ID	K183529
Device Name	AE-120A EEG Head Set
Applicant	Nihon Kohden Corporation
Product Code	OMC · Neurology
Decision Date	Mar 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

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 facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above).

Device Story

Battery-powered (2 AA) wireless EEG headset; captures/amplifies brain electrical activity via 8-channel Ag/AgCl electrode array (10-20 montage); transmits data via 2.4 GHz Bluetooth to Nihon Kohden EEG-1200A or EEG-9100 systems. Used in clinics/labs by trained medical professionals. Headset secured via chin/top/rear straps. Output displayed on compatible EEG system software for clinician review/interpretation. No automated diagnostic alerts or conclusions provided. Benefits include wireless, real-time EEG data acquisition for neurological diagnosis.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included electrode impedance, DC offset, and noise (ANSI/AAMI EC12:2000). Electrical safety and EMC testing per IEC 60601-1, 60601-1-2, 60601-2-26, and wireless coexistence testing. Biocompatibility testing per ISO 10993-5 and 10993-10.

Technological Characteristics

8-channel EEG headset; Ag/AgCl electrodes; 2.4 GHz Bluetooth wireless connectivity; 200 Hz sampling rate; 12-bit ADC resolution; >90 dB CMRR; 1200 Mohm input impedance. Powered by 2 AA alkaline batteries. Reusable headset with disposable electrodes/gel. Software-compatible with Nihon Kohden EEG-1200A/EEG-9100. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993.

Indications for Use

Indicated for adults (ages 18+) in medical facilities (physician's office, lab, clinic) to amplify, capture, and wirelessly transmit brain electrical activity for review by trained medical professionals to assist in diagnosing neurological disorders. Contraindications: None stated; device provides no diagnostic conclusions or automated alerts.

Regulatory Classification

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.

Predicate Devices

Ceribell Pocket EEG Device (K170363)
Ceribell Instant EEG Headband (K171459)

Reference Devices

iEEG (K131944)
BrainScope Z-100 (K082886)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K183529 Traditional 510(k) Summary | Submitter | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo, Japan 161-8560 (949) 680-9048 (Thomas Bento) | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Natalie Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 Phone: (858) 705-0350 Fax: (858) 764-9739 Email: 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 Electroencephalograph 21 CFR 882.1400; Class II; Electroencephalograph GXY (Secondary); Cutaneous Electrode 21 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 | |-----------------------------------------------------------------|------------------|----------------------------------------------------------------------|----------------------------------|------------------------------| | Reduced Montage Standard EEG (Primary Predicate) | K170363 | Reduced- Montage Standard Electroencephalograph | Ceribell Pocket EEG Device | Ceribell, Inc | | Electrode Component (Secondary Predicate) | K171459 | Cutaneous Electrode | Ceribell Instant EEG Headband | Ceribell, Inc | | Reference Devices (Not Intended as Predicates) | K131944 | Reduced- Montage Standard Electroencephalograph | iEEG | Jordan NeuroScience, Inc. | | Devices (Not Intended as Predicates) | K082886 | Non-Normalizing Quantitative Electroencephalograph Software | BrainScope Z-100 | BrainScope Company Inc. | {6}------------------------------------------------ ### 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 Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 trained medical professional using the Nihon Kohden electroencephalograph systems cleared in K080546 and K011204 to assist in the diagnosis of neurological disorders. | K171459: A single-use disposable headpiece with an integrated array of 10 passive cutaneous electrodes, that are applied to the patient's head to record EEG signals when connected to an EEG recording device. K170363: Device intended to record and store EEG signals, and to present EEG signals to medical staff. | Similar intended use. The combination of the 2 Ceribell devices together provide the same intended use. The combination of the subject device and a Nihon Kohden specific EEG system provides the same intended use: assisting in the diagnosis of neurological disorders by amplifying, capturing, and sending electrical activity of the brain and patient data for review by a medical professional. | | | AE-120A EEG Head Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | | Characteristic | | | | | 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) | 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. (Rx only) The Ceribell Instant EEG Headband is an electroencephalogram | Similar; The combination of the 2 Ceribell devices provides the same intended use. The combination of the subject device and a Nihon Kohden specific EEG system provides the same intended use: assisting in the diagnosis of neurological disorders by amplifying, capturing, and sending electrical activity of the brain and patient data for review by a medical professional. (Rx only) | | Device Class & Regulation | Class II per 21 CFR 882.1400 Electroencephalograph (Head Set) Class II per 21 CFR 882.1320 (for electrodes within headset) | Class II per 21 CFR 882.1400 Electroencephalograph (EEG Device) Class II per 21 CFR 882.1320 (Instant EEG Headband - cutaneous electrodes) | Same | | Product Code(s) | Primary Proposed: OMC Secondary Proposed: GXY | K170363 cleared under: OMC K171459 cleared under: GXY | Same | | Modalities | EEG | EEG | Same | | Type of patient contact | Electrodes and gel contact patient's scalp | Electrodes and gel contact patient's scalp | Same | | Characteristic | AE-120A EEG Head Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | | Electrodes | 10 passive Ag/AgCl electrodes | 10 passive Ag/AgCl electrodes | Same Subject device EEG disk electrode of Ag cleared in K171124 but with different length of lead. | | Type of use - Electrodes | Single use, non-sterile, disposable | Single use, non-sterile, disposable | Same | | Type of use - EEG device | AE-120A EEG Head set is reusable and non-patient contacting. Belts are patient contacting and reusable (they can be cleaned & disinfected but are recommended for single patient use) | Ceribell Pocket EEG Device is reusable and non-patient contacting. Ceribell Instant EEG headband is single use, patient contacting and disposable. | Subject device is reusable whereas predicate is single use disposable. However, this difference does not raise different questions of safety and effectiveness. | | 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 60601-2-26 IEC 62133 | Same: Refer to performance testing section of this Summary for details on the standards to which the subject device claims conformance and other performance testing. Note: IEC 62133 does not apply to AE-120A because the subject device is powered by alkaline batteries. | | Characteristic | AE-120A EEG Head Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | | Input dynamic range | 1 mVp-p | Unknown (presumed to be same as it meets IEC 60601-2-26) | Similar; AE-120A complies with the requirement of the input dynamic range specified in clause 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 meets IEC 60601-2-26) | Similar AE-120A complies with the requirement of the input noise specified in clause 201.12.1.101.3, IEC 60601-2-26 | | Transfer of data to EEG | Bluetooth 2.4 GHz | Micro-USB cable | Whereas the subject device transmits the data wirelessly in real time via Bluetooth to the compatible EEG system, the Ceribell Pocket EEG Device transmits the data via a cable after collection. The following two legally marketed reference devices are cited to support this scientific methodology of wireless transmission of EEG data transfer as acceptable for the intended use. The reference 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 with 100-240 V AC power adapter (Device does not work when connected to AC to recharge) | Similar; The differences do not raise any different questions of safety or effectiveness | | Data format | Nihon Kohden original format | Edf | Similar; Since the AE-120A EEG Head Set provides the data to only Nihon Kohden specified EEG's, this difference does not raise any different questions of safety or effectiveness. | | Characteristic | AE-120A EEG Head Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | | Compatibility | Works only with Nihon Kohden specified EEG's: EEG-1200A series (K080546) EEG-9100 (K011204) | Ceribell Instant EEG Headband works only with Ceribell Pocket EEG Device | Similar; Both subject and predicate device are intended to be connected to external EEG recording devices. The differences in EEG recording compatibility does not raise any different questions of safety or effectiveness | | EEG Software | AE-120A EEG Head Set comes with EEG software to be placed on the compatible EEG for interaction with and viewing of EEG data | Ceribell Pocket EEG Device comes with EEG Recording Viewer Software | Similar. Both devices come with software for viewing the EEG data collected with the device. The AE-120A EEG Head Set software for the associated Nihon Kohden EEG allows the user to interact with the head set and review and interpret the data on the EEG. | | Connector | Single connector of electrodes to AE- 120A Head Set | Integrated single cable connector in Ceribell Instant EEG Headband to connect to EEG recording device | Same | | Able to accommodate different patient head sizes | AE-120A EEG Head Set has flexible arms that are adjusted to fit different adult patient head sizes along with adjustments from the belts/ straps (chin) | Ceribell Instant EEG Headband comes in three sizes Small (48.4 - 53.6 cm) Medium (53.3 -56.5 cm) Large (55.5 - 62 cm) | Similar; Both subject and predicate devices can accommodate different patient sizes. AE- 120A is limited to adults only to be sure that its flexibility is adequate for the range of head sets | | Conductive Electrolyte Material | Conductive electrolyte paste is included in a packet gel reservoir integrated into each electrode. User inserts electrode into the electrode attachment position in Head Set with paste. | Conductive electrolyte gel is included in a packet gel reservoir integrated into each electrode assembly. User is also able to add additional electrolyte gel when needed using a syringe | Same | | Characteristic | AE-120A EEG Head Set K183529 | Ceribell Pocket EEG Device K170363 and Ceribell Instant EEG Headband K171459 | Comment | | Biocompatibility | Patient contacting components verified with Cytotoxicity, Sensitization, and Irritation per ISO 10993-5and ISO 10993-10 (or previous clearance or previous use of material/processing for same patient contact and duration). These components include: electrodes, electrode gel, paste | Patient contacting components verified with Cytotoxicity, Sensitization, and Irritation per ISO 10993-5and ISO 10993-10 | Similar; All patient contacting components evaluated according to ISO 10993-1 and associated FDA guidance |…

AE-120A EEG Head Set

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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AE-120A EEG Head Set

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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