Who is the manufacturer of NeuralScan System?

Medeia, Inc. filed the 510(k) submission for NeuralScan System (K192753).

What is the FDA product code for NeuralScan System?

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

What is the regulatory pathway for NeuralScan System?

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

What are the predicate devices for NeuralScan System?

eVox System (K171781); CognisionTM (K141316).

Who can help prepare an FDA 510(k) submission like NeuralScan System?

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.

NeuralScan System

K192753 · Medeia, Inc. · GWQ · Mar 17, 2020 · Neurology

Device Facts

Record ID	K192753
Device Name	NeuralScan System
Applicant	Medeia, Inc.
Product Code	GWQ · Neurology
Decision Date	Mar 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

Intended Use

The NeuralScan System is intended for the acquisition, display, analysis, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

Device Story

NeuralScan System acquires, displays, and stores EEG and ERP signals; utilizes EEG cap with electrodes to capture brain electrical activity; amplifier transmits signals via USB or Wi-Fi to laptop running NeuralScan Evoke software. System includes subject response button and ear buds for auditory stimuli. Used by qualified medical personnel in clinics or sports settings. Software provides GUI for study initiation, live data streaming, impedance monitoring, and standard frequency/EP analysis. Physician interprets data; software provides no automated diagnosis. Benefits include non-invasive physiological signal monitoring to aid clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including signal reproduction accuracy, input dynamic range, noise levels, frequency response, common mode rejection, and wireless coexistence. Software verification and validation performed.

Technological Characteristics

23-channel EEG amplifier (21 EEG, 2 bio); 24-bit A/D conversion; sampling rates 200/500/1000 Hz; input impedance >200 MΩ; common mode rejection >110 dB. Connectivity via USB or Wi-Fi. Power: Li-Ion battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26. Non-sterile, durable goods.

Indications for Use

Indicated for all age groups for the acquisition, display, analysis, and storage of EEG and ERP signals to aid in diagnosis. Intended for use by qualified medical personnel in healthcare, medical, or athletic/sports clinics, or outside medical facilities under supervision.

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

eVox System (K171781)
CognisionTM (K141316)

Related Devices

K213900 — WAVi SCAN EEG System and Accessories · Wavi Co. · May 6, 2022
K171781 — eVox System · Evoke Neuroscience, Inc. · Dec 13, 2017
K033399 — GEODESIC EEG SYSTEM SERIES 100 · Electrical Geodesics, Incorporated · Aug 4, 2004
K081151 — COMPUMEDICS NEUVO · Compumedics USA, Ltd. · Sep 8, 2008
K232779 — QUEX ED; QUEX S · Qx World, Ltd. · Oct 11, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr Dayton, Ohio 45430 ### Re: K192753 Trade/Device Name: NeuralScan System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, GWQ Dated: February 19, 2020 Received: February 20, 2020 ### Dear Daniel Lehtonen: 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 probibitions 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. 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 {1}------------------------------------------------ 801); medical device reporting (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/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 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 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192753 Device Name NeuralScan System Indications for Use (Describe) The NeuralScan System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis. 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) | ### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in a combination of colors, with the "M" in green and yellow, the "ede" in black, and the "ia" in blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font size. # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device Systems Act 1990 and 21 CFR Sec. 807.92 510(k) Number: K192753 #### a1 APPLICANT INFORMATION: | Date Prepared: | 26 September 2019 | |----------------|---------------------------------------------------------------| | Name: | Medeia, Inc. | | Address: | 7 W. Figueroa Street Suite 300 Santa Barbara, CA, 93101 | | Contact Person: | Slav Danev | |-----------------|------------------| | Phone Number: | +1 800 433 4609 | | Fax Number: | +1 800 433 4609 | | Email: | danev@medeia.com | #### a2 NAME OF DEVICE: | Trade Name: | NeuralScan System | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | EEG/EP System, EEG Amplifier | | Classification Name: | Non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 (OLT); Full-montage standard electroencephalograph 21 CFR 882.1400 (GWQ); Stimulator, auditory, evoked response 21 CFR 882.1900 (GWJ) | | Classification Panel: | Neurology | #### аЗ PREDICATE DEVICES: | Predicate Device: | K171781; eVox System | |-------------------|----------------------| | Predicate Device: | K141316; CognisionTM | The FDA database for recalls was searched on 15 Aug 2019 during the preparation of the 510(k) submission and no recalls for the devices noted above were found. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Medeia. The word "Medeia" is written in a bold, sans-serif font, with the first letter "M" in green and blue gradient. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font. #### a4 STATEMENT OF INTENDED USE: The NeuralScan System is intended for the acquisition, display, analysis, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis. #### a5 DESCRIPTION OF THE DEVICE: The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter). The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data. The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized. The NeuralScan System is intended for prescription use in any healthcare, medical, athletic or sports clinic, or outside of medical facilities provided they are led by qualified medical personnel. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D Prescription devices. #### TECHNOLOGICAL CHARACTERISTIC COMPARISON: аб NeuralScan product share similar device characteristics, intended use, performance, specifications, sensors and is the same in design, function, and application to the predicate devices. The comparison table, beginning on page 5, demonstrates that the NeuralScan device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the NeuralScan device should perform as intended in the specified use conditions. Based on comparisons of device technological characteristics, features, materials, intended use and performance the NeuralScan has been shown to be substantially equivalent to the commercially available predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the first letter "M" in green and blue, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font. #### b1 NON-CLINICAL TESTING: Bench testing was carried out on the following characteristics: - . Electroencephalograph (EEG) - Measurement accuracy - Communication, data transmission and storage - Reliability (QoS) Wireless Quality of Service - Electromagnetic compatibility (EMC) - Electrical safety testing - . Wireless Coexistence Wi-Fi testing - . Software verification and validation testing - Biocompatibility verification In addition to the above, usability testing was also conducted. Referenced Standards and Performance Testing: The NeuralScan device was tested and meets the requirements of following - IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety and essential performance ● Ed3.1 2005+A1:2012 - IEC 60601-1-2:2014 - Medical electrical equipment-basic safety and essential performance-EMC - . IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Basic safety and essential performance of electroencephalographs - ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements | Test | Test Method Summary | Results / P or F (per IEC 60601-2-26 performance limits) | |------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Accuracy of signal reproduction Purpose: verify signal is accurately reproduced over a range of amplitudes. | Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.1. Amplitude of 2Hz Triangle wave varied from 50μV to 500μV. IEC 60601-2-26 Pass-Fail Limit: error < 20% | Pass Test shows that NeuroScan system accurately reproduces EEG signals over the specified range | | Input dynamic range and differential offset voltage Purpose: verify signal accuracy in presence of dc offset voltages. | Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.2. 1mV 6Hz Triangle wave with 300mV offset added. IEC 60601-2-26 Pass-Fail Limit: amplitude error < 10% | 300mV Offset: 1.5% error: Pass 187mV Offset: 1.5% error: Pass | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the first letter "M" in green and blue. The rest of the letters are in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font. | Test | Test Method Summary | Results / P or F (per IEC 60601-2-26 performance limits) | |------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Input Noise Purpose: verify that the signal noise caused by amplifier does not exceed max 6µV peak-to-valley | Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.3. Inputs shorted together. IEC 60601-2-26 Pass-Fail Limit: max 6µV peak-to-valley | Maximum noise: 3.4 µV: Pass | | Frequency Response Purpose: verify signal is accurately reproduced over a range of frequencies | Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.4. Triangle wave Amplitude established at 5Hz, is then adjusted to 0.5 Hz and 50Hz. IEC 60601-2-26 Pass-Fail Limit: output amplitude > 71%, < 110% | 0.5 Hz: 100%: Pass 5 Hz: 105%: Pass 50 Hz: 76%: Pass | | Common mode rejection Purpose: verify amplifier rejects common mode noise | Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.5. Apply 1Vrms at 60Hz to all inputs tied together. IEC 60601-2-26 Pass-Fail Limit: output amplitude < 10mm (= 100µVpp) | With 0 DC Offset: 67.3µVpp: Pass With 187mV dc Offset: 68µVpp: Pass | ### Software Verification and Validation Testing Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator. #### b2 CLINICAL TESTING: No Clinical testing was necessary to determine substantial equivalence. #### CONCLUSIONS DRAWN FROM TESTING: b3 Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the NeuralScan device was subjected to the same type of testing. The results support the conclusion that the NeuralScan device is substantially equivalent to the Predicate devices. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in bold, black letters, with the "M" in green and blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in smaller, light blue letters. # Substantial Equivalence Comparison Table | Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 510 (k) Number | | K171781 | K141316 | | | | Product codes | OLT, GWQ, GWJ | GWQ, GWJ | OLT, GWJ, OMC | | | | Indications for Use | The NeuralScan System is intended for the acquisition, display, analysis, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis. | The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. | The COGNISION system is for use by qualified clinical professional in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information. | Product contains multiple product codes which are generally required for a complete system. The NeuralScan System and the eVox device share the product codes: GWQ: Full Montage System GWJ: Evoked response auditory stimulator The NeuralScan System, the COGNISION system share the product code: OLT: Non-normalizing quantitative electroencephalograph software and GWJ: Evoked response auditory stimulator | | | Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | | | Principle of Operation | The NeuralScan System device is used for acquisition of physiological signals using two or more channels of Electroencephalography (EEG) from the scalp. It consists of a NeuralScan amplifier, a laptop computer (base station), a patient EEG cap, subject response button, ear buds, and a charging cord. The NeuralScan amplifier and software provide a means to: - Initiate a study, track user EEG and ERP data and enter text or questionnaire information acquire and save signals to the memory of the device, transmit signal data from the device, visually inspect the acquired signal. - manage event- related Potentials | The eVox System device is used for acquisition of physiological signals using two or more channels of electroencephalography (EEG) from the scalp. It consists of an eVox amplifier, a laptop computer (base station), a patient EEG cap, subject response button, ear buds, and a charging cord. The eVox amplifier and software provide a means to: - initiate a study, track user EEG and ERP data and enter text or questionnaire information, acquire and save signals to the memory of the device, transmit signal data from the device, visually inspect the acquired signal. - manage event- related Potentials | The COGNISION EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data. The system uses elastic bands to accurately position 10 electrode pods around the head. EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires. The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). The HCU communicates via a wireless data link to a Windows PC to stream EEG data. Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods. | The NeuralScan System has a principle of operation that closely matches that of its predicates. All devices use skin coupling methods, either through electrodes or sensors which transmits patient EEG and ERP from the surface of the scalp to an amplifier. The connection between the amplifier and electrodes is a wired connection for the devices. All devices convert the analog data into digital data which is then transmitted to a base station or computer. Once transmitted to the base station, the devices display and store the data on the base station and allow the user to export the data to a file. | | | Patient population | All age groups | All age groups | Adult Population | | | | Use environment | Intended for use in any healthcare facility, medical facility, athletic or sports clinics, or outside of medical facilities provided they are led by qualified medical personnel. | Intended for use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel. | Physicians' Offices | | | | FDA Device Class | Class II | Class II | Class II | | | | Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | | | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | | | | System Components | NeuralScan System consists of: - a NeuralScan amplifier, - a laptop computer (base station), - a patient EEG cap, - subject response button, ear buds, - and a charging cord. | eVox System consists of: - an eVox amplifier, - a laptop computer (base station), - a patient EEG cap, - subject response button, ear buds, - and a charging cord. | COGNISIONTM consists of: - Head Set - Auditory stimulator - Handheld Control Unit (HCU) including Interface Software - Connecting Headset cable between the headset and the handheld control unit | | | | Sterile | No | No | No | | | | Single Use | No | No | No | | | | Shelf life | Durable good | Durable good | Durable good | | | | Interface with Amplifier | USB or WiFi to PC | Class 2 Bluetooth version 2.0 to PC | Bluetooth 2.0/4.0 | | | | Power Supply | Li-Ion Battery, with USB cable for charging the battery. | Li-Ion Battery, with USB cable for charging the battery. | Li-Ion Battery | | | | Typical Biopotential Signals Recorded | Electroencephalography (EEG), EP/ERP | Electroencephalography (EEG), EP/ERP | Electroencephalography (EEG), EP/ERP | | | | Electroencephalography (EEG), ERP | | | | | | | ERP Stimulus Modality | Auditory; Visual | Auditory; Visual | Auditory…