The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.

The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Device Description

The Lucid M1 System is an adjunctive, portable, non-invasive, non-ionizing radiation, point-of-care transcranial Doppler (TCD) diagnostic ultrasound system. It is designed to non-invasively measure and display cerebral blood flow velocity over the head and neck with a reusable, non-sterile 2-MHz hand-held probe. It can also be used bilaterally to monitor the blood flow velocity of the vessels insonated via the temporal window of the head with a headset with two reusable, non-sterile 2-MHz monitoring transducers. The system can also provide an emboli count for emboli detection.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond general statements of substantial equivalence to a predicate device. The information focuses on design, safety, and functional equivalence rather than quantitative performance metrics and clinical study results.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for performance metrics in a quantitative manner. Instead, it demonstrates "substantial equivalence" to a predicate device (Spencer Technologies TCD 100 M). The "reported device performance" is largely described in terms of functional equivalence and compliance with general safety standards.

Feature/Characteristic	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Lucid M1 System Performance
Indications for Use	Equivalent to Spencer TCD 100 M	"adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity...and measures the occurrence of transient emboli signals." (Equivalent)
Product Code, Class	IYN, ITX; Class II	IYN, ITX; Class II (Equivalent)
Energy Used/Delivered	Ultrasound Energy	Ultrasound Energy (Equivalent)
Sample Volume	Similar to predicate	2 to 12mm in 1mm steps
Depth	Similar to predicate	23 to 151mm
Acoustic Output (ISPTA)	Global maximum derated ISPTA < 720 mW/cm² (as predicate)	< 720 mW/cm² (specifically 675mW/cm²)
Acoustic Output (MI)	Global maximum MI < 1.0 (as predicate)	< 1.0
Acoustic Output (TIC)	Max TIC (as predicate)	Max TIC of 2.5 (user informed on display)
Clinical Measurements	Equivalent to predicate (e.g., Peak, Diastolic velocity, Mean, PI, Embolus Count)	Maximum Velocity, Mean Velocity, Minimum Velocity, Pulsatility Index, Cerebrovascular Reactivity, Embolus Count
Rechargeable Battery	Not present on predicate (user convenience feature)	Lithium Ion (TCD Driver), Lithium Polymer (Tablet). Compliant with IEC 62133 and UL 2054.
M-Mode	Traditional M-Mode (as predicate)	Traditional M-Mode + Modified M-Mode
Cerebrovascular Reactivity Calculations	Manual calculations (as predicate)	Automated CVR calculations
Safety and Electrical	Meet applicable safety requirements (IEC standards)	Complies with IEC 60601-1, 60601-1-2, 60601-2-37, etc. (Equivalent)
Biocompatibility	Pass biocompatibility evaluation	Evaluated per ISO 10993-1

2. Sample size used for the test set and the data provenance:

The document explicitly states: "The Lucid M1 System does not require clinical testing to show substantial equivalence to its predicate device in safety and effectiveness." Therefore, no test set of patient data was used for clinical performance evaluation. The evaluation appears to be based on non-clinical testing and comparison of technical characteristics to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set was used for performance evaluation that required expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.

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:

Not applicable. This device is an ultrasound system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Its "algorithm" refers to internal processing, not necessarily AI for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device is a medical ultrasound system that outputs measurements and displays. Its "algorithm" is responsible for processing the raw ultrasound signals into interpretable data (e.g., velocity, emboli count, CVR calculation). The document implies that the algorithms perform these analyses without direct human intervention in the calculation process itself, though a human operates the device and interprets the results. The non-clinical testing would have verified the accuracy and functionality of these internal algorithms and their outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing, the "ground truth" would have been established through engineering benchmarks, calibrated measurement equipment, and compliance with recognized standards (e.g., for acoustic output, electrical safety). For example, acoustic output measurements against the NEMA UD 2-2004 standard would serve as the ground truth for acoustic performance. There's no mention of a clinical ground truth (like pathology or outcomes data) being used for this submission.

8. The sample size for the training set:

Not applicable, as this is a traditional 510(k) submission for an ultrasound system, not a machine learning or AI-driven device requiring a "training set" in the conventional sense. The "algorithm" mentioned refers to signal processing and calculation logic, not an algorithm trained on a dataset.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2016

Neural Analytics, Inc. % Mr. Javad Seyedzadeh Regulatory and Quality Advisor 2440 S. Sepulveda Blvd. Suite 115 LOS ANGELES CA 90064

Re: K160442 Trade/Device Name: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2 MHz Transducers Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX Dated: September 23, 2016 Received: September 26, 2016

Dear Mr. Seyedzadeh:

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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number ( if known )	K160442
Device Name	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2 MHz Transducers
Indications for Use (Describe)	The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices formeasuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head andneck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to beused in fetal applications, and is not intended to be used inside the sterile field.
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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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ระหว่าง

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler(Specify)	CombinedOther*(Specify)
Ophthalmic	Ophthalmic			N
Fetal Imaging &Other	Fetal
	Abdominal
Cardiac	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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Tissue Motion Doppler, and Color Velocity Imaging

Doppler angle
Demodulation
Wall filter
Color scale (velocity)

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FDA for the prevention of devices.

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indications for Use Form

System: Lucid M1 System
Manufacturer: 400008 Hudson Plz
Rogers, AR 72758-1122

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Clinical Application		Mode of Operation
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indications for Use Form

Clinical Application	Specific(Tracks 1 & 3)	M	PWD
General(Track 1 Only)
Ophthalmic	Ophthalmic	N
Fetal Imaging &Other	FetalAbdominalIntra-operative (Specify)Intra-operative (Neuro)LaparoscopicPediatricSmall Organ (Specify)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)IntravascularOther (Specify)Cardiac AdultCardiac PediatricIntravascular (Cardiac)Trans-esoph. (Cardiac)Intra-cardiacOther (Specify)Peripheral vesselOther (Specify)		N
Cardiac
PeripheralVessel

N
new indication; P = previously cleared by FDA; E = added under this appendi

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Image /page/6/Picture/0 description: The image is a logo for Neural Analytics. The logo is set against a blue background. The letters 'NA' are displayed in white in a stylized, bold font, with the 'A' appearing to be formed by two diagonal lines meeting at the top. Below the letters, the words 'NEURAL ANALYTICS' are written in a smaller, sans-serif font, also in white.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

510(k) Summary

Lucid M1 Transcranial Doppler Ultrasound System with 2-MHz Transducer

Date Prepared	February 10, 2016
Manufacturer	Neural Analytics, Inc.2440 South Sepulveda Blvd, Suite 115Los Angeles, CA 90064Phone: (310) 819-1676Facsimile: (310) 819-1676Internal Contact: Jay Yonemoto
	Email: Jay@neuralanalytics.com
Official Correspondent	Javad SeyedzadehRegulatory and Quality AdvisorNeural Analytics, Inc.(914) 473-1678javad@neuralanalytics.com
Common Name	Transcranial Doppler (TCD) Ultrasound System2 MHz Ultrasound Transducer
Trade Name	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1System) with 2 MHz Transducers
Model Number(s)	M1 (Lucid M1 System)40-00008 (handheld 2 MHz transducer)40-00009 (monitoring 2 MHz transducer)
Federal RegulationNumber	21 CFR 892.155021 CFR 892.1570
Product Codes	IYN, ITX
Class	Class II Device

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Image /page/7/Picture/0 description: The image is a logo for Neural Analytics. The logo consists of the letters "NA" in white, stacked on top of each other. Below the letters is the text "NEURAL ANALYTICS" in a smaller font, also in white. The background of the logo is a solid blue color. The logo is simple and modern, with a clean design.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

Predicate Device	K002533Spencer Technologies, Inc.TCD 100 M, Transcranial Doppler Ultrasound System, CFR892.1550, IYN
	Transducer PWD 13, Diagnostic Ultrasound Transducer; CFR892.1570, ITX
Performance Standards	There are no required performance standards under theFederal Food, Drug and Cosmetic Act. Voluntary standards towhich we will conform include: IEC 60601-1, IEC 60601-1-2,IEC 60601-1-6 and IEC 60601-2-37, IEC 62133 (TCD Driverrechargeable battery) & UL 2504 (Tablet rechargeablebattery).
Special Controls	There are no special controls as a special report is no longerrequired. The guidance referenced is "Guidance for Industryand FDA Staff - Information for Manufacturers SeekingMarketing Clearance of Diagnostic Ultrasound Systems andTransducers” dated September 9, 2008.

Device Description

Indications for Use

The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, the Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.

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Image /page/8/Picture/0 description: The image is a logo for Neural Analytics. The logo features the letters 'NA' in a stylized, sans-serif font, with the 'N' and 'A' connected at the top. The letters are white and are set against a blue square background. Below the letters, the words 'NEURAL ANALYTICS' are written in a smaller, sans-serif font, also in white.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

TechnologicalCharacteristic	Neural Analytics Lucid M1Transcranial Doppler UltrasoundSystem (Lucid M1 System)	Spencer Technologies TCD 100 MTranscranial Doppler UltrasoundSystem (K002533)
Product Code,Class	IYN, ITXClass II	IYN, ITXClass II
Indications forUse	The Lucid M1 System is a medicalultrasound system intended for use asan adjunct to the standard clinicalpractices for measuring and displayingcerebral blood flow velocity within themajor conducting arteries and veins ofthe head and neck. Additionally, TheLucid M1 System measures theoccurrence of transient emboli signalswithin the blood stream.The device is not intended to replaceother means of evaluating vital patientphysiological processes, is not intendedto be used in fetal applications, and isnot intended to be used inside thesterile field.	The TCD 100M transcranial Dopplerultrasound system is intended for use asa diagnostic ultrasound fluid flowanalysis system:1. For the measurement of cerebralartery blood velocities to determine thepresence-of-hemodynamically significant deviationsfrom normal values2. To assess arterial cerebral blood flowfor the occurrence of micro-embolicsignals.Vessels intended for observation include,but are not limited to, the middle, anteriorand posterior cerebral arteries, via thetemporal windows, the vertebral andbasilar arteries via the foramen magnum,and the ophthalmic artery andintracranial internal carotid artery via theeye.The TCD 100M is intended for useduring:Diagnostic examsSurgical interventionsThe device is not intended to replaceother means of evaluating vital patientphysiological processes, is not intendedto be used in fetal applications, and isnot intended to be used inside the sterilefield.
Energy Used/Delivered	Ultrasound Energy	Ultrasound Energy
TechnologicalCharacteristic	Neural Analytics Lucid M1Transcranial Doppler UltrasoundSystem (Lucid M1 System)	Spencer Technologies TCD 100 MTranscranial Doppler UltrasoundSystem (K002533)
Design	1. Base Ultrasound Unit (touch screendisplay, integrated PC Board, TCDultrasound driver sub-system)2. Reusable, non-sterile 2-MHzhandheld probe or headset with tworeusable, non-sterile 2-MHz monitoringtransducers3. Software/firmware4. Algorithm	1. Base Ultrasound Unit (single boardPC, master and slave Doppler boards,transducer detector circuit, flat paneldisplay, keyboard, mouse, remotecontrol keypad, audio output, hard disk,parallel port)2. Reusable, non-sterile 2-MHz handheldprobe or headset with 2 reusable, non-sterile 2-MHz monitoring probes3. Software/firmware4. Algorithm
Mechanism ofAction	Doppler Ultrasound, with the followingmodes: Unilateral, Bilateral,Multichannel, Monitoring, M-Mode,Modified M-Mode	Doppler Ultrasound, with the followingmodes: Unilateral, Bilateral,Multichannel, Monitoring, M-Mode
Accessories	2MHz PW 16mm hand held probes2MHz PW 16mm monitoring probes	2Mhz PW 16mm hand held probes2Mhz PW 16mm monitoring probes
Performance	Sample Volume: 2 to 12mm in 1mmstepsDepth: 23 to 151mmPower% 0 to 100% where 100%represents Ispta.3 upper-tolerance limit720 mW/cm²	Similar information is provided by thepredicate device
Acoustic Output	The Lucid M1 System global maximumderated ISPTA is designed to be<720mW/cm². The Lucid M1 Systemglobal maximum MI is designed to be <1.0. The design of Lucid M1 System willexceed a TIC (Cranial Thermal Index)of 1.0. The maximum TIC for the LucidM1 System is 2.5.	Similar information is provided by thepredicate device
ClinicalMeasurements	• Maximum Velocity• Mean Velocity• Minimum Velocity• Pulsatility Index• Cerebrovascular Reactivity• Embolus Count	• Peak• Diastolic velocity• Mean• PI• Delta Percent• Embolus Count
Track	Track 3	Track 1
TechnologicalCharacteristic	Neural Analytics Lucid M1Transcranial Doppler UltrasoundSystem (Lucid M1 System)	Spencer Technologies TCD 100 MTranscranial Doppler UltrasoundSystem (K002533)
Patient-ContactMaterials(Transducers)	Transducer Front Face: Luran HD-20(BASF)Transducer Body: Tecason P(Ensigner)	Transducer Front Face: Luran HD-20(BASF)Transducer Body: Tecason P (Ensigner)
Mains Input	100 to 240 VAC 50 to 60 Hz	100 to 240 VAC 50 to 60 Hz
RechargeableBattery	Lithium Ion (TCD Driver)Lithium Polymer (Tablet)	None
Labeling	Electrical Hazard Warnings Non-temporal window scanning precaution (on-screen caution) Not intended for fetal use warning ALARA caution Physician order caution Supplemental TIC	Electrical Hazard Warnings Non-temporal window scanning precaution (on-screen caution) Not intended for fetal use warning ALARA caution Physician order caution Supplemental TIC

Technological Characteristics Compared to Predicate Device

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Image /page/9/Picture/0 description: The image is a logo for Neural Analytics. The logo is white text on a blue background. The letters 'NA' are stacked on top of each other in a stylized font, and the words 'NEURAL ANALYTICS' are written below the letters in a smaller font.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

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Image /page/10/Picture/0 description: The image is a logo for Neural Analytics. The logo consists of the letters 'NA' in a stylized, sans-serif font, stacked on top of each other. The letters are white and are set against a blue background. Below the letters, the words 'NEURAL ANALYTICS' are written in a smaller, sans-serif font, also in white.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

There are no unique features compared to the predicate device in principles of operation, specifications, performance, safety, and effectiveness.

Substantial Equivalence Discussion

The Lucid M1 System is substantially equivalent to the Spencer Technologies TCD 100 M Transcranial Doppler Ultrasound System (K002533) based on indications for use and comparison of the functional capabilities. Both of the devices are intended to provide a diagnostic ultrasound fluid flow analysis. Features common to all systems include:

. Transcranial Doppler ultrasound systems used for fluid flow analysis
. Monitor the cerebral arteries via the temporal windows
Utilize two transducers which are attached via a headset for cephalic monitoring
. Use substantially equivalent operating modes
. Measure equivalent hemodynamic indices
Have equivalent monitoring functions
Display velocity spectrum and M-Mode
. Manufactured with materials that have been evaluated and found to be safe for the intended use of the device
Have patient contact surfaces are manufactured from the same materials

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Image /page/11/Picture/0 description: The image is a logo for Neural Analytics. The logo is white text on a blue background. The logo consists of the letters 'NA' stacked on top of each other, with the words 'NEURAL ANALYTICS' written below the letters.

Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

. Manufactured to meet applicable physical, mechanical, and electrical safety requirements
The Lucid M1 System is substantially equivalent to the Spencer Technologies TCD 100 M Transcranial Doppler Ultrasound System (K002533). This is based on the comparison of the indications for use and comparison of the functional capabilities. Both of the devices are intended to provide a diagnostic ultrasound fluid flow analysis.

Device	Indications For Use	Comparison
Lucid M1 System	The Lucid M1 System is an adjunctive, portable,non-invasive, non-ionizing radiation, point-of-caretranscranial Doppler (TCD) diagnostic ultrasoundsystem. It is designed to non-invasively measureand display cerebral blood flow velocity over thehead and neck with a reusable, non-sterile 2-MHzhand-held probe. It is also used bilaterally to monitorthe blood flow velocity of the vessels insonated viathe temporal window of the head with a headsetwith two reusable, non-sterile 2-MHz monitoringtransducers. The system can also provide an embolicount for emboli detection.	Equivalentto Predicate
TCD 100 M (K002533)	The TCD 100M is a computer based ultrasoundsystem intended for transcranial Doppler (TCD), witha single type of pulse wave Doppler transducer thatcan be used free-hand (or mounted in a head framefor longer term monitoring). This comprises a Track1 device with output exceeding cephalic limits andmaximum Thermal Index Cranial included in thelabeling (user manual). An M-mode image is used tohelp position the sample gate for Doppler signal,and for detection of embolic signals. The m-modeimage does not represent a new insonation modebut rather is an additional display of information fromthe conventional pulsed Doppler signal.

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Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

The minor differences (discussed below) between the Lucid M1 System and the Spencer Technologies TCD 100 M Transcranial Doppler Ultrasound System (K002533) do not raise new questions of safety or effectiveness. These differences are discussed as follows:

Performance:

The Lucid M1 System, uses a sample length of 2 to 12mm with a depth of 23 to 151mm. The sample length specified in the Lucid M1 System limits the selection to lengths that are commonly used. Similar information is provided by the predicate device (K002533).

Acoustic Output:

The Lucid M1 System has a global maximum derated ISPTA of 675mW/cm² which is less than 720mW/cm². The Lucid M1 System has a maximum Cranial Thermal Index (TIC) of 2.5. The user is kept informed of the current TIC value because it is presented on the Lucid M1 System display. Similar information is provided by the predicate device (K002533).

Rechargeable Battery:

The Lucid M1 System utilizes rechargeable batteries to allow the user to perform exams disconnected from the mains outlet (AC wall socket). The system allows a single channel TCD exam for a cumulative time of at least 1 hour. The rechargeable batteries in the Lucid M1 System will be compliant with the IEC 62133 (First and Second Edition Rechargeable Nickel or Lithium) and UL 2054 (Alkaline Cell or Lithium/Alkaline Packs) standards.

The TCD 100 M (K002533) does not have rechargeable battery. This is a user convenience feature that does not impact the operation of the unit.

Modified M-Mode:

In addition to the traditional M-mode found on the TCD 100M, the Lucid M1 System utilizes a modified M-mode display which is a presentation of the standard M-mode display information in a signal strength vs depth format. Using the Modified M-mode display, the operator can quickly acquire the spectrogram signal and therefore perform a faster exam. Using this feature, they can visualize the M-mode signal strength along the horizontal axis thereby allowing them to set the depth of the sample gate. The operator simply aligns the depth setting using the highest signal strength peak.

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Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

Automated Cerebrovascular Reactivity calculations:

Cerebrovascular Reactivity calculations are currently performed using a hand calculator and reading the measurements from the display. The Automated Cerebrovascular Reactivity feature avoids this manual operation by recommending a minimum velocity, maximum velocity and mean velocity and automatically generates a CVR calculation. The operator has an option to manually re-select the locations of the minimum. maximum, and mean velocity estimates in accordance to standard clinical practice.

The TCD 100M does not have this feature.

General Safety and Effectiveness and Performance Data

The Lucid M1 System is equivalent to currently distributed transcranial Doppler ultrasound systems with 2 MHz transducers. Maximum acoustic output levels for the Lucid M1 System will be below pre-amendment levels for acoustic intensity for this application, and for Mechanical Index for all applications. On-screen cautions will indicate appropriate power levels prior to the user beginning an exam. Power levels will be displayed at all times during scanning, and a standard spectrum display will be shown.

The design of the Lucid M1 System is being developed in accordance with the approved design plan and the requirements of 21 CFR Part 820. Quality management system procedures include, but are not limited to, risk analysis, requirement reviews, design reviews, verification and validation, performance testing, and safety testing.

Clinical Testing

The Lucid M1 System does not require clinical testing to show substantial equivalence to its predicate device in safety and effectiveness.

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Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

Summary of Non-Clinical Testing and Reliance on Standards

The Lucid M1 System is evaluated for acoustic output, biocompatibility, and accuracy, as well as thermal, electrical, electromagnetic, and mechanical safety. Non-clinical testing to support thermal, mechanical, electromagnetic, and mechanical safety is conducted per the FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, using applicable sections of the following voluntary standards:

IEC 60601-1: Medical electrical equipment Part 1: General requirements for . basic safety and essential performance
. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
. IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. NEMA Standards Publication UD 2-2004(R2009) Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
NEMA Standards Publication UD 3-2004(R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
. IEC 60601-1-6: 2010 Medical electrical equipment - Part 1-6: General Requirements For Safety – Collateral Standard: Usability
. IEC 62133: 2012 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
. UL 2054: 2004 Standard for Household and Commercial Batteries
ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

Determination of Substantial Equivalence

The Lucid M1 System is determined to be substantially equivalent to devices of the same type that are currently lawfully distributed in interstate commerce in the United States with regard to intended use, modes, clinical measurements, acoustical power output, head fixation devices, safety and effectiveness.

Neural Analytics' Lucid M1 System and Spencer Technologies' TCD 100M are both transcranial Doppler ultrasound flow systems with monitoring functions. Both systems

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Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

monitor the cerebral arteries via the temporal windows and allow the user to examine the anterior and posterior cerebral arteries via the temporal windows, the vertebral and basal arteries via the foramen magnum, and the ophthalmic and intracranial internal carotid arteries via the eye.

Both systems have equivalent modes and use pulsed wave Doppler (PWD) and use color M-mode for location of the vessel of interest. Additionally, both devices:

Are transcranial Doppler ultrasound systems used for fluid flow analysis
. Monitor the cerebral arteries via the temporal windows
. Utilize two transducers which are attached via a headset for cephalic monitoring
Use substantially equivalent operating modes
Measure equivalent hemodynamic indices
Have equivalent monitoring functions
. Display velocity spectrum and M-Mode
. Are manufactured with materials that have been evaluated and found to be safe for the intended use of the device
. Have patient contact surfaces are manufactured from the same materials
. Are manufactured to meet applicable physical, mechanical, and electrical safety requirements

Conclusion

The documentation provided demonstrates that:

. The Lucid M1 System and transducers are substantially equivalent to the predicate devices.
. There are no new questions of safety and effectiveness concerning the Lucid M1 System and transducers.
. The Lucid M1 System is designed to be at least as safe and effective as the predicate devices.
. The Lucid M1 System is designed to perform as well as the predicate devices.

Accordingly, the Lucid M1 System is believed to be substantially equivalent to a predicate device of the same type which is lawfully distributed in interstate commerce in the United States.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.