Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology and measurements.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "measuring and displaying cerebral blood flow velocity" and "measuring the occurrence of transient emboli signals," which are all diagnostic functions, not therapeutic ones.

Diagnostic

Yes
The device description clearly states, "The Lucid M1 System is an adjunctive, portable, non-invasive, non-ionizing radiation, point-of-care transcranial Doppler (TCD) diagnostic ultrasound system." The "intended use" also notes it is "intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity... [and] measuring the occurrence of transient emboli signals." These functions are consistent with diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "medical ultrasound system" and includes a "reusable, non-sterile 2-MHz hand-held probe" and a "headset with two reusable, non-sterile 2-MHz monitoring transducers," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Lucid M1 System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's a medical ultrasound system for measuring and displaying cerebral blood flow velocity and detecting emboli within the body. IVD devices are used to examine specimens taken from the body (like blood, urine, tissue).
Device Description: The description reinforces that it's a non-invasive ultrasound system using a probe and headset applied to the head and neck. This is a direct interaction with the patient's body, not with a sample.
Lack of Mention of Samples: There is no mention of collecting or analyzing biological samples.

Therefore, the Lucid M1 System falls under the category of a diagnostic imaging device, specifically an ultrasound system, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes

IYN, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Energy

Anatomical Site

Head and neck (major conducting arteries and veins of the head and neck)
Temporal windows (cerebral arteries)
Foramen magnum (vertebral and basilar arteries)
Eye (ophthalmic artery and intracranial internal carotid artery)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Point-of-care. Intended user not specified but implied to be a healthcare professional.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K002533

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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

2

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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 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. |
| 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

3

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ระหว่าง

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler
(Specify)	Combined
Other*
(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)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

്കുന്ന വേണ്ടുപ്പ്

Tissue Motion Doppler, and Color Velocity Imaging

Doppler angle
Demodulation
Wall filter
Color scale (velocity)

үс бэлгээ үкиолүүд эх тээхүү 110 баст эги той "Үү," тогиолыг хэлэгээн хэлэлтэй хараан хэрэглэлтэй хараар 14.000 г

FDA for the prevention of devices.

A THE one and the collection as in as info the comments of

(01.108 ЯНЭ IS тэч) эгU попчинагач

4

indications for Use Form

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

:swollot sr ybod namnd and birin to anig min 10 minuter 10000-0 :asonomia 18000-0 :asonomia
2000-0 :

Clinical Application		Mode of Operation
ໂຍ ລອມ ອງ	pecific	N	ama	CWD	റിയിലും കുറച്ചു. അത്രശ്രീ പ്രവരിച്ചു. അത്തിനും വിശ്വാസ്ത്രിക്കുന്നു വിവ്യാവരുന്നു. അവലംബം വിശ്വാസ്ത്രിക്കുന്നു വിവ്യാവരുന്നു. അവലംബം വിശ്വാസ്ത്രിക്കുന്നു വിവ്യാവരുന്നു. അവ		*ƏŞIƏÇILI
Track 1 Only	Tracks 1 & 3)				əldəq	(Ayisədç) Şəxşqırıq Qarıqqında	specify
ാന്ധ്യമായിരുന്നും വിവ	omulsityda		Z
ສ ສິບາຸຣິຍະມາ [ຍາວ
Other	sunwopqy
	una-operative (Specifi
	itraoperative (Neur
	poposomeds.
	Pedistic
	giosds) argal (Specifical
	olleydən prizudəN
	ədən cinsinə aid bitki növü. İstinadlar Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmi		N
	Trans-sucts
	SUISEA-SURTT
	ETÜRETİRETİRİ
	rus-sessorg. (nou-Card



	(reisigasis-omasny) അവലംബം എന്നാടനു) ((reuomuseum)) ഗുട്ടുവും വിശ്വാസ്ത്രവു
	utrevescula
	the the checity
Cardian	unda seipus
	ardisc Pediatio
	овірль?) пыповельны
	rans-esoph. (Cardiac
	ntra-cardisc
	the heads (Specify
Perphers	əssəs fistəsində filmləri fəsiləsinə filmləri fəsiləsinin fəsiləsinə cinsinə aid bitki filmləri fəsiləsinə cinsinə aid bitki filmləri fəsiləsinə cinsinə aid
Vessel	Other (Specify)
	basqqs sidi rəbnu bəbbə — q :AQA vd bərçələ ylənələrə — 9 :nonkəsibni wəri — V

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

ลินธุรเนโ วเทอนทะH เว็บไซต์ (1-2) เปิดตัว อุทานีที่ที่ 19,000 บุ๊ก เจมาการที่ 10 รอบดน างนิว 10 รวมตหรัฐ *

Internation Poloo Due Color Color CorosiT

.гээлvэр элхэгээгтэй хот хот хан əti yd bərkələ yarının əsr mərkəzi ədə vəf "V", nonissibati vən se bəstəsibət sməsi "strammə" karin

(ЯПО) поцептеля элічэб (ПЛО 10 году). НЯПО 10 годатизиод

(001.108 ЯНЭ 12 тэм) эгU попартагэтч

5

indications for Use Form

| Clinical Application | Specific
(Tracks 1 & 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| General
(Track 1 Only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | N | | | | | |
| Fetal Imaging &
Other | Fetal
Abdominal
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 Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify) | | | | N | | | | |
| Cardiac | | | | | | | | | |
| Peripheral
Vessel | | | | | | | | | |

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

รินทรานา วันเชียนที่ 17-5 เวอร์ตการ เรื่องเทรา วิทยารนี รายนางที่ เรตนางการสอบ 10 รอไตพรรส ร

Internation Poloo Due Color Color CorosiT

.гээлvэр элхэгээгтэй хот хот хан əti yd bərələ yarının əsr mərkəzi ilə "A", nonisibati wən se bəstəsibət sməl : sanəmiroo karolibb A

(ЯПО) поцептеля элічэб (ПЛО 10 году). НЯПО 10 годатизиод

(001.108 ЯНЭ 12 тэм) эгU попартагэтч

6

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 115
Los Angeles, CA 90064
Phone: (310) 819-1676
Facsimile: (310) 819-1676
Internal Contact: Jay Yonemoto
	Email: Jay@neuralanalytics.com
Official Correspondent	Javad Seyedzadeh
Regulatory and Quality Advisor
Neural Analytics, Inc.
(914) 473-1678
javad@neuralanalytics.com
Common Name	Transcranial Doppler (TCD) Ultrasound System
2 MHz Ultrasound Transducer
Trade Name	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1
System) with 2 MHz Transducers
Model Number(s)	M1 (Lucid M1 System)
40-00008 (handheld 2 MHz transducer)
40-00009 (monitoring 2 MHz transducer)
Federal Regulation
Number	21 CFR 892.1550
21 CFR 892.1570
Product Codes	IYN, ITX
Class	Class II Device

7

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 | K002533
Spencer Technologies, Inc.
TCD 100 M, Transcranial Doppler Ultrasound System, CFR
892.1550, IYN |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Transducer PWD 13, Diagnostic Ultrasound Transducer; CFR
892.1570, ITX |
| Performance Standards | There are no required performance standards under the
Federal Food, Drug and Cosmetic Act. Voluntary standards to
which we will conform include: IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-6 and IEC 60601-2-37, IEC 62133 (TCD Driver
rechargeable battery) & UL 2504 (Tablet rechargeable
battery). |
| Special Controls | There are no special controls as a special report is no longer
required. The guidance referenced is "Guidance for Industry
and FDA Staff - Information for Manufacturers Seeking
Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers” dated September 9, 2008. |

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.

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.

8

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

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.

| Technological
Characteristic | Neural Analytics Lucid M1
Transcranial Doppler Ultrasound
System (Lucid M1 System) | Spencer Technologies TCD 100 M
Transcranial Doppler Ultrasound
System (K002533) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | IYN, ITX
Class II | IYN, ITX
Class II |
| 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.
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. | The TCD 100M transcranial Doppler
ultrasound system is intended for use as
a diagnostic ultrasound fluid flow
analysis system:

For the measurement of cerebral
artery blood velocities to determine the
presence-of-
hemodynamically significant deviations
from normal values
To assess arterial cerebral blood flow
for the occurrence of micro-embolic
signals.
Vessels intended for observation include,
but are not limited to, the middle, anterior
and posterior cerebral arteries, via the
temporal windows, the vertebral and
basilar arteries via the foramen magnum,
and the ophthalmic artery and
intracranial internal carotid artery via the
eye.
The TCD 100M is intended for use
during:
Diagnostic exams
Surgical interventions
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. |
| Energy Used/
Delivered | Ultrasound Energy | Ultrasound Energy |
| Technological
Characteristic | Neural Analytics Lucid M1
Transcranial Doppler Ultrasound
System (Lucid M1 System) | Spencer Technologies TCD 100 M
Transcranial Doppler Ultrasound
System (K002533) |
| Design | 1. Base Ultrasound Unit (touch screen
display, integrated PC Board, TCD
ultrasound driver sub-system)
Reusable, non-sterile 2-MHz
handheld probe or headset with two
reusable, non-sterile 2-MHz monitoring
transducers
Software/firmware
Algorithm | 1. Base Ultrasound Unit (single board
PC, master and slave Doppler boards,
transducer detector circuit, flat panel
display, keyboard, mouse, remote
control keypad, audio output, hard disk,
parallel port)
Reusable, non-sterile 2-MHz handheld
probe or headset with 2 reusable, non-
sterile 2-MHz monitoring probes
Software/firmware
Algorithm |
| Mechanism of
Action | Doppler Ultrasound, with the following
modes: Unilateral, Bilateral,
Multichannel, Monitoring, M-Mode,
Modified M-Mode | Doppler Ultrasound, with the following
modes: Unilateral, Bilateral,
Multichannel, Monitoring, M-Mode |
| Accessories | 2MHz PW 16mm hand held probes
2MHz PW 16mm monitoring probes | 2Mhz PW 16mm hand held probes
2Mhz PW 16mm monitoring probes |
| Performance | Sample Volume: 2 to 12mm in 1mm
steps
Depth: 23 to 151mm
Power% 0 to 100% where 100%
represents Ispta.3 upper-tolerance limit
720 mW/cm² | Similar information is provided by the
predicate device |
| Acoustic Output | The Lucid M1 System global maximum
derated ISPTA is designed to be