Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

K160442 · Neural Analytics, Inc. · IYN · Oct 21, 2016 · Radiology

Device Facts

• Record ID: K160442
• Device Name: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
• Applicant: Neural Analytics, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended 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.

Device Story

Lucid M1 is a portable, non-invasive, point-of-care transcranial Doppler (TCD) ultrasound system. It uses 2-MHz handheld probes or a headset with two monitoring transducers to insonate cerebral vessels via temporal windows. The system processes ultrasound signals to measure and display blood flow velocity and detect transient emboli. It features a 'Modified M-mode' display (signal strength vs. depth) to assist operators in sample gate positioning and provides automated Cerebrovascular Reactivity (CVR) calculations. Used by clinicians in point-of-care settings, the device aids in hemodynamic assessment. Output is viewed on a touch-screen display, supporting clinical decision-making by providing real-time velocity spectra and hemodynamic indices. The device is battery-operated for mobility.

Clinical Evidence

Bench testing only. No clinical data required for substantial equivalence. Testing included acoustic output measurement, biocompatibility, thermal safety, electrical safety, electromagnetic compatibility, and mechanical safety per FDA guidance and voluntary standards (IEC 60601 series, NEMA UD 2/3, ISO 10993-1).

Technological Characteristics

Portable TCD ultrasound system; 2-MHz reusable, non-sterile transducers. Transducer face: Luran HD-20 (BASF); Body: Tecason P (Ensigner). Modes: Unilateral, Bilateral, Multichannel, Monitoring, M-Mode, Modified M-Mode. Connectivity: Touch screen display, battery-powered (Li-ion/Li-polymer). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62133, UL 2054, ISO 10993-1. Software-based signal processing for velocity and emboli detection.

Indications for Use

Indicated for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity in major conducting arteries and veins of the head and neck, and for measuring transient emboli signals in the blood stream. Not for fetal applications or use within the sterile field.

Regulatory Classification

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.

Predicate Devices

• Spencer Technologies, Inc. TCD 100 M (K002533)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | |
| 510(k) Number ( <i>if known</i> ) | 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<br>measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and<br>neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.<br><br>The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be<br>used in fetal applications, and is not intended to be used inside the sterile field. |
| Type of Use (Select one or both, as applicable) | |
| <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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)

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***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

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"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 [phone] EF

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

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Tissue Motion Doppler, and Color Velocity Imaging

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2. Demodulation
3. Wall filter
4. Color scale (velocity)

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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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| ສ ສິບາຸຣິຍະມາ [ຍາວ | | | | | | | |
| Other | sunwopqy | | | | | | |
| | una-operative (Specifi | | | | | | |
| | itraoperative (Neur | | | | | | |
| | poposomeds. | | | | | | |
| | Pedistic | | | | | | |
| | giosds) argal (Specifical | | | | | | |
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| | Trans-sucts | | | | | | |
| | SUISEA-SURTT | | | | | | |
| | ETÜRETİRETİRİ | | | | | | |
| | rus-sessorg. (nou-Card | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
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| | 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

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## indications for Use Form

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

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.<br>2440 South Sepulveda Blvd, Suite 115<br>Los Angeles, CA 90064<br>Phone: [phone]<br>Facsimile: [phone]<br>Internal Contact: Jay Yonemoto |
| | Email: [e-mail] |
| Official Correspondent | Javad Seyedzadeh<br>Regulatory and Quality Advisor<br>Neural Analytics, Inc.<br>[phone]<br>[e-mail] |
| Common Name | Transcranial Doppler (TCD) Ultrasound System<br>2 MHz Ultrasound Transducer |
| Trade Name | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1<br>System) with 2 MHz Transducers |
| Model Number(s) | M1 (Lucid M1 System)<br>40-00008 (handheld 2 MHz transducer)<br>40-00009 (monitoring 2 MHz transducer) |
| Federal Regulation<br>Number | 21 CFR 892.1550<br>21 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 | K002533<br>Spencer Technologies, Inc.<br>TCD 100 M, Transcranial Doppler Ultrasound System, CFR<br>892.1550, IYN |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Transducer PWD 13, Diagnostic Ultrasound Transducer; CFR<br>892.1570, ITX |
| Performance Standards | There are no required performance standards under the<br>Federal Food, Drug and Cosmetic Act. Voluntary standards to<br>which we will conform include: IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-1-6 and IEC 60601-2-37, IEC 62133 (TCD Driver<br>rechargeable battery) & UL 2504 (Tablet rechargeable<br>battery). |
| Special Controls | There are no special controls as a special report is no longer<br>required. The guidance referenced is "Guidance for Industry<br>and FDA Staff - Information for Manufacturers Seeking<br>Marketing Clearance of Diagnostic Ultrasound Systems and<br>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<br>Characteristic | Neural Analytics Lucid M1<br>Transcranial Doppler Ultrasound<br>System (Lucid M1 System) | Spencer Technologies TCD 100 M<br>Transcranial Doppler Ultrasound<br>System (K002533) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Class | IYN, ITX<br>Class II | IYN, ITX<br>Class II |
| Indications for<br>Use | The Lucid M1 System is a medical<br>ultrasound system intended for use as<br>an adjunct to the standard clinical<br>practices for measuring and displaying<br>cerebral blood flow velocity within the<br>major conducting arteries and veins of<br>the head and neck. Additionally, The<br>Lucid M1 System measures the<br>occurrence of transient emboli signals<br>within the blood stream.<br>The device is not intended to replace<br>other means of evaluating vital patient<br>physiological processes, is not intended<br>to be used in fetal applications, and is<br>not intended to be used inside the<br>sterile field. | The TCD 100M transcranial Doppler<br>ultrasound system is intended for use as<br>a diagnostic ultrasound fluid flow<br>analysis system:<br>1. For the measurement of cerebral<br>artery blood velocities to determine the<br>presence-of-<br>hemodynamically significant deviations<br>from normal values<br>2. To assess arterial cerebral blood flow<br>for the occurrence of micro-embolic<br>signals.<br>Vessels intended for observation include,<br>but are not limited to, the middle, anterior<br>and posterior cerebral arteries, via the<br>temporal windows, the vertebral and<br>basilar arteries via the foramen magnum,<br>and the ophthalmic artery and<br>intracranial internal carotid artery via the<br>eye.<br>The TCD 100M is intended for use<br>during:<br>Diagnostic exams<br>Surgical interventions<br>The device is not intended to replace<br>other means of evaluating vital patient<br>physiological processes, is not intended<br>to be used in fetal applications, and is<br>not intended to be used inside the sterile<br>field. |
| Energy Used/<br>Delivered | Ultrasound Energy | Ultrasound Energy |
| Technological<br>Characteristic | Neural Analytics Lucid M1<br>Transcranial Doppler Ultrasound<br>System (Lucid M1 System) | Spencer Technologies TCD 100 M<br>Transcranial Doppler Ultrasound<br>System (K002533) |
| Design | 1. Base Ultrasound Unit (touch screen<br>display, integrated PC Board, TCD<br>ultrasound driver sub-system)<br>2. Reusable, non-sterile 2-MHz<br>handheld probe or headset with two<br>reusable, non-sterile 2-MHz monitoring<br>transducers<br>3. Software/firmware<br>4. Algorithm | 1. Base Ultrasound Unit (single board<br>PC, master and slave Doppler boards,<br>transducer detector circuit, flat panel<br>display, keyboard, mouse, remote<br>control keypad, audio output, hard disk,<br>parallel port)<br>2. Reusable, non-sterile 2-MHz handheld<br>probe or headset with 2 reusable, non-<br>sterile 2-MHz monitoring probes<br>3. Software/firmware<br>4. Algorithm |
| Mechanism of<br>Action | Doppler Ultrasound, with the following<br>modes: Unilateral, Bilateral,<br>Multichannel, Monitoring, M-Mode,<br>Modified M-Mode | Doppler Ultrasound, with the following<br>modes: Unilateral, Bilateral,<br>Multichannel, Monitoring, M-Mode |
| Accessories | 2MHz PW 16mm hand held probes<br>2MHz PW 16mm monitoring probes | 2Mhz PW 16mm hand held probes<br>2Mhz PW 16mm monitoring probes |
| Performance | Sample Volume: 2 to 12mm in 1mm<br>steps<br>Depth: 23 to 151mm<br>Power% 0 to 100% where 100%<br>represents Ispta.3 upper-tolerance limit<br>720 mW/cm² | Similar information is provided by the<br>predicate device |
| Acoustic Output | The Lucid M1 System global maximum<br>derated ISPTA is designed to be<br><720mW/cm². The Lucid M1 System<br>global maximum MI is designed to be <<br>1.0. The design of Lucid M1 System will<br>exceed a TIC (Cranial Thermal Index)<br>of 1.0. The maximum TIC for the Lucid<br>M1 System is 2.5. | Similar information is provided by the<br>predicate device |
| Clinical<br>Measurements | • Maximum Velocity<br>• Mean Velocity<br>• Minimum Velocity<br>• Pulsatility Index<br>• Cerebrovascular Reactivity<br>• Embolus Count | • Peak<br>• Diastolic velocity<br>• Mean<br>• PI<br>• Delta Percent<br>• Embolus Count |
| Track | Track 3 | Track 1 |
| Technological<br>Characteristic | Neural Analytics Lucid M1<br>Transcranial Doppler Ultrasound<br>System (Lucid M1 System) | Spencer Technologies TCD 100 M<br>Transcranial Doppler Ultrasound<br>System (K002533) |
| Patient-Contact<br>Materials<br>(Transducers) | Transducer Front Face: Luran HD-20<br>(BASF)<br>Transducer Body: Tecason P<br>(Ensigner) | Transducer Front Face: Luran HD-20<br>(BASF)<br>Transducer Body: Tecason P (Ensigner) |
| Mains Input | 100 to 240 VAC 50 to 60 Hz | 100 to 240 VAC 50 to 60 Hz |
| Rechargeable<br>Battery | Lithium Ion (TCD Driver)<br>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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## Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission

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## 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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## 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,<br>non-invasive, non-ionizing radiation, point-of-care<br>transcranial Doppler (TCD) diagnostic ultrasound<br>system. It is designed to non-invasively measure<br>and display cerebral blood flow velocity over the<br>head and neck with a reusable, non-sterile 2-MHz<br>hand-held probe. It is also used bilaterally to monitor<br>the blood flow velocity of the vessels insonated via<br>the temporal window of the head with a headset<br>with two reusable, non-sterile 2-MHz monitoring<br>transducers. The system can also provide an emboli<br>count for emboli detection. | Equivalent<br>to Predicate |
| TCD 100 M (K002533) | The TCD 100M is a computer based ultrasound<br>system intended for transcranial Doppler (TCD), with<br>a single type of pulse wave Doppler transducer that<br>can be used free-hand (or mounted in a head frame<br>for longer term monitoring). This comprises a Track<br>1 device with output exceeding cephalic limits and<br>maximum Thermal Index Cranial included in the<br>labeling (user manual). An M-mode image is used to<br>help position the sample gate for Doppler signal,<br>and for detection of embolic signals. The m-mode<br>image does not represent a new insonation mode<br>but rather is an additional display of information from<br>the conventional pulsed Doppler signal. | |

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