NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM

K060112 · Nodecrest, LLC · IYN · May 5, 2006 · Radiology

Device Facts

• Record ID: K060112
• Device Name: NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
• Applicant: Nodecrest, LLC
• Product Code: IYN · Radiology
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values 2) 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 mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Nodecrest Transcranial Doppler is intended for use during: a) Diagnostic exams b) 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.

Device Story

EMS9U Transcranial Doppler (TCD) system; uses pulse wave (PWD) and continuous wave (CWD) Doppler transducers (2MHz, 4MHz, 8MHz) to measure blood velocity and detect micro-embolic signals. Operates free-hand or head-frame mounted. Supplementary M-mode display assists in locating blood flow signals and positioning sample gates. System hardware identical across three models; software features differentiate functionality. Used in diagnostic exams and surgical interventions by clinicians. Output provides real-time blood flow data for hemodynamic assessment. Benefits include non-invasive monitoring of cerebral blood flow and emboli detection.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through electrical safety testing (IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, UL 2601-1) and biocompatibility testing (cytotoxicity, sensitization, skin irritation, acute toxicity, intracutaneous reactivity, implantation).

Technological Characteristics

TCD ultrasound system; 2MHz, 4MHz, 8MHz transducers. PWD and CWD modes. FFT-based frequency spectrum analysis (256/512 dots). Depth measurement 5-136 mm. Gain 0-40dB. Electrical safety per IEC 60601-1 series. Biocompatibility per ISO 10993 and USP standards. Software-controlled feature set.

Indications for Use

Indicated for diagnostic ultrasound fluid flow analysis in adults. Used for measuring cerebral artery blood velocities and assessing arterial cerebral blood flow for micro embolic signals. Vessels include middle, anterior, and posterior cerebral arteries, vertebral mid basilar arteries, ophthalmic artery, and intracranial internal carotid artery. 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

• Rimed Smart-Lite™ Transcranial Doppler (K974588)

Submission Summary (Full Text)

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K060112

# Noderrest LLC MAY - 5 2006

## SUMMARY STATEMENT

| Contact Person: | David G. Pegler |
|-----------------------|-----------------------------------------------------------------------|
| Address: | Nodecrest LLC<br>1478 Powells Tavern Place<br>Herndon, Virginia 20170 |
| Phone: | 703-627-6636 |
| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic |
| Common Usual Name: | Transcranial Doppler Ultrasound System |
| Classification: | Class II |
| Product Code: | 90 IYN |
| Classification Panel: | Radiology |

### Device Description

The EMS9U range is a Transcranial Doppler (TCD) diagnostic ultrasound system, with a pulse wave and / or continuous wave Doppler transducer that can be used free hand (or head frame mounted for longer term monitoring). A supplementary M-mode disala ( nay be used to help locate blood flow signals to position the sample gate for Doppler signal, and for detection of emboli signals. Each of the three models in the range is identical in terms of hardware the difference being features that the end user does not request are turned off in the software.

### Intended Use

The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:

1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values

2) 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

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vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.

The Nodecrest Transcranial Doppler is intended for use during:

- a) Diagnostic exams
b) 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.

| Parameters | Nodecrest | Rimed Ltd. |
|-----------------------------------|---------------------------------------------------------------|-------------------------------------|
| 510(k) Number | | K974588 |
| Transducer Frequency | 2MHz, 4MHz, 8MHz | 2MHz, 4MHz, 8MHz |
| Frequency Spectrum | FFT 256/512 dots | 64/512 dots |
| Frequency Ranges | 1 to 16 MHz | 2 to 32 MHz |
| Depth Measurement | 5 to 136 mm | 15-150 mm |
| Gain | 0 ~ 40db | Manually control 20 steps |
| Clinical Application<br>for: 2MHz | | |
| PWD | Ophthalmic, Adult Cephalic<br>& Peripheral Vascular | Ophthalmic, Adult Cephalic |
| CWD | Ophthalmic & Peripheral<br>Vascular | Ophthalmic & Peripheral<br>Vascular |
| Clinical Application<br>for: 4MHz | | |
| PWD | Peripheral Vascular | |
| CWD | Peripheral Vascular | Peripheral Vascular |
| Clinical Application<br>for: 8MHz | | |
| PWD | Peripheral Vascular | |
| CWD | Peripheral Vascular | Ophthalmic & Peripheral<br>Vascular |
| General Electrical<br>Testing | IEC 60601-1-1,<br>IEC 60601-1-2, IEC 60601-<br>1-4, UL 2601-1 | EN 60601-1-1 &<br>EN 60601-1-2 |
| Biocompatibility Tests | | |
| ISO 10993 | Cytotoxicity, Sensitization | Unknown |

### 12.1 Product Comparison Chart

22

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| | skin irritation | |
|-----|------------------------------------------------------------------------------|---------|
| USP | Acute Toxicity,<br>Intracutaneous Reactivity,<br>Implantation & Cytotoxicity | Unknown |

# 12.2 Summary of Safety and Effectiveness:

The Nodecrest Transcranial Doppler Ultrasound System and the Rimed Smart-Lite™ Transcranial Doppler have similar intended use: both offer similar transducer frequency, frequency spectrum, frequency ranges, depth measurement, gain, and offer similar clinical applications. Both systems meet IEC 60601-1 & IEC 60601-1-2 Standards for general electrical safety of medical devices and electrical emissions.

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DEPARTMENT OF HEALTH & HUMAN SERVICE

Public Health Se

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nodecrest, LLC % Mr. E. J. Smith President Smith Associates 1676 Village Green, Suite A CROFTON MD 21114

MAY 5 2006

Re: K060112

Trade Name: Nodecrest Transcranial Doppler Ultrasound System

Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic pulsed doppler imaging system

Regulation Number: 21 CFR 892.1570

Regulation Name: Diagnostic ultrasonic transducer

Regulatory Class: II

Product Code: IYN and ITX

Dated: March 1, 2006

Received: March 2, 2006

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Nodecrest Transcranial Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

| 2 MHz |
|-------|
| 4 MHz |
| 8 MHz |

Image /page/3/Picture/20 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in bold in the center of the logo.

Investing and Promoting Public Health

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at [phone].

Sincerely yours,

David A. Lyman

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (If known): < 060112

Device Name: Nodecrest Transcranial Doppler Ultrasound System

Indications for Use:

The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:

1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values

2) 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 mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eve.

The Nodecrest Transcranial Doppler is intended for use during:

- a) Diagnostic exams
b) 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Depaon

ive. Abdominal

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148 - 124 - 12

And and and the same of the states

#### Diagnostic Ultrasound Indications for Use Form

Friday of the commend to the states

#### Fill out one form for each ultrasound system and each transqucer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the hurnan body as follows:

| Clinical Application: | A | B | M | PWID | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|------|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: EMS 9U TRANSCRANIAL Doppler SYSTEM 2MHz PROBE

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

(Division Sign-Oll)
Division of Reproductive, Abdominal, F-3 and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

011

:

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19, 2017

#### Disgnostic Uitrasound Indications for Use Form

Fill out one form for cech ultrasound system and each transduder.

Intended Use: Diagnostic ultrasound imaging or fivid flow andlysis of the human body as follows:

| | | Mode of Operation | | | | | | | | | | |
|-------------------------------|---|-------------------|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | X | X | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

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

Additional Comments: EMS9U TRANSCRANIAL DOPPLE

SYSTEM 4MHZ PROBE

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

F-3

Prescription Use (Per 21 CFR 801.109)

Daniel A. Larson

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 5 புரு) Number

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Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | XX | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N= new Indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: EMS9U TRANSCRANIAL DOPPER SYSTEM

8MHZ PROBE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

F-3

Daniel A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal,
and Radiological Devices A (Alol 510(k) Number _

:

19