INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD

K974588 · Rimed , Ltd. · IYN · Aug 7, 1998 · Radiology

Device Facts

• Record ID: K974588
• Device Name: INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD
• Applicant: Rimed , Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation

Device Story

Intra-View and Smart-Lite are bilateral transcranial Doppler systems. Devices utilize ultrasound transducers (2, 4, 8 MHz) to emit sound waves into the body and detect echoes from moving blood cells. Systems process these signals to perform fluid flow analysis and diagnostic imaging. Operated by clinicians in a medical setting, the systems provide real-time Doppler data to assist in assessing vascular conditions. Output is displayed for physician interpretation to support clinical decision-making regarding blood flow and vascular health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Ultrasound systems utilizing 2MHz, 4MHz, and 8MHz transducers. Modes of operation include Pulsed Wave Doppler (PWD) and Continuous Wave Doppler (CWD). Compliant with 21 CFR 892.1550.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in adult cephalic, ophthalmic, and peripheral vascular applications using 2MHz, 4MHz, and 8MHz transducers in pulsed wave Doppler (PWD) or continuous wave Doppler (CWD) modes.

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.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

Rimed Ltd. c/o A. Stein Regulatory Affairs Consulting P.O.B. 454 Ginot Shomron, 44853 Israel

K974588 Re: Trade Name: Intra-View Bilateral Transcranial Doppler Device and Smart-Lite Portable Bilateral Transcranial Doppler Device Regulatory Class: 1 1 Product Code: 90 IYN/21 CFR 892.1550 Dated: June 18, 1998 Received: June 29, 1998

Dear Ms. Stein:

We have reviewed your Section 510(k) 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 Intra-View and Smart-Lite Transcranial Doppler Systems, as described in your premarket notification:

Transducer Model Number

2MHz, 4MHz, 8MHz

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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Page 2 - A. Stein

If you desire specific advice for your device on our labeling regulation (21
CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2] CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | X | X | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

## Additional Comments: Intra-View Transcranial Doppler System 2, 4 and 8 MHz Transducers

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wilianh

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

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

| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

Additional Comments: Intra-View Transcranial Doppler System 2 MHz Transducer

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

Concurrence of CDRH, Office of Device Ev

vice Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 510(k) Number

{4}------------------------------------------------

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

| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

## Additional Comments: Intra-View Transcranial Doppler System 4 MHz Transducer

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

Concurrence of CDRH, Office of Device Evaluation (OD

Device Evaluation (ODE)

---

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number,

{5}------------------------------------------------

| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | X | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

## Additional Comments: Intra-View Transcranial Doppler System 8 MHz Transducer

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

Concurrence of CDRH, Office of Device Evaluation (CDE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

{6}------------------------------------------------

# Indications for Use Form

# 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: Mode of Operation

| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | X | X | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

### Additional Comments: Smart-Lite Transcranial Doppler System 2, 4 and 8 Mhz Transducers

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological J 510(k) Numbe

{7}------------------------------------------------

#### Indications for Use Form

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

| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

#### Additional Comments: Smart-Lite Transcranial Doppler System 2 MHz Transducer

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

vice Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974588

{8}------------------------------------------------

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

| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Mode of Operation | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

Additional Comments: Smart-Lite Transcranial Doppler System 4 MHz Transducer

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

Concurrence of CDRH, Office of Device Exaluation (OD)

Willians

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974588

Prescription Use (Per 21 CFR 801.109)

24

{9}------------------------------------------------

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

| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | X | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

Mode of Oneration

Additional Comments: _Smart-Lite Transcranial Doppler System 8 MHz Transducer

(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 of Reproductive, Abdominal, B and Radiological Devices 510(k) Number