COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM

K963290 · Endosonics Corp. · IYO · Aug 6, 1997 · Radiology

Device Facts

• Record ID: K963290
• Device Name: COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
• Applicant: Endosonics Corp.
• Product Code: IYO · Radiology
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This system is indicated for intra-luminal use in both peripheral and coronary applications.

Device Story

The Endosonics ColorFlo Option is an add-on for the Oracle InVision Intravascular Imaging System. It processes ultrasound signals from intravascular imaging catheters to provide a real-time color-coded map of relative blood velocity overlaid on standard 2D grayscale intravascular ultrasound (IVUS) images. Unlike conventional Doppler, which requires flow toward or away from the transducer, ColorFlo detects particle (red blood cell) flow perpendicular to the imaging plane (along the catheter's long axis) using ultrahigh-speed electronics and proprietary algorithms. Brighter colors indicate faster blood flow; slower motion is less bright; regions without motion appear in standard grayscale. The system is used by clinicians in clinical settings to visualize blood flow dynamics within vessels. The output assists physicians in assessing vascular flow, potentially aiding in the diagnosis and management of peripheral and coronary vascular conditions.

Clinical Evidence

Bench testing only. The document provides acoustic output measurements (I_apta and I_appa) for catheter models 82700/84700 and 82300/84300 to demonstrate safety and performance. No clinical study data is presented.

Technological Characteristics

Intravascular ultrasound imaging system with color velocity overlay. Utilizes ultrahigh-speed electronics and proprietary algorithms for signal processing. Operates in B-mode and Color Velocity Imaging modes. Acoustic outputs: I_apta 1.13–5.89 mW/cm², I_appa 3.71–20.77 W/cm². Compatible with 2.9F and 3.5F catheters. Internal system option requiring only a keyboard modification.

Indications for Use

Indicated for intra-luminal diagnostic ultrasound imaging and fluid flow analysis in peripheral and coronary vasculature. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Endosonic Cathscanner III Intravascular Imaging System
• Endosonics Visions Five 64 3.5F model 84700 Intravascular Imaging Catheter
• Endosonics Visions Five 64 F/X Model 82700 Intravascular Imaging Catheter
• Millar Mikro-Tip Doppler Catheter Model DC-101
• Small Vessel Balloon Angioplasty Catheter (Cook Incorporated)
• ATL Ultramark 8 Ultrasound Imaging System
• CVIS Insight System
• Platinum System with the CVI Option (Philips Imagings Systems)

Submission Summary (Full Text)

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K963290

# 510(k) Summary

Submitted By: Endosonics Corporation
3078 B Prospect Park Drive
Rancho Cordova, CA 95670
916-638-8008
Contact: Adam Savakus

Summary Preparation: August 20, 1996

Device: Endosonics ColorFlo Option for the Oracle InVision Intravascular Imaging System

Common or Usual Name: Ultrasonic Imaging System

Predicate Devices:
Endosonic Cathscanner III Intravascular Imaging System
Endosonics Visions Five 64 3.5F model 84700 Intravascular Imaging Catheter
Endosonics Visions Five 64 F/X Model 82700 Intravascular Imaging Catheter

Millar Mikro-Tip Doppler Catheter Model DC-101
Millar Instruments Incorporated
Houston, TX

Small Vessel Balloon Angioplasty Catheter
Cook Incorporated
Bloomington, IN 47402

ATL Ultramark 8 Ultrasound Imaging System
Advanced Technology Labs
Bothell WA

CVIS Insight System
Cardiovascular Imaging Systems
Sunnyvale, CA

Platinum System with the CVI Option
Philips Imagings Systems

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# 510(k) Summary

The Endosonics ColorFlo Option for the Oracle Imaging System is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide blood flow information. This additional flow information is provided as a color overlay over the standard 2D echo image.

The Endosonics Visions catheters and imaging system with the ColorFlo Option are substantially equivalent to existing devices such as the Endosonics Visions Microrail and Visions Model 54700 catheters with the Cathscanner II & III Imaging Systems, the Cook Small Vessel Balloon Angioplasty catheter, the ATL Ultramark 8 Imaging System, the Millar Mikro Tip Doppler catheter, the Philips Platinum Imaging System with the CVI Option, and the CVIS Insight imaging system and catheters.

The Endosonics ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System (the "ColorFlo Option") utilizes a novel patented technology to provide a visual depiction of blood flow through the vessel.

The ColorFlo technology can provide a two dimensional map of relative blood velocity which is overlayed onto the conventional black and white intravascular ultrasound image. Regions which contain faster moving red blood cells are signified by brighter colors, whereas regions of slow motion are less bright. Regions in which there is no or little motion perpendicular to the transducer are presented as clear, or non-colored. These regions appear in grey scale as in the standard display.

The ColorFlo processor detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. This is unlike conventional doppler imaging in which the blood must flow towards or away from the transducer. This is possible by utilizing ultrahigh speed electronics and Endosonics proprietary algorithms.

The ColorFlo system can detect blood velocities in the following range:

- The lower limit on particle detection is between 12 cm/sec and 5 cm/sec, depending on the intervening attenuation. (The higher limit is obtained with maximum tissue attenuation between the transducer and region of flow.)

- The upper limit on particle detection is between 110 cm/sec and 107 cm/sec, depending on the intervening attenuation. (The lower limit is obtained with maximum tissue attenuation between the transducer and region of flow.)

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The ColorFlo Option is available on the Endosonics Oracle InVision Imaging System. This option is an internal option, and no changes to the physical appearance of the system are made with the exception of an additional key on the keyboard.

The acoustic outputs for the 3.5F model 82700 and 84700 catheter when used with the Color Flo option were found to be:

$$
\begin{array}{l}
I_{\text{apta}} = 5.89 \ \mathrm{mW/cm^2} \\
I_{\text{appa}} = 20.77 \ \mathrm{W/cm^2}
\end{array}
$$

The acoustic outputs for the 2.9F model 82300 and model 84300 catheters in color mode operation were found to be:

$$
\begin{array}{l}
I_{\text{apta}} = 1.13 \ \mathrm{mW/cm^2} \\
I_{\text{appa}} = 3.71 \ \mathrm{W/cm^2}
\end{array}
$$

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG - 6 1997

Adam Savakus
Vice President
Clinical and Regulatory Affairs
Endosonics Corporation
3078-B Prospect Park Drive
Rancho Cordova, CA 95670

Re: K963290
ColorFlo Option for the Oracle In-Vision
Intravascular Ultrasound Imaging System
Dated: July 2, 1997
Received: July 3, 1997
Regulatory class: II
21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Savakus:

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 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.

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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 510(k) 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 the market.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

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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Ultrasound Device Indications Statement Page 1 of 2

510(k) Number (if known): K963290

Device Name: Oracle In-Vision Intravascular Ultrasound Imaging System with ColorFlo Option; Transducer Model 82700/84700

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

Additional Comments:

This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.

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

Concurrence of CDRH, Office of Device Evaluation (ODS)

Prescription Use (Per 21 CFR 801.109)


(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963290

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Ultrasound Device Indications Statement Page 2 of 2

510(k) Number (if known): K963290

Device Name: Oracle In-Vision Intravascular Ultrasound Imaging System with ColorFlo Option; Transducer Model 82300/84300

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

Additional Comments:

This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.

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

Concurrence of CDRN, Office of Device Evaluation (ODR)

Prescription Use (Per 21 CFR 801.109)