RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM

K965223 · Endosonics Corp. · IYO · Jun 29, 1998 · Radiology

Device Facts

• Record ID: K965223
• Device Name: RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
• Applicant: Endosonics Corp.
• Product Code: IYO · Radiology
• Decision Date: Jun 29, 1998
• 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: Intravascular Imaging; Coronary and Peripheral Vascular - all catheters use the same imaging mold.

Device Story

Resolve Option is a software enhancement for the Oracle InVision Intravascular Imaging System. It processes ultrasound data collected during uniform catheter withdrawal to generate a longitudinal 2D display of the vasculature, supplementing standard cross-sectional 2D echo images. The system includes a computer-assisted boundary detection function to identify vessel boundaries; operators must review, accept, or manually correct these boundaries before the system performs measurements. Used in clinical settings by physicians for intravascular imaging, the device aids in visualizing vessel morphology. It provides clinicians with additional anatomical information to support diagnostic decision-making and procedural planning during peripheral and coronary interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Software-based imaging enhancement for existing ultrasound systems. Provides 2D longitudinal display and computer-assisted boundary detection. Operates on the Oracle InVision platform. Acoustic output levels remain unchanged from the base system. No changes to hardware materials or sterilization methods.

Indications for Use

Indicated for diagnostic ultrasound imaging of the peripheral and coronary vasculature in patients requiring intravascular assessment.

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

• EndoSonics 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
• Echo-Scan System
• Tomtec Imaging System
• ATL Ultramark 8 & 9 Ultrasound Imaging System
• CVIS Insight System
• Philips DCI Angiographic Analysis System

Reference Devices

• EndoSonics Visions Microrail
• Visions Model 54700 catheters
• Cathscanner II Imaging System
• Cook Small Vessel Balloon Angioplasty catheter
• CVIS Ultra Imaging system

Submission Summary (Full Text)

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EndoSonics Corporation Oracle InVision Resolve Option
JUN 29 1998
510(k) Premarket Notification
December 30, 1996

# 510(k) Summary

K965223

## Submitted By:

EndoSonics Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
916-638-8008
Contact: Adam Savakus

## Summary Preparation:

December 24, 1996

## Device:

EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System

## Common or Usual Name:

Ultrasonic Imaging System

## Predicate Devices:

EndoSonics 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

Echo-Scan System
Tomtec Imaging System
Boulder, CO

ATL Ultramark 8& 9 Ultrasound Imaging System
Advanced Technology Labs
Bothell WA

CVIS Insight System
Cardiovascular Imaging Systems
A Boston Scientific Company
Sunnyvale, CA

Philips DCI Angiographic Analysis System
Philips Incorporated

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EndoSonics Corporation Oracle InVision Resolve Option
510(k) Premarket Notification
December 30, 1996

# 510(k) Summary

The EndoSonics Resolve 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 an alternative 2D display of ultrasound information. This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.

The EndoSonics catheters and imaging system with the Resolve 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 Philips DCI Angiographic analysis system, and the CVIS Insight and Ultra Imaging systems and catheters.

The acoustic outputs for all models remain unchanged due to the addition of the Resolve software option.

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

JUN 29 1998

Adam Savakus
Vice President, Clinical and Regulatory Affairs
Endosonics Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670

Re: K965223
Resolve Option for the Oracle InVision Intravascular
Ultrasound Imaging System
Regulatory Class: II
Product Code: 90 IYO
Dated: May 21, 1998
Received: May 22, 1998

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 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 catheters intended for use with the Oracle InVision Intravascular Ultrasound Imaging System and the Endosonics Automatic Pull-Back Device (Model PBD-1), as described in your premarket notification:

Catheter Model Number

| Visions™ 2.9 F Model 84300 | Visions™ F/X 2.9 F Model 82300 |
| --- | --- |
| Visions™ 3.5 F Model 84700 | Visions™ F/X 3.5 F Model 82700 |

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 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.

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Page 2 - Adam Savakus

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you 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 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 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

Enclosures

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Ultrasound Device Indications Statement Page 1 of 1

510(k) Number (if known): K965223

Device Name: RESOLVE Option for the ORACLE InVision System

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 | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | X | | | | | | | | |

Additional Comments:

Intravascular Imaging; Coronary and Peripheral Vascular - all catheters use the same imaging mold.

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

Concurrence of CDRN, Office of Device Evaluation (ODE)

David C. Segman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K965223

Prescription Use (Per 21 CFR 301.109)