VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)

K982329 · Endosonics Corp. · ITX · Jan 14, 1999 · Radiology

Device Facts

• Record ID: K982329
• Device Name: VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
• Applicant: Endosonics Corp.
• Product Code: ITX · Radiology
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide: - An image of the vessel lumen and wall structures. (1) - (2) Dimensional measurements from the image.

Device Story

The Visions 8.2F PV is an over-the-wire intravascular ultrasound (IVUS) imaging catheter. It functions as an adjunct to conventional angiography to provide cross-sectional visualization of vessel lumen and wall structures in the peripheral vasculature. The device is operated by clinicians in a clinical setting. It captures ultrasonic signals to generate images, which are then used by the healthcare provider to assess vascular morphology and perform dimensional measurements. This information assists in clinical decision-making during vascular procedures, potentially benefiting the patient by providing detailed anatomical data beyond standard angiography.

Clinical Evidence

Bench testing only. Testing included radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. Acoustic output measurements were also reported (0.0158 mW/cm, 0.044 W/cm2, 0.012 MI). No clinical data was provided.

Technological Characteristics

Over-the-wire intravascular ultrasound imaging catheter; 7.0F shaft with 8.2F maximum distal diameter. Constructed from biocompatible materials. Operates as an ultrasonic imaging device. Connectivity and software details are not specified in the provided documentation.

Indications for Use

Indicated for patients requiring evaluation of vascular morphology in peripheral vasculature blood vessels as an adjunct to conventional angiographic procedures.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter
• EndoSonics Cathscanner Model 302 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

Submission Summary (Full Text)

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K982329

## JAN 1 4 1999

EndoSonics Corporation
Visions 8.2F PV Models 88900

510(k) Premarket Notification
June 30, 1998

## 510(k) Summary

| Submitted By: | EndoSonics Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670<br>916-638-8008<br>Contact: Adam Savakus |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | June 30, 1998 |
| Device: | EndoSonics Visions 8.2F PV Intravascular Imaging Catheter |
| Common or Usual Name: | Ultrasonic Imaging Catheter |
| Predicate Devices: | EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter |
| | EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter |
| | Millar Mikro-Tip Doppler Catheter Model DC-101<br>Millar Instruments Incorporated<br>Houston, TX |
| | Small Vessel Balloon Angioplasty Catheter<br>Cook Incorporated<br>Bloomington, IN 47402 |
| | ATL Ultramark 8 Ultrasound Imaging System<br>Adva...l Techno'ogy Labs<br>Bothell WA |
| | CVIS Insight System<br>Cardiovascular Imaging Systems<br>Sunnyvale, CA |

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## 510(k) Summary

The EndoSonics Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.

The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.

The EndoSonics Visions 8.2F PV catheter is substantially equivalent to existing devices such as the EndoSonics Cathscanner Model 302 and Visions Model 84700 catheters with the Oracle (Cathscanner III) Imaging System, the Cook Small Vessel Balloon Angioplasty catheter, the ATL Ultramark 8 imaging system, the Millar Mikro Tip Doppler catheter, and the CVIS Insight imaging system and catheters

All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed.

Testing of the EndoSonics Visions catheters include radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the devices meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip show that the catheter tip met design specifications.

The acoustic outputs for the Visions 8.2F PV catheter were found to be:

= 0.0158 mW/cm-= 0.044 W/cm2 = 0.012 MI

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 4 1999

Mr. Adam Savakus Vice President, Clinical and Regulatory Affairs EndoSonics Corporation 2870 Kigore Road Rancho Cordova, CA 95670

Re: K982329 Trade Name: Visions 8.2F PV Ultrasoinic Imaging Catheter (Model 88900) Regulatory Class: II Product Code: ITX Dated: October 16, 1998 Received: October 19, 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.

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Reqister. Please note: this

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Page 2 - Mr. Adam Savakus

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 diaqnostic 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

K98 2329

Visions 8.2F PV Ultrasoinic Imaing Catheter (Model 88900) Device Name:

Indications for Use:

The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.

The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:

- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chrityl-mytten

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)