VISTA BRITE TIP CATHETERS

K971572 · Cordis Corp. · DQY · Jul 14, 1997 · Cardiovascular

Device Facts

• Record ID: K971572
• Device Name: VISTA BRITE TIP CATHETERS
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature.

Device Story

Single lumen guiding catheter; nylon body with stainless steel braid wire; transition segments of varying durometer nylons for stiffness gradient; polyurethane Brite Tip segment with radiopaque filler. Used by physicians for intravascular delivery of interventional or diagnostic devices into coronary, peripheral, and neurovasculature. Facilitates access to target vascular sites.

Clinical Evidence

Bench testing only; biocompatibility testing successfully completed.

Technological Characteristics

Single lumen catheter; nylon body; stainless steel braid wire; polyurethane tip with radiopaque filler; variable durometer segments for stiffness transition.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into the coronary, peripheral, and neurovasculature. Prescription use only.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Cordis Vista Brite Tip
• Cordis Endovascular Systems, ENVOY Guiding Catheters
• DVI, Devices for Vascular Intervention

Submission Summary (Full Text)

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00-00008
K971572

## Summary Of Safety And Effectiveness

JUL 1 4 1997

| General Provisions | The name of the device is: |
|--------------------|----------------------------|
|--------------------|----------------------------|

| Proprietary Name | Common or Usual Name |
|------------------------------------------|-----------------------|
| Cordis Vista Brite Tip® Guiding Catheter | Percutaneous Catheter |

| Predicate Device | The names of the predicate devices are: <ul><li>Cordis Vista Brite Tip</li><li>Cordis Endovascular Systems, ENVOY Guiding Catheters</li><li>DVI, Devices for Vascular Intervention</li></ul> |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Classification | The FDA has classified guiding catheters as Class II. |
|----------------|-------------------------------------------------------|
|----------------|-------------------------------------------------------|

| Performance Standards | There are no performance standards applicable under Section 514 of the Food, Drug, and Cosmetic Act for Angiographic Catheters. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|

| Indications for Use | The Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Device Description | The Vista Brite Tip Guiding Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Continued on next page

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PREMARKET NOTIFICATION Cordis Corporation Vista Brite Tip® Catheter

## Summary Of Safety And Effectiveness, Continued

| Biocompatibility | All appropriate biocompatibility tests for the guiding catheters were successfully completed. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | The Cordis Guiding Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters. |

¹ Any statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suuites." 42 Fed. Reg. (1977).

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUM V SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of thick, stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacqueline Zimovan Regulatory Affairs & Clinical Research Associate Cordis Corporation JUL 1 4 1997 P.O. Box 025700 Miami, Florida 33102-5700

K971572 Re: Cordis Vista Brite Tip Catheters Requlatory Class: II (two) Product Code: DQY Dated: April 29, 1997 Received: April 30, 1997

Dear Ms. Zimovan:

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 reqistration, listinq 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. Existinq major requlations affectinq 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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.

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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,

Thomas J. Callahan

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

Enclosure

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## INDICATIONS FOR USE

| | 510(K) Number (if known): [To be assigned by the FDA] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Vista Brite Tip® Guiding Catheter |
| Indications for Use: | The guiding catheter is intended for use for intravascular<br>introduction of interventional/diagnostic devices into the coronary,<br>peripheral, and neurovasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Taua A. hy

(Division Sign-Off)

Division of Cardion and Neurological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _