MODIFICATION TO ENVOY AND VISTA BRITE TIP

K021593 · Cordis Corp. · DQY · Jun 13, 2002 · Cardiovascular

Device Facts

• Record ID: K021593
• Device Name: MODIFICATION TO ENVOY AND VISTA BRITE TIP
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems. Envoy – The Envoy guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional / diagnostic devices.

Device Story

Single lumen guiding catheter; 6 French (0.070" ID); reinforced body with tightly wound stainless steel braid wire; variable durometer transitions for stiffness gradient from body to tip; polycarbonate hub. Used by physicians for intravascular delivery of interventional or diagnostic devices into coronary, peripheral, or neurovascular systems. Device facilitates access to target vasculature.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

6 French (0.070" ID) single lumen catheter; reinforced body with stainless steel braid wire; variable durometer polymer construction for stiffness transition; polycarbonate hub. Biocompatible materials. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into the coronary, peripheral, or neurovascular systems.

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

• Vista Brite Tip® and Envoy® Guiding Catheters

Submission Summary (Full Text)

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# Attachment - 4

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# 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | Trade Names: Vista Brite Tip® and Envoy® Guiding Catheters<br>Common/Classification Name: Percutaneous Catheter |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | • Vista Brite Tip® and Envoy® Guiding Catheters |
| Classification | Class II |
| Performance<br>Standards | No performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for Percutaneous Catheters. |
| Intended Use<br>and Device<br>Description | Vista Brite Tip - The guiding catheter is intended for use for intravascular<br>introduction of interventional / diagnostic devices into the coronary or<br>peripheral vascular systems.<br><br>Envoy – The Envoy guiding catheter is intended for use in the peripheral,<br>coronary, and neurovasculature for the intravascular introduction of<br>interventional / diagnostic devices.<br><br>Device Description:<br>• 6 French (ID 0.070");<br>• Single lumen catheter with a reinforced body (tightly wound stainless<br>steel braid wire);<br>• Catheter body transitions provide a gradual decrease in material stiffness<br>(varying durometers) from the body to the tip; and,<br>• Polycarbonate hub. |
| Biocompatibility | All materials used in the these devices are biocompatible. |

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#### Attachment - 4 - 510(k) Summary of Safety and Effectiveness, continued

The Cordis Vista Brite Tip® and Envoy® Guiding Catheters are substantially Summary of equivalent to the previously cleared Cordis Vista Brite Tip® and Envoy® Guiding Substantial Equivalence Catheters.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

Cordis Corporation Stephen M. Enos, RN Manager, Regulatory Affairs 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K021593

6F (0.070") Vista Brite Tip® and Envoy® Guiding Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: 74 DQY Dated: May 14, 2002 Received: May 15, 2002

Dear Mr. Enos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Stephen M. Enos, RN

CFR Part 807); iabeling (21 CFR Part 801); good manufacturing practice requirements as set. forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Della Till

Donna-Bea Tillman. Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment - 2

### Indications for Use Statement

| 510(k) Number (if known) | The 510(k) number has not yet been assigned. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 6F (0.070") Vista Brite Tip® and Envoy® Guiding Catheters |
| Indications for Use | Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.<br>Envoy - The Envoy guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional / diagnostic devices. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dalatur
Division of Cardiovascular & Respiratory Devices
510(k) Number K021593

Prescription Use /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________