TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER

K972518 · Cordis Neurovascular, Inc. · KRA · Nov 4, 1997 · Cardiovascular

Device Facts

• Record ID: K972518
• Device Name: TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or provide support to facilitate the placement of guidewires.

Device Story

Single-lumen infusion catheter with variable stiffness shaft; designed for navigation through peripheral, coronary, and neurovasculatures. Features hydrophilic outer coating and PTFE-lined lumen for lubricity and trackability; proximal shaft reinforced with stainless steel braid for pushability. Used by clinicians in interventional procedures to deliver diagnostic, embolic, or therapeutic agents; also facilitates guidewire exchange and placement. Device provides mechanical access to target vasculature; clinical benefit derived from targeted agent delivery and procedural support.

Clinical Evidence

Bench testing only. Biocompatibility testing successfully performed.

Technological Characteristics

Single-lumen catheter; variable stiffness shaft; stainless steel braid reinforcement; PTFE lumen liner; hydrophilic outer coating. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring selective infusion of diagnostic, embolic, or therapeutic agents into peripheral, coronary, or neurovasculatures, or for guidewire exchange and placement support.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• CES Infusion Catheters (K965181)
• Venture™ II Infusion Catheter (K945904)
• UltraFuse-X™ Infusion/Guide Wire Exchange Catheter (K952872)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows two lines of text. The first line reads "0-000016". The second line reads "K972518". The text appears to be handwritten in a bold, sans-serif font.

## Summary of Safety and Effectiveness

NOV - 4 1997

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| General<br>Provisions | Common or Usual Name: Continuous Flush Catheter |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Trade Name: CES Infusion Catheters, including Transit™ Infusion Catheter RapidTransit™ Infusion Catheter Speedster™ Infusion Catheter Prowler™ Infusion Catheter |

| Predicate | The predicates are listed in the table below |
|-----------|----------------------------------------------|
| Devices | Devices |

| Device | Company | 510(k) Number,<br>Clearance Date | Product Code | Predicate for: |
|----------------------------------------------------------|--------------------------------------|----------------------------------|--------------|------------------------------------------------------|
| CES Infusion<br>Catheters | Cordis Endovascular<br>Systems, Inc. | K965181, 3/21/97 | KRA | Design, materials,<br>sterilization and<br>packaging |
| Venture™ II<br>Infusion Catheter | Scimed Life Systems | K945904, 5/19/95 | KRA | Indications/claims |
| UltraFuse-X™<br>Infusion/Guide Wire<br>Exchange Catheter | Scimed Life Systems | K952872, 7/27/95 | KRA | Indications/claims |

## Classification Class II

Performance Performance standards have not been established by the FDA under Standards Section 514 of the Food, Drug and Cosmetic Act.

{1}------------------------------------------------

| Intended Use | CES Infusion Catheters are intended to be used as a mechanism for<br>the selective infusion of various diagnostic, embolic and therapeutic<br>agents into the peripheral, coronary and neurovasculatures. The<br>catheters can also be used to exchange one guidewire for another or<br>provide support to facilitate the placement of guidewires. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The CES Infusion Catheters contain a single lumen and a variable<br>stiffness shaft in order to traverse and deliver agents to the coronary,<br>peripheral and neurovasculatures. The outside of the shaft includes a<br>hydrophilic coating and the lumen is lined with PTFE in order to<br>increase lubricity and trackability. The proximal shaft is reinforced<br>with a stainless steel braid to enhance pushability. |
| Biocompatibility | All applicable biocompatibility tests were successfully performed on<br>the CES Infusion Catheters. |
| Summary of<br>Substantial<br>Equivalence | The CES Infusion Catheters are substantially equivalent* in design,<br>materials, sterilization and indications for use to other commercially<br>available catheters. |

^* A statement of substantial equivalence to another product is required by 21CFR 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 suits" 42 Fed. Reg. 42,520, et seg. (1977).

{2}------------------------------------------------

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. . . . . . .

Ms. Lisa Wells Cordis Endovascular Systems, Inc. 14740 N.W. 60th Avenue Miami Lakes, Florida 33014

Re : K972518 CES Infusion Catheters Regulatory Class: II (two) Product Code: 74 KRA - -Dated: October 22, 1997 Received: October 23, 1997

Dear Ms. Wells:

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 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.

NOV - 4 1997

{3}------------------------------------------------

Page 2 - Lisa Wells

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 requlation (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. 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 ·

{4}------------------------------------------------

510(k) Number: K972518

## INDICATIONS FOR USE

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Tan A. Pr

(Division Sign-Off) Division of Cardinatoriatoria: Respiratory, and Neurological Devices 9725 18 510(k) Number _