HYPERTRANSIT INFUSION CATHETER

K043538 · Cordis Neurovascular, Inc. · KRA · Apr 18, 2005 · Cardiovascular

Device Facts

• Record ID: K043538
• Device Name: HYPERTRANSIT INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use

Device Story

Variable stiffness, single-lumen infusion catheter; designed for access to small, tortuous vasculature. Features hydrophilic coating for lubricity; PTFE-lined inner lumen for guidewire/device movement; radiopaque body and distal marker for fluoroscopic visualization. Select configurations include pre-shaped tips. Used by physicians in clinical settings (e.g., cath lab) for delivery of diagnostic, embolic, or therapeutic agents and for guidewire support during interventional procedures. Output is the delivery of agents to target vessels; visualization under fluoroscopy aids physician navigation and placement. Benefits include improved access to complex vascular anatomy and precise agent delivery.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing (dimensional inspection, joint pull, burst testing, particulate testing, coating integrity, flow rate) and acute animal studies.

Technological Characteristics

Variable stiffness, single-lumen catheter; PTFE-lined inner lumen; hydrophilic coating; radiopaque body and distal marker. Available in various configurations including pre-shaped tips. Sterilization method not specified.

Indications for Use

Indicated for infusion of diagnostic, embolic, and therapeutic agents in coronary, neuro, and peripheral vasculatures; guidewire exchange/support; and superselective angiography of peripheral and coronary vessels.

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

• MASSTRANSIT® Infusion Catheter (K983003)
• Renegade HI-FLO Microcatheter (K000177)
• PROWLER® SELECT™ Infusion Catheters (K021591)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Applicant's<br>Name | Cordis Neurovascular, Inc.<br>14000 NW 57th Court<br>Miami, Florida 33014 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Maritza Celaya<br>Regulatory Affairs Manager<br>[phone]<br>[phone] (Fax) |
| Trade Name /<br>Common Name | The trade name of the device is: HYPERTRANSIT™ Infusion Catheter.<br>The common name of the device is: Catheter, Continuous Flush. |
| Classification | These devices have been classified as Class II, per 21 CFR 870.1210 (KRA)<br>which have been classified within the Division of Cardiology and Respiratory<br>Devices. |
| Performance<br>Standard | There are no performance standards applicable under Section 514 of the<br>Food, Drug and Cosmetic Act for Continuous Flush Catheters. |
| Intended Use | The HYPERTRANSIT™ Infusion Catheter is intended to be used as a<br>mechanism for the infusion of various diagnostic and embolic agents in the<br>coronary, neuro and peripheral vasculatures, for guidewire exchange/support<br>and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the<br>coronary and peripheral vasculature. |
| | All agents must be used in accordance with manufacturer's instructions for<br>use |
| Device<br>Description | The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a<br>variable stiffness, single lumen catheter designed to access small, tortuous<br>vasculature. Each configuration has a hydrophilic coating to provide lubricity<br>for navigation of vessels. The inner lumen is lined with PTFE to facilitate<br>movement of guidewires and other devices. The catheter body is radiopaque<br>to aid visualization under fluoroscopy, and the distal tip is distinguished by a<br>radiopaque marker. Select configurations are available with pre-shaped tips. |

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

The predicate devices are listed in the table below: Predicate Devices

| Device | Company | 510(k)<br>Number | Product Code | Predicate for: |
|-------------------------------------------|----------------------------------|------------------|--------------|--------------------------------------------|
| MASSTRANSIT®<br>Infusion Catheter | Cordis<br>Neurovascular, Inc. | K983003 | KRA | Intended Use<br>Sterilization |
| Renegade HI-FLO<br>Microcatheter | Boston Scientific<br>Corporation | K000177 | KRA | Intended Use<br>Dimensions<br>Performance |
| PROWLER®<br>SELECT™ Infusion<br>Catheters | Cordis<br>Neurovascular, Inc. | K021591 | KRA | Intended Use<br>Sterilization<br>Packaging |

## The following in-vitro and in-vivo testing was conducted to support Summary of substantial equivalence to the predicate devices. Studies

| <b>Comparative Testing</b> |
|------------------------------------------------------------|
| Linear Stiffness |
| Flow Rate Testing |
| Shape Retention |
| Acute Animal Studies |
| Embolic Particle (PVA) Functional Compatibility<br>Testing |
| Pushable Coil Functional Compatibility Testing |

The following in-vitro and in-vivo testing was conducted to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended.

| Performance Testing |
|--------------------------|
| Dimensional Inspection |
| Joint Pull Test |
| Static Burst Test |
| Dynamic Burst Test |
| Particulate Testing |
| Coating Integrity |
| Flow Rate Testing |
| Acute Animal Studies |
| Biocompatibility Testing |

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| Summary of | The HYPERTRANSIT™ Infusion Catheter is similar in its basic design |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Substantial | indication for use, sterilization, and performance characteristics to the |
| Equivalence | predicate devices, the MASSTRANSIT® Infusion Catheter, the PROWLER® SELECT™ Infusion Catheter and the Renegade HI FLO Microcatheter. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2005

Ms. Maritza Celaya Regulatory Affairs Manager Cordis Neurovascular, Inc. P.O. Box 025700 Miami, FL 33102-5700

Re: K043538

Trade/Device Name: HYPERTRANSIT™ Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: March 18, 2005 Received: March 21, 2005

Dear Ms. Celaya:

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Maritza Celaya

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
t (2005) (2000) (2006) (2006) (20053) (20053) 542 of the Act): 21 CFR 1000-1 forth in the quality systems (QS) regulation (21 -51 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 31 cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA imding of substantial equive 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), please
r the register and and any and 18 10 - Alge, also, alless note the regulati If you desire specific advice for your uc vice on on A. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the r contact the Office of Compilalice at (24) 270 - 1207 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR from the Division of Small "Misbranding by reference to prematicilities under the Act from the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-200 other general internation on your responsionines and its toll-free number [phone] or 1980)
Manufacturers, International and Consumer Assistance at its toll-arcery/supp Manufacturers, International and Consumer Assistance at les confire and consistements of the

Sincerely yours,

R. Wichner

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 Effective Date: 11/15/00

Image /page/5/Picture/2 description: The image shows the word "Cordis" in a bold, sans-serif font. A horizontal line is drawn underneath the word. Below the line, the text "a Johnson & Johnson company" is written in a cursive font. The logo is simple and corporate, likely representing the brand identity of Cordis, a company owned by Johnson & Johnson.

Page 1 of 1

510(k) Number (if known):

Device Name: HYPERTRANSIT™ Infusion Catheter

## Indications for Use Statement

The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and perioheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of theraseutic agents in the coronary and peripheral vasculature.

All agents must be used in accordance with manufacturer's instructions for use

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Mana K. Jochner

Prescription Use ✓

Division Slan-Off) ardiovascular De goer-The-Counter Use____

510(k) Number K04