PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

K020680 · Cordis Neurovascular, Inc. · KRA · Mar 27, 2002 · Cardiovascular

Device Facts

• Record ID: K020680
• Device Name: PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 27, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROWLER® SELECT™ Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

Device Story

Single-lumen infusion catheter; stiff proximal shaft; flexible distal section; radiopaque body with distal markers; hydrophilic coating; PTFE inner liner. Used by physicians in neuro, peripheral, and coronary vascular procedures. Functions as conduit for infusion of diagnostic, embolic, or therapeutic agents; provides guidewire support/exchange; facilitates superselective angiography. Device is inserted into vascular system to deliver agents or support interventional tools. Benefits include targeted delivery of therapeutic agents and improved access to distal vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included outer diameter inspection, visual inspection, flexible coil/distal zone length inspection, lateral stiffness, trackability, joint pull test, and static burst testing. All materials confirmed biocompatible.

Technological Characteristics

Single-lumen catheter; stiff proximal shaft; flexible distal section; radiopaque body with distal markers; hydrophilic coating; PTFE inner liner. Accommodates .014" guidewires. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring infusion of diagnostic, embolic, or therapeutic agents into neuro, peripheral, or coronary vascular systems, guidewire exchange/support, or superselective angiography. For prescription use only.

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

• PROWLER® Infusion Catheters (K965181, K972518)
• PROWLER® PLUS Infusion Catheters (K993266)
• PROWLER® Infusion Catheters with pre-shaped tips (K003925)

Submission Summary (Full Text)

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# MAR 2 7 2002

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## Summary of Safety and Effectiveness

| Submitter's Name/Contact Person | The submitter of this special 510(k) is:<br>Cordis Neurovascular, Inc.<br>14000 N.W. 57th Court<br>Miami Lakes, Florida 33014<br><br>Establishment Registration No. 1058196<br><br>Contact: Maritza Celaya<br>Sr. Regulatory Affairs Associate<br><br>Tel: [phone]<br>Fax: [phone]<br><br>March 1, 2002 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name / Common Name | Trade Name: PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips<br><br>Common/Classification Name: Catheters, Continuous Flush |
| Classification | Class II |
| Performance Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards. |
| Intended Use and Device Description | The PROWLER® SELECT™ Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures. |
| Device Description | The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .014" and smaller depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen. |

Continued on next page

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

| Device | Company | 510 (k) Number | Product Code |
|--------------------------------------------------------|-------------------------------|--------------------|--------------|
| PROWLER®<br>Infusion Catheters | Cordis Neurovascular,<br>Inc. | K965181<br>K972518 | 74KRA |
| PROWLER® PLUS<br>Infusion Catheters | Cordis Neurovascular,<br>Inc. | K993266 | 74KRA |
| PROWLER®<br>Infusion Catheters<br>with pre-shaped tips | Cordis Neurovascular,<br>Inc. | K003925 | 74KRA |

### Summary of Studies

Design verification testing showed that the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips performed as intended. No new questions of safety and effectiveness were raised. Design verification testing included:

- . Outer Diameter Dimension Inspection (pre-coating)
- Visual Inspection .
- . Flexible Coil Length Inspection/Distal Zone Length Inspection
- Lateral Stiffness .
- . Trackability
- Joint Pull Test .
- Static Burst Testing .

All materials used in the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are biocompatible.

Summary of Substantial Equivalence

The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 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 a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Ms. Maritza Celaya Sr. Regulatory Affairs Associate Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014

Re: K020680

> PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without preshaped tips Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: March 1, 2002 Received: March 4, 2002

#### 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.

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Page 2 - Ms. Maritza Celaya

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 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 your 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,

Elias Mallis

Ron

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement

Page 1 of 10 - 0 0 0 Effective Date: 11/15/00

Page 1 of 1

510(k) Number (if known): K020680

Device Name: PROWLER® SELECT™ 10 and 14 Infusion Catheters (with and without pre-shapes)

### Indications for Use Statement

The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the interiment of variousing of vailouire I he F N W HER SEELCY - Intelsion Catents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire diagnoste, ontoone, and therepount and ingraphy of the peripheral and coronary vasculatures.

> Division of Cardiovascular & Respiratory Devices 510(k) Number 112200 mostis Kozo680

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

OR

Over-The-Counter Use