MODIFICATION TO SUPERCROSS CATHETER

K014118 · Abbott Vascular, Inc. · DQY · Jan 11, 2002 · Cardiovascular

Device Facts

• Record ID: K014118
• Device Name: MODIFICATION TO SUPERCROSS CATHETER
• Applicant: Abbott Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

Device Story

SuperCross Catheter is a percutaneous catheter used to navigate stenotic or tortuous peripheral arteries (iliac, femoral, popliteal, tibial, renal). Device features 7 French compatible shaft (stainless steel braided polyimide/polyurethane) with hydrophilic coating; distal end includes steerable dilator actuated by wire/lever; proximal end includes handle and rotating hemostasis valve. Operator (physician) uses device to facilitate placement/positioning of other catheters. Guidewire lumen accepts 0.018" non-polymer coated guidewire. Device is purely mechanical; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

7 French compatible; stainless steel braided polyimide and polyurethane shaft; hydrophilic coating; steerable distal dilator; rotating hemostasis valve; 0.018" guidewire lumen. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring navigation of stenotic or tortuous iliac, femoral, popliteal, tibial, and renal arteries to facilitate placement/positioning of other catheters. Contraindicated for use in coronary or cerebral vasculature and for lesion dilation.

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

• SuperCross™ Catheter (K001856)

Submission Summary (Full Text)

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Perclose, Special 510(k) Application SuperCross™ Catheter Confidential

## VII. SPECIAL 510(k) SUMMARY

K014118

| A. | Sponsor/Submitter: | Perclose, An Abbott Laboratories Company<br>400 Saginaw Drive<br>Redwood City, CA 94063<br>Tel: [phone]<br>Fax: [phone] |
|----|------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | B. Contact Person: | Sevrina Ciucci<br>Regulatory Affairs Coordinator<br>[phone] |
| | C. Date of Submission: | December 12, 2001 |
| D. | Trade (Brand) Name: | SuperCross™ Catheter |
| E. | Common Name: | Percutaneous Catheter |
| F. | Classification: | Class II |
| G. | Classification Name: | Percutaneous Catheter, 21 CFR Part 870.1250 |
| H. | Product Code: | 74DQY |
| I. | Predicate Device: | SuperCross™ Catheter (K001856) |

#### J. Intended Use:

The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

### Device Description: K.

The SuperCross Catheter features a 7 French compatible hydrophilically coated stainless steel braided polyimide and polyurethane shaft, which is attached to a steerable dilator at the distal end of the device. The proximal end of the shaft is connected to a handle and rotating hemostasis valve assembly. The dilator consists of two halves. One half articulates about a hinge pin and the other half is fixed to the shaft. The dilator is actuated by a wire connected to a lever and it may be rotated 360 degrees with the control of the shaft. A guidewire lumen through the device accepts a non-polymer coated 0.018" guide wire.

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### L. Summary of Substantial Equivalence:

Perclose has submitted information on the indication for use, design, principle of operation, biocompatibility and performance characteristics to establish that the SuperCross Catheter is equivalent to currently marketed predicate device.

The SuperCross Catheter has the same intended use and technological characteristics as the predicate device (K001856). Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use.

In conclusion, the SuperCross Catheter has been shown to be equivalent to the Class II predicate, the previous generation SuperCross Catheter, on which the device is based.

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The logo is black and white and appears to be a scan of a document.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

Ms. Sevrina Ciucci Regulatory Affairs Perclose, An Abbott Laboratories Company 400 Saginaw Drive Redwood City, CA 94063

Re: K014118

Trade Name: SuperCross™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 12, 2001 Received: December 14, 2001

Dear Ms. Ciucci:

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. Sevrina Ciucci

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,

Odegtall
Bram D. Zuckerman, M.D.

Bram D. 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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# V. INDICATIONS FOR USE STATEMENT

Special 510(k) Number:

K014118

Device Name:

Indications for Use:

SuperCross™ Catheter The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

There is no change to the Indications for Use.

Division of Cardiovascular & Respiratory Devices
510(k) Number K014118

**Prescription Use**
**(Per 21 CFR 801.109)**