ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1

K031417 · Intra Luminal Therapeutics, Inc. · DQY · Jul 11, 2003 · Cardiovascular

Device Facts

• Record ID: K031417
• Device Name: ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ILT Safe-Cross® .035" Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

Single-lumen intravascular support catheter; 135 cm length; 4.4 French diameter. Used in conjunction with steerable guide wires to access remote cardiovascular regions; facilitates guide wire exchange; provides conduit for saline or diagnostic contrast agents. Operated by physicians in clinical settings. Device provides mechanical support for wire navigation; does not perform automated analysis or processing. Benefits include improved access to difficult vascular anatomy.

Clinical Evidence

Bench testing only. Biocompatibility testing and in vivo performance studies conducted to verify functional requirements and material safety.

Technological Characteristics

Single-lumen catheter; Biocoat Hydak® hydrophilic coating; 135 cm effective length; 4.4 French (0.057") max OD; 0.041" ID tip. Sterile, single-use; ethylene oxide sterilized. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use with a guide wire to access discrete regions of the vasculature, facilitate guide wire exchange, and serve as a conduit for saline or diagnostic contrast agents in patients requiring cardiovascular access.

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

• Spectranetics .035 Support Catheter (K022138)
• IntraLuminal Therapeutics, Inc. ILT Safe-Cross® Support Catheter (K030984)

Submission Summary (Full Text)

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Original 510(k) Premarket Notification ILT Safe-Cross .035" Support Catheter

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### SUBMITTER INFORMATION

| A. | Company Name: | IntraLuminal Therapeutics, Inc |
|-----------------------|--------------------|---------------------------------------------------------------------------------|
| B. | Company Address: | 6354 Corte del Abeto<br>Suite A<br>Carlsbad, CA 92009 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Pamela Misajon<br>Vice President of Regulatory Affairs and<br>Quality Assurance |
| DEVICE IDENTIFICATION | | |
| A. | Trade Name: | ILT Safe-Cross® .035" Support Catheter |
| B. | Catalog Number: | C135SN1 |
| C. | Common Name: | Support Catheter |

Classification Name: Percutaneous Catheter D. Device Class: Class II (per 21 CFR 870.1250) ய்

# IDENTIFICATION OF PREDICATE DEVICE

The ILT Safe-Cross® .035" Support Catheter is similar in design, materials, mode of operation and intended use to the Spectranetics .035 Support Catheter cleared under 510(k) K022138 and the IntraLuminal Therapeutics, Inc. ILT Safe-Cross® Support Catheter cleared under 510(k) K030984.

# DEVICE DESCRIPTION

The ILT Safe-Cross® .035" Support Catheter is a single-lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with steerable wires to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® .035" Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

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The effective length of the ILT Safe-Cross® .035" Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 4.4 French (0.057"). The I.D. at the tip of the ILT Safe-Cross® .035" Support Catheter is a nominal 0.041" and the inside diameter will accommodate commercially available 0.035" quide wires.

The ILT Safe-Cross® .035" Support Catheter is packaged in a Tyvek® covered tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.

#### INTENDED USE

The ILT Safe-Cross® .035" Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one quide wire for another can occur. The Catheter mav also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

## TECHNOLOGICAL CHARACTERISTICS

The ILT Safe-Cross® .035" Support Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device.

#### BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing and in vivo bench studies were conducted to evaluate the biological and performance characteristics of the ILT Safe-Cross® .035" Support Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.

## CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the ILT Safe-Cross® .035" Support Catheter is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2003

Intraluminal Therapeutics c/o Ms. Pamela Misajon 6354 Corte Del Abeto, Suite A Carlsbad, CA 92009

Re: K031417

ILT Safe-Cross .035" Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: May 2, 2003 Received: June 27, 2003

Dear Ms. Misajon:

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. Pamela Misajon

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), 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) you may obtain. 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,

N.O.e.d.Tu

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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K031417

#### INDICATIONS FOR USE

510(k) Number:

ILT Safe-Cross® .035" Support Catheter Device Name: The Safe-Cross® .035" Support Catheter is indicated for use Indications for Use: with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an

> exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

DeLattre

510(k) Num