SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1

K031692 · Intra Luminal Therapeutics, Inc. · DQY · Aug 22, 2003 · Cardiovascular

Device Facts

• Record ID: K031692
• Device Name: SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

Coaxial lumen intravascular catheter; used with guide wires to access remote vascular regions; facilitates guide wire placement and exchange; provides conduit for saline or diagnostic contrast agents. Operated by clinicians in vascular procedures. Device features deflecting segment; 135-140 cm length; 2.5 F shaft diameter; 3.5 F deflecting segment diameter. Single-use; sterile; ethylene oxide sterilized.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed material safety. Performance testing verified functional requirements, including pressure handling and dimensional specifications.

Technological Characteristics

Coaxial lumen catheter; Biocoat Hydak® hydrophilic coating; 135-140 cm length; 2.5 F shaft OD; 3.5 F deflecting segment OD; 0.016" tip ID; compatible with 0.014" guide wires. Sterilized via ethylene oxide. Single-use.

Indications for Use

Indicated for patients requiring access to discreet regions of the peripheral vasculature to facilitate guide wire placement, guide wire exchange, or delivery of saline/contrast agents.

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

• ILT Deflecting Catheter (K010531)

Submission Summary (Full Text)

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# 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 Quality<br>Assurance |
| | DEVICE IDENTIFICATION | |
| A. | Trade Name: | Safe-Cross® Deflecting Catheter |
| A. | Trade Name: | Safe-Cross® Deflecting Catheter |
| B. | Catalog Number: | C114ND1 |
| C. | Common Name: | Support Catheter |
| D. | Classification Name: | Percutaneous Catheter |
| E. | Device Class: | Class II (per 21 CFR 870.1250) |

## IDENTIFICATION OF PREDICATE DEVICE

The Safe-Cross® Deflecting Catheter is similar in design, materials, and intended use to the IntraLuminal Therapeutics, Inc. ILT Deflecting Catheter cleared under 510(k) K010531.

### DEVICE DESCRIPTION

The Safe-Cross® Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting 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 Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.

The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav 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 Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the peripheral vasculature and facilitate placement of the guide wire. 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.

#### TECHNOLOGICAL CHARACTERISTICS

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

#### BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing and bench studies were conducted to evaluate the biological and performance characteristics of the Safe-Cross® Deflecting 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 Safe-Cross® Deflecting Catheter is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

IntraLuminal Therapeutics, Inc. c/o Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6254 Corte del Abeto, Suite A Carlsbad, CA 92009

Re: K031692

Trade Name: Safe-Cross Deflecting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 30, 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

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Page 2 – Ms. Pamela Misajon

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 (OS) 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]. 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 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,

Arlene B. Brown

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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#### INDICATIONS FOR USE

| 510(k) Number: | K031692 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ILT Safe-Cross® Deflecting Catheter |
| Indications for Use: | The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting 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

Ashley B. Beams
(Division Sign Off)

(Division Sign-Off) (Division Sign-Qili)
Division of Cardiovascular Devices

510(k) Number *k031692*