MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

K033929 · Intra Luminal Therapeutics, Inc. · DQX · Jan 12, 2004 · Cardiovascular

Device Facts

• Record ID: K033929
• Device Name: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

Device Story

System comprises RF crossing wires (0.014", 0.018", 0.035" diameters) and console with display/footswitch. Optical fiber in wire provides visualization of vessel structures; RF energy delivered to distal tip assists in crossing total occlusions. Used in clinical setting by physicians; practitioner navigates wire using optical feedback, then triggers discrete RF energy via footswitch to penetrate occlusion. Output allows wire advancement through previously impassable lesions; facilitates subsequent placement of interventional devices. Benefits include improved success in crossing chronic total occlusions in lower extremity arteries.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing, in vitro bench testing, and in vivo animal studies. Bench testing confirmed performance characteristics meet specifications. Animal studies verified system components function together to satisfy intravascular performance requirements.

Technological Characteristics

System includes RF crossing wires (0.014", 0.018", 0.035") and console. Features optical fiber for visualization and RF energy delivery for tissue crossing. Sterilized via ethylene oxide; single-use. Connectivity involves Y-site hub with optical and RF connectors to console. Materials and design are similar to predicate.

Indications for Use

Indicated for patients requiring vascular intervention for total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities to facilitate device placement.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Safe-Cross Radio Frequency Total Occlusion Crossing System (K033708)

Submission Summary (Full Text)

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K033929

JAN 1 2 2004

Special 510(k): Device Modification Safe-Cross® RF TO Crossing System [Peripheral]

## 510(K) SUMMARY

#### SUBMITTER INFORMATION

| A. | Company Name: | IntraLuminal Therapeutics, Inc. |
|----|--------------------|------------------------------------------------------------------------------|
| B. | Company Address: | 6354 Corte Del Abeto – 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 Assurance |

## DEVICE IDENTIFICATION

| A. | Device Trade Name: | Safe-Cross® Radio Frequency Total Occlusion<br>Crossing System |
|----|----------------------|----------------------------------------------------------------|
| B. | Device Common Name: | Catheter Guide Wire |
| C. | Classification Name: | Catheter Guide Wire |
| D. | Device Class: | Class II (per 21 CFR 870.1330) |

## IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the Safe-Cross Radio Frequency Total Occlusion Crossing The production of the by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K033708.

## DEVICE DESCRIPTION

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
- 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
- 0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
- Safe-Cross Console with Display and Footswitch .

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The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR inout on the console to allow the medical practitioner to visualize structures within the wessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

#### INTENDED USE

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

## TECHNOLOGICAL CHARACTERISTICS

The components of the Safe-Cross System are similar in basic materials, design, construction and performance to the predicate device. The RF Crossing Wires have been modified to improve handling and add a 0.018" diameter model. The performance of the modified Safe-Cross System has been verified through biocompatibility testing, bench testing and animal testing.

## BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing has been conducted to verify that the materials in the modificd RF Crossing Wires are safe. In vitro bench testing was conducted to evaluate the performance characteristics of the modified RF Crossing Wires. Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications and do not raise additional safety issues. In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model.

## CONCLUSIONS DRAWN FROM STUDIES

On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device.

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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 features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2004

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

Re: K033929

Safe-Cross® Radio Frequency Total Occlusion Crossing System | Peripheral] Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: December 17, 2003 Received: December 18, 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. Ilsting 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 Codc 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. Pamela Misajon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ Issualler of a substitute equirements of the Act
that FDA has made a determination that your device of provenies. You must that FDA has made a decemmation and your can your be Federal agencies. You must or any Federal statutes and regulations administered by not limited to: registration and listing (21 l comply with all the Act S requirements, moradias couring practice requirements as schools.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing as and in allectronic CFR Part 807), idoeinig (21 CFR Part 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product faction control provisions (occions of the envirological in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket nothcation. THE PDA intime of backman of 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 If you desire specific advice for your ac [phone]. Also, please note the regulation entitled, a contact the Office of Compuner at (30) 37 Friday (21CFR Part 807.97). You may obtain "Misoranding by relevelee to premanters in the Act from the Division of Small other general information on your respensed.rate at its toll-free number [phone] or [phone] or at its Internet address

[phone] 6rains nv / cdrh / dsma / dsmamain. html

Sincerely yours,

Arlile B. Ban

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 (if known): | 1033929 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Safe-Cross® Radio Frequency Total Occlusion Crossing<br>System |
| Indications For Use: | The Safe-Cross® Radio Frequency Total Occlusion<br>Crossing System is indicated for use in facilitating the<br>placement of devices used in vascular interventions of<br>total occlusions in native iliac and superficial femoral<br>arteries (SFA) of the lower extremities. |

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use --------(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Boam

(Division Sion ... ) Division of randict assettar Devices

510(K) Number K-033929 (SM. K

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