MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

K040037 · Intra Luminal Therapeutics, Inc. · DQX · Mar 3, 2004 · Cardiovascular

Device Facts

• Record ID: K040037
• Device Name: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 3, 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 percutaneous interventions in native coronary arteries with total occlusions.

Device Story

System facilitates crossing total occlusions in native coronary arteries; consists of RF crossing wire (0.014" diameter, 175cm or 275cm lengths), torquer, tip shaping tool, and console. Optical coherence reflectometry (OCR) input on console allows visualization of vessel structures for navigation; RF energy output enables wire tip to cross occlusion. Used in clinical settings by physicians; console provides visual feedback to guide wire advancement. Benefits include improved ability to navigate and cross total occlusions during percutaneous interventions.

Clinical Evidence

No clinical data. Evidence includes biocompatibility testing, in vitro bench testing, animal studies, and software validation. Bench testing confirmed device specifications; animal studies verified intravascular performance and component integration.

Technological Characteristics

System includes RF crossing wire, torquer, and console integrating RF generator and OCR unit. Wires are single-use, non-pyrogenic. Connectivity via optical connector to console. Software validation performed. Biocompatibility verified.

Indications for Use

Indicated for facilitating device placement during percutaneous interventions in native coronary arteries with total occlusions.

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 (K032031)

Submission Summary (Full Text)

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MAR - 3 2004

K040037

# 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 |

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 System, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K032031.

#### DEVICE DESCRIPTION

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

- 175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
- 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
- Safe-Cross RF System Console with Display and Footswitch .

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The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The I he modified Sale-Cross RF Bystein is simmal nt a Y-Site hub that houses the optic proximal end of the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the imput on the console to anow the medical proceed to the RF couput on the digit vessel for havigation purposes. The re-over to provide discrete RF energy to the distal console: - This anoving 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 The Kr Crossing Wire is packaged warate peel pouch. The packaged RF Crossing Wire i oot. A rorquer is provided the 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 percutaneous interventions in native coronary arteries with total occlusions.

# TECHNOLOGICAL CHARACTERISTICS

The components of the Safe-Cross System are similar in basic materials, design, constition and performance to the predicate device. The RF Generator and OCR Unit have been combined into a single console. The RF Crossing Wires have been modified to improve handling and add a 175cm length model. The performance of the modified Safe-Cross System has been verified through biocompatibility testing, bench testing, animal testing and software validation testing.

# BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing has been conducted to verify that the materials in the modified 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 raisc 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Intraluminal Therapeutics, Inc. Ms. Pamela Misajon Ms. Pamela Misajon
Vice President of Regulatory Affairs and Quality Assurance 6354 Corte Del Abeto - Suite A Carlsbad, CA 92009

Re:

K040037
Trade/Device Name: Safe-Cross® Radio Frequency Total Occlusion Crossing System
Trade/Device Name: Safe-Cross® 1920 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 8, 2004 Received: January 9, 2004

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQK J prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices mendments. for use stated in the enclosure) to regally manced the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the organision of the Federal Food. Drue commerce prior to May 28, 1976, the enaculient with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the A.M. (PMA).
and Cosmetic Act (Act) that do not required to seems as annovalisions of the A.t. Th and Cosmetic Act (Act) that do not require approvations provisions of the Art. The Art. The Art. The Art. The You may, therefore, market the device, subject to the general cannual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements to
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 If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controls: Listers in as a 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Pederal Regarations, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issuance of a subscribe complies with other requirements of the Act
that FDA has made a determination that your device Foderal agencies. You mus that FDA has made a determination mat your areas by other Federal agencies. You must or any Federal statutes and regulations administers, but not limited to: registration and listing (2)
comply with all the Act's requirements, including, but not times asset comply with all the Act s requirements, merading, out all relative 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
s (2001); for the state (2001) (2005) = 500 = 500 = 500 = 640 = 540 = 1000-1 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Acction 5 product radiation control provisions (Scottons of the easines in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin maketing your actives waters of your device to a legally premarket notification. The FDA inding of substantal equive 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 ior your do 1100%. Also, please note the regulation entitled, and contact the Office of Comphaneous (30 rysification" (21CFR Part 807.97). You may obtain "Misbranding by reletence to promantee to promantee the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 00 other general information on your responsible to toll-free number [phone] or
Manufacturers, International and Consumer Assistance of Address (domemore http:// Manufacturers, International and Combanets http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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): | k040037 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 percutaneous interventions<br>in native coronary arteries with total occlusions. |

Prescription Use X (Part 21 CFR 801 Subpart D)

and the control of the control of the control of the control of the contribution of the first of the first of the first of the first of the first of the first of the first of

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)

| (Division Sign-Off) | |
|-------------------------|---------|
| Division of Cardiovasc' | |
| 510(k) Number | K040057 |