SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

K032031 · Intra Luminal Therapeutics, Inc. · DQX · Jan 7, 2004 · Cardiovascular

Device Facts

• Record ID: K032031
• Device Name: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 comprises 0.014" RF crossing wire (straight/angled tip), optical coherence reflectometry (OCR) unit with display, and RF generator with footswitch. Used in clinical settings by physicians for percutaneous coronary interventions. Wire connects to OCR unit for vessel structure visualization and to RF generator for discrete energy delivery to distal tip. RF energy assists wire navigation through total occlusions. Physician monitors OCR output to guide wire placement; RF energy facilitates crossing. Benefits include improved ability to navigate occluded coronary vessels, enabling subsequent interventional device placement.

Clinical Evidence

Human clinical studies conducted to verify safety and performance in crossing total occlusions in native coronary arteries. Results indicate device performs as intended without unacceptable risk. Supporting data includes biocompatibility testing, in vitro bench testing, and in vivo animal studies confirming functional integration and safety.

Technological Characteristics

System includes 0.014" guidewire, OCR unit, and RF generator. Materials, design, and construction are similar to predicate. Sensing principle: Optical Coherence Reflectometry (OCR). Actuation: RF energy delivery to distal tip. Sterilization: Ethylene oxide gas. Single-use.

Indications for Use

Indicated for patients requiring percutaneous intervention in native coronary arteries with total occlusions 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-Steer™ Guide Wire System (K021323)

Submission Summary (Full Text)

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JAN - 7 2004

1632031

# 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: | Guidewire |
| D. | Classification Name: | Catheter Guidewire |
| E. | Device Class: | Class II (per 21 CFR 870.1330) |

## IDENTIFICATION OF PREDICATE DEVICE

The predicate device is the Safe-Steer™ Guide Wire System, manufactured by Intraluminal Therapeutics and cleared under 510(k) Premarket Notification number K021323.

# DEVICE DESCRIPTION

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:

- 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
- Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
- Safe-Cross RF Generator with Footswitch and Interface Cable .

The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub

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that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" 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, construction and performance to the predicate device. The RF Generator is an additional component of the Safe-Cross System. The performance of the RF Cenerator has been verified through bench, animal, and human clinical studies.

## BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing, in vitro bench testing and in vivo animal studies were conducted to cvaluate the biological and performance characteristics of the Safe-Cross System. Biocompatibility test results indicate that the patient components of the Safe-Cross Crossing Wire are biocompatible. Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications. In Vivo animal studies demonstrate that the various components of the Safe Cross System function together, as intended, in the animal model and do not raise unanticipated safety issues.

## CLINICAL STUDIES

Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System when used in human subjects for the indicated use of crossing total occlusions in native coronary arteries. The results of the clinical studies indicate that the device performs as intended and docs not involve unacceptable risk to the patient.

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# CONCLUSIONS DRAWN FROM STUDIES

The results of nonclinical and clinical testing demonstrate that Safe-Cross System is substantially equivalent to the predicate device and satisfies the requirements of the device specifications.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

IntraLuminal Therapcutics, Inc. c/o Ms. Pamela Misajon Vice President of Regulatory Affairs and Quality Assurance 6354 Corte Del Abeto - Suite A Carlsbad, CA 92009

K032031 Rc:

Safe-Cross Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Codc: DQX Dated: October 10, 2003 Received: October 14, 2003

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave te riewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prices 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 adultcration.

If your device is classified (scc 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. Pamela Misajon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles or a succession complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delemmation that your as room of rederal agencies. You must or any Federal statutes and regulations administered by out not limited to: registration and listing (21 comply with all the Act S requirements, more 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manat 820); and if applicable, the electronic form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Doctors of Persons of Personal in your Section 510(k) i his letter will anow you to begin manxeting your substantial equivalence of your device to a legally premarket notification. The PDA miding of bassanaal vqur 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 act [phone]. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain Misolalling by reference to promanters in the Act from the Division of Small other general information on your respenser Assistance at its toll-frec number [phone] or [phone] or at its Internet address

(501) : 15 057 : 6 da.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Elson Diaz for

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: | To Be Assigned By FDA K632031 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Safe-Cross® RF TO Crossing System |
| Indications For 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Olesa Dike for Anne Parker

510(K) Numbe