MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM

K021323 · Intra Luminal Therapeutics, Inc. · DQX · May 22, 2002 · Cardiovascular

Device Facts

• Record ID: K021323
• Device Name: MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

Device Story

System comprises 0.014" guide wire with integrated optic fiber and OCR unit with display monitor. Fiber optic sensor provides real-time feedback on distal tip location relative to vessel wall. Used by physicians during percutaneous coronary interventions to facilitate catheter placement in total occlusions. Output displayed on monitor assists clinician in navigating wire through occluded vessels; aids in avoiding vessel wall perforation. Benefits include improved navigation accuracy in complex coronary anatomy.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993-1. Performance testing verified conformance to product specifications under company Design Control Procedures (21 CFR 820).

Technological Characteristics

0.014" guide wire with integrated optic fiber; OCR unit with display monitor. Materials biocompatible per ISO 10993-1. Class II device (21 CFR 870.1330).

Indications for Use

Indicated for patients undergoing 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-Steer™ Guidewire System (K011986)

Submission Summary (Full Text)

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# 510 (K) #: KO21323

Special 510(k): Device Modification Safe-Steer™ Guide Wire System

## 510(K) SUMMARY

#### SUBMITTER INFORMATION 10.1

| 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 |

### 10.2 DEVICE IDENTIFICATION

| A. | Device Trade Name: | Safe-Steer™ Guide Wire System |
|----|----------------------|--------------------------------|
| C. | Device Common Name: | Catheter Guide Wire |
| D. | Classification Name: | Catheter Guide Wire |
| E. | Device Class: | Class II (per 21 CFR 870.1330) |

#### IDENTIFICATION OF PREDICATE DEVICE 10.3

The predicate device is the Safe-Steer™ Guidewire System, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K011986.

## 10.4 DEVICE DESCRIPTION

The Safe-Steer™ Guide Wire System consists of the following:

- Safe-Steer™ 0.014" Guide Wire ●
- Safe-Steer™ OCR Unit with Display Monitor .

The Safe-Steer™ Guide Wire is similar to a conventional 0.014" coronary guide wire, except that it incorporates an optic fiber, which runs the length of the guide wire. The Safe-Steer™ Guide Wire is connected to the OCR Unit, providing information on the Display Monitor of the location of the distal tip relative to the vessel wall.

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### 10.5 INTENDED USE

The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

#### TECHNOLOGICAL CHARACTERISTICS 10.5

The Safe-Steer™ Guide Wire is similar in basic materials, design, construction and mechanical performance to the predicate device.

#### BIOCOMPATIBILITY AND PERFORMANCE DATA 10.6

The materials used to manufacture the patient components of the Safe-Steer Guide Wire have been subjected to biocompatibility testing in accordance with ISO 10993-1 and relevant FDA Guidance to ensure biological safety for the intended use.

The Safe-Steer Guide Wire has been subjected to performance testing to verify conformance to the requirements of the product specification.

Testing has been conducted in accordance with the Design Control Procedures of the company as required by the Quality System Regulation (21 CFR 820).

## 10.7 CONCLUSIONS DRAWN FROM STUDIES

On the basis of the testing conducted on the Safe-Steer™ Guide Wire 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 Safe-Steer™ Guide Wire is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces merging into one, suggesting unity and collaboration.

Public Health Servic

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

AY 2 2 2002

Ms. Pamela Misajon IntraLuminal Therapeutics, Inc. 6354 Corte Del Abeto, Suite A Carlsbad, CA 92009

Re: K021323

SAFE-STEER™ Guide Wire System Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 25, 2002 Received: April 26, 2002

### Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your be 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

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Page 2 - Ms. Pamela Misajon

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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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. Daghlian

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) #: K021323

Special 510(k): Device Modification Safe-Steer™ Guide Wire System

# INDICATIONS FOR USE

KOHISS KOZI323 510(k) Number:

Device Name:

Safe-Steer™ Guide Wire System

Indications For Use:

The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K021323 |

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

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