SAFE-STEER GUIDE WIRE SYSTEM

K011986 · Intra Luminal Therapeutics, Inc. · DQX · Apr 3, 2002 · Cardiovascular

Device Facts

• Record ID: K011986
• Device Name: SAFE-STEER GUIDE WIRE SYSTEM
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• 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

The SAFE-STEER™ Guide Wire System is a sterile, single-use guide wire (0.014" diameter, 175/275 cm length) with an integrated optical fiber; used with a support catheter. The system includes a reusable Optical Coherence Reflectometry (OCR) unit. The guide wire transmits near-infrared light into the vessel; reflected light is captured and processed by the OCR unit. The system calculates and displays a unique intensity versus distance measurement, representing the relative distance between the wire tip and the vessel wall. Used in clinical settings by physicians to navigate total occlusions in native coronary arteries. The visual output assists the clinician in positioning the guide wire and catheter, potentially improving procedural success in complex occlusions.

Clinical Evidence

The submission included software, performance, biocompatibility, packaging, and clinical testing. Specific metrics were not detailed in the summary, but the device was determined to meet internal product specifications and requirements for substantial equivalence to predicate devices.

Technological Characteristics

Guide wire (0.014" diameter, 175/275 cm length) with lubricious hydrophilic coating. Features an integrated optical fiber for near-infrared light transmission and reflection sensing. Reusable OCR unit for signal processing and display. Sterilized via ethylene oxide.

Indications for Use

Indicated for patients undergoing percutaneous interventions in native coronary arteries with total occlusions to facilitate catheter 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

• ACS Hi-Torque Cross-it Guide Wire (K981381 & K990639)
• ACS Hi-Torque Standard Guide Wire (K881897 & K881787)

Submission Summary (Full Text)

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### APR 0 3 2002

## 6.0 Summary of Safety and Effectiveness for the SAFE-STEER™ Guide Wire System

| 6.1 | Trade Name: | SAFE-STEER™ Guide Wire System |
|-----|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Common Name: | Guide Wire, Cardiovascular or Peripheral |
| | Classification: | DQX, Title 21 CFR Section: 870.1330 |
| 6.2 | Manufacturer: | IntraLuminal Therapeutics, Inc.<br>6354 Corte Del Abeto<br>Carlsbad, CA 92009<br>Phone: [phone]<br>Fax: [phone] |

Pamela L. Misajon Contact: Vice President of Regulatory Affairs and Quality Assurance

Date of Preparation: March 28, 2002

#### Substantially Equivalent Legally Marketed Devices: 6.3

| Product Name | 510(k) Numbers |
|--------------------------------------|-------------------|
| 1. ACS Hi-Torque Cross-it Guide Wire | K981381 & K990639 |
| 2. ACS Hi-Torque Standard Guide Wire | K881897 & K881787 |

#### Device Description: 6.4

The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single-use guide wire with an integrated optical fiber. The guide wire is used with a support catheter of choice that will accommodate a .014" guidewire. The optical fiber in the guide wire is connected to a reusable Optical Coherence Reflectometry (OCR). The guide wire core has an embedded optical fiber that transmits near infrared light and the reflection is relayed back to the OCR unit and then a unique intensity versus distance measurement is exhibited on the OCR display. The trace of the slope on the OCR display distinguishes the distance from the tip of the wire and the vessel wall. The display output exhibits the relative distance between the wire tip and vessel wall. The guide wire is provided in lengths of 175 cm and 275 cm long and has a diameter of 0.014" with a lubricious hydrophilic coating in the distal region. The guide wire is sterilized by ethylene oxide and packaged to maintain the sterile barrier.

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### 6.0 Summary of Safety and Effectiveness for the SAFE-STEER™ Guide Wire System (continued)

#### 6.5 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 of Substantial Equivalence 6.6

The IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is comprised of a guide wire used with a support catheter of choice to facilitate the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

The indications for use are similar to both the ACS Hi-Torque Standard and the ACS Hi-Torque Cross-It guide wires. The models and sizes are similar to commercially distributed quide wires.

#### Performance Data 6.7

Safety and performance testing was performed to demonstrate that the IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is substantially equivalent to the predicate devices.

The testing included software, performance, biocompatibility, packaging, clinical and comparative tests.

- Conclusion: In conclusion, the IntraLuminal Therapeutics SAFE-STEER™ Guide 6.8 Wire System meets the requirements for being substantially equivalent to predicate devices and meets internal product specifications.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela L. Misajon Vice President of Regulatory Affairs and Quality Assurance IntraLuminal Therapeutics, Inc. 6354 Corte Del Abeto Carlsbad, CA 92009

APR 0 3 2002

Re: K011986

Trade Name: SAFE-STEER™ Guide Wire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 28, 2001 Received: January 29, 2001

Dear Ms. Misajon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bocuse of to the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the energiant date of the Medical Device Amendments, or to devices that provision in the Provisions with the provisions of the Federal Food, Drug, and Cosmetic nu v och roendomics and 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 therers, manions of the Act include requirements for annual registration, listing of devices, good connolor provizion, 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 n your de foo to such additional controls. Existing major regulations affecting your device can be finer of babyer to easil 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 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

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Page 2. - Ms. Pamela L. Misajon

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) rins letter will anow your to ough finding of substantial equivalence of your device to a legally premaince noutheation - The sification 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 en itled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Toganation 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,

Koda Tellh

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number: K011986 IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire Device Name: 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)

Prescription Use __ V (Per 21 CFR 801.109) OR Over-The-Counter Use

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Division of Cardiovascular & Respiratory Devices
510(k) Number K011906
vascular & Respiratory