ILT TORQUER, MODEL 114TR1

K021243 · Intra Luminal Therapeutics, Inc. · DQX · Jul 11, 2002 · Cardiovascular

Device Facts

• Record ID: K021243
• Device Name: ILT TORQUER, MODEL 114TR1
• Applicant: Intra Luminal Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.

Device Story

The ILT Torquer is a plastic manual accessory used to manipulate and control guide wires (0.014" to 0.035") during vascular procedures. The device features finger tabs that, when squeezed, open internal jaws to allow side-loading onto a guide wire already in place within a catheter. Releasing the tabs closes the jaws to grip the wire, enabling the clinician to rotate and advance the wire. It is a single-use, sterile device intended for clinical use. It provides no patient contact and functions as a mechanical interface between the clinician's hand and the guide wire to facilitate navigation through the vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. In vitro studies confirmed the device satisfies functional performance requirements for guide wire manipulation.

Technological Characteristics

Plastic construction; manual mechanical actuation via finger tabs and internal jaws; accommodates 0.014" to 0.035" guide wires; sterile (ethylene oxide); single-use; no patient contact.

Indications for Use

Indicated for use in manipulating a guide wire to access discreet regions of the vasculature. No specific patient population, age, or gender restrictions provided.

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

• Boston Scientific Corporation wireClip (K003398)

Submission Summary (Full Text)

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#### 'JUL 11 2002

Ko21243

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### SUBMITTER INFORMATION

| A. | Company Name: | IntraLuminal Therapeutics, Inc |
|-----------------------|--------------------|---------------------------------------------------------------------------------|
| B. | Company Address: | 6354 Corte del Abeto<br>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<br>Quality Assurance |
| DEVICE IDENTIFICATION | | |

| A. | Trade Name: | ILT Torquer |
|----|----------------------|--------------------------------|
| B. | Catalog Number: | A114TR1 |
| C. | Common Name: | Torquer |
| D. | Classification Name: | Catheter Guide Wire Accessory |
| E. | Device Class: | Class II (per 21 CFR 870.1330) |

## INDENTIFICATION OF PREDICATE DEVICE

The ILT Torquer is substantially equivalent to the Boston Scientific Corporation wireClip™ cleared under 510(k) K003398.

## DEVICE DESCRIPTION

The IntraLuminal Therapeutics Torquer is a plastic device that allows for manipulating and directional control of a guide wire. The Torquer will accommodate commercially available quide wires ranging in size from 0.014" to 0.035". The Torquer can be sideloaded onto the quide wire after the wire is in place within the catheter. When the finger tabs of the ILT Torquer are squeezed and the iaws of the ILT Torquer open, the quide wire can be placed inside. Releasing the finger tabs allows the jaws to close, capturing and firmly gripping the guide wire.

The ILT Torquer is packaged in a Tyvek®/mylar pouch that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", and is intended for single use only.

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#### INTENDED USE

221247

The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.

### TECHNOLOGICAL CHARACTERISTICS

The ILT Torquer is similar in basic materials, design, construction and mechanical performance to the predicate device.

#### BIOCOMPATIBILITY AND PERFORMANCE DATA

Biocompatibility testing is not required for ILT Torquer because there is no patient contact. In vitro bench studies were conducted to evaluate the performance characteristics of the ILT Torquer. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.

### CONCLUSIONS DRAWN FROM STUDIES

The results of testing demonstrate that the ILT Torquer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville · MD 20850

JUL 11 2002

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

Re: K021243

> ILT Torquer Regulation Number: 870.1330 Regulation Name: Catheter Cannula Regulatory Class: II (two) Product Code: DQX Dated: April 18, 2002 Received: April 19, 2002

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, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);

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Page 2 - Ms. Pamela Misajon

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sath Tum

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

Enclosure

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Original 510(k) Premarket Notification ILT Torquer

22243

#### INDICATIONS FOR USE

510(k) Number:

ILT Torquer Device Name:

Indications for Use:

The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

DeM

on Sian-Off of Cardiovascular and Respiratory Dev

510(k) Number K021243