IQ HYDROPHILIC GUIDE WIRE

K032183 · Boston Scientific Corp · DQX · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K032183
• Device Name: IQ HYDROPHILIC GUIDE WIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The IQ™ Hydrophilic Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature.

Device Story

Steerable, spring-tipped guide wire; 0.014-inch diameter; 185cm or 300cm lengths. Corewire features PTFE-coated stainless steel segment coupled to tapered Nitinol segment; distal end jacketed with Tungsten-loaded polyurethane sleeve and ICE® hydrophilic coating. Distal 3cm includes radiopaque spring coil, centering sleeve, and stainless steel ribbon. Used by physicians in clinical settings to facilitate catheter placement during intravascular interventions. Provides tactile feedback and steerability for navigation through vasculature. 185cm version compatible with AddWire™ Extension Wire. Single-use, sterile, non-pyrogenic.

Clinical Evidence

Bench testing only. Evaluated torque response, tip prolapse, tip shapeability, marker location, coating adherence, tensile strength, combined load, visual inspection, polymer peel, device compatibility, biocompatibility, and shelf-life. Results met all minimum requirements.

Technological Characteristics

Materials: PTFE-coated stainless steel, Nitinol, Tungsten-loaded polyurethane, ICE® hydrophilic coating. Construction: Spring-tipped, steerable wire with distal radiopaque coil. Dimensions: 0.014-inch diameter, 185/300cm lengths. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients undergoing PTCA, PTA, or other intravascular interventional procedures requiring placement/exchange of balloon dilatation catheters or therapeutic devices. Contraindicated for use in cerebral vasculature.

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

• PT2™ Guide Wire (K030617)
• Luge™ Guide Wire (K973945)

Submission Summary (Full Text)

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K032183

AUG - 1 2003

Special 510(k): Device Modification
BSC IQ Hydrophilic Guide Wire

## 510(k) Summary
per 21 CFR §807.92

| Submitter's Name<br>and Address | Boston Scientific Corporation (BSC)<br>One Scimed Place<br>Maple Grove, MN 55311 | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name and<br>Information | Anne V. Rossi<br>Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | July 16, 2003 | | |
| Proprietary<br>Name(s) | IQ™ Hydrophilic Guide Wire | | |
| Common Name | Catheter Guide Wire | | |
| Product Code | 74DQX | | |
| Classification of<br>Device | Class II, 21 CFR Part 870.1330 | | |
| Predicate Devices | PT2™ Guide Wire | K030617 | May 21, 2003 |
| | Luge™ Guide Wire | K973945 | January 12, 1998 |
| Device<br>Description | The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coating<br>are steerable, spring-tipped guide wires. The IQ™ Hydrophilic<br>is available in a nominal diameter of 0.014 inches, Moderate<br>Support, and nominal lengths of 185 and 300 centimeters with<br>Brachial and Femoral marks at 90cm and 100cm respectively.<br>The distal three centimeters of all models are radiopaque spring<br>coils and available in either a straight shapeable or a pre-<br>formed J-Tip.<br>The IQ™ Hydrophilic corewire consists of a PTFE coated SS<br>corewire segment joined via a nickel-chromium alloy coupler to<br>a tapered Nitinol corewire segment. The distal segment of this<br>corewire is coated with an adhesive pre-coat that is jacketed<br>with a Tungsten loaded polyurethane sleeve. This polymer<br>sleeve is coated with ICE® Hydrophilic coating. A SS centering<br>sleeve attaches a SS ribbon to the distal end of the corewire.<br>The distal most portion of the corewire, the centering sleeve and<br>the SS ribbon reside within the hollow center of the 3-cm spring-<br>coil.<br>The 185-centimeter version of the IQ™ Hydrophilic is designed<br>with a proximal extension section that allows connection to the<br>AddWire™ Extension Wire. | | |

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The IQ™ Hydrophilic Guide Wires are intended to facilitate the Intended Use of placement and exchange of balloon dilatation catheters or other Device therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.

Technological The IQ™ Hydrophilic Guide Wires utilize similar materials and Characteristics methods of construction as the currently marketed PT2™ Guide Wire family of quide wires. The differences in construction are the addition of a spring-coil to the distal most tip and a SS ring at the ribbon/corewire joint.

Non-Clinical Test Testing and evaluation of the IQ™ Hydrophilic Guide Wires Summary included torque response, tip prolapse, tip shapeability, marker location, coating adherence/presence, tensile, combined load, visual inspection, polymer peel, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements and are adequate for their intended use. The IQ™ Hydrophilic Guide Wires are considered to be substantially equivalent to guide wires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of in vitro testing and evaluation.

KC32183

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Boston Scientific Corporation c/o Anne V. Rossi Specialist, Regulatory Affairs One Scimed Place Maple Grove, MN 55311

Re: K032183

> IQ™ Hydrophilic Guide Wire Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: July 16, 2003 Received: July 21, 2003

## Dear Ms. Rossi:

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.

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Page 2 - Ms. Anne V. Rossi

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 systems (OS) 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), 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) you may obtain. 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,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use Statement

| 510(k) Number<br>(if known) | K032183 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IQ™ Hydrophilic Guide Wire |
| Indications For<br>Use | The IQ™ Hydrophilic Guide Wires are intended to facilitate the<br>placement of balloon dilatation catheters or other therapeutic<br>devices during PTCA, PTA, or other intravascular interventional<br>procedures. The IQ™ Hydrophilic Guide Wires are not intended<br>for use in the cerebral vasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR §801.109)

Over-The-Counter Use OR

N'DeCartha

iovascular Devices

510(k) Number K032183