KINETIX GUIDEWIRE, PLUS GUIDEWIRE

K081021 · Boston Scientific Corp · DQX · Aug 8, 2008 · Cardiovascular

Device Facts

• Record ID: K081021
• Device Name: KINETIX GUIDEWIRE, PLUS GUIDEWIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Kinetix™ Guidewires are 0.014" PTCA guidewires designed to facilitate placement and exchange of therapeutic devices during intravascular procedures. The device features a micro-slotted nitinol sleeve replacing traditional spring coils to provide specific rail support and tip characteristics. Two models are available: Kinetix (soft, a-traumatic tip; moderate rail support) and Kinetix Plus (stiffer tip; intermediate rail support). Used by physicians in clinical settings during PTCA/PTA procedures. The device is provided sterile and non-pyrogenic for single-procedure use. It functions as a mechanical guide for catheter navigation within the vasculature.

Clinical Evidence

Bench testing only. Evaluation included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence, tensile and shear strength, combined load, visual inspection, device compatibility, biocompatibility, and shelf-life. Results demonstrated the device met all minimum requirements and is adequate for its intended use.

Technological Characteristics

0.014" PTCA guidewire. Construction: micro-slotted Nitinol hypotube, Inconel 625 shaping ribbon, Polyurethane distal coating. Mechanical sensing/actuation. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for facilitating placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. Not for use in cerebral vasculature. Single-use only.

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

• IQ™ Guidewire (K040140)

Submission Summary (Full Text)

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| | 510(k) Summary per<br>21 CFR §807.92 | | AUG - 8 2008 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------|
| Submitter's Name<br>and Address | Boston Scientific Corporation (BSC)<br>One Scimed Place<br>Maple Grove, MN 55311 | | |
| Contact Name and<br>Information | Christine Thomas<br>Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | April 9, 2008 | | |
| Proprietary<br>Name(s) | Kinetix™ Guidewire | | |
| Common Name | Catheter Guidewire | | |
| Product Code | DQX | | |
| Classification of<br>Device | Class II, 21 CFR Part 870.1330 | | |
| Predicate Device | IQ™ Guidewire | K040140 | February 12,<br>2004 |
| Device<br>Description | The Kinetix™ Guidewires are two 0.014" PTCA<br>guidewires utilizing a micro-slotted nitinol sleeve that<br>replaces the traditional spring coil. The Kinetix<br>Guidewires are similar in design and manufacture to the<br>spring-coil IQ™ Guidewires (K040140 on February 12,<br>2004). | | |
| | The two distinct models are: | | |
| | Kinetix™ Guidewire - A guidewire with a soft, a-traumatic<br>tip and a moderate rail support. | | |
| | Kinetix™ Plus Guidewire - A guidewire with a stiffer tip<br>than the moderate support version and an intermediate<br>rail support. | | |

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| Intended Use of Device | Kinetix™ Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The Kinetix Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | The Kinetix™ Guidewires utilize similar materials and methods of construction as the IQ™ Guide Wires (K040140, cleared on February 12, 2004). The significant difference in construction is the utilization of a micro-slotted Nitinol hypotube to replace the Inconel 625 (Nickel-Chrome alloy) spring coil. In addition there are two other material changes: the shaping ribbon material is changing from 304V Stainless Steel to Inconel 625 (Nickel-Chrome alloy) and the distal lubricious coating is changing from Silicone to Polyurethane. |
| Non-Clinical Test Summary | Testing and evaluation of the Kinetix™ Guidewires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. |
| | Test results verified that the Kinetix™ Guidewires met all of the minimum requirements and are adequate for their intended use. |
| | The Kinetix™ Guidewires are considered substantially equivalent to guidewires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of in vitro testing and evaluation. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine Thomas Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311

AUG - 8 2008

Re: K081021

> Trade/Device Name: Kinetix™ Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Dated: July 23, 2008 Received: July 24, 2008

Dear Ms. Thomas:

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Christine Thomas

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

R. Vachner

1 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 Statement

| 510(k) Number<br>(if known) | K081021 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | KinetixTM Guidewire |
| Indications For<br>Use | KinetixTM Guidewires are intended to facilitate placement<br>and exchange of balloon dilatation catheters or other<br>therapeutic devices during PTCA or PTA or other<br>intravascular interventional procedures. The KinetixTM<br>Guidewires are not intended for use in the cerebral<br>vasculature. The devices are provided non-pyrogenic,<br>sterile, and intended for one procedure only. |

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR §801.109)

OR Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number k081021