SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

K092396 · Spectranetics Corp. · DQY · Sep 4, 2009 · Cardiovascular

Device Facts

• Record ID: K092396
• Device Name: SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
• Applicant: Spectranetics Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

Intravascular support catheter; used by interventional cardiologists, radiologists, and vascular surgeons during endovascular procedures. Device guides/supports guidewires, facilitates wire exchanges, and acts as conduit for saline or diagnostic contrast agents. Features include variable lengths, diameters, and tip configurations; three radiopaque markers on distal shaft for geometry estimation; standard female luer on proximal end; lubricious hydrophilic coating on distal section. Operated manually by physician in clinical setting. Benefits include improved access to vasculature and streamlined delivery of diagnostic/therapeutic fluids.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological comparison to predicate devices.

Technological Characteristics

Intravascular catheter; hydrophilic coating on distal shaft; three radiopaque markers for visualization; standard female luer connector. Materials, design, and construction consistent with predicate devices.

Indications for Use

Indicated for patients with coronary or peripheral vascular disease requiring guidewire support, wire exchange, or delivery of saline/contrast agents during endovascular procedures.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Spectranetics Quick Cross® Extreme Support Catheters (K082561)
• Spectranetics Quick Cross Support 2 Catheters (K072750)

Submission Summary (Full Text)

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# K092396 SECTION 5 - 1

Quick-Cross Extreme Support Catheter Special 510(k) Submission

Spectranetics Corporation requests that the attached "Summary" for the Quick-Cross® Extreme Support Catheters be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.

| Owner/Manufacturer: | Spectranetics Corporation<br>96 Talamine Court<br>Colorado Springs, CO 80907 |
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Contact Person:

Name Title Office Phone: BlackBerry Fax

Cheryl Hastings Regulatory Affairs & Compliance Manager 719-447-2482 719-659-1848 719-447-2040

Date of Summary Preparation: July 31, 2009

Establishment Registration Number: 1721279

Trade Name of Device: Spectranetics Quick Cross® Extreme Support Catheters

Common Name: Support Catheters

Classification Name: Catheters Percutaneous

Class: II

Product Code: DOY

Predicate Devices: Spectranetics Quick Cross® Extreme Support Catheters K082561 and the Spectranetics Quick Cross Support 2 Catheters K072750

Device Description: The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm

Confidential

9/2/2009

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Quick-Cross Extreme Support Catheter Special 510(k) Submission

Indications for Use: Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

## Intended Use:

#### Intended Customers

The primary customers are those physicians that perform endovascular treatment of vascular disease, namely Interventional Cardiologists, Interventional Radiologists and Vascular Surgeons who are trained in endovascular procedures.

#### Intended Patient Population

The intended patient population is those suffering from vascular disease, both coronary and peripheral.

#### Technological Comparison:

The 0.014" and the 0.018" Quick Cross® Extreme is a smaller lumen version of the previously approved 0.035" Spectranetics Quick-Cross® Extreme (K082561). The products are substantially equivalent with regards to materials, design principles and construction. The 0.014" and the 0.018" Quick Cross® Extreme is also substantially equivalent to the 0.014" and the 0.018" Ouick Cross® (K072750) with regards to dimensions, specifications and intended use.

#### Conclusion:

The0.014" and the 0.018" Quick Cross® Extreme catheters are substantially equivalent to the predicate device the 0.035" Spectranetics Quick-Cross® Extreme (K082561) and substantially equivalent to the Quick Cross® (K072750).

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Confidential

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 0 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Cheryl Hastings Regulatory Affairs & Compliance Manager Spectranetics Corporation 9965 Federal Drive Colorado Springs, CO 80921

Re: K092396

Trade/Device Name: Quick-Cross Extreme Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 30, 2009 Received: August 5, 2009

Dear Ms. Hastings:

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 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. Cheryl Hastings

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Dunia D. Lachner

Bram Zuckerman, M.D.
Director

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

Enclosure

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### SECTION 4 - 1 Quick-Cross Extreme Support Catheter Special 510(k) Submission

# Indications for Use

510(k) Number:

KO92396

Device Name: Quick-Cross® Extreme Support Catheter

Indications for Use:

Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Prescription Use only X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duner R. Vachner

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(Division Sign-Off) (Division Olgh Jign of Cardiovascular Devices

510(k) Number_Ko9239 (6