CROSS-PILOT TURBO ELITE SUPPORT CATHETER

K090913 · Spectranetics Corp. · DQY · May 4, 2009 · Cardiovascular

Device Facts

• Record ID: K090913
• Device Name: CROSS-PILOT TURBO ELITE SUPPORT CATHETER
• Applicant: Spectranetics Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: May 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Cross-Pilot™ Turbo elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.

Device Story

Intravascular support catheter; used to guide/support laser catheters during vascular access; provides conduit for saline or contrast agent delivery. Features 3 radiopaque markers on distal shaft for geometry estimation; hydrophilic coating. Operated by clinicians in vascular procedures. Device functions as a mechanical conduit; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data presented. Functional testing confirmed device performance met specified requirements.

Technological Characteristics

Intravascular catheter with hydrophilic coating; 3 radiopaque markers on distal shaft; standard female luer proximal connection. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring vascular access where guidance and support for Spectranetics laser catheters are necessary, and for the delivery of saline or diagnostic contrast agents.

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

• Cross-Pilot™ Turbo elite Support Catheter (K082559)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Cross-Pilot™ Turbo elite® Support Catheter

i690913

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

MAY - 4 2009

| Proprietary Name: | Cross-Pilot™ Turbo elite® Support Catheter |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Support Catheter |
| Classification Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Product Classification and Code: | 21 CFR 870.1250, DQY |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 3007284006 |
| Contact Person: | Brandon Hansen<br>Regulatory Affairs<br>Spectranetics Corporation<br>9965 Federal Drive<br>Colorado Springs, CO 80921<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |

### Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

K090913

Image /page/0/Picture/9 description: The image shows the word "Spectranetics" in a stylized, bold, italicized font. The word is written in black ink and appears to be the name of a company or product. The font is distinctive and easily recognizable.

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K090913

Special 510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Cross-Pilot™ Turbo elite® Support Catheter

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### Device Description

The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths 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.

#### Indication for Use

Cross-Pilot™ Turbo elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.

### Substantially Equivalent Devices

In Spectranetics' opinion, the Cross-Pilot™ Turbo elite "Support Catheter is believed to be substantially equivalent to the following predicate device currently in interstate commerce with respect to comparable features, materials of construction and intended use.

- Cross-Pilot" Turbo elite Support Catheter (Spectranetics Corp., Colorado . Springs, CO) - K082559
Labeling, packaging, materials and sterilization of the Cross-Pilot" Turbo elite Support Catheter has not changed from that of the predicate devices listed above.

#### Summary of Studies

Spectranetics performed device functional testing to support that the Cross-Pilot Turbo elite Support Catheter is equivalent to the predicate device. All device functional test results for the Cross-Pilot™ Turbo elite Support Catheter met specified requirements.

#### Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the Spectranetics Cross-Pilot" Turbo elite "Support Catheter through this Special 510(k) Premarket Notification.

Spectranetics

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2009

Spectranetics Corporation c/o Mr. Brandon Hansen Manager, Global Regulatory Affairs 9965 Federal Drive Colorado Springs, CO 80921

Re: K090913

Cross-Pilot Turbo Elite Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 31, 2009 Received: April 1, 2009

Dear Mr. Hansen:

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 - Mr. Brandon Hansen

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 (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.

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 the reporting of adversc events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours.

Prem D. Zukerman, M.D.

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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## INDICATION FOR USE

510(k) Number (if known):

5090913

Device Name:

Cross-Pilot" Turbo elite® Support Catheter

Indication For Use:

Cross-Pilot" Turbo elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.

| Prescription Use | 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 IF NEEDED)

Concurrence of CDRH, Office of Dovice Evaluation (ODE)

Jtittlestar for B Zuckerman

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510(k) Number K690913

Spectranetics Confidential