CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS

K061710 · St Jude Medical · DQY · Jul 14, 2006 · Cardiovascular

Device Facts

• Record ID: K061710
• Device Name: CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system.

Device Story

The CPS Direct PL Peelable Outer Guide Catheter is a medical device used for intracardiac access within the venous system. It functions as a conduit for delivering contrast media, implantable left heart leads, and associated delivery tools. The device is designed to support fluid delivery while minimizing blood loss. It can be used in conjunction with inner catheters as part of a system. The device is intended for use by clinicians in a hospital or clinical setting during cardiac implantation procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peelable outer guide catheter designed for venous system access. Functions as a conduit for delivery of contrast and cardiac leads. Compatible with inner catheter systems. No specific materials or software algorithms described.

Indications for Use

Indicated for intracardiac access of the venous system of the heart for delivery of contrast medium, St. Jude Medical devices (including implantable left heart leads and delivery tools), and fluid support where minimizing blood loss is required.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

St. Jude Medical c/o Ms. Adele Shoustal Regulatory Affairs Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342

Re: K061710

Trade Name: CPS Direct™ PL Peelable Outer Guide Catheter Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: DQY Dated: June 15, 2006 Received: June 19, 2006

Dear Ms. Shoustal:

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. Adele Shoustal

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 (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 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 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,

Bhemmermonfr

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

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:

| 510(k) Number (if known) | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CPS Direct PL Peelable Guide Outer Catheter |
| Indications for Use | The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system. |

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) | X |
|---------------------------------------|----|
| | OR |
| Over-The-Counter Use | |

*(Division Sign-Off)*

Division of Cardiovascular Devices

| 510(k) Number | K04/710 |
|---------------|---------|
|---------------|---------|

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CPS Direct™ PL Peelable Outer Guide Catheter Special 510(k) St. Jude Medical

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