CPS DIRECT SL II SLITTABLE OUTER CATHETER

K103250 · St. Jude Medical, Cardiac Rhythm Management Divisi · DQY · Jan 19, 2011 · Cardiovascular

Device Facts

• Record ID: K103250
• Device Name: CPS DIRECT SL II SLITTABLE OUTER CATHETER
• Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters 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, the outer guide catheters can work with inner catheters as a system.

Device Story

CPS Direct SL II Slittable Outer Catheter functions as a conduit for intracardiac access; facilitates delivery of contrast media and implantable left heart leads/tools; supports fluid delivery while minimizing blood loss. Used in clinical settings by physicians during cardiac implantation procedures. Device acts as a guide catheter, potentially in conjunction with inner catheters. Benefits include streamlined lead delivery and reduced blood loss during venous access.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Percutaneous slittable outer catheter; designed for venous system access; compatible with inner catheters; mechanical conduit for fluid/device delivery.

Indications for Use

Indicated for intracardiac access of the venous system of the heart for delivery of contrast medium, implantable left heart leads, and delivery tools, and for 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 9 2011

St. Jude Medical, CRDM c/o Ms. Colleen Canan Regulatory Affairs 15900 Valley View Court Sylmar, CA 91342

Re: K103250

> Trade/Device Name: CPS Direct SL II Slittable Outer Catheter Models DS2C007 and DS2C017 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 17, 2010 Received: December 20, 2010

Dear Ms. Canan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Colleen Canan

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/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

OBram 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 (if known) | K103250 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CPS Direct SL II Slittable Outer Catheter |
| Indications for Use | The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters 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, the 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 | K103250 |
|---------------|---------|
|---------------|---------|

CPS Direct® SL II slittable

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Outer Catheter Special 510(k) St. Jude Medical ・

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