CPS AIM SL SLITTABLE INNER CATHETER

K082932 · St Jude Medical · DQY · Dec 12, 2008 · Cardiovascular

Device Facts

• Record ID: K082932
• Device Name: CPS AIM SL SLITTABLE INNER CATHETER
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The St. Jude Medical CPS Aim SL Slittable inner catheter intended use is designed for intracardiac access of the coronary sinus and subselection 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.

Device Story

CPS Aim SL Slittable Inner Catheter functions as a conduit for intracardiac access; facilitates coronary sinus access and venous system subselection; enables delivery of contrast media and medical devices (e.g., guidewires). Used in conjunction with outer guide catheters as a system. Operated by physicians in clinical/surgical settings during cardiac implantation procedures. Slittable design allows for removal while maintaining guidewire position.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Slittable inner catheter design; intended for use with outer guide catheters; facilitates delivery of contrast and guidewires. Technical specifications and materials are consistent with percutaneous catheter standards (21 CFR 870.1250).

Indications for Use

Indicated for intracardiac access of the coronary sinus and subselection of the venous system of the heart; serves as a conduit for delivery of contrast medium and St. Jude Medical devices (e.g., guidewires) during implantation 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a person embracing another person. The symbol is composed of three curved lines that form the shape of a person's arms and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2008

St. Jude Medical Cardiac Rhythm Management Division C/O Colleen Canan 15900 Valley View Court Sylmar, CA 91342

Re: K082932

Trade/Device Name: CPS Aim SL Slittable Inner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 10, 2008 Received: November 13, 2008

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.

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.

{1}------------------------------------------------

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); 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 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 yours,

Dma R. bachner

Image /page/1/Picture/5 description: The image contains a handwritten symbol or signature. The symbol appears to be a stylized combination of curved lines and a straight line. It is drawn in black ink on a white background. The symbol is located on the left side of the image.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use Statement -

›

| 510(k)<br>Number<br>(if known) | K082932 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CPS Aim SL Slittable inner catheter |
| Indications<br>for Use | The St. Jude Medical CPS Aim SL Slittable inner catheter intended use<br>is designed for intracardiac access of the coronary sinus and subselection<br>of the venous system of the heart, and to serve as a conduit during<br>implantation for the delivery of contrast medium and St. Jude Medical<br>devices, including guidewires. In addition, the inner catheters can work<br>with outer guide 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<br>(Per 21 CFR 801. 109) | X OR Over-The-Counter Use _______ |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|

(Division Sign-Off)

(Division Sign-Off)
Division of Cardrovascular Devices

510(k) number K0 82932

CPS Aim® SL slittable Inner Catheter Special 510(k) St. Jude Medical