CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148

K053217 · St Jude Medical · DQY · Mar 8, 2006 · Cardiovascular

Device Facts

• Record ID: K053217
• Device Name: CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The St. Jude Medical CPS Aim™ Inner Catheter 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

The CPS Aim™ Inner Catheter is a percutaneous, radiopaque introducer used to access the coronary sinus and subselect venous branches within the heart. It features a flexible distal tip and a PTFE-lined inner diameter to enhance lubricity. The device is designed to function as a conduit for delivering contrast medium and medical devices, such as guidewires, and can be used in conjunction with an outer guide catheter as a system. It is intended for use by clinicians in a clinical setting during implantation procedures.

Clinical Evidence

Bench testing only. Evidence includes mechanical, functional, and biocompatibility testing to support substantial equivalence. No clinical data was required or provided.

Technological Characteristics

Percutaneous catheter with 71 cm working length; eight curve configurations; radiopaque; flexible distal tip; PTFE-lined inner diameter. Sterilized via Ethylene Oxide (EtO).

Indications for Use

Indicated for patients requiring intracardiac access to the coronary sinus and subselection of the heart's venous system for the delivery of contrast media and 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.

Predicate Devices

• Medtronic Attain™ Select (K042194)
• Guidant Rapido™ (K021455)

Submission Summary (Full Text)

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

K 053 217

# PREMARKET NOTIFICATION [510(K)] SUMMARY

| Date Prepared: | November 16, 2005 |
|---------------------------------------------------------------------------|------------------------------------------------------------------|
| Submitter: | St. Jude Medical, CRMD |
| Address: | 15900 Valley View Court<br>Sylmar, CA 91324 |
| Phone: | 818 493-2629 |
| Fax: | 818 493-3615 |
| Contact Person: | Deanna Hughes |
| Trade Name/Proprietary<br>Name: | CPS Aim™ Inner Catheter |
| Common Name: | Catheter, Percuatenous |
| Classification: | Class II, 21 CFR 870.1250 |
| Legally marketed device<br>to which your firm is<br>claiming equivalence: | Medtronic Attain™ Select (K042194), Guidant Rapido™<br>(K021455) |

#### Device Description:

The inner catheter is an introducer that shall be used to primarily subsclect a coronary sinus vein branch in the venous system.

The CPS Aim730 Inner Catheters will have eight different curve configurations. The catheters will have a working length of 71 cm, are radiopaque, and have a flexible distal tip. The inner diameter of the catheter is lined with polytetrafluoroethylene (PTFF) to ensure additional lubricity. The catheters function as an inner catheter and can work with an outer guide catheter as a system.

## Intended Use of the Device:

The St. Jude Medical CPS Aim™ Inner Catheter is designed for intracardiac access of the coronary sinus and subsclection 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.

page 1 of 2
Page 13 of 172

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

## Technological Characteristics of the Device Compared to the Predicate Device:

The CPS Aim™ Inner Catheters use similar technology, have similar intended uses, functions, materials and method of operation of the following predicate devices.

- Medtronic Attain Select™, K042194 .
- Guidant Rapido™ Inner Catheter, K021455 .

## Summary of Studies:

Device comparison testing was performed to support equivalency of the CPS Aim™ Inner Catheters to the predicate devices. Verification was also performed which included mechanical, functional and biocompatibility testing with the CPS Aim™ meeting all specified design and performance specifications.

#### Biocompatibility Information:

St. Jude Medical has performed biocompatibility testing on the patient tissue contacting materials used in the CPS Aim inner catheter and have been found to be biocompatible.

#### Sterilization Validation:

The CPS Aim™ Inner Catheters are sterilized using a validated Ethylene Oxide (EtO) sterilization process.

## Conclusion:

St. Jude Medical considers the CPS Aim™ Inner Catheters to be substantially equivalent to the legally marketed predicate and referenced devices. The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.

K053217
page 204 of 2

Page 14 of 172

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

Image /page/2/Picture/2 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 8

St. Jude Medical c/o Ms. Deanna Hughes Sr. Regulatory Affairs Specialist 15900 Valley View Court Sylmar, CA 91324

Re: K053217

Trade Name: CPS Aim™ Inner Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 06, 2006 Received: February 07, 2006

Dear Ms. Hughes:

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 usn 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.

{3}------------------------------------------------

Page 2 – Ms. Deanna Hughes

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/cdrl/industry/support/index.html.

Sincerely yours,

B.Zimmerman for

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

Enclosure

{4}------------------------------------------------

#### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

CPS Aim™ Inner Catheter Device Name:

Indications for Use:

The St. Jude Medical CPS Aim™ Inner Catheter 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.

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: OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Zimmerman

n Slan-Off of Cardiovascular Davices

Page 8 of 172