ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM

K053431 · Medtronic, Ireland · DQY · Mar 16, 2006 · Cardiovascular

Device Facts

• Record ID: K053431
• Device Name: ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
• Applicant: Medtronic, Ireland
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.

Device Story

Attain Select™ II 6248DEL Delivery Catheter System is a telescoping catheter assembly comprising a delivery catheter and an inner catheter; designed for use with a separate Medtronic Attain outer guide catheter. System facilitates coronary sinus access and sub-selection of left heart venous anatomy. Physician operates system in clinical setting to deliver contrast media or transvenous devices. Device provides mechanical navigation and access to target anatomy; enables precise placement of therapeutic devices. Benefits include improved access to complex venous structures for cardiac procedures.

Clinical Evidence

Bench testing only. Device integrity testing included mechanical, functional, and biocompatibility assessments. Biocompatibility testing performed per ISO 10993-1:2003 for external communicating devices with limited exposure (<24 hours) to circulating blood.

Technological Characteristics

Telescoping catheter system (delivery catheter and inner catheter). Materials tested for biocompatibility per ISO 10993-1:2003. Sterilization via Ethylene Oxide (EtO). Available in two models with 90° or 130° curved tips.

Indications for Use

Indicated for delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy in patients requiring such access. Intended for use with outer catheters.

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™ Access 6218A Left Heart Delivery System (K021589)
• Medtronic Attain™ Select™ Guide Catheter Set for Left-Heart Delivery (K042194)
• Guidant RAPIDO™ Cut-Away Guiding Catheter (K031505)

Submission Summary (Full Text)

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MAR 16 2006

k053431

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| 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE |
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| Date Prepared: | December 7, 2005 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic Ireland<br>Parkmore Business Park West<br>Galway<br>Ireland |
| Submission Correspondent: | Michelle Nivala<br>Regulatory Affairs Specialist<br>Medtronic, Inc.<br>1015 Gramsie Road<br>Shoreview<br>MN 55126-3082<br>USA |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail | [e-mail] |
| Proprietary Name: | Attain Select™ II 6248DEL Delivery Catheter<br>System |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |

### Device Description

The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical

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Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" on the right. The circular symbol contains a stylized image of a person in motion. The word "Medtronic" is written in a bold, sans-serif font.

053431
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# Indications for Use

The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.

### Substantially Equivalent Devices:

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:

- Medtronic Attain™ Access 6218A Left Heart Delivery System (K#021589, May . 30, 2002)
- Medtronic Attain™ Select™ Guide Catheter Set for Left-Heart Delivery . (K#042194, cleared September 15, 2004)
- Guidant RAPIDO™ Cut-Away Guiding Catheter (K#031505, cleared June 25, ● 2003)

# Summary of Studies:

Device integrity testing was performed to support the equivalency of the Attain Select™ II 6248DEL Delivery Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ II 6248DEL Delivery Catheter System met all specified design and performance requirements.

### Biocompatibility Information

Medtronic has tested the materials used to fabricate the Attain Select™ II 6248DEL Delivery Catheter System for biocompatibility. The testing performed by Medtronic is consistent with International Standard ISO 10993-1: 2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheters included in the Attain Select™ II 6248DEL Delivery Catheter System are external communicating devices with limited exposure (<24 hours) to circulating blood.

### Sterilization Validation

The Attain Select™ II 6248DEL Delivery Catheter System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

### Conclusion

Through the data and information presented, Medtronic Ireland considers the Attain Select™ II 6248DEL Delivery Catheter System to be substantially equivalent to legally marketed predicate devices.

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JUN 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Ireland c/o Ms. Clare Higgins Regulatory Affairs Co-ordinator Parkmore Business Park West Galway, IRELAND

Re: K053431

Attain Select II 6248DEL Delivery Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: February 13, 2006 Received: February 15, 2006

Dear Ms. Higgins:

This letter corrects our substantially equivalent letter of March 16, 2006.

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.

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

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Page 2 - Ms. Clare Higgins

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,

Bhemimma fir

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

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# INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Attain Select™ II 6248DEL Delivery Catheter System

Indications For Use: The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium i and transvenous devices to the coronary sinus and left heart venous anatomy.

The delivery catheter system is indicated for use with outer catheters.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Kimmerman
(Division Sign-Off)

(Division Sign-OM)
Division of Cardiovascular Devices
510(k) Number K053431

Medtronic Ireland Attain Select™ II 6248DEL Delivery Catheter System Traditional 510(k)