ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY

K042194 · Medtronic Vascular · DQY · Sep 15, 2004 · Cardiovascular

Device Facts

• Record ID: K042194
• Device Name: ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

Device Story

Set of 3 catheters (straight, 90° curve, 180° curve) designed for left-heart access; 70cm working length; 7 French (2.4 mm) max outer diameter; radiopaque, flexible tips. Functions as inner catheter within dual-catheter assembly; facilitates delivery of contrast media and transvenous devices (guide wires up to 0.89 mm) to coronary sinus and left-heart venotomy. Used in clinical settings by physicians; compatible with Medtronic Attain Fixed Shape or Deflectable catheters. Provides pathway for device placement; enables contrast visualization; assists in cardiac procedure navigation.

Clinical Evidence

Bench testing only. Device integrity, mechanical, functional, and biocompatibility testing performed. Biocompatibility testing conducted per ISO 10993-1:2003 for external communicating devices with limited exposure (<24 hours) to circulating blood. No clinical data presented.

Technological Characteristics

Percutaneous catheter set; 7 French (2.4 mm) max outer diameter; 70cm working length; radiopaque flexible tips. Materials tested per ISO 10993-1:2003. Sterilized via Ethylene Oxide (EtO).

Indications for Use

Indicated for delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy in patients requiring left-heart access. Used as part of a dual-catheter assembly with an outer guide catheter delivery system.

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 AttainTM Access 6218A Left-Heart Delivery System (K021589)
• Attain™ Prevail® Steerable Catheter Set, Model 6228CTH (K031211)
• Guidant RAPIDOTM Guiding Catheter (K021455)

Submission Summary (Full Text)

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SEP 1 5 2004

CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Date Prepared: | August 11, 2004 |
|------------------------|-----------------------------------------------------------------------|
| Submitter: | Medtronic Ireland<br>Parkmore Business Park West<br>Galway<br>Ireland |
| Contact: | Lynn Jensen<br>Sr. Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail | [e-mail] |
| Proprietary Name: | Attain Select™ 6238TEL Guide Catheter Set for<br>Left-heart Delivery |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DOY |

#### Device Description

The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.

The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be

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used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.

# Indications for Use

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

#### 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 AttainTM Access 6218A Left-Heart Delivery System (K#021589, . cleared May 30, 2002)
- Attain™ Prevail® Steerable Catheter Set, Model 6228CTH (K031211, cleared . July 17, 2003)
- Guidant RAPIDOTM Guiding Catheter (K#021455, cleared August 2, 2002) .

## Summary of Studies:

Device integrity testing was performed to support the equivalency of the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.

## Biocompatibility Information

Medtronic has tested the materials used to fabricate the Attain Select™ 6238TEL. Guide Catheter Set for Left-Heart Delivery 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 devices included in the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery are external communicating devices with limited exposure (<24 hours) to circulating blood.

#### Sterilization Validation

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

## Conclusion

Through the data and information presented, Medtronic Ireland considers the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to be substantially equivalent to legally marketed predicate devices.

022 94

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Medtronic, Inc. c/o Ms. Lynn Jensen Sr. Regulatory Affairs Specialist Parkmore Business Park West Galway IRELAND

Re: K042194

K042194
Medtronic Attain Select™ 6238 TEL Guide Catheter Set for Left-Heart Delivery: Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: August 11, 2004 Received: August 12, 2004

Dear Ms. Jensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tose stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to comments that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices mat have been roomsonial of a premarket approval of a premarket approval application (PMA). allo Costience Act (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general oonly of over in the 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 If your device is classified (600 a00 roy als. Existing major regulations affecting your device can thay be subject to suell additional conserver , 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. Lynn Jensen

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/dsma/dsmamain.html

Sincerely yours,

Blimmima for
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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery

X042194

Indications For Use: The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

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)

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Bhumima
(Division Sign-Off)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number KOH2144

Medtronic Ireland Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery Traditional 510(k)