MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

K082670 · Medtronic, Inc. · DQY · Dec 4, 2008 · Cardiovascular

Device Facts

• Record ID: K082670
• Device Name: MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
• Applicant: Medtronic, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Device Story

The Attain Prevail™ 6228CTH80 Steerable Catheter Set is a percutaneous catheter system used by physicians to provide a pathway for delivering transvenous devices into the coronary sinus and coronary vasculature. The set includes an 80cm steerable catheter, guidewire, Y-connector with valve, extension set, 3-way stopcock, guidewire clip, and two guidewire torque tools. The device is operated by a physician in a clinical setting to facilitate navigation through the vasculature. By providing a stable, steerable pathway, the device assists in the precise placement of therapeutic transvenous devices, potentially improving procedural outcomes for patients undergoing cardiac interventions.

Clinical Evidence

Bench testing only. Device integrity, sterilization validation, and biocompatibility testing (per ISO 10993-1:2003) were performed to confirm performance and safety. No clinical data was required or provided.

Technological Characteristics

The device is a percutaneous steerable catheter set. Materials are biocompatible for external communicating use with limited exposure (<24 hours). Sterilization is performed via Ethylene Oxide (EtO). The system includes a steerable catheter, guidewire, and accessories (Y-connector, stopcock, torque tools).

Indications for Use

Indicated for patients requiring transvenous device delivery to the coronary sinus and coronary vasculature of the heart.

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

• Attain Prevail™ 6228CTH Steerable Catheter Set (K031211)
• Attain Prevail™ 6228SYS Left-Heart Delivery System, 80 cm Prevail catheter (K032622)

Submission Summary (Full Text)

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K082670

Image /page/0/Picture/1 description: The image contains the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol appears to depict a stylized representation of the human body.

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# DEC 0 4 2008

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Date Prepared: | September 12, 2008 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic Ireland<br>Parkmore Business Park West<br>Galway<br>Ireland |
| Submission Correspondent: | Beth Claas<br>Senior Regulatory Affairs Specialist<br>Medtronic, Inc.<br>8200 Coral Sea Street<br>MS MVS11<br>Mounds View MN 55112<br>USA |
| Telephone: | ([phone] |
| Fax: | (+1-651) -367-0603 |
| E-Mail: | [e-mail] |
| Proprietary Name: | Attain Prevail™ 6228CTH80 Steerable Catheter Set |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm<br>Steerable catheter, one guidewire, one Y-connector with valve, one extension set,<br>3-way stopcock, one guidewire clip and two guidewire torque tools. |
| Indications For Use: | The steerable catheter set is indicated to provide a pathway for delivery of<br>transvenous devices to the coronary sinus and coronary vasculature of the heart. |
| Substantially Equivalent Devices: | The Attain Prevail™ 6228CTH80 Steerable Catheter Set uses similar technology<br>and has similar intended uses, function, materials and method of operation to the<br>following predicate devices:<br>- Attain Prevail™ 6228CTH Steerable Catheter Set (510(k) K031211). Also<br>commercialized under this 510(k) number is the current Attain Prevail™<br>6228CTH80 Steerable Catheter Set.<br>- Attain Prevail™ 6228SYS Left-Heart Delivery System, 80 cm Prevail catheter<br>(510(k) K032622). |
| Summary of Studies: | Device integrity testing was performed to support the equivalency of the Attain<br>Prevail™ 6228CTH80 Steerable Catheter Set to the predicate devices. Testing<br>included bench, sterilisation and biocompatibility testing. The Attain Prevail™<br>6228CTH80 Steerable Catheter Set met all specified design and performance<br>requirements. |

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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" in bold, sans-serif font on the right. The circular symbol contains a stylized representation of a human figure within a circle.

Biocompatibility Information:

The biocompatibility evaluation completed for the Attain Prevail™ 6228CTH80 Steerable Catheter Set verifies that this device is biocompatible.

The testing which supports the biocompatibility of the Attain Prevail™ 6228CTH80 Steerable Catheter Set is consistent with International Standard ISO10993-1:2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing."

When classified according to this standard, this device is categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than) < 24 hours

Sterilization Validation:

The Attain Prevail™ 6228CTH80 Steerable Catheter Set will continue to be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion:

Through the data and information presented, Medtronic Ireland considers the Attain Prevail™ 6228CTH80 Steerable Catheter Set to be substantially equivalent to legally marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 4 2008

Medtronic, Inc. c/o Ms. Beth Claas Senior Regulatory Affairs Specialist 8200 Coral Sea Street MS MVS11 Mounds View, MN 55112

Re: K082670

Roo2070
Trade/Device Name: Attain Prevail™ 6228CTH80 Steerable Catheter Set Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: November 5, 2008 Received: November 7, 2008

Dear Ms. Claas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the enactment date of the Medical Device Ameridaents, or to Commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). allu Costietle Act (110t) that to hovice, subject to the general controls provisions of the Act. The 1 ou may, utcrefore, market the Act include requirements for annual registration, listing of general condois provisions of associety, 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 chassined (600 above) als. Existing major regulations affecting your device can thay be subject to satin additions, 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 of any I cach sunntes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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### Page 2 - Ms. Beth Class

forth in the quality systems (OS) 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.

Duma R. Vachner

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

Enclosure

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## INDICATION FOR USE

510(k) Number (if known):_KOBILIO

Device Name: Attain Prevail™ 6228CTH80 Steerable Catheter Set

The steerable catheter set is indicated to provide a pathway for delivery of Indications For Use: transvenous devices to the coronary sinus and coronary vasculature of the heart.

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)

Duane R. Holmes
(Division Sign-Off)

Division of Cardrovascular Devices

510(k) Number_K082670