ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

K112917 · Medtronic, Inc. · DQY · Oct 27, 2011 · Cardiovascular

Device Facts

• Record ID: K112917
• Device Name: ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
• Applicant: Medtronic, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Attain 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Device Story

The Attain 6216A/6218A Left Heart Delivery System is a percutaneous catheter system used to access the coronary sinus and left heart chambers. The system comprises guide catheters, a dilator, a guidewire, a valve to minimize blood loss, and a slitter for catheter removal. Operated by a physician in a clinical setting, the device facilitates the introduction of transvenous devices (such as leads or balloon catheters). The distal tip is radiopaque to allow for visualization under fluoroscopy, assisting the physician in navigating the vasculature. By providing a stable pathway to the left heart, the device enables the successful implantation of cardiac rhythm management devices, potentially benefiting patients requiring cardiac resynchronization therapy or similar interventions.

Clinical Evidence

No clinical investigation has been performed for this device. Substantial equivalence is supported by bench testing and design verification.

Technological Characteristics

Catheter construction includes an inner liner, outer jacket, and encapsulated wire braid. Distal tip is radiopaque for fluoroscopic imaging. Proximal hub allows interface with other devices. Sterilized via Ethylene Oxide (EtO). Biocompatibility per ISO 10993-1:2003 (external communicating device, limited exposure <24 hours).

Indications for Use

Indicated for patients requiring the introduction of balloon catheters into the coronary sinus or the placement of leads into the vessels of the left heart via the coronary sinus.

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 Access 6218A Left Heart Delivery System (K021589)
• Attain LDS 6216A Left Heart Delivery System (K021587)
• Attain 6218A-AM Guide Catheter for Left-Heart Delivery (K024035)
• Attain 6216A-MP Guide Catheter for Left-Heart Delivery (K024032)
• Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery (K090659)

Submission Summary (Full Text)

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

## K112917

## OCT 2 7 2011

CONFIDENTIAL May not be reproduced without written permission from Medtronic Ireland

## 4.0 510(k) Summary

| Date Prepared: | September 29th, 2011 |
|--------------------------|----------------------------------------------------------------|
| Applicant: | Medtronic Ireland |
| | Parkmore Business Park West |
| | Galway |
| | Ireland |
| Primary Correspondent: | Aoife Kerans |
| | Regulatory Affairs Specialist |
| | Medtronic Ireland |
| | Parkmore Business Park West |
| | Galway |
| | Ireland |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Alternate Correspondent: | Deborah Kidder |
| | Principal Regulatory Affairs Specialist |
| | Cardiac Rhythm Disease Management |
| | 8200 Coral Sea Street |
| | MS MVS11 |
| | Mounds View MN 55112 |
| | USA |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Proprietary Name: | Attain LDS 6216A Left Heart Delivery System |
| | Attain Access 6218A Left Heart Delivery System |
| | Attain 6216A and 6218A Guide Catheters for Left Heart Delivery |

12

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

| Common Name: | Attain 6216A Left Heart Delivery System<br>Attain 6218A Left Heart Delivery System<br>Attain 6216A and 6218A Guide Catheters for Left Heart Delivery |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name: | Catheter, Percutaneous<br>Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The modified Attain 6216A and 6218A Left Heart Delivery<br>Systems contain one or two guide catheters, one guide catheter<br>dilator, one guidewire, one valve and one slitter. They are designed<br>to access the coronary sinus and the chambers of the heart using<br>the guidewire to access the vein, the valve to reduce blood loss<br>during the implant procedure, the guide catheter to introduce a<br>transvenous device, the guide catheter dilator to facilitate catheter<br>passage and the slitter to remove the guide catheter.<br><br>The modified Attain 6216A and 6218A Left Heart Delivery<br>Systems are available in two models:<br>Attain LDS 6216A Left Heart Delivery SystemAttain Access 6218A Left Heart Delivery System<br>All components with the exception of the guide catheter (shape,<br>length and quantity) and dilator (length) are identical in both<br>models.<br><br>The modified Attain 6216A/6218A Guide Catheters for Left Heart<br>Delivery are individual packs, each containing one guide catheter<br>and one guide catheter dilator. They are also designed to access the<br>coronary sinus and the chambers of the heart using the guide<br>catheter to introduce a transvenous device and the guide catheter<br>dilator to facilitate catheter passage.<br><br>The modified Attain 6216A and 6218A Guide Catheters are<br>available in seven models as follows:<br>Attain 6216A-MB2 Guide Catheter for Left Heart DeliveryAttain 6216A-MP Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-AM Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-45S Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-EH Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-50S Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-57S Guide Catheter for Left Heart Delivery |
| | Each model is different with respect to guide catheter shape and<br>length and the dilator length. |
| Indications For Use: | The modified Attain 6216A/6218A Product Family is intended for<br>introducing balloon catheters into the coronary sinus or leads into<br>vessels of the left heart via the coronary sinus. |
| Substantially Equivalent<br>Devices: | The modified Attain 6216A/6218A Product Family uses similar<br>technology and has similar intended uses, function, materials and<br>method of operation to the following predicate devices: |
| | • Attain Access 6218A Left Heart Delivery System (510(k)<br>K021589). Also commercialized under this 510(k) number<br>is the Attain 6218A-45S, 6218A-50S, 6218A-57S and<br>6218A-EH Guide Catheters for Left-Heart Delivery<br>individual packs. |
| | • Attain LDS 6216A Left Heart Delivery System (510(k)<br>K021587). Also commercialized under this 510(k) number<br>is the Attain™ 6216A-MB2 Guide Catheter for Left-Heart<br>Delivery. |
| | • Attain 6218A-AM Guide Catheter for Left-Heart Delivery<br>(510(k) K024035). Also commercialized under this 510(k)<br>number is the Attain™ 6218A-EH Guide Catheter for Left-<br>Heart Delivery individual pack. |
| | • Attain 6216A-MP Guide Catheter for Left-Heart Delivery<br>(510(k) K024032) |
| | • Attain Command 6250 Left Heart Delivery Systems and<br>Guide Catheters for Left Heart Delivery (510(k) K090659). |
| | |
| Summary of Technological<br>Characteristics: | The modified Attain 6216A and 6218A guide catheters for left<br>heart delivery consist of an inner liner, and an outer jacket, with a<br>wire braid encapsulated between the inner liner and outer layers.<br>The distal tip is radiopaque to facilitate imaging under fluoroscopy<br>and the hub at the proximal end of the shaft allows interfacing of<br>the catheter with other devices used during the procedure. The<br>catheter is packaged with a dilator. Additionally, the Attain 6216A<br>and 6218A left heart delivery systems contain a valve to reduce<br>blood loss and slitters to remove the guide catheter. The<br>technological characteristics of the modified Attain 6216A and<br>6218A Product Family are identical to the predicate Attain 6216A<br>and 6218A Product Family (510(k) K024032, K024035, K021587<br>and K021589) and the Attain Command Product Family<br>(K090659). |
| Summary of Studies: | The modified Attain 6216A and 6218A Product Family met all<br>specified design and performance requirements. |
| Summary of Clinical Data: | No clinical investigation has been performed for this device. |
| Biocompatibility<br>Information: | The biocompatibility evaluation completed verifies that the<br>modified Attain 6216A/6218A Left Heart Delivery Systems and<br>the modified Attain 6216A/6218A Guide Catheters for Left Heart<br>Delivery are biocompatible.<br>The testing which supports the biocompatibility of the modified<br>Attain 6216A/6218A Product Family is consistent with<br>International Standard ISO10993-1:2003, "Biological Evaluation<br>of Medical devices- Part 1: Evaluation and Testing." When<br>classified according to this standard, the catheter and dilator<br>included in the modified Attain 6216A/6218A Product Family are<br>categorized as external communicating devices with limited<br>exposure i.e. whose contact with circulating blood is (less than) <<br>24hours. |
| Sterilization Validation: | The modified Attain 6216A and 6218A Product Family will be<br>sterilized using a validated Ethylene Oxide (EtO) sterilization<br>process. |
| Conclusion: | Through the data and information presented, Medtronic Ireland<br>considers the modified Attain 6216A and 6218A Product Family to<br>be substantially equivalent to the predicate devices. |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONFIDENTIAL May not be reproduced without written permission from Medtronic treland

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

CONFIDENTIAL May not be reproduced without written permission from Medtronic Ireland

i

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

Confidential May not be reproduced without written permission from MedIronic Ireland ા ર

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The text is in all caps and arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

OCT 2 7 2011

Medtronic, Inc. c/o Ms. Deborah Kidder Regulatory Affairs Specialist 8200 Coral Sea Street Mounds View, MN 55112

Re: K112917

> Trade/Device Name: Attain Catheter Product Family models 6216A and 6218A Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 30, 2011 Received: October 3, 2011.

Dear Ms. Kidder:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{5}------------------------------------------------

Page 2 – Ms. Deborah Kidder

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

ICC

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indication for Use

510(k) Number (if known):

Device Name: Attain 6216A and 6218A Product Family

Indications For Use: The Attain 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sınus.

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112917