ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY

K024032 · Medtronic Vascular · DQY · Dec 30, 2002 · Cardiovascular

Device Facts

• Record ID: K024032
• Device Name: ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery 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-MP is a percutaneous guide catheter designed for left-heart delivery. It consists of a multi-purpose shaped guide catheter and a guide catheter dilator. The device is used by physicians to facilitate the introduction of balloon catheters or leads into the coronary sinus and vessels of the left heart. The primary modification from predicate systems is a change in the distal section shape to accommodate varying patient anatomy and physician preference, alongside the removal of auxiliary components like hemostasis valves and guidewires. The device is intended for prescription use.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro testing, packaging validation, and sterilization validation. Biocompatibility testing confirmed compliance with ISO 10993-1.

Technological Characteristics

Percutaneous guide catheter with dilator. Materials are identical to predicate devices. Sterilization via 100% Ethylene Oxide (ETO). Complies with ISO 10993-1 for biocompatibility. No software or electronic components.

Indications for Use

Indicated for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus in patients requiring left-heart access.

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 LDS 6216A Left-heart Delivery System (K021587)
• Medtronic Attain Access 6218A Left-heart Delivery System (K021589)

Submission Summary (Full Text)

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DEC 3 0 2002

# 510(K) Summary of Substantial Equivalence

| Date prepared | December 3, 2002 |
|---------------------------|-------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Ireland<br>Parkmore Business Park West<br>Galway, Ireland. |
| Submission Correspondent: | Lynn Jensen<br>Sr. Regulatory Affairs Specialist<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Proprietary Name: | Attain ™ 6216A-MP Multi-purpose Guide<br>Catheter for Left-heart delivery |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR § 870.1250 |
| Product Code: | 74 DQY |

#### Performance Standard

Performance standards do not currently exist for these devices. None established under Section 514.

#### Device Description

The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery features one (1) Muli-purpose shaped guide catheter for passing balloon catheters or appropriate leads and one (1) guide catheter dilator to facilitate guide catheter passage.

The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery contains a dilator that is cleared for market distribution via 510(k).

The key change being made to the catheter is the change in the shape of the distal section in order to respond to the needs of physician preferences and to address subtle anatomical differences between patients. Other changes include the elimination of the existing system components (i.e. adjustable hemostasis valves, guidewires, guidewire clip, guide catheter slitters) which are commercialised with

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#### CONFIDENTIAL

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

the Attain™ Access 6218A Left-heart delivery system, with the exception of the guide catheter dilator. The revised configuration of one (1) guide catheter and one (1) guide catheter dilator per package has necessitated changes to the associated packaging and labelling. In addition, the modified device will be given a new model number, Attain™ 6216A-MP.

#### Indications for Use

The intended use of the Medtronic Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus

#### Substantially Equivalent Device

Attain LDS 6216A and Attain Access 6218A Left-heart Delivery System Predicate Devices

| Attain™ 6216A-<br>MP Multi-purpose<br>Guide Catheter<br>for Left-heart<br>delivery | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------|------------------|
| 6216A-MP<br>Multi-purpose<br>Guide Catheter | Medtronic Attain LDS<br>6216A Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K021587 |
| | Medtronic Attain Access<br>6218A Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K021589 |
| Guide Catheter<br>Dilator | Medtronic Attain Access<br>6218A Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K021589 |

#### Summary of Studies

In vitro testing, packaging and sterilization validation testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery meets all of its design and performance requirements.

#### Biocompatibility Information

The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery is biocompatible and meets the requirements of ISO 10993-1. The materials used to fabricate the Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery are identical to those used to fabricate the guide catheters of the predicate devices.

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## Sterilization Validation

The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.

### Conclusion (Statement of Equivalence)

Through the data and information presented, as well as similarities to a legally marketed device, Medtronic, Inc. considers the Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery to be substantially equivalent to the previously discussed legally marketed predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. c/o Ms. Lynn Jensen Senior Regulatory Affairs Specialist Cardiac Rhythm Management 7000 Central Avenue, N.E. Minneapolis, MN 55432

Re: K024032

Trade Name: Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-Heart Delivery Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: December 3, 2002 Received: December 6, 2002

Dear Ms. Jensen:

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 ('ontrols) 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.

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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 musi comply with all the Act's requirements, including, but not limited to: registration and lisung (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 vour Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

J. QUTTA
Bram D. Zuckerman, M.D.

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

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Indications for Use Statement

| 510(k) Number (if known): | N/A |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery |
| Indications For Use: | The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">X</div> |
|----------------------|---------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|


| (Division Sign-Off) | |
|------------------------------------|--|
| Division of Cardiovascular Devices | |

510(k) Numbe