ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218

K021589 · Medtronic Vascular · DQY · May 30, 2002 · Cardiovascular

Device Facts

• Record ID: K021589
• Device Name: ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Attain™ Access 6218A Left-heart delivery system 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 Access 6218A is a percutaneous delivery system used by clinicians to facilitate the placement of balloon catheters or cardiac leads into the coronary sinus and left heart vessels. The system comprises guide wires, adjustable hemostasis valves to minimize blood loss, guide catheters, a guide catheter dilator, guide catheter slitters, and a guide wire clip. The device is a modification of the predicate Attain Access 6218 system, featuring an updated guide catheter distal tip segment containing Tungsten Carbide-filled polyether block amide, along with a revised configuration of slitters and valves. It is used in a clinical setting during implant procedures to provide access for therapeutic devices.

Clinical Evidence

Bench testing only. In vitro performance testing, biocompatibility testing per ISO 10993-1, and sterilization validation were performed to demonstrate substantial equivalence.

Technological Characteristics

System includes guide wires, hemostasis valves, guide catheters, dilator, and slitters. Guide catheter distal tip incorporates Tungsten Carbide-filled polyether block amide. Sterilization via 100% Ethylene Oxide (ETO).

Indications for Use

Indicated for patients requiring the introduction of balloon catheters into the coronary sinus or leads into 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

• Medtronic Attain Access 6218 Left-heart Delivery System (K012083)

Submission Summary (Full Text)

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MAY 3 0 2002

K021589

CONFIDENTIAL

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

# 510(K) Summary of Substantial Equivalence

Date prepared Submitter:

Submission Correspondent:

Telephone: Fax:

E-Mail:

Proprietary Name:

Common Name: Device Classification: Product Code:

May 13, 2002

Medtronic, Inc. Parkmore Business Park West Galway, Ireland.

Karen Reidt, RAC Sr. Product Regulation Manager 7000 Central Avenue N.E. Minneapolis. MN 55432

[phone]

[phone]

[e-mail]

Attain™ Access 6218A Left-heart delivery system

Catheter, Percutaneous

Class II, 21 CFR § 870.1250

74 DQY

### Performance Standard

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

### Device Description

The left-heart delivery system features two guide wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

The Attain Access 6218A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and

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#### CONFIDENTIAL

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

the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.

### Indications for Use

The intended use of the Medtronic Attain Access 6218A Left-heart delivery system 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 Access<br>6218A Left-heart<br>Delivery System<br>Device | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|----------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------|------------------|
| 45 cm and 50 cm<br>Guide Catheters | Medtronic Attain Access<br>6218 Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| Guide Catheter<br>Dilator | Medtronic Attain Access<br>6218 Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| Adjustable<br>Hemostasis Valve | Medtronic Attain Access<br>6218 Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| 120 cm Guide<br>Wires | Medtronic Attain Access<br>6218 Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| 4 Fr and 6 Fr<br>Guide Catheter<br>Slitters | Medtronic Attain Access<br>6218 Left-heart Delivery<br>System | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| Guide Wire Clip | Class I device, exempt from premarket notification | | |

Attain Access 6218A Left-heart Delivery System Predicate Device

### Summary of Studies

In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain Access 6218A meets all of its design and performance requirements.

### Biocompatibility Information

Biocompatibility testing was performed on representative samples of Attain product. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.

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## Sterilization Validation

The Attain Access 6218A Left-heart delivery system 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 Through the data and microniation the Attain Access 6218A Left-heart marketed device, medically equivalent to the previously discussed legally marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2002

Ms. Karen Reidt Principal Regulatory Affairs Specialist Cardiac Rhythm Management Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Re: K021589

Trade Name: Attain™ Access 6218A Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 13, 2002 Received: May 15, 2002

Dear Ms. Reidt:

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.

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#### Page 2 - Ms. Karen Reidt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 yours,

Reala Well

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory 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.

## Indications for Use Statement

NA KO21589 510(k) Number (if known): Attain™ Access 6218A Left-heart delivery system Device Name:

Indications For Use:

The Attain™ Access 6218A Left-heart delivery system 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 (Per 21 CFR 801.109)

Over-The-Counter Use_

Division of Cardiovascular & Respiratory Devices
510(k) Number K021589

OR

Special 510(k): Device Modification Premarket Notification Attain™ Access 6218A Left-heart delivery system