ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

K012083 · Medtronic Vascular · DQY · Aug 28, 2001 · Cardiovascular

Device Facts

• Record ID: K012083
• Device Name: ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Attain Access 6218 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 6218 is a left-heart delivery system used by physicians during cardiac procedures to facilitate the placement of leads or balloon catheters into the coronary sinus and left heart vessels. The system includes guide wires, an adjustable hemostasis valve to minimize blood loss, guide catheters, a guide catheter dilator, guide catheter slitters, and a guide wire clip. The device is used in a clinical setting to assist in venogram imaging and lead implantation. It is designed for single use and is compatible with current and future leads. By providing a stable delivery platform, the system aids the clinician in navigating the coronary sinus, potentially improving the efficiency and success of left ventricular lead placement.

Clinical Evidence

The device was evaluated in two Medtronic-sponsored IDE clinical studies for left ventricular lead implantation. It performed as expected during venogram imaging and lead placement via the coronary sinus. Bench testing included compatibility testing, incoming inspection, and package qualification, all of which met specified requirements.

Technological Characteristics

System includes 7 French or smaller steerable intracardiac catheters, guide wires, guide catheters, dilators, slitters, and hemostasis valves. Materials are blood-contacting and tested for biocompatibility per ISO 10993-1. Sterilization is performed using 100% Ethylene Oxide (ETO).

Indications for Use

Indicated for patients requiring the introduction of balloon catheters into the coronary sinus or the placement of 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 GC IV Coronary Guiding Catheter (K950490)
• SafeSheath MSP (K003731)
• GC III (Vector, Vector X) Coronary Guiding Catheter (K950179)
• Zuma Guiding Catheter (K990707)
• Percutaneous Introducer Kit (K965167)
• Y-Adaptor W/Touhy Borst Valve (K895580)
• TFX Medical Guide Wire (K963320)

Submission Summary (Full Text)

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

Attachment E

## 510(K) Summary of Substantial Equivalence

| Date prepared | July 2, 2001 |
|------------------------|----------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Contact: | Karen Reidt, RAC<br>Sr. Product Regulation Manager |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Proprietary Name: | Attain™ Access 6218 Left-heart delivery system |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR § 870.1250 |
| Product Code: | 74 DQY |

## Device Description

The left-heart delivery system features two guide wires to facilitate venous access, an adjustable hemostasis valve 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.

A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads.

The Attain Access Model 6218 combines components that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

#### Indications for Use

The intended use of the Medtronic Attain Access 6218 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

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

| Substantially Equivalent Devices | |
|----------------------------------|--|
|----------------------------------|--|

#### Attain Access 6218 Left-heart Delivery System Predicate Devices

| Attain Access<br>Model 6218 Left-<br>heart Delivery<br>System Device | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|----------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------|------------------|
| 45 cm and 50 cm<br>Guide Catheters | Medtronic GC IV Coronary<br>Guiding Catheter | Medtronic Interventional<br>Vascular (MIV)<br>Danvers, MA 01923 | K950490 |
| | SafeSheath MSP (Same as<br>SafeSheath CSG) | Thomas Medical<br>Malvern, PA 19355 | K003731 |
| | GC III (Vector, Vector X)<br>Coronary Guiding Catheter | Medtronic Interventional<br>Vascular (MIV)<br>Danvers, MA 01923 | K950179 |
| | Zuma Guiding Catheter | Medtronic Interventional<br>Vascular (MIV)<br>Danvers, MA 01923 | K990707 |
| Guide Catheter<br>Dilator | Percutaneous Introducer Kit<br>(Component) | MedAmicus<br>Minneapolis, MN 55447 | K965167 |
| | SafeSheath MSP (Same as<br>SafeSheath CSG) | Thomas Medical<br>Malvern, PA 19355 | K003731 |
| Adjustable<br>Hemostasis Valve | Y-Adaptor W/Touhy Borst<br>Valve | Angeion Corp<br>Plymouth, MN 55441 | K895580 |
| 120 cm Guide<br>Wires | TFX Medical Guide Wire | TFX Medical Group<br>Jaffrey, NH 03452 | K963320 |
| 4 Fr and 6 Fr<br>Guide Catheter<br>Slitters | Percutaneous Introducer Kit<br>(Component) | MedAmicus<br>Minneapolis, MN 55447 | K965167 |
| Guide Wire Clip | Class I device, exempt from premarket notification | | |

#### Summary of Studies

Compatibility Testing, incoming inspection of final packaged device and package qualification testing was performed to support substantial equivalence to the predicate devices. Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements.

The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.

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

### Biocompatibility Information

Biocompatibility testing was performed on the materials which are blood contacting. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.

### Sterilization Validation

The Attain Access 6218 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.

#### Conclusion

Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Inc, considers the Attain Access 6218 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2001

Ms. Karen Reidt Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K012083

Trade Name: Attain Access 6218 Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 2, 2001 Received: July 3, 2001

Dear Ms. Reidt:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your becally is substantially equivalent (for the indications for use above and we nere acterine as a marketed predicate devices marketed in interstate commerce stated in une encrosare) to tegally markets of the Medical Device Amendments, or to devices that prior to may 20, 1978, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act. The Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Frices, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frenancer Ippe of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspootions, the Food and may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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

#### Page 2 - Ms. Karen Reidt

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dalla Mela

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Preliminary Information

# Indications for Use

| 510(k) Number (if known): | N/A K012083 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Attain™ Access 6218 Left-heart delivery system |
| Indications For Use: | The Attain Access 6218 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)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K612083

Meditronic confidential