ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM

K012130 · Medtronic Vascular · DQY · Aug 28, 2001 · Cardiovascular

Device Facts

• Record ID: K012130
• Device Name: ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
• 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 LDS 6216 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

Attain LDS 6216 is a percutaneous delivery system for left-heart lead placement; includes guide catheters, hemostasis valve, guide catheter dilator, guide catheter slitters, and percutaneous introducer kit. Used by physicians in clinical settings for venogram imaging and left ventricular lead placement via the coronary sinus. System facilitates venous access and lead delivery; hemostasis valve minimizes blood loss during procedures. Single-use device; distributed for use with current and future leads.

Clinical Evidence

Clinical evidence includes data from the Medtronic Model 8040 InSync System (G980219) and Model 7272 InSync ICD System (G990176) investigations. The device performed as expected for venogram imaging and left ventricular lead placement via the coronary sinus. Bench testing included compatibility, incoming inspection, and package qualification testing.

Technological Characteristics

System includes guide catheters, hemostasis valve, dilator, slitters, and introducer kit. Materials are blood-contacting and tested for biocompatibility per ISO 10993-1. Sterilization via 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)

Submission Summary (Full Text)

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K012130

Attachments

Attain LDS 6216 Left-heart Delivery System

510(k) Premarket Notification

AUG 2 8 2001

## 510(k) Summary of Substantial Equivalence

| Date prepared | July 6, 2001 | |
|------------------------|----------------------------------------------------------------------|--|
| Submitter: | Medtronic, Inc.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 | |
| Contact: | Karen Reidt<br>Sr. Product Regulation Manager | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| E-Mail: | [e-mail] | |
| Proprietary Name: | Attain™ LDS 6216 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 catheters for passing venogram balloon catheters or appropriate leads an adjustable hemostasis valve to reduce blood loss during the implant procedure, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters and a percutaneous introducer kit to facilitate venous access.

The Attain LDS 6216 is intended for single use only and will be distributed independently for use with current and future leads.

The Attain LDS 6216 combines devices 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 LDS 6216 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

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| Attain LDS 6216<br>Left-heart<br>Delivery System<br>Device | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------|------------------|
| 40 cm and 45 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 |
| Percutaneous<br>Introducer Kit | Percutaneous Introducer Kit<br>(Component) | MedAmicus<br>Minneapolis, MN 55447 | K965167 |
| 4 Fr and 6 Fr<br>Guide Catheter<br>Slitters | Percutaneous Introducer Kit<br>(Component) | MedAmicus<br>Minneapolis, MN 55447 | K965167 |

## Substantially Equivalent Devices

#### Attain LDS 6216 Left-heart Delivery System Predicate Devices

### 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 LDS 6216 passed all of the in vitro specified requirements, and ensures that the Attain LDS 6216 meets all of its design and performance requirements.

The Attain LDS 6216 was included in the Medtronic Model 8040 InSync System (MIRACLE) clinical investigation (G980219, approved, September 30, 1998) and Model 7272 InSync ICD System (MIRACLE ICD) clinical investigation (G990176, approved per 5-day notification, October 6, 2000). The Attain LDS 6216 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.

### Biocompatibility Information

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

Image /page/1/Picture/10 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. To the left of the word is a circular graphic with a stylized image of a person. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.

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## Sterilization Validation

The Attain LDS 6216 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 LDS 6216 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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: K012130

Trade Name: Attain LDS 6216 Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 6, 2001 Received: July 9, 2001

#### Dear Ms. Reidt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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#### 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 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 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,

Deale Telle

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

Enclosure

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510(k) Premarket Notification

# Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

NA RO12130

Attain™ LDS 6216 Left-heart delivery system

The Attain LDS 6216 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 V (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Dell Tule
Division of Cardiovascular & Respiratory Devices
510(k) Number K012150

Image /page/5/Picture/16 description: The image shows the Medtronic logo and the word "Confidential" in black font. The Medtronic logo is on the left side of the image. The word "Medtronic" is in bold font and is larger than the word "Confidential". The word "Confidential" is on the right side of the image.

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