10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600

K013517 · Medtronic Vascular · DQY · Apr 25, 2002 · Cardiovascular

Device Facts

• Record ID: K013517
• Device Name: 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

Device Story

System provides percutaneous access pathway for cardiac procedures; includes needle, syringe, guide wire, adjustable hemostasis valve, deflectable catheter, dilator, and slitters. Used in clinical settings by physicians to facilitate introduction of diagnostic/therapeutic devices into heart chambers, coronary vasculature, or coronary sinus. Deflectable mechanism allows navigation within vasculature. Single-use, sterile device. Output is physical access pathway; enables delivery of secondary devices (leads/balloons) to target cardiac sites. Benefits include facilitated navigation and reduced blood loss during implantation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included environmental conditioning, mechanical integrity, compatibility, and package/shelf-life validation. All results met specified requirements. Biocompatibility testing performed on all blood-contacting materials per ISO 10993-1.

Technological Characteristics

Percutaneous catheter system; includes deflectable catheter, dilator, hemostasis valve, guide wire, and slitters. Materials are biocompatible per ISO 10993-1. Sterilization via 100% Ethylene Oxide (EtO). Mechanical design facilitates navigation in coronary vasculature.

Indications for Use

Indicated for patients requiring transvenous access to heart chambers, coronary vasculature, or coronary sinus for the introduction of diagnostic/therapeutic devices, balloon catheters, or left-heart leads.

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

• Model 6216 Medtronic Attain LDS Left-heart delivery system (K012130)
• Model 6218 Medtronic Attain Access Left-heart delivery system (K012083)
• GCIII (Vector, Vector X) Coronary Guiding Catheter (K950179)
• Cardima Naviport Deflectable Guiding Catheter (K974683)
• SafeSheath CSG (K003731)
• Marinr Series EP Diagnostic Catheters (K931794)

Reference Devices

• MedAmicus, Inc. Percutaneous Introducer (K893658)
• MedAmicus, Inc. Percutaneous Venous Introducer (K965167)

Submission Summary (Full Text)

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

510(k) Premarket Notification Attachment C

Model 10600 Deflectable Catheter System

K

## 510(k) Summary of Substantial Equivalence

| Date Prepared: | October 19, 2001 | |
|---------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>7000 Central Ave. N.E.<br>Minneapolis, MN 55432 | |
| Contact: | Kristy K. Mollner, RAC<br>Product Regulation Manager<br>Telephone:<br>Facsimile:<br>E-mail: | [phone]<br>[phone]<br>[e-mail] |
| Trade / Proprietary Name: | Medtronic Model 10600 Deflectable Catheter System | |
| Common Name: | Catheter, Percutaneous | |
| Device Classification: | Class II, 21 CFR 870.1250 | |
| Product Code: | 74 DQY | |

#### Device Description

The Medtronic Model 10600 Deflectable Catheter System features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, an adjustable hemostasis valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and slitters to remove the deflectable catheter.

The Model 10600 Deflectable Catheter System is provided STERILE and is intended for single use only.

The Model 10600 Deflectable Catheter System 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 Medtronic Model 10600 Deflectable Catheter System is indicated to provide a pathway through which diagnostic and therapeutic devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

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

510(k) Premarket Notification Attachment C

# Substantially Equivalent Devices

# Medtronic Model 10600 Deflectable Catheter System Predicate Devices

| Medtronic Model 10600<br>Deflectable Catheter<br>System | Predicate Device | Predicate Device<br>Manufacturer | 510(k) |
|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------|---------|
| Guide Catheter | Model 6216 Medtronic Attain<br>LDS Left-heart delivery system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012130 |
| | Model 6218 Medtronic Attain<br>Access Left-heart delivery<br>system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |
| | GCIII (Vector, Vector X)<br>Coronary Guiding Catheter | Medtronic Interventional<br>Vascular (MIV)<br>Danvers, MA 01923 | K950179 |
| | Cardima Naviport Deflectable<br>Guiding Catheter | Cardima<br>Fremont, CA 94538 | K974683 |
| | SafeSheath CSG (Same as<br>SafeSheath MSP) | Thomas Medical<br>Malvern, PA 19355 | K003731 |
| | Marinr Series EP Diagnostic<br>Catheters | Medtronic CardioRhythm<br>Minneapolis, MN 55432 | K931794 |
| Guide Catheter Dilator<br>Adjustable Hemostasis<br>Valve<br>Guide Wire<br>Guide Catheter Slitters<br>Guide Catheter<br>Percutaneous Introducer | Model 6216 Medtronic Attain<br>LDS Left-heart delivery system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012130 |
| | Model 6218 Medtronic Attain<br>Access Left-heart delivery<br>system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |

#### Additionally, the sterilization process and biocompatibility of the Medtronic 10600 Deflectable Catheter System is substantially equivalent to the following devices:

| MedAmicus, Inc. Percutaneous Introducer<br>(also known as Solotrak) | MedAmicus, Inc.<br>Plymouth, MN 55447 | K893658 |
|---------------------------------------------------------------------|------------------------------------------|---------|
| MedAmicus, Inc. Percutaneous Venous<br>Introducer | MedAmicus, Inc.<br>Plymouth, MN 55447 | K965167 |
| Medtronic Attain LDS Model 6216 Left-<br>heart delivery system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012130 |
| Medtronic Attain Access Model 6218<br>Left-heart delivery system | Medtronic, Inc.<br>Minneapolis, MN 55432 | K012083 |

Ironic confiderial

..............................................................................................................................................................................

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

510(k) Premarket Notification Attachment C

### Summary of Studies

Device integrity testing was conducted to support that the Medtronic Model 10600 Deflectable Catheter System is equivalent to the predicate devices. Testing included: Environmental Conditioning, Mechanical Testing, Compatibility Testing, Package/Shelf Life Testing. All device test results for the Medtronic Model 10600 Deflectable Catheter System met specified requirements.

#### Biocompatibility Information

Biocompatibility testing was conducted on all blood contacting materials. The testing performed on this product was done in accordance with ISO 10993-1 and results demonstrate that all materials were found to be biocompatible.

#### Sterilization Validation

The Medtronic Model 10600 Deflectable Catheter System is sterilized using a validated 100% Ethylene Oxide (EtO) sterilization process.

#### Conclusion

Through the data and information presented, numerous similarities support a determination of substantial equivalence and therefore market clearance of the Medtronic Model 10600 Deflectable Catheter System through this 510(k) Pre-market Notification.

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three lines curving upwards and a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2002

Ms. Kristy K. Mollner, RAC Product Regulation Manager Cardiac Rhythm Management Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K013517

Trade Name: Model 10600 Deflectable Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: February 1, 2002 Received: February 4, 2002

Dear Ms. Mollner:

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.

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

#### Page 2 - Ms. Kristy K. Mollner, RAC

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,

Sincerely, years,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Premarket Notification Indications for Use

Model 10600 Deflectable Catheter System K

# INDICATIONS FOR USE

510(k) Number (if known):

N/A K013517

Device Name:

Indications For Use:

Model 10600 Deflectable Catheter System

The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and 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 K013517

editronic confideral

10