ECHELON MICRO CATHETER

K051990 · Micro Therapeutics, Inc. · KRA · Jan 4, 2006 · Cardiovascular

Device Facts

• Record ID: K051990
• Device Name: ECHELON MICRO CATHETER
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Echelon ™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

Device Story

Echelon Micro Catheter is an endhole, single-lumen catheter designed for navigation through peripheral and neuro vasculature. Device features a semi-rigid proximal shaft transitioning to a flexible distal shaft to facilitate anatomical advancement; dual radiopaque markers at the distal end allow for fluoroscopic visualization. Outer surface is coated for increased lubricity. Device is introduced over a steerable guidewire; proximal end includes a standard luer adapter for accessory attachment. Used by physicians in clinical settings to deliver therapeutic agents or contrast media. Benefits include precise, controlled delivery of materials to target vascular sites.

Clinical Evidence

Bench testing only. In-vitro performance testing included dimensional inspection, visual analysis, tensile strength, burst pressure, flow rate, torque, tip reshape-ability/retention, tip measurements, and guidewire/coil friction. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device.

Technological Characteristics

Single-lumen, endhole catheter. Features semi-rigid proximal shaft and flexible distal shaft. Includes dual radiopaque markers for fluoroscopy. Outer surface lubricious coating. Biocompatibility per ISO 10993-1. Mechanical testing includes tensile, burst, and torque strength.

Indications for Use

Indicated for accessing peripheral and neuro vasculature for controlled selective infusion of therapeutic agents (e.g., embolization materials) and diagnostic materials (e.g., contrast media) in patients requiring such procedures.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• MTI Rebar® Micro Catheter (K993672)
• MTI Echelon Micro Catheter (K030688)
• MTI Echelon Micro Catheter (K031992)

Submission Summary (Full Text)

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## Micro Therapeutics, Inc.

Kos/990

Traditional 510(k) (modification to K030688, K031992 and K042187) Echelon™ Micro Catheter Family July 20, 2005

## 510(k) Summary 4.

| Prepared July 21, 2005 | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| TRADE NAME<br>GENERIC NAME<br>CLASSIFICATION | Echelon™ Micro Catheter | |
| Catheter, Continuous Flush and Syringe | | |
| Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 | | |
| SUBMITTED BY | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | Contact: Marilyn R. Pourazar<br>Manager, Regulatory Affairs<br>[phone] x1293 |
| PREDICATE<br>DEVICE(S) | MTI K993672 MTI Rebar® Micro Catheter decision date 4-Jan-2000<br>MTI K030688, MTI Echelon Micro Catheter decision date March 27, 2003<br>MTI K031992, MTI Echelon Micro Catheter decision date August 3, 2003 | |
| DEVICE<br>DESCRIPTION | The Echelon Micro Catheter is an endhole, single-lumen catheter<br>designed to be introduced over a steerable guidewire into the<br>vasculature. The proximal end of the catheter incorporates a standard<br>luer adapter to facilitate the attachment of accessories. The catheter<br>has a semi-rigid proximal shaft which transitions into the flexible<br>distal shaft to facilitate the advancement of the catheter in the<br>anatomy. Dual radiopaque markers at the distal end facilitate<br>fluoroscopic visualization. The outer surface of the catheter is coated<br>to increase lubricity. | |
| INDICATIONS FOR<br>USE | The Echelon ™ Micro Catheter is intended to access peripheral and<br>neuro vasculature for the controlled selective infusion of physician-<br>specified therapeutic agents such as embolization materials and of<br>diagnostic materials such as contrast media. | |
| TESTING | <i>In-vitro</i> performance testing of the MTI Echelon™ Micro Catheter<br>included dimensional inspection, visual analysis, tensile strength tests,<br>tip tensile strength, burst pressure tests, flow rate tests, torque tests,<br>tip reshape-ability /retention, tip offset distances measurement, tip<br>length measurement specification, guidewire friction, coil friction and<br>performance under simulated conditions. | |
| | The biocompatibility of the MTI Echelon™ Micro Catheter was<br>verified in accordance with ISO 10993-1, Biological Evaluation of<br>Medical Devices. Test results confirmed biocompatibility of the<br>catheter was tested as an external communicating, blood contact,<br>limited exposure (<24 hrs) device. | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The MTI Echelon™ Micro Catheters are substantially equivalent to<br>the predicate devices in intended use and principles of operation. | |

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Micro Therapeutics, Inc. Traditional 510(k) (modification to K030688, K031992 and K042187) Echelon™ Micro Catheter Family July 20, 2005

## ડ. Truthful and Accuracy Certification

Pursuant to 21 CFR 807.87(j), I Marilyn R Pourazar, certify that to the best of my know!edge and belief and based upon the data and information submitted to me in the course of my responsibilities as Regulatory Affairs Manager of Micro Therapeutics, Inc., and in reliance thereupon, the data and information submitted in this Premarket notification are truthful and accurate and that no facts material for a review of the substantial equivalence of this device have been knowingly omitted from this submission.

Marilyn R. Pourazar

Manager, Regulatory Affairs Micro Therapeutics, Inc.

7-20-05

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Date

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 4

Micro Therapeutics, Inc c/o Ms. Marilyn R. Pourazar Manager of Regulatory Affairs 2 Goodyear Irvine, CA 92618

Re: K051990

> Trade Name: MTI Echelon Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 30, 2005 Received: December 01, 2005

Dear Ms. Pourazar:

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. Marilyn R. Pourazar

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Dina R. Richter

Image /page/3/Picture/5 description: The image shows the name and title of Bram D. Zuckerman, M.D. He is the Director of the Division of Cardiovascular Devices. The division is part of the Office of Device Evaluation. The office is part of the Center for Devices and Radiological Health.

Enclosure

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## Indications for Use

510(k) Number (if known): K051990

Device Name:

Indications For Use:

The MTI Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_≤ 05 19 90

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