ECHELON MICRO CATHETER, MODEL 105-5091

K031992 · Micro Therapeutics, Inc. · KRA · Aug 7, 2003 · Cardiovascular

Device Facts

• Record ID: K031992
• Device Name: ECHELON MICRO CATHETER, MODEL 105-5091
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Special
• 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 end-hole, single-lumen catheter designed for navigation through peripheral and neuro vasculature. Device features semi-rigid proximal shaft transitioning to flexible distal shaft to facilitate anatomical advancement; dual radiopaque markers at distal end allow fluoroscopic visualization; outer surface coated for increased lubricity. Used by physicians in clinical settings to deliver therapeutic agents or contrast media. Device is introduced over a steerable guidewire. Benefits include precise, controlled delivery of materials to target vascular sites.

Clinical Evidence

Bench testing only. In-vitro performance testing included dimensional inspection, tensile strength, burst pressure, flow rate, torque tests, and performance under simulated conditions. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device.

Technological Characteristics

End-hole, single-lumen catheter. Semi-rigid proximal shaft, flexible distal shaft. Dual radiopaque markers. Lubricious outer coating. Biocompatibility per ISO 10993-1. Class II device (21 CFR 870.1210, 870.4450).

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 Echelon™ Micro Catheter (K030688)

Submission Summary (Full Text)

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

Micro Therapeutics, Inc. wwo. So 110rup Subscribed on to K030688)
Special 510(k) (modification to K030688)
Echelon™ Micro Catheter
June 26, 2003

K031992

AUG - 7 2003

## 510(k) Summary 4.

| TRADE NAME | Echelon™ Micro Catheter | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| GENERIC NAME | Catheter, Continuous Flush | |
| CLASSIFICATION | Class II (21 CFR 870.1210) and Class II (21 CFR 870.4450) | |
| SUBMITTED BY | Micro Therapeutics, Inc. | Marilyn R. Pourazar |
| | 2 Goodyear | Regulatory Affairs |
| | Irvine, CA 92618 | [phone] |
| PREDICATE<br>DEVICE(S) | MTI Echelon™ Micro Catheter (K030688) | |
| DEVICE<br>DESCRIPTION | The MTI Echelon™ Micro Catheter is an end-hole, single-lumen<br>catheter designed to be introduced over a steerable guidewire into the<br>vasculature. The catheter has a semi-rigid proximal shaft which<br>transitions into the flexible distal shaft to facilitate the advancement<br>of the catheter in the anatomy. Dual radiopaque markers at the distal<br>end facilitate fluoroscopic visualization. The outer surface of the<br>catheter is coated to increase lubricity. | |
| INDICATIONS<br>FOR 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.<br>This is the same intended use as predicate device Echelon Micro<br>Catheter K030688. | |
| TESTING | In-vitro performance testing of the MTI Echelon™ Micro Catheter<br>included dimensional inspection, tensile strength tests, burst pressure<br>tests, flow rate tests, torque tests and performance under simulated<br>conditions.<br>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 Catheter is substantially equivalent to the<br>predicate devices in intended use and principles of operation. | |

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

AUG - 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031992

> Echelon™ Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: June 26, 2003 Received: June 27, 2003

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.

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

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

## Page 2 - Ms. Marilyn Pourazar

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 (OS) 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 vour 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/dsma/dsmamain.html

Sincerely yours,

KQeith

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Micro Therapeutics, Inc. Special 510(k) (modification to K030688) Echelon™ Micro Catheter June 26, 2003

## Indications for Use Statement 6.

**510(k) Number (if known):** K031992

Device Name:

MTI Echelon™ Micro Catheter

Indications for 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.

## (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

Nde Certn

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031992