ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90

K042187 · Micro Therapeutics, Inc. · KRA · Sep 2, 2004 · Cardiovascular

Device Facts

• Record ID: K042187
• Device Name: ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Sep 2, 2004
• 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

Endhole, single-lumen micro catheter; introduced over steerable guidewire into peripheral and neuro vasculature. Features semi-rigid proximal shaft transitioning to flexible distal shaft; proximal luer adapter for accessory attachment; dual radiopaque markers for fluoroscopic visualization; lubricious outer coating. Used by physicians in clinical settings to deliver therapeutic or diagnostic agents. Device facilitates navigation through complex anatomy; enables targeted infusion; assists in embolization or diagnostic imaging procedures.

Clinical Evidence

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

Technological Characteristics

Single-lumen catheter with lubricious coating and dual radiopaque markers. Materials evaluated per ISO 10993-1. Mechanical design features semi-rigid to flexible shaft transition. No energy source or software components.

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)
• MTI Echelon™ Micro Catheter (K031992)

Submission Summary (Full Text)

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## Micro Therapeutics, Inc. Special 510(k) (modification to K030688 and K031992) Tip-Shape Echelon™ Micro Catheter August 6, 2004

## SEP = 2 2004

## 510(k) Summary 4.

| TRADE NAME | Tip-Shape 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.<br>2 Goodyear<br>Irvine, CA 92618 | Marilyn R. Pourazar<br>Regulatory Affairs<br>[phone] x293 |
| PREDICATE<br>DEVICE(S) | MTI Echelon™ Micro Catheter (K030688)<br>MTI Echelon™ Micro Catheter (K031992) | |
| DEVICE<br>DESCRIPTION | The Tip-shape Echelon Micro Catheter is an endhole, single-lumen<br>catheter 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<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 devices Echelon Micro<br>Catheter K030688 and K031992. | |
| TESTING | In-vitro performance testing of the MTI Tip Shape Echelon™ Micro<br>Catheter included Dimensional and Visual Analysis, Tip Tensile<br>Strength, Pressure Testing, Guidewire Friction, Coil Friction, Tip<br>Reshape-ability and Retention, Tip offset distances measurement and<br>Tip length measurement specification.<br>The biocompatibility of the MTI Tip Shape Echelon™ Micro<br>Catheter was verified in accordance with ISO 10993-1, Biological<br>Evaluation of Medical Devices. Test results confirmed<br>biocompatibility of the catheter was tested as an external<br>communicating, blood contact, limited exposure (<24 hrs) device. | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The MTI Tip Shape Echelon™ Micro Catheter is substantially<br>equivalent to the predicate devices in intended use and principles of<br>operation. | |

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

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

Re: K042187

Tip-Shape Echelon Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: August 6, 2004 Received: August 12, 2004

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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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/dsma/dsmamain.html

Sincerely yours,

Dvina R. Vochner

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

Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042187

Device Name: MTI Tip-Shape Echelon™ Micro Catheter

Indications For Use:

The Tip-Shape 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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. Wachner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_E04 2183