MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055

K034036 · Micro Therapeutics, Inc. · KRA · Feb 13, 2004 · Cardiovascular

Device Facts

• Record ID: K034036
• Device Name: MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Marathon™ Flow Directed 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

Single-lumen, endhole micro catheter designed for subselective infusion in tortuous, distal vessels. Features semi-rigid proximal shaft and highly flexible distal shaft; includes radiopaque distal marker for fluoroscopic visualization; outer surface coated for lubricity. Accompanied by stylet to increase distal rigidity during introduction into guiding catheter. Used by physicians in clinical settings to deliver therapeutic or diagnostic agents. Output is the delivery of specified agents to target vasculature; facilitates clinical decision-making regarding embolization or diagnostic imaging. Benefits include improved access to distal anatomy for targeted therapy.

Clinical Evidence

Bench testing only. MTI performed in vitro and in vivo tests to verify and validate product design, including biocompatibility, angiographic visualization, dimensional verification, and functional performance.

Technological Characteristics

Single-lumen, endhole micro catheter. Materials: distal shaft (Echelon-derived), proximal shaft (UltraFlow-derived). Features: radiopaque distal marker, lubricious outer coating, luer adapter, and stylet. Connectivity: None. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for accessing peripheral and neuro vasculature for controlled selective infusion of physician-specified therapeutic agents (e.g., embolization materials) and diagnostic materials (e.g., contrast media).

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

• UltraFlow™ HPC Flow Directed Micro Catheter (K024118)
• Echelon™ Over the Wire Micro Catheter (K030688)

Submission Summary (Full Text)

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FEB 1 3 2004

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Micro Therapeutics, Inc. Traditional 510(k) Marathon™ Flow Directed Micro Catheter
December 24, 2003

## 510(k) Summary 4.

| Prepared December 24, 2003 | | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------|
| TRADE NAME | Marathon™ Flow Directed Micro Catheter | | |
| GENERIC NAME | Flow Directed Micro Catheter | | |
| CLASSIFICATION | Class II (21 CFR 870.1210) | | |
| SUBMITTED BY | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT | Bill Hyatt<br>Regulatory Affairs<br>[phone] |
| PREDICATE<br>DEVICE(S) | UltraFlow™ HPC Flow Directed Micro Catheter (K024118),<br>cleared February 3, 2003<br>Echelon™ Over the Wire Micro Catheter (K030688),<br>cleared March 28, 2003 | | |
| DEVICE<br>DESCRIPTION | The Marathon™ Micro Catheters are single-lumen, endhole catheters designed<br>for the subselective infusion of physician specified therapeutic agents or contrast<br>media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and<br>a highly flexible distal shaft to facilitate the advancement of the catheter in the<br>anatomy. The proximal end of the catheter incorporates a standard luer adapter to<br>facilitate the attachment of accessories. The catheter has a radiopaque marker at<br>the distal end to facilitate fluoroscopic visualization. The outer surfaces of the<br>catheter are coated to increase lubricity. The stylet accompanying the catheter is<br>used to increase the rigidity of the distal section during introduction into the<br>guiding catheter. | | |
| INDICATIONS FOR<br>USE | The Marathon Micro Catheter is intended to access peripheral and neuro<br>vasculature for the controlled selective infusion of physician-specified therapeutic<br>agents such as embolization materials and of diagnostic materials such as contrast<br>media. | | |
| TESTING | MTI performed in vitro and in vivo tests to verify and validate product design.<br>Tests included the following:<br>• Biocompatibility<br>• Angiographic visualization<br>• Dimensional verification<br>• Functional performance | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Marathon Flow Directed Micro Catheter has<br>(1) substantially equivalent device and embolic material compatibility to predicate<br>devices (UltraFlow and Echelon Micro Catheters) , including DMSO and Onyx®<br>compatibility,<br>(2) substantially equivalent flow directability and accessibility to the predicate<br>UltraFlow HPC Flow Directed Micro Catheter device,<br>(3) substantially equivalent materials and construction to the predicate devices<br>(distal shaft = Echelon, proximal shaft = UltraFlow), and<br>(4) an identical intended use to the predicate device (Echelon). | | |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

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

Re: K034036

Marathon™ Flow Directed Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 24, 2003 Received: December 29, 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 (sec 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 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/dsma/dsmamain.html

Sincerely yours,

Duauch P. Vichenel

Bram D. Zuckerman M.D. 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):

K030436

Device Name:

MT! Marathon™Flow Directed Micro Catheter

## Indications For Use:

The Marathon™ Flow Directed 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 (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)

Duma R. Vachner
(Division Sign-Off)

Tivision of Cardiovascular Devices

umber k030436