MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 by MICRO THERAPEUTICS, INC.

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 Description

The Marathon™ Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician specified therapeutic agents or contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.

AI/ML Overview

This document is a 510(k) summary for the Marathon™ Flow Directed Micro Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance against specific metrics. Therefore, several requested elements cannot be extracted directly from the provided text.

Here is the information that can be gleaned and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated as Numerical Acceptance Criteria
Biocompatibility	"MTI performed in vitro and in vivo tests to verify and validate product design...Biocompatibility" (Implied as met, but no specific benchmark or result provided.)
Angiographic visualization	"MTI performed in vitro and in vivo tests to verify and validate product design...Angiographic visualization" (Implied as met, but no specific benchmark or result provided.)
Dimensional verification	"MTI performed in vitro and in vivo tests to verify and validate product design...Dimensional verification" (Implied as met, but no specific benchmark or result provided.)
Functional performance	"MTI performed in vitro and in vivo tests to verify and validate product design...Functional performance" (Implied as met, but no specific benchmark or result provided.)
Device and Embolic Material Compatibility (including DMSO and Onyx®)	"substantially equivalent device and embolic material compatibility to predicate devices" (Implied as met, but no specific benchmark or result provided.)
Flow Directability and Accessibility	"substantially equivalent flow directability and accessibility to the predicate UltraFlow HPC Flow Directed Micro Catheter device" (Implied as met, but no specific benchmark or result provided.)
Materials and Construction	"substantially equivalent materials and construction to the predicate devices" (Implied as met, but no specific benchmark or result provided.)
Intended Use	"an identical intended use to the predicate device (Echelon)" (Implied as met, as it's identical.)

Explanation: The document describes "in vitro and in vivo tests" that were performed, but it does not specify quantitative acceptance criteria (e.g., "Visualization must be X to Y" or "Biocompatibility must pass ISO 10993 XYZ levels"). Instead, it states that the device is "substantially equivalent" to predicate devices for various characteristics. This indicates that the performance was assessed against the predicates, but the exact acceptance thresholds are not provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: The document states "MTI performed in vitro and in vivo tests." This implies the testing was conducted by or for Micro Therapeutics, Inc. However, it does not specify the country of origin of any patient data (if applicable to "in vivo tests," which could also refer to animal studies) or whether the data was retrospective or prospective. Given the nature of a 510(k) for a micro catheter, "in vivo" could refer to animal models rather than human patient data for demonstrating substantial equivalence for engineering characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The 510(k) summary does not mention expert review or ground truth establishment in the context of device performance testing.

4. Adjudication Method for the Test Set

This information is not provided. There is no mention of an adjudication process for any test results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a micro catheter), not an AI algorithm.
Therefore, there is no effect size related to human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not applicable. The device is a physical micro catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated in relation to the "in vitro and in vivo tests." The "ground truth" for a physical device like a catheter would typically be its measured physical properties (e.g., dimensions, force, flow rates) and biological compatibility, verified against established standards or predicate device performance.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" for a physical medical device.

Summary

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FEB 1 3 2004

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.2 GoodyearIrvine, CA 92618	CONTACT	Bill HyattRegulatory Affairs(949) 837-3700
PREDICATEDEVICE(S)	UltraFlow™ HPC Flow Directed Micro Catheter (K024118),cleared February 3, 2003Echelon™ Over the Wire Micro Catheter (K030688),cleared March 28, 2003
DEVICEDESCRIPTION	The Marathon™ Micro Catheters are single-lumen, endhole catheters designedfor the subselective infusion of physician specified therapeutic agents or contrastmedia in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft anda highly flexible distal shaft to facilitate the advancement of the catheter in theanatomy. The proximal end of the catheter incorporates a standard luer adapter tofacilitate the attachment of accessories. The catheter has a radiopaque marker atthe distal end to facilitate fluoroscopic visualization. The outer surfaces of thecatheter are coated to increase lubricity. The stylet accompanying the catheter isused to increase the rigidity of the distal section during introduction into theguiding catheter.
INDICATIONS FORUSE	The Marathon Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeuticagents such as embolization materials and of diagnostic materials such as contrastmedia.
TESTING	MTI performed in vitro and in vivo tests to verify and validate product design.Tests included the following:• Biocompatibility• Angiographic visualization• Dimensional verification• Functional performance
SUMMARY OFSUBSTANTIALEQUIVALENCE	The Marathon Flow Directed Micro Catheter has(1) substantially equivalent device and embolic material compatibility to predicatedevices (UltraFlow and Echelon Micro Catheters) , including DMSO and Onyx®compatibility,(2) substantially equivalent flow directability and accessibility to the predicateUltraFlow HPC Flow Directed Micro Catheter device,(3) substantially equivalent materials and construction to the predicate devices(distal shaft = Echelon, proximal shaft = UltraFlow), and(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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
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.(b)
Classification. Class II (performance standards).