The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

Device Description

The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.

AI/ML Overview

This is not an AI/ML device. This is a medical device, a catheter, for which the manufacturer is seeking approval for a modified version with a different coating. Therefore, the questions related to AI/ML device performance metrics, such as accuracy, AUC, F1 score, expert consensus for ground truth, training/test set sizes, and MRMC studies, are not applicable here.

The submission is a Special 510(k) for the Marksman™ Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in the hydrophilic coating. The safety and performance verification is based on engineering and biocompatibility testing, not on AI/ML performance evaluation.

Here's how the provided information relates to the general concept of acceptance criteria and proving device meets them, adapted for a non-AI/ML medical device:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria/Performance Metrics: The primary "acceptance criteria" here is substantial equivalence to the predicate device, specifically demonstrating that the new Biocoat™ coating does not introduce new risks and that the device maintains its existing safety and performance characteristics.
- Reported Device Performance: The submission states:
  - Biocompatibility: "The Marksman™ Catheter with Biocoat™ coating meets the requirements for biocompatibility." and "All test results obtained were acceptable for the device's intended use."
  - Safety and Performance Verification Tests: "These tests yielded acceptable results substantially equivalent to the predicate device."
- Table: While not presented in a formal table in the provided text as numerical values for specific performance metrics (which are typical for AI/ML devices), the key areas of evaluation and their "performance" are summarized as "SAME" or "acceptable results".

Acceptance Criteria Category	Reported Device Performance
Design, Function, Indications, Packaging, Sterilization, Shelf life, Labeling	SAME as predicate device (substantially equivalent).
Manufacturing	SAME as predicate device, except for hydrophilic coating.
Materials	SAME as predicate device, except for hydrophilic coating.
Biocompatibility	Meets requirements, acceptable for intended use.
Risk Evaluation	No new risks identified, safety and effectiveness profile similar to predicate.
Safety & Performance Verification Tests (dimensional, material, access/tractability, coating durability, particulate)	Acceptable results, substantially equivalent to predicate device.

Sample size used for the test set and the data provenance
- This question is not applicable in the context of an AI/ML system evaluating data. For a physical medical device, testing typically involves a sufficient number of device units or components to ensure statistical confidence in the results for the specific tests performed (e.g., biocompatibility on samples, mechanical stress tests on multiple catheters). The document doesn't specify the exact number of units tested for each physical or biological test, but it indicates the tests were performed.
- Provenance: The biocompatibility testing was performed by Toxikon (Bedford, MA), a certified laboratory. The nature of testing is likely prospective in that the new coating was specifically manufactured and then tested according to predetermined protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of device submission. There is no concept of "ground truth" established by experts in the context of evaluating the performance of a physical catheter with a new coating; rather, it relies on standardized physical, chemical, and biological testing methods.
Adjudication method
- This is not applicable.
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
- This is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable.
The type of ground truth used
- This is not applicable. For this device, "ground truth" is analogous to established scientific and engineering principles, material standards, and biological responses as measured by validated laboratory tests and existing clinical knowledge of similar devices and materials.
- Specifically, biocompatibility relies on standardized in vitro and in vivo biological tests (e.g., per EN ISO 10993-1: 2009 for biocompatibility). Physical performance validation uses engineering and material testing methods.
The sample size for the training set
- This is not applicable. There is no "training set" for this type of medical device.
How the ground truth for the training set was established
- This is not applicable.

Summary

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K111490

SEP 1 6 2011

8. 510(k) Summary

SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitted by:

Chestnut Medical Technologies, Inc., an ev3 Company 173 Jefferson Drive Menlo Park, CA 94025 Tel.: (650) 566-0057 Fax: (650) 566-0072

Contact Person: Daniel Cher, M.D.

Date summary prepared: May 12, 2011

Trade Name: Marksman™ Catheter

Common Name: Catheter

Classification Name: Catheter, Continuous Flush (21 CFR 870.1210, Product Code KRA)

Device Description:

Indications for Use:

The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

Special 510(k) Marksman Catheter

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Substantial Equivalence Determination

バ

The information presented in this Special 510k shows that the Marksman™ Catheter with
the alternative Biocoat™ coating is substantially equivalent to the predicate Marksman™

Design:	SAME: The subject and predicate device are substantiallyequivalent with respect to design characteristics.
Function:	SAME: The subject and predicate device are substantiallyequivalent with respect to functional characteristics.
Manufacturing:	The subject and predicate device are the same with respect totechnological manufacturing processes with the exception of thehydrophilic coating.
Materials:	The subject and predicate devices are composed of exactly thesame materials, with the exception of the hydrophilic coating. Allthe materials have an extensive clinical history of safe use inmedical devices.
Indications:	SAME: The subject and predicate device maintain the sameindication.
Packaging:	SAME: The subject and predicate devices utilize the samepackaging configurations.
Sterilization:	SAME: The subject and predicate devices are both sterilizedutilizing the same Ethylene Oxide sterilization cycle validated inaccordance with ISO 11135 - Medical Devices - Validation andRoutine Control of Ethylene Oxide Sterilization.
Labeling:	SAME: Both the subject and predicate devices have the samelabeling.
Shelf life:	SAME: The subject and predicate device maintain the same shelflife indication.
Biocompatibility:	SAME: Biocompatibility testing of the Marksman™ Catheter wasperformed according to the relevant sections of standard EN ISO10993-1: 2009. Tests were performed by Toxikon (Bedford, MA),a laboratory certified to EN/ISO/IEC 17025:2005 (Title: GeneralRequirements for the Competence of Testing and CalibrationLaboratories). When evaluated according to the above listedbiocompatibility standards, the Marksman™ Catheter utilizing thealternative hydrophilic Biocoat™ is not toxic (local or systemic),

	sensitizing, locally irritating or otherwise harmful. All test results obtained were acceptable for the device's intended use. The MarksmanTM Catheter with BiocoatTM coating meets the requirements for biocompatibility. The BiocoatTM coating is a widely used coating in the industry Micro Therapeutics, Inc./ev3 Inc.'s Rebar Micro Catheter's coating (Ref. 510K # K993672) & (Ref. Special 510k # K001966-Rebar Micro Catheter).
Risk:	SAME: A risk evaluation was conducted to show that no new risks were identified and that the safety and effectiveness profile is similar to the well-established predicate device cleared for the market. As an alternative coating, BiocoatTM, the team has determined that no new risks have been identified. This well-established coating is currently used by many of our products for the same purpose and confirmatory tests show there we no new risks specifically associated with coating of the MarksmanTM Catheter.
Safety andPerformanceVerificationTests:	SAME: Verification testing for changes implemented in the MarksmanTM Catheters included dimensional inspection, material and component verification, access/tractability /coating durability, and particulate testing. These tests yielded acceptable results substantially equivalent to the predicate device.

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ﺰ

Special 510(k) Marksman Catheter .

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle with outstretched wings, overlaid with a caduceus symbol. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ev3. Inc. c/o Dr. Daniel Cher Vice President of Clinical and Regulatory Affairs 173 Jefferson Drive Menlo Park, CA 94025

Re: K111490

Trade/Device Name: Marksman™ Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: August 25. 2011 Received: August 26, 2011

SEP 16 66

Dear Dr. Cher:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting of medical

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Page 2 – Dr. Daniel Cher

device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOtfices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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): K-111490

Device Name: Marksman™ Catheter.

Indications for Use:

The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) の 2006年には、 2005年には、 1000年には、 2005年には、 2005年には、 2005年には、 2005年に、 1000年に、 1000年に、 1000年に、 1000

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510/k) Number_

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Special 510(k) Marksman Catheter

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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).