MARKSMANN CATHETER

K091559 · Chestnut Medical Technologies, Inc. · KRA · Sep 18, 2009 · Cardiovascular

Device Facts

• Record ID: K091559
• Device Name: MARKSMANN CATHETER
• Applicant: Chestnut Medical Technologies, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

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

Device Story

Marksman™ Catheter is a variable stiffness, single-lumen catheter for accessing small, tortuous vascular areas. It features a hydrophilic-coated distal segment for lubricity, a PTFE liner to facilitate device movement, and a radiopaque distal tip for fluoroscopic visualization. The distal tip is shapeable. Used by physicians in clinical settings to introduce interventional devices (e.g., embolic agents, coils, stents) or infuse diagnostic/therapeutic agents into neuro, peripheral, and coronary vasculature. The device is single-use only.

Clinical Evidence

Clinical evaluation was conducted in neurovascular anatomy, considered the worst-case representation of cardiac and peripheral vascular anatomies, to demonstrate that no new risks were identified and the safety and effectiveness profile is similar to well-established predicate devices.

Technological Characteristics

Variable stiffness, single-lumen catheter. Materials include PTFE liner and hydrophilic coating. Radiopaque distal tip. Sterilized via Ethylene Oxide per ISO 11135. No electronic components or software.

Indications for Use

Indicated for patients requiring introduction of interventional devices or infusion of diagnostic/therapeutic agents into neuro, peripheral, and coronary vasculature.

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.

Submission Summary (Full Text)

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

# 5. 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. 173 Jefferson Drive Menlo Park, CA 94025 Tel .: [phone] Fax: [phone]

Contact Person: Daniel Cher, M.D.

Date summary prepared: May 27, 2009

Trade Name: Marksman™ Catheter

Common Name: Catheter

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

## 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.

## Indications for Use:

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

## Marksman Catheter

# CONFIDENTIAL

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

#### Substantial Equivalence Determination

The information presented in the 510k shows that the Marksman™ Catheter is substantially equivalent to predicate endovascular catheters in regards to the following aspects:

Design:

The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations in flexibility, length of coated segments and lubricity are what differentiate these catheters. Each manufacturer optimizes these design variations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of a specific devices such as embolic agents, coils and stents.

Function:

The subject and predicate devices are substantially equivalent with respect to functional characteristics.

Manufacturing: The subject and predicate devices are similar with respect to

Materials:

Indications:

Packaging:

technological manufacturing processes.

The subject and predicate devices are composed of similar materials, all of which have an extensive clinical history of safe use in medical devices.

The subject and predicate devices maintain similar indications.

The subject and predicate devices utilize similar packaging configurations.

Sterilization:

The subject and predicate devices are both sterilized utilizing a Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.

Labeling:

Both the subject and predicate devices have similar labeling.

Clinical evaluation was conducted to show that no new risks were identified and that the . safety and effectiveness profile is similar to well-established predicate devices cleared for the market. Evaluation was performed in the more complex and higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies.

Marksman Catheter

## CONFIDENTIAL

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 1 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Chestnut Medical Technologies, Inc. 1 C/O Daniel Cher, M.D. 173 Jefferson Dr. Menlo Park, CA 94025

Re: K091559

Trade/Device Name: Marksman™M Catheter Regulation Number: 21 CFR 870,1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: September 10, 2009 Received: September 11, 2009

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.

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 (reporting of medical

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

Page 2 - Daniel Cher, M.D.

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/CDRHOffices/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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Duma R. V. Achmer

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K091559

Device Name: Marksman™ Catheter.

Indications for Use:

The Marksman™ Catheter is intended 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)

> Concurrence of CDRH, Office of Device Evaluation (ODE) oursel & pilmit

> > CONFIDENTIAL

(Division Sign Off) Division of Cardionascular Devices

510(K) Number_KO91559

Page 1 of 1

Marksman Catheter