MICRUS MICROCATHETER, MODEL COURIER 270

K092702 · Micrus Endovascular Corporation · DQO · Nov 20, 2009 · Cardiovascular

Device Facts

• Record ID: K092702
• Device Name: MICRUS MICROCATHETER, MODEL COURIER 270
• Applicant: Micrus Endovascular Corporation
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Micrus Courier 270 Microcatheter is intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Device Story

Variable stiffness, single-lumen microcatheter; designed for accessing small, tortuous vasculature. Used with guiding catheter and steerable guide wire. Features hydrophilic outer coating for reduced friction; PTFE-coated inner lumen for device movement. Includes shaft marker at 90 cm; two radiopaque marker bands for fluoroscopic visualization. Luer fitting on hub for accessory attachment. Packaged with steam shaping mandrel. Operated by physicians in clinical settings to facilitate delivery of diagnostic/therapeutic agents; aids in tracking over guide wires without wire displacement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Variable stiffness single-lumen catheter; hydrophilic outer coating; PTFE-coated inner lumen; radiopaque marker bands; luer fitting; steam shaping mandrel. Sterilization method not specified.

Indications for Use

Indicated for delivery of diagnostic agents (contrast media) and therapeutic agents (occlusion coils) into peripheral, coronary, and neurovasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Courier Microcatheter (K060116)

Submission Summary (Full Text)

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Micrus Courier 270 Microcatheter 510(k) Premarket Notification ...

λ092702

510(%) Summary

# Micrus Endovascular Corporation Micrus® Courier® 270 Microcatheter

This 510(k) Summary for the Micrus Courier 270 Microcatheter is submitted in accordance with the requirements of 21 C.F.R. § 807.92.

### GENERAL INFORMATION

NOV 2 0 2009

Manufacturer:

Micrus Endovascular Corporation 821 Fox Lane San Jose, CA 95131 Phone: [phone] Est. Registration No. 2954740

Contact Person:

Patrick Lee Manager, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]

Date Prepared:

August 31, 2009

# DEVICE CLASSIFICATION

| Classification: | Class II |
|----------------------|--------------------------------------------------------|
| Trade Name: | Courier® Microcatheter 0.0270" ID - Straight |
| Product Code: | DQO |
| Generic/Common Name: | Catheter, Intravascular, Diagnostic (21CFR § 870.1200) |

### PREDICATE DEVICES

- . 510(k) no. K060116, Courier Microcatheter, May 12, 2006
#### INTENDED USE

Micrus Courier 270 Microcatheter is intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

## INDICATIONS FOR USE

Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

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# DEVICE DESCRIPTION

Micrus Courier Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.

### SUBSTANTIAL EQUIVALENCE

The Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials. The microcatheter is intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature. The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate. The modification to the device has not altered the fundamental technology of the predicate devices.

### CONCLUSION

As described in this 510(k) Summary, Micrus Endovascular Corporation considers the Micrus Courier 270 Microcatheter to be substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The emblem itself is a stylized representation of a human figure with outstretched arms, symbolizing care and protection.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Micrus Endovascular Corporation c/o Mr. Patrick Lee Manager, Regulatory Affairs 821 Fox Lane San Jose, CA 95131

NOV 2 0 2009

Re: K092702

Trade/Device Name: Courier® Microcatheter 0.0270"ID - Straight Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: October 26, 2009 Received: October 27, 2009

Dear Mr. Lee:

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.

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## Page 2 - Mr. Patrick Lee

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Diner E. Lachner

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

Koga 702 510(k) Number (if known):

Device Name: Micrus "Courier 270" Microcatheter

Indications For Use:

Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dumas R. Holmes

ision Sign-Off) of Cardiovascular Devices

:(k) Number K092702

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