MICRUS COURIER ENZO MICROCATHETER 0.017

K070456 · Micrus Endovascular Corporation · DQO · May 24, 2007 · Cardiovascular

Device Facts

• Record ID: K070456
• Device Name: MICRUS COURIER ENZO MICROCATHETER 0.017
• Applicant: Micrus Endovascular Corporation
• Product Code: DQO · Cardiovascular
• Decision Date: May 24, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Device Story

Diagnostic intravascular catheter; used to deliver contrast media or occlusion coils into peripheral, coronary, or neuro vasculature. Features in-vivo shapeable tip; operator adjusts tip angle (±45° to ±90°) via external knob. Eliminates need to remove catheter for re-shaping to accommodate patient anatomy. Operated by clinicians in clinical settings. Used with standard accessories: guiding catheters, guidewires, rotating hemostatic valves, stopcocks, valves, femoral sheaths, and saline flush systems. Benefits include improved navigation and procedural efficiency by allowing real-time tip adjustment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Diagnostic intravascular catheter; 0.0170" diameter. Features mechanical in-vivo tip deflection mechanism controlled by an external knob. Compatible with standard 5-7F guiding catheters and guidewires. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring delivery of diagnostic or therapeutic agents into peripheral, coronary, or neuro vasculature.

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

• Micrus® Courier™ Pre-Shaped Microcatheter (K061963)

Submission Summary (Full Text)

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K070456

### 510(k) Summary

# MAY 2 4 2007

# Micrus Endovascular Corporation Micrus® Courier Enzo™ Microcatheter 0.0170"

This 510(k) summary for the Micrus® Courier Enzo™ Microcatheter 0.0170"'is submitted in accordance with the requirements of 21 C.F.R. § 807.92.

# GENERAL INFORMATION

| Manufacturer: | Micrus Endovascular Corporation<br>821 Fox Lane<br>San Jose, California 95131<br>Phone: [phone]<br>Est. Registration No. 2954740 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | R. Michael Crompton<br>Vice President, Regulatory / Clinical Affairs<br>& Quality |
| Date Prepared: | February 15, 2007 |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | Micrus® Courier Enzo™ Microcatheter 0.0170" |
| Generic/Common Name: | Diagnostic intravascular catheter (21 CFR § 870.1200) |

### PREDICATE DEVICE

Micrus@ Courier™ Pre-Shaped Microcatheter (reference: K061963)

#### INTENDED USE

The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into peripheral, coronary, and neuro vasculature.

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# DEVICE DESCRIPTION

The Micrus® Courier Enzo™ Microcatheter 0.0170" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±45° to ±90° from the neutral position. The Micrus® Courier Enzo™ Microcatheter 0.0170"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping tool is required. This design feature allows the clinician to adjust the catheter tip shape to accommodate variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.

The accessories for the Micrus Courier Enzo Microcatheter 0.0170", which are not supplied as part of the sales unit, are identical to those for the Micrus Courier Pre-Shaped Microcatheters and include:

- . Guiding catheter (generally, 5-7F)
- Guidewire compatible with the microcatheter .
- . Rotating Hemostatic Valves (RHV); two (2) required
- . 3-way stopcock
- . 1-way valve
- Femoral sheath .
- Continuous Saline Flush Set-ups with Pressure Bags, one as a flush for the guiding . catheter and the other as a flush for the microcatheter

# SUBSTANTIAL EQUIVALENCE

The Micrus® Courier Enzo™ Microcatheter 0.0170"is substantially equivalent to the predicate device identified previously. The Micrus® Courier Enzo™ Microcatheter 0.0170"is substantially equivalent to the predicate device with regard to intended use, shape of distal tip angle, and function.

Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0170" demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to diagnostic intravascular catheters when used in accordance with its Instructions for Use.

#### CONCLUSION

As described in this 510(k)·Summary, Micrus Endovascular Corporation considers the Micrus® Courier Enzo™ Microcatheter 0.0170'' substantially equivalent to the Micrus® Courier™ Pre-Shaped Microcatheter based on a comparison of intended uses and the results of in-vitro tests.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains a logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles three human profiles or faces stacked on top of each other, with flowing lines suggesting movement or connection.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2007

Micrus Endovascular Corporation c/o Mr. R. Michael Crompton Vice President, Regulatory Clinical Affairs and Quality 821 Fox Lane San Jose, CA 95131

Re: K070456 Micrus® Courier Enzo™ Microcatheter 0.0170" Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: DQO Dated: May 8, 2007 Received: May 9, 2007

Dear Mr. Crompton:

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 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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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 or any x 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) rms lower watification. 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/industry/support/index.html.

Sincerely yours,

Dana R. Bachner

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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# Statement of Indications for Use

510(k) Number (if known): K070456

Device Name: Micrus® Courier Enzo™ Microcatheter - 0.0170"

Indications for Use: The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Prescription Use × (Per 21 C.F.R. 801 Subpart D)

AND/OR

Over-the-Counter Use (21 C.F.R. 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. luchene

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko7 0466

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