MICRUS COURIER MICROCATHETERS

K060116 · Micrus Endovascular Corporation · DQO · May 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060116
• Device Name: MICRUS COURIER MICROCATHETERS
• Applicant: Micrus Endovascular Corporation
• Product Code: DQO · Cardiovascular
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

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

Micrus Courier Microcatheters are single-lumen, intravascular diagnostic/therapeutic catheters. Device consists of flexible shaft (Pebax/nylon with PTFE liner, stainless steel reinforcement), atraumatic distal tip with two radiopaque markers, luer hub, and hydrophilic coating. Used by physicians in clinical settings to navigate peripheral, coronary, and neuro vasculature. Operates by manual advancement/retraction to deliver contrast media or embolic coils. Radiopaque markers facilitate visualization under fluoroscopy for precise placement. Benefits include improved trackability through tortuous anatomy and compatibility with specific embolic coil systems, aiding in minimally invasive vascular procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included tensile strength, flexibility/stiffness, burst pressure (>300 PSI), biocompatibility (ISO 10993-1), air/liquid leakage (ISO 10555-1), fatigue tolerance in tortuous arterial models, corrosion resistance, kink resistance, tracking force, and tip shape retention.

Technological Characteristics

Single-lumen catheter; materials: Pebax, nylon, PTFE liner, stainless steel reinforcement; hydrophilic coating (Hydromer); two radiopaque marker bands; EtO sterilization (SAL 10^-6); dimensions vary by model (165, 170, 190, 210) with ID 0.0165"-0.0210" and OD 1.7-3.0 Fr; manual operation.

Indications for Use

Indicated for delivery of diagnostic agents (contrast media) and therapeutic agents (occlusion coils) into peripheral, coronary, and 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 Microcatheter, Concourse-14 (K032624)

Submission Summary (Full Text)

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# Safety and Efficacy Summary ll.

## A. Contact Information

K.016

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Endovascular Corporation 610 Palomar Avenue Sunnyvale, CA 94085

## B. Device Name

Micrus Microcatheters, Courier," 165, 170, 190, & 210 Device: Catheter, Intravascular, Diagnostic Regulation Number: 870.1200 Product Code: DQO Device Class: 2

## C. Predicate Device(s)

| Number | Description | Clearance Date |
|---------|------------------------------------|----------------|
| K032624 | Micrus Microcatheter, Concourse-14 | Sept 10, 2003 |

## D. Device Description

The Micrus Microcatheters consist of 4 major components:

- 트 A flexible shaft with a lubricious liner extruded from Teflon. The shaft is reinforced with stainless steel (coiled distally and braided proximally). The outer shaft jacket is made from Pebax and nylon Grilamid L25).
- 트 An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- l A standard luer hub insert, which is molded onto the flexible shaft.
- l A hydrophilic coating (Hydromer), which covers the distal 100 centimeters of the Microcatheters.

### E. 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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# F. Intended Use Predicate Device (per products' Instructions for Use)

The Micrus Microcatheter, Concourse-14 is 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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Micrus Endovascular Corporation

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| G. Technological (Physical and Mechanical) Characteristics as Compared to Predicate | | | |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Characteristic | Predicate: Micrus Concourse-14 | Micrus Courier 165, 170, 190, & 210 | Equivalence |
| Shaft Materials | Pebax with PTFE liner | Pebax and nylon with PTFE liner | Substantially equivalent |
| Shaft Design | Flexible single lumen shaft. The catheter shaft is made from Pebax with a PTFE liner. The distal flexible tip is atraumatic with 2 radiopaque markers. | Flexible single lumen shaft. The catheter shaft is made from Pebax & nylon with a PTFE liner. The distal flexible tip is atraumatic with 2 radiopaque markers. | Substantially equivalent |
| Distal Shaft Length<br>(dry & hydrated states) | 20 to 25 cm | 30 to 35 cm | Substantially equivalent |
| Proximal ID/OD<br>(dry & hydrated states) | ID: 0.0165" – 175"<br><br>OD: 0.031" (2.4 French) | Inner diameters are within specifications:<br>Courier 165 ID is .0165" minimum<br>Courier 170 ID is 0.0170" minimum<br>Courier 190 ID is 0.0190" minimum<br>Courier 210 ID is 0.0210" minimum<br>Outer diameters are within specifications:<br>Courier 165 OD is 0.033" max. (2.3 Fr.)<br>Courier 170 OD is 0.034" max. (2.4 Fr.)<br>Courier 190 OD is 0.042" max. (3.0 Fr.)<br>Courier 210 OD is 0.042" max. (3.0 Fr.) | Substantially equivalent |
| Distal ID/OD<br>(Dimensions unchanged in<br>dry & hydrated states) | ID: 0.0165"<br><br>OD: 0.025" (1.9 French) | Inner diameters are within specifications:<br>Courier 165 ID is .0165" minimum<br>Courier 170 ID is 0.0170" minimum<br>Courier 190 ID is 0.0190" minimum<br>Courier 210 ID is 0.0210" minimum<br>Outer diameters are within specifications:<br>Courier 165 OD is 0.023" max. (1.7 Fr.)<br>Courier 170 OD is 0.024" max. (1.8 Fr.)<br>Courier 190 OD is 0.032" max. (2.5 Fr.)<br>Courier 210 OD is 0.032" max. (2.5 Fr.) | Substantially equivalent |

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Micrus Endovascular Corporation

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| Shaft Marker | Tip Markers | Coating | Effective Length<br>(dry & hydrated states) | MicroCoil Compatibility | New feature. |
|----------------------------------------------------|-------------------------------------------------|----------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| No shaft marker | Two radiopaque marker bands, spaced 3 cm apart. | Hydrophilic coating. | 150 cm (59") | Coils:<br>Compatible with 10-System embolic coils.<br>Wires:<br>Compatible with 0.010" and 0.014" guide wires. | Substantially<br>equivalent |
| Shaft marker located at 90 cm from the distal tip. | Two radiopaque marker bands, spaced 3 cm apart. | Hydrophilic coating. | 150 cm (59") | Coils:<br>Courier 165 & 170 are compatible with 10-System embolic coils; Courier 190 & 210 are compatible with 18-System coils.<br>Wires:<br>Courier 165 & 170 are compatible with 0.010" and 0.014" guide wires; Courier 190 & 210 are compatible with 0.014" and 0.018" guide wires. | Substantially<br>equivalent |

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Micrus Endovascular Corporat

# H.

Dicusson of Non-Clinical Tests and Concludes were based upon the intended use of the dovin
the performal tots performed on the Microcations of SC Sterlits, included and reall

The following table outlines the important device characteristics and the non-clinical test data generated:

| Test or<br>Comparison | Concourse-14 | Courier 165, 170, 190, & 210 | Substantial<br>Equivalence |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Tensile strength<br>and tip attachment<br>strength | The shaft to hub junction has a minimum<br>tensile strength of 1.12 lb (5 Newtons).<br>All transition junctions of the shaft have a<br>minimum tensile strength of 0.67 lb (3<br>Newtons). | The shaft to hub junction has a minimum<br>tensile strength of 1.12 lb (5 Newtons). All<br>transition junctions of the shaft have a<br>minimum tensile strength of 0.67 lb (3<br>Newtons). | Substantially<br>Equivalent |
| Flexibility/Stiffness | Demonstrates adequate flexibility to bend<br>easily when under pressure, such as that<br>exerted by vessel tortuosity. | As compared to the predicate,<br>demonstrates adequate flexibility to bend<br>easily when under pressure, such as that<br>exerted by vessel tortuosity. | Substantially<br>Equivalent |
| Burst Pressure | Demonstrates a burst strength greater than<br>300 PSI. | Demonstrates a burst strength greater than<br>300 PSI. | Substantially<br>Equivalent |
| Biocompatibility | Materials in the microcatheter<br>successfully pass all biocompatibility<br>testing per ISO 10993-1. | Materials in the microcatheter successfully<br>pass all biocompatibility testing per ISO<br>10993-1. | Substantially<br>Equivalent |
| Air leakage at hub | No air leakage during testing with<br>negative pressure applied to the catheter<br>hub per ISO 10555-1. | No air leakage during testing with negative<br>pressure applied to the catheter hub per<br>ISO 10555-1. | Substantially<br>Equivalent |
| Liquid leakage | Demonstrates there is no liquid leakage<br>during testing at 46.4 PSI (maintained for<br>30 seconds) per ISO 10555-1. | Demonstrates there is no liquid leakage<br>during testing at 46.4 PSI (maintained for<br>30 seconds) per ISO 10555-1. | Substantially<br>Equivalent |
| Fatigue tolerance<br>and catheter<br>material integrity | | Catheter advanced and retracted 20 times<br>in a tortuous arterial model with a 150-<br>micron filter in a distal location. No<br>catheter particulate or debris resulted from<br>the rigorous stress placed upon the<br>catheter during advancement and<br>retraction | Substantially<br>Equivalent |
| Chemical<br>Integrity/Corrosion<br>Resistance | Demonstrates corrosion resistance per<br>ISO 10555-1 in saline solution and boiling<br>distilled water. | No change to the design of the Courier<br>microcatheters affected corrosion<br>resistance. | Substantially<br>Equivalent |
| Material Used | Pebax shaft. PTFE liner. Hydrophilic<br>coating. All materials are biocompatible. | Pebax shaft. PTFE liner. Hydrophilic<br>coating. All materials are biocompatible. | Substantially<br>Equivalent |
| Labeling | Label content complies with regulatory<br>requirements of all markets where the<br>product is sold. Product labels contain at<br>least 2 removable stickers, which specify<br>the catalog number, lot number and<br>product name. | Label content complies with regulatory<br>requirements of all markets where the<br>product is sold. Product labels contain at<br>least 2 removable stickers, which specify<br>the catalog number, lot number and<br>product name. | Substantially<br>Equivalent |
| Proximal shaft kink<br>radius | Demonstrates a minimum kink resistant<br>radius | Demonstrates a minimum kink resistant<br>radius of 0.325" in the proximal shaft. | Substantially<br>Equivalent |
| Distal shaft kink<br>radius | Demonstrates a minimum kink resistant<br>radius of 0.07" in the distal shaft. | Demonstrates a minimum kink resistant<br>radius of 0.07" in the distal shaft. | Substantially<br>Equivalent |
| Tracking force | Demonstrates the microcatheter is able to<br>track through a tortuous path. | Demonstrates the microcatheter is able to<br>track through a tortuous path with less or<br>equal force (friction) than the predicate | Substantially<br>Equivalent |
| | | | |
| Tip shape retention | Demonstrates the Microcatheter maintains<br>its tip shape when subjected to 3 hours of<br>soaking in a 37°C. bath. | Demonstrates the Microcatheter maintains<br>its tip shape when subjected to 3 hours of<br>soaking in a 37°C. bath. | Substantially<br>Equivalent |
| Packaging Integrity | Tyvek Pouch. | Tyvek Pouch. | Equivalent |
| | Sterile and non-pyrogenic in unopened<br>packaging that is designed to maintain<br>sterility unless the primary product pouch<br>has been opened or damaged. | Sterile and non-pyrogenic in unopened<br>packaging that is designed to maintain<br>sterility unless the primary product pouch<br>has been opened or damaged. | |
| | Packaging qualified to prevent microbial<br>recontamination for a minimum of 3-yrs. | The Courier microcatheters use the same<br>packaging as is used for the Concourse<br>microcatheter. The package integrity has<br>been qualified to prevent microbial<br>recontamination for a minimum of 3-yrs. | |
| Shipping/transit<br>testing | Demonstrates the microcatheter<br>successfully withstands the domestic and<br>international distribution environment, per<br>ISO 10555-1. | Demonstrates the microcatheter<br>successfully withstands the domestic and<br>international distribution environment, per<br>ISO 10555-1. | Substantially<br>Equivalent |
| Sterility | Sterilized using EtO with a sterility<br>assurance level of 10-6 | Sterilized using EtO with a sterility<br>assurance level of 10-6 | Substantially<br>Equivalent |
| | The above non-clinical testing has demonstrated the substantially equivalent performance of the Microcatheters | | |

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Micrus Endovascular Corporation

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The above non-clinical testing has demonstrated the substantially equivalent performance of the Micrus Microcatheters,
"Courier," with the predicate "Concourse" Microcatheter.

41 41
1.1 1
1

The above non-climical testing has and and and and seriormance of the Micrus Micrus Microcalleres,
"Courier," with the produce" Microcaties:
The catheres are single lumen cat

Micrus Endovascular Corporatic

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# I. 510(k) Summary of Safety and Efficacy

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Corporation, it is concluded that the "Courier" Microcatheters are substantially equivalent to the "Concourse-14" in safety and effectiveness.

Ray Mabus

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Endovascular Corporation January 9, 2006

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the emblem.

# Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

12 2006 MAY

Micrus Endovascular Corporation c/o Ms. Margaret Webber Director, Regulatory and Clinical Affairs 821 Fox Lane San Jose. CA 95131

K060116 Re:

Micrus Courier Microcatheters Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter Intravascular, Diagnostic Regulatory Class: II Product Code: DQO Dated: March 31, 2006 Received: April 4, 2006

Dear Ms. Webber:

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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# Page 2 - Ms. Margaret Webber

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 [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,

Duna R. Voelmer

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): _ |< C 6 O / 16

Device Name: Micrus Courier Microcatheters" Model #s MST165000-00. MST170000-00, MST190000-00, & MST210000-00

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 (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)

bana R. la Innes

510(k) Numbe