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 Description

The Micrus Microcatheters consist of 4 major components:

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).
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.
A standard luer hub insert, which is molded onto the flexible shaft.
A hydrophilic coating (Hydromer), which covers the distal 100 centimeters of the Microcatheters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Micrus Courier Microcatheters, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Micrus Courier Microcatheters were based on demonstrating "substantial equivalence" to the predicate device, the Micrus Microcatheter, Concourse-14. This was achieved through a series of non-clinical tests comparing various physical and mechanical characteristics. The table below summarizes these criteria and the reported performance of the Courier Microcatheters.

Study Details

Below are the details of the study as extracted from the provided text:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the "sample size" in terms of number of devices tested for each characteristic. It lists the tests performed and the general performance criteria.
- The data provenance is not explicitly mentioned as a specific country, but the testing was performed by "Micrus Endovascular Corporation," based in Sunnyvale, CA, USA, and later registered from San Jose, CA, USA. This suggests the testing was conducted in the USA.
- The study is a retrospective comparison as it compares the new device's (Courier) characteristics against an existing, legally marketed predicate device (Concourse-14). The testing itself for the Courier device would be considered prospective in its execution, but the comparison framework is retrospective to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is primarily physical and mechanical in nature, usually performed by engineers or technicians according to established standards. Expert clinical judgment for ground truth in the sense of diagnosis or outcomes is not applicable here as this is not a diagnostic device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided and is not typically relevant for the type of non-clinical, physical/mechanical testing described in the document. Such tests generally have objective pass/fail criteria.
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:
- No, an MRMC comparative effectiveness study was not done. This document describes the non-clinical (physical and mechanical) performance testing of a microcatheter, which is a medical instrument, not a diagnostic imaging or AI-assisted device. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This pertains to an AI algorithm, and the device in question is a physical microcatheter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests was based on established engineering and material science standards (e.g., ISO 10555-1, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (Micrus Microcatheter, Concourse-14). The aim was to demonstrate that the new device met or exceeded these established standards and was substantially equivalent to the predicate.
The sample size for the training set:
- Not applicable. This term relates to machine learning models. The current document describes a physical medical device.
How the ground truth for the training set was established:
- Not applicable. This term relates to machine learning models.

Summary

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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

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(dry & hydrated states)	20 to 25 cm	30 to 35 cm	Substantially equivalent
Proximal ID/OD(dry & hydrated states)	ID: 0.0165" – 175"OD: 0.031" (2.4 French)	Inner diameters are within specifications:Courier 165 ID is .0165" minimumCourier 170 ID is 0.0170" minimumCourier 190 ID is 0.0190" minimumCourier 210 ID is 0.0210" minimumOuter diameters are within specifications:Courier 165 OD is 0.033" max. (2.3 Fr.)Courier 170 OD is 0.034" max. (2.4 Fr.)Courier 190 OD is 0.042" max. (3.0 Fr.)Courier 210 OD is 0.042" max. (3.0 Fr.)	Substantially equivalent
Distal ID/OD(Dimensions unchanged indry & hydrated states)	ID: 0.0165"OD: 0.025" (1.9 French)	Inner diameters are within specifications:Courier 165 ID is .0165" minimumCourier 170 ID is 0.0170" minimumCourier 190 ID is 0.0190" minimumCourier 210 ID is 0.0210" minimumOuter diameters are within specifications:Courier 165 OD is 0.023" max. (1.7 Fr.)Courier 170 OD is 0.024" max. (1.8 Fr.)Courier 190 OD is 0.032" max. (2.5 Fr.)Courier 210 OD is 0.032" max. (2.5 Fr.)	Substantially equivalent

. $ C rı 1 iaal /Dhara т. て

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Micrus Endovascular Corporation

、

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

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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:

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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Test or Comparison Characteristic	Acceptance Criteria (based on Predicate Concourse-14)	Reported Device Performance (Courier 165, 170, 190, & 210)
Shaft Materials	Pebax with PTFE liner	Pebax and nylon with PTFE liner (Substantially equivalent)
Shaft Design	Flexible single lumen shaft of Pebax with a PTFE liner; atraumatic distal flexible tip with 2 radiopaque markers.	Flexible single lumen shaft of Pebax & nylon with a PTFE liner; atraumatic distal flexible tip with 2 radiopaque markers. (Substantially equivalent)
Distal Shaft Length (dry & hydrated states)	20 to 25 cm	30 to 35 cm (Substantially equivalent)
Proximal ID/OD (dry & hydrated states)	ID: 0.0165" – 175"; OD: 0.031" (2.4 French)	Inner diameters are within specifications: Courier 165 ID is .0165" min, Courier 170 ID is 0.0170" min, Courier 190 ID is 0.0190" min, Courier 210 ID is 0.0210" min; Outer diameters are within specifications: Courier 165 OD is 0.033" max (2.3 Fr.), Courier 170 OD is 0.034" max (2.4 Fr.), Courier 190 OD is 0.042" max (3.0 Fr.), Courier 210 OD is 0.042" max (3.0 Fr.). (Substantially equivalent)
Distal ID/OD (Dimensions unchanged in dry & hydrated states)	ID: 0.0165"; OD: 0.025" (1.9 French)	Inner diameters are within specifications: Courier 165 ID is .0165" min, Courier 170 ID is 0.0170" min, Courier 190 ID is 0.0190" min, Courier 210 ID is 0.0210" min; Outer diameters are within specifications: Courier 165 OD is 0.023" max (1.7 Fr.), Courier 170 OD is 0.024" max (1.8 Fr.), Courier 190 OD is 0.032" max (2.5 Fr.), Courier 210 OD is 0.032" max (2.5 Fr.). (Substantially equivalent)
Shaft Marker	No shaft marker	Shaft marker located at 90 cm from the distal tip. (Substantially equivalent - new feature)
Tip Markers	Two radiopaque marker bands, spaced 3 cm apart.	Two radiopaque marker bands, spaced 3 cm apart. (Substantially equivalent)
Coating	Hydrophilic coating.	Hydrophilic coating. (Substantially equivalent)
Effective Length (dry & hydrated states)	150 cm (59")	150 cm (59") (Substantially equivalent)
MicroCoil Compatibility	Coils: Compatible with 10-System embolic coils; Wires: Compatible with 0.010" and 0.014" guide wires.	Coils: Courier 165 & 170 are compatible with 10-System embolic coils; Courier 190 & 210 are compatible with 18-System coils; Wires: 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 equivalent)
Tensile strength and tip attachment strength	Shaft to hub junction minimum tensile strength of 1.12 lb (5 Newtons); all transition junctions minimum tensile strength of 0.67 lb (3 Newtons).	Shaft to hub junction minimum tensile strength of 1.12 lb (5 Newtons); all transition junctions minimum tensile strength of 0.67 lb (3 Newtons). (Substantially Equivalent)
Flexibility/Stiffness	Demonstrates adequate flexibility to bend easily when under pressure, such as that exerted by vessel tortuosity.	As compared to the predicate, demonstrates adequate flexibility to bend easily when under pressure, such as that exerted by vessel tortuosity. (Substantially Equivalent)
Burst Pressure	Demonstrates a burst strength greater than 300 PSI.	Demonstrates a burst strength greater than 300 PSI. (Substantially Equivalent)
Biocompatibility	Materials successfully pass all biocompatibility testing per ISO 10993-1.	Materials successfully pass all biocompatibility testing per ISO 10993-1. (Substantially Equivalent)
Air leakage at hub	No air leakage during testing with negative pressure applied to the catheter hub per ISO 10555-1.	No air leakage during testing with negative pressure applied to the catheter hub per ISO 10555-1. (Substantially Equivalent)
Liquid leakage	Demonstrates no liquid leakage during testing at 46.4 PSI (maintained for 30 seconds) per ISO 10555-1.	Demonstrates no liquid leakage during testing at 46.4 PSI (maintained for 30 seconds) per ISO 10555-1. (Substantially Equivalent)
Fatigue tolerance and catheter material integrity	(No specific quantitative criteria mentioned for predicate)	Catheter advanced and retracted 20 times in a tortuous arterial model with a 150-micron filter in a distal location. No catheter particulate or debris resulted. (Substantially Equivalent)
Chemical Integrity/Corrosion Resistance	Demonstrates corrosion resistance per ISO 10555-1 in saline solution and boiling distilled water.	No change to the design of the Courier microcatheters affected corrosion resistance. (Substantially Equivalent)
Material Used	Pebax shaft. PTFE liner. Hydrophilic coating. All materials are biocompatible.	Pebax shaft. PTFE liner. Hydrophilic coating. All materials are biocompatible. (Substantially Equivalent)
Labeling	Label content complies with regulatory requirements; labels contain at least 2 removable stickers with catalog number, lot number, and product name.	Label content complies with regulatory requirements; labels contain at least 2 removable stickers with catalog number, lot number, and product name. (Substantially Equivalent)
Proximal shaft kink radius	Demonstrates a minimum kink resistant radius (no specific value given for predicate)	Demonstrates a minimum kink resistant radius of 0.325" in the proximal shaft. (Substantially Equivalent)
Distal shaft kink radius	Demonstrates a minimum kink resistant radius of 0.07" in the distal shaft.	Demonstrates a minimum kink resistant radius of 0.07" in the distal shaft. (Substantially Equivalent)
Tracking force	Demonstrates the microcatheter is able to track through a tortuous path.	Demonstrates the microcatheter is able to track through a tortuous path with less or equal force (friction) than the predicate. (Substantially Equivalent)
Tip shape retention	Demonstrates the Microcatheter maintains its tip shape when subjected to 3 hours of soaking in a 37°C. bath.	Demonstrates the Microcatheter maintains its tip shape when subjected to 3 hours of soaking in a 37°C. bath. (Substantially Equivalent)
Packaging Integrity	Tyvek Pouch. Sterile and non-pyrogenic in unopened packaging designed to maintain sterility unless opened/damaged. Qualified to prevent microbial recontamination for a minimum of 3-yrs.	Tyvek Pouch. Sterile and non-pyrogenic in unopened packaging designed to maintain sterility unless opened/damaged. Uses same packaging as Concourse microcatheter, qualified to prevent microbial recontamination for a minimum of 3-yrs. (Equivalent)
Shipping/transit testing	Demonstrates the microcatheter successfully withstands the domestic and international distribution environment, per ISO 10555-1.	Demonstrates the microcatheter successfully withstands the domestic and international distribution environment, per ISO 10555-1. (Substantially Equivalent)
Sterility	Sterilized using EtO with a sterility assurance level of 10-6.	Sterilized using EtO with a sterility assurance level of 10-6. (Substantially Equivalent)

Test orComparison	Concourse-14	Courier 165, 170, 190, & 210	SubstantialEquivalence
Tensile strengthand tip attachmentstrength	The shaft to hub junction has a minimumtensile strength of 1.12 lb (5 Newtons).All transition junctions of the shaft have aminimum tensile strength of 0.67 lb (3Newtons).	The shaft to hub junction has a minimumtensile strength of 1.12 lb (5 Newtons). Alltransition junctions of the shaft have aminimum tensile strength of 0.67 lb (3Newtons).	SubstantiallyEquivalent
Flexibility/Stiffness	Demonstrates adequate flexibility to bendeasily when under pressure, such as thatexerted by vessel tortuosity.	As compared to the predicate,demonstrates adequate flexibility to bendeasily when under pressure, such as thatexerted by vessel tortuosity.	SubstantiallyEquivalent
Burst Pressure	Demonstrates a burst strength greater than300 PSI.	Demonstrates a burst strength greater than300 PSI.	SubstantiallyEquivalent
Biocompatibility	Materials in the microcathetersuccessfully pass all biocompatibilitytesting per ISO 10993-1.	Materials in the microcatheter successfullypass all biocompatibility testing per ISO10993-1.	SubstantiallyEquivalent
Air leakage at hub	No air leakage during testing withnegative pressure applied to the catheterhub per ISO 10555-1.	No air leakage during testing with negativepressure applied to the catheter hub perISO 10555-1.	SubstantiallyEquivalent
Liquid leakage	Demonstrates there is no liquid leakageduring testing at 46.4 PSI (maintained for30 seconds) per ISO 10555-1.	Demonstrates there is no liquid leakageduring testing at 46.4 PSI (maintained for30 seconds) per ISO 10555-1.	SubstantiallyEquivalent
Fatigue toleranceand cathetermaterial integrity		Catheter advanced and retracted 20 timesin a tortuous arterial model with a 150-micron filter in a distal location. Nocatheter particulate or debris resulted fromthe rigorous stress placed upon thecatheter during advancement andretraction	SubstantiallyEquivalent
ChemicalIntegrity/CorrosionResistance	Demonstrates corrosion resistance perISO 10555-1 in saline solution and boilingdistilled water.	No change to the design of the Couriermicrocatheters affected corrosionresistance.	SubstantiallyEquivalent
Material Used	Pebax shaft. PTFE liner. Hydrophiliccoating. All materials are biocompatible.	Pebax shaft. PTFE liner. Hydrophiliccoating. All materials are biocompatible.	SubstantiallyEquivalent
Labeling	Label content complies with regulatoryrequirements of all markets where theproduct is sold. Product labels contain atleast 2 removable stickers, which specifythe catalog number, lot number andproduct name.	Label content complies with regulatoryrequirements of all markets where theproduct is sold. Product labels contain atleast 2 removable stickers, which specifythe catalog number, lot number andproduct name.	SubstantiallyEquivalent
Proximal shaft kinkradius	Demonstrates a minimum kink resistantradius	Demonstrates a minimum kink resistantradius of 0.325" in the proximal shaft.	SubstantiallyEquivalent
Distal shaft kinkradius	Demonstrates a minimum kink resistantradius of 0.07" in the distal shaft.	Demonstrates a minimum kink resistantradius of 0.07" in the distal shaft.	SubstantiallyEquivalent
Tracking force	Demonstrates the microcatheter is able totrack through a tortuous path.	Demonstrates the microcatheter is able totrack through a tortuous path with less orequal force (friction) than the predicate	SubstantiallyEquivalent

Tip shape retention	Demonstrates the Microcatheter maintainsits tip shape when subjected to 3 hours ofsoaking in a 37°C. bath.	Demonstrates the Microcatheter maintainsits tip shape when subjected to 3 hours ofsoaking in a 37°C. bath.	SubstantiallyEquivalent
Packaging Integrity	Tyvek Pouch.	Tyvek Pouch.	Equivalent
	Sterile and non-pyrogenic in unopenedpackaging that is designed to maintainsterility unless the primary product pouchhas been opened or damaged.	Sterile and non-pyrogenic in unopenedpackaging that is designed to maintainsterility unless the primary product pouchhas been opened or damaged.
	Packaging qualified to prevent microbialrecontamination for a minimum of 3-yrs.	The Courier microcatheters use the samepackaging as is used for the Concoursemicrocatheter. The package integrity hasbeen qualified to prevent microbialrecontamination for a minimum of 3-yrs.
Shipping/transittesting	Demonstrates the microcathetersuccessfully withstands the domestic andinternational distribution environment, perISO 10555-1.	Demonstrates the microcathetersuccessfully withstands the domestic andinternational distribution environment, perISO 10555-1.	SubstantiallyEquivalent
Sterility	Sterilized using EtO with a sterilityassurance level of 10-6	Sterilized using EtO with a sterilityassurance level of 10-6	SubstantiallyEquivalent
	The above non-clinical testing has demonstrated the substantially equivalent performance of the Microcatheters