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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Micrus Courier 270 Microcatheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about specific "acceptance criteria" based on device performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in terms of clinical or diagnostic effectiveness.

Medical devices like microcatheters are typically evaluated for performance in terms of mechanical properties, biocompatibility, and functional aspects (e.g.,
delivery of agents, trackability). The document states that the "Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials," and that "The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate." This implies that the 'acceptance criteria' for this 510(k) submission are met by demonstrating equivalence to a legally marketed predicate device, rather than through a de novo clinical trial demonstrating specific performance metrics against a predefined threshold.

Therefore, most of the requested information cannot be extracted from the provided text, as it pertains to clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance) typically found in documents for AI/ML-driven devices or devices requiring clinical performance data beyond substantial equivalence.

Information that can be inferred or is directly stated:

Intended Use/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.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (Summary of Equivalence)
Substantial Equivalence to Predicate Device	The device is substantially equivalent to predicate devices in terms of intended use, design, specifications, and materials.
	Uses the same methods and materials in construction, packaging, and sterilization as its predicate.
	Modification to the device has not altered the fundamental technology of the predicate devices.

Note: The document does not provide specific quantitative performance metrics (e.g., in a clinical setting) against which acceptance criteria would typically be set for AI/ML or novel diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No information available. This type of study data is not typically part of a 510(k) summary for a substantial equivalence claim for a microcatheter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
No information available. Ground truth establishment with experts is not detailed as there isn't a performance study described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information available. Adjudication methods are not applicable to the type of information presented in this 510(k) summary.

5. 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 information available. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information available. This is not an AI/ML device, and no standalone algorithm performance study is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information available. Ground truth for performance metrics is not discussed, as the document focuses on substantial equivalence of design and function. The 'ground truth' for the regulatory submission is essentially the predicate device's established safety and effectiveness.

8. The sample size for the training set
No information available. This is not an AI/ML device, and no training set is relevant.

9. How the ground truth for the training set was established
No information available. Not applicable.

Summary

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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: 408-433-1400 Est. Registration No. 2954740

Contact Person:

Patrick Lee Manager, Regulatory Affairs Phone: (408) 433-1428 Fax: (408) 433-1585 plee@micruscorp.com

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

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DEVICE DESCRIPTION

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 (800) 638-2041 or (240) 276-3150 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:

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

Page 1 of 1

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).