The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.

Device Description

The Meridian Guidewire is a stainless steel guidewire with a radiopaque, distal coil. The distal portion of the guidewire is hydrophilically coated. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

AI/ML Overview

This 510(k) summary describes a guidewire, which generally undergo non-clinical (bench) testing rather than clinical studies with human participants. Therefore, many of the typical clinical study parameters (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable in the same way they would be for AI/ML-based diagnostic devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating substantial equivalence to a predicate device, not necessarily meeting specific numerical performance metrics in a clinical study. The "acceptance criteria" are implied by the similarity to the predicate and the successful completion of non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Safe for use in the body.	Biocompatibility testing performed.
Bench Testing Performance: Meets functional and safety requirements through laboratory tests.	Extensive bench testing performed.
In vitro Design Validation: Design is suitable for intended use in a controlled environment.	In vitro design validation study performed.
Shelf-life: Maintains integrity and functionality over time.	Shelf-life testing performed.
Sterility & Safety (Bioburden, Pyrogen, EtO residuals): Meets sterilization and safety standards.	Assessment of bioburden, pyrogen, EtO residuals, and sterility performed.
Similar Technological Characteristics to Predicate: Materials, dimensions, accessories, and packaging are comparable.	Materials and dimensions similar to predicate. Packaging materials and accessories identical to predicate.
Identical Principles of Operation: Operates in the same fundamental way as the predicate.	Identical principles of operation.
Identical Indications for Use: Used for the same medical purposes as the predicate.	Identical indications for use.

Study Details

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" would be the guidewire itself and its components, subjected to various bench and in vitro tests. The provenance is the manufacturer (Micro Therapeutics dba ev3 Neurovascular, Irvine, CA, USA). All testing would have been conducted in a controlled laboratory environment.
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): Not applicable for this type of device and submission. "Ground truth" for guidewires is typically established by engineering specifications, material standards, and validated testing protocols, not expert clinical consensus on individual cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against engineering standards and established testing methodologies.
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: Not applicable. This document describes a medical device (guidewire), not an AI/ML diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a guidewire, the "ground truth" for performance is based on adherence to design specifications, material properties, biomechanical test results (e.g., tensile strength, torqueability, lubricity), sterility standards, and biocompatibility requirements, all of which are scientifically measured and compared against established benchmarks or the predicate device.
The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

・

510(k) Summary .

JAN 2 6 2010

KO93681

510(k) Owner:	Micro Therapeutics dba ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Deborah Baker-JanisSenior Regulatory Affairs Specialist,Regulatory AffairsTelephone: (949) 297-9246E-mail: dbakerjanis@ev3.net
Date Summary Prepared:	25 November 2009
Trade Name of Device:	Meridian Guidewire
Common Name of Device:	Catheter Guidewire
Classification of Device:	DQX, Catheter Guidewire (21 CFR 870.1330), Class II
Predicate Device:	SilverSpeed Guidewire (K993257)
Device Description:	The Meridian Guidewire is a stainless steel guidewire with aradiopaque, distal coil. The distal portion of the guidewire ishydrophilically coated. Included within the sterile pouch is a torquedevice to assist in guidewire manipulation and a guidewire introducer toease the introduction of the guidewire into the catheter hub and/orhemostasis valve.
Intended Use:	The Meridian Guidewire is indicated for general intravascular use to aidin the selective placement of catheters in the peripheral, visceral, andcerebral vasculature during diagnostic and/or therapeutic procedures.
Summary of Technological Characteristics:	The Meridian Guidewire and the predicate device both consist of a coreguidewire with overlying soldered distal coil. The materials anddimensions of the Meridian Guidewire are similar to those of thepredicate device. The packaging materials and materials comprisingthe accessories are identical to those of the predicate device.
Non-Clinical Performance Data:	Biocompatibility testing, extensive bench testing, and an in vitro designvalidation study were performed as well as shelf-life testing and anassessment of bioburden, pyrogen, EtO residuals, and sterility.
Conclusion:	The Meridian Guidewire is substantially equivalent to the SilverSpeedGuidewire based on the successful completion of non-clinical testing,identical principles of operation and indications for use, similarities inthe design, materials, and dimensions of the device, identicalaccessories and final packaging, and similar design specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized bird, possibly an eagle or similar avian creature, with its wings spread in a dynamic, abstract form. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and the country it represents.

Public Health Service

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

JAN 2 6 2010

Micro Therapeutics, Inc. c/o Ms. Deborah Baker-Janis Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92681

Re: K093681

Trade/Device Name: Meridian Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: November 25, 2009 Received: November 27, 2009

Dear Ms. Baker-Janis: .

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Deborah Baker-Janis

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

vuna R. V. Muniz

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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2. Indications for Use Statement

Indications for Use

510(k) Number (if known): KO9 368 |

Device Name: Meridian Guidewire

Indications for Use: The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, and cerebral vasur ture during diagnostic and/or therapeutic procedures.

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)

Dumar. Voondurmense of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_Ko.93681

Page 1 of 1

CONFIDENTIAL

PAGE 4

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.