The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are 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 Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

Change in the degree of polymerization with the base coat . material.
. Elimination of Brown Oxide pigment from base coat material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Hydrophilic Guidewire and its substantial equivalence determination. It does not include details of a clinical study or acceptance criteria with associated performance metrics for a device to meet specific performance targets. Instead, it focuses on non-clinical (bench and biocompatibility) testing to support changes to an existing device, and then a determination of substantial equivalence to predicate devices.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided.

However, I can extract the information related to the non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily relying on substantial equivalence and non-clinical testing for minor device modifications, the "acceptance criteria" are implied by successful completion of standard evaluations and demonstration of comparable performance to predicate devices. Specific quantitative targets for each test are not explicitly detailed in the provided text.

Test Category	Specific Test	Implied Acceptance Criteria (Based on context)	Reported Device Performance
Biocompatibility	USP Physiochemical Extraction	Meet established USP standards for physiochemical properties.	Successfully passed.
	Cytotoxicity (ISO MEM Elution)	Non-cytotoxic.	Successfully passed.
	Sensitization (ISO Guinea Pig Maximization)	Non-sensitizing.	Successfully passed.
	ISO Intracutaneous Reactivity	Non-irritating.	Successfully passed.
	ISO Acute Systemic Injection	No acute systemic toxicity.	Successfully passed.
	Material Mediated Rabbit Pyrogen	Non-pyrogenic.	Successfully passed.
	ASTM Hemolysis Assay (Direct Contact)	Non-hemolytic.	Successfully passed.
	Complement Activation C3a and SC5b-9 Assay	Acceptable levels of complement activation.	Successfully passed.
	Four Hour Thromboresistance Evaluation in Dogs	Acceptable thromboresistance.	Successfully passed (no indication of issues).
Bench Testing	Visual Inspection	Conformance to visual specifications (e.g., no defects, complete coating).	Successfully passed (implied, as no issues reported).
	Tip Buckling (Flexibility)	Maintain appropriate flexibility and resistance to buckling.	Successfully passed (implied comparable to predicate).
	Tip Shapeability	Maintain intended shapeability for clinical use.	Successfully passed (implied comparable to predicate).
	Tip Retention	Maintain tip integrity and retention.	Successfully passed (implied comparable to predicate).
	Coating Adherence	Maintain coating integrity and adhesion.	Successfully passed.
	Friction Test	Demonstrate acceptable friction profile (e.g., comparable to predicate).	Successfully passed (implied comparable to predicate).
	Torque Response	Maintain expected torque response (e.g., comparable to predicate).	Successfully passed (implied comparable to predicate).
Shelf-life Testing	36-month Accelerated Aging	Maintain all functional and safety parameters for the specified shelf-life.	Successfully passed.
Overall Substantial	Equivalence to Predicate Devices	Identical indications for use, similar design, materials, dimensions, and accessories.	Achieved: FDA determined the device is substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not specified for any of the non-clinical tests. The text indicates "no clinical or animal testing was performed" beyond the specified biocompatibility and bench tests. The dog study (thromboresistance) is an animal study, but its sample size is not mentioned.
Data Provenance: The tests are standard laboratory/bench tests and an animal study. No human clinical data from any country is presented. The testing would have been conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" here is determined by objective physical and chemical testing standards and biological responses in laboratory settings, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. As above, this pertains to clinical data interpretation, not objective non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The submission explicitly states "no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device," except for the listed biocompatibility and bench tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device (guidewire), not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility: Established ISO and ASTM standards, and direct biological responses (e.g., cytotoxicity, sensitization, hemolysis, pyrogenicity, in-vivo thromboresistance in dogs).
For bench testing: Engineering specifications, performance characteristics comparable to predicate devices, and internal quality control standards.
For shelf-life: Stability and performance measurements over time, extrapolated from accelerated aging data.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI/ML model that requires a training set. The "training" for this device's development would be engineering design, material science, and manufacturing process development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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Device Description:

The following modifications have been made to the device:

Change in the degree of polymerization with the base coat . material.
. Elimination of Brown Oxide pigment from base coat material.

Intended Use:

Non-Clinical Performance Data:

The Hydrophilic 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.

The following tests were performed to support the changes to the Hydrophilic Guidewires:

Biocompatibility Testing

USP Physiochemical Extraction .
Cytotoxicity: ISO MEM Elution Using L-929 Mouse Fibroblast Cells
Sensitization: ISO Guinea Pig Maximization Sensitization . Test
ISO Intracutaneous Reactivity Test .
ISO Acute Systemic Injection Test .
Material Mediated Rabbit Pyrogen Test .
ASTM Hemolysis Assay Direct Contact Method .
Complement Activation C3a and SC5b-9 Assay .

Four Hour Thromboresistance Evaluation in Dogs . Bench Testing

Visual Inspection .
Tip Buckling (Flexibility) .
Tip Shapeability .
Tip Retention .
. Coating Adherence.
Friction Test .
Torque Response

Shelf-life Testing

36-month Accelerated Aging .
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.

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Substantial Equivalence Determination

The information presented in the 510(k) shows that the Hydrophilic Guidewires are substantially equivalent to the predicate devices previously in regards to the identical indications for use, device design, similar device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

March 7,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Analia Staubly Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K124007

Trade/Device Name: SilverSpeed™, Mirage™, X-celerator™ Exchange, and X-pedion™ Hydrophilic Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 21, 2012 Received: December 26, 2012

Dear Ms. Staubly:

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.

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

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Page 2 - Analia Staubly

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 yours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K124007

SilverSpeed™, Mirage™, X-celerator™ Exchange, and Device Name: X-pedion™ Hydrophilic Guidewires

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)

Victor Krauthamer -S 2013.03.05 18:38:20 -05'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number _ K124007

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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.