The 14 Wire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures. The device is not intended for use in the coronary arteries.

The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures.

The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.

Device Description

The 14 Wire is a stainless steel guidewire with a radiopaque distal segment. 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

The provided text describes a 510(k) submission for a medical device (14 Wire Standard Hydrophilic Guidewire & 14 Wire LS Hydrophilic Guidewire). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not involve studies demonstrating AI performance against acceptance criteria in the way described in your request (e.g., sample sizes for AI, expert reader studies, MRMC studies, training sets, etc.).

Therefore, I cannot provide the information you requested regarding acceptance criteria and a study proving a device meets those criteria in the context of AI performance for this specific document. The document describes a traditional medical device (a guidewire) and its evaluation through extensive bench testing and biocompatibility assessments, not an AI software component.

Here's a breakdown of why this document doesn't fit your request:

No AI Component: The device is a physical guidewire, not an AI algorithm or software.
No "Test Set" or "Training Set": These terms apply to AI/ML model development and validation, which is not relevant here.
No "Experts" for Ground Truth (in the AI sense): While engineers and scientists evaluated the guidewire performance, this is not analogous to radiologists or pathologists establishing ground truth for AI algorithms.
No "Acceptance Criteria" for AI Performance Metrics: The "acceptance criteria" for this device would be its performance against engineering specifications (e.g., tensile strength, lubricity), not metrics like sensitivity, specificity, or AUC for an AI model.

The "Non-Clinical Tests" section lists the types of tests performed. These are all bench tests of the physical properties and performance of the guidewire.

However, to directly address the structure of your request, and clarify what is present in the document versus what is not, I will populate the table and subsequent points based on the provided text, indicating "Not Applicable" or explaining the absence of information where appropriate for an AI-centric request.

Acceptance Criteria and Device Performance (Non-AI Context)

The document does not explicitly present a table of quantitative acceptance criteria alongside performance for each test in a pass/fail format. Instead, it lists the types of non-clinical tests performed and then concludes that based on these tests, the device is substantially equivalent to predicates. The "performance" is implicitly deemed acceptable if it meets the standards demonstrated by the predicate devices and overall safety/effectiveness for its intended use.

Here's an interpretation based on the provided text, framed to align with your table request, acknowledging the non-AI nature:

Acceptance Criteria Category (Implicit)	Reported Device Performance (Implicit)
Mechanical Performance	Demonstrated through testing of:
Tip Flexibility	(Performance not quantified, but deemed acceptable)
Tip Buckling Force	(Performance not quantified, but deemed acceptable)
Torque Response	(Performance not quantified, but deemed acceptable)
Tip Shapeability	(Performance not quantified, but deemed acceptable)
Tip Shape Retention	(Performance not quantified, but deemed acceptable)

1. Sample sizes used for the test set and the data provenance:

Sample Size (Test Set): Not specified in terms of number of guidewires or test repetitions for each non-clinical test. The document states "extensive bench testing" and "an in vitro design validation study."
Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal, non-clinical laboratory tests.
Retrospective or Prospective: Not applicable in the AI/clinical study sense. These are prospective, controlled bench tests and in vitro studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable in the context of ground truth for an AI algorithm. The tests were performed by engineers/technicians in a laboratory setting.
Qualifications of Experts: Not specified. Standard practice for such tests implies qualified engineering and lab personnel.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. This is a physical device undergoing objective bench testing, not subjective interpretation. Test results would be compared against internal specifications or predicate device performance.

4. 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:

MRMC Study: No. This is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Study: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of Ground Truth: Not applicable in the AI sense. The "ground truth" for guidewire performance comes from engineering specifications, established scientific principles, and comparison to the performance of legally marketed predicate devices through objective physical measurements.

7. The sample size for the training set:

Sample Size (Training Set): Not applicable. This is not an AI device.

8. How the ground truth for the training set was established:

Ground Truth Establishment (Training Set): Not applicable. This is not an AI device.

Summary

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K113454

FEB 2 4 2012

3. 510(k) Summary

510(K) Summary

510(k) Owner:	Micro Therapeutics d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Gregory J. GeissingerManager, Regulatory AffairsTelephone: (949) 297-9781E-mail: ggeissinger@ev3.net
Date SummaryPrepared:	10 February 2012
Trade Name ofDevice:	14 Wire Standard Hydrophilic Guidewire &14 Wire LS Hydrophilic Guidewire
Common Name ofDevice:	Catheter Guidewire
Classification ofDevice:	DQX, Catheter Guidewire (21 CFR 870.1330), Class II
Predicate Devices:	0.014" Transend EX Platinum Guidewire (K971254)0.014" Transend EX Guidewire (K964611)
DeviceDescription:	The 14 Wire is a stainless steel guidewire with a radiopaquedistal segment. The distal portion of the guidewire ishydrophilically coated. Included within the sterile pouch is atorque device to assist in guidewire manipulation and a guidewireintroducer to ease the introduction of the guidewire into thecatheter hub and/or hemostasis valve.
Intended Use:	The 14 Wire is indicated for general intravascular use to aid inthe selective placement of catheters in the peripheral andcerebral vasculature during diagnostic and/or therapeuticprocedures. The device is not intended for use in the coronaryarteries.
	The Guidewire Torque Device is intended to facilitate guidewiremanipulation during interventional procedures.
	The Guidewire Introducer is intended to facilitate guidewireinsertion into a catheter hub or through a hemostasis valve.
Non-ClinicalPerformance Data:	Biocompatibility testing, extensive bench testing, and an in vitrodesign validation study were performed as well as shelf-lifetesting and an assessment of bioburden, pyrogen, EtO residuals,and sterility.

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Non-Clinical Tests

Visual Inspection
Dimensional Inspection .
Tip Flexibility .
Tip Buckling Force .
Torque Response .
. Tip Shapeability
Tip Shape Retention .
. Flexing Test
. Coating Adherence
Navigation .
Kink Resistance ●
Torque Strength .
Tensile Strength ●
. Coating Lubricity
. Fracture Test
Corrosion Resistance .

Conclusion:

The 14 Wire is substantially equivalent to the 0.014" Transend EX and EX Platinoon Guidewires based on the successful completion of non-clinical testing, identical principles of operation and nearly identical indications for use, as well as similarities in the design, materials, dimensions, accessories, packaging, and performance specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is in black and white.

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

Micro Therapeutics, Inc. c/o Mr. Gregory J. Geissinger Manager, Regulatory Affairs 9775 Toledo Way Irvine, CA 92618

FEB 2 4 2012

Re: K113454

Trade/Device Name: 14 Wire Standard Hydrophilic Guidewire & 14 Wire LS Hydrophilic Guidewire

Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DOX Dated: February 10, 2012 Received: February 13, 2012

Dear Mr. Geissinger:

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. 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

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Page 2 – Mr. Gregory J. Geissinger

(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 (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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.S. Hillebenin

for 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 Statement 2.

! !.

Indications for Use

510(k) Number (if known):

Device Name: 14 Wire Standard & 14 Wire LS

Indications for Use: The 14 Wire Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective the optime of catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures. The device is not intended for use in the coronary arteries.

The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures.

The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.

AND/OR

Prescription Use __ X

(Part 21 CFR 801 Subpart D)

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)

M.L. Kelleher

Page 1 of 1

(Division Sign-Off) Division of Cardiovascular Devices

K-113454 510(k) Number_

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.