Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on physical properties and standard testing for guidewires and accessories, with no mention of AI or ML.

Therapeutic

No
The device aids in the selective placement of catheters during diagnostic and/or therapeutic procedures, but it does not directly provide therapy. It is an accessory to therapeutic procedures.

Diagnostic

No

The device is a guidewire, torque device, and introducer, used to aid in the selective placement of catheters during diagnostic and/or therapeutic procedures, but it does not perform any diagnostic function itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (stainless steel guidewire, torque device, introducer) and mentions bench testing and in vitro studies, indicating a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "general intravascular use to aid in the selective placement of catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural assistance, not for testing samples outside the body to diagnose conditions.
Device Description: The description details a guidewire, torque device, and introducer – all components used in interventional procedures within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.

IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely procedural and mechanical within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQX, DOX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and cerebral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Biocompatibility testing, extensive bench testing, and an in vitro design validation study were performed as well as shelf-life testing and an assessment of bioburden, pyrogen, EtO residuals, and sterility.

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.

Key Metrics

Not Found

Predicate Device(s)

K971254, K964611

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K113454

FEB 2 4 2012

3. 510(k) Summary

510(K) Summary

:

| 510(k) Owner: | Micro Therapeutics d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory J. Geissinger
Manager, Regulatory Affairs
Telephone: (949) 297-9781
E-mail: ggeissinger@ev3.net |
| Date Summary
Prepared: | 10 February 2012 |
| Trade Name of
Device: | 14 Wire Standard Hydrophilic Guidewire &
14 Wire LS Hydrophilic Guidewire |
| Common Name of
Device: | Catheter Guidewire |
| Classification of
Device: | DQX, Catheter Guidewire (21 CFR 870.1330), Class II |
| Predicate Devices: | 0.014" Transend EX Platinum Guidewire (K971254)
0.014" Transend EX Guidewire (K964611) |
| 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. |
| Intended Use: | 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. |
| Non-Clinical
Performance Data: | Biocompatibility testing, extensive bench testing, and an in vitro
design validation study were performed as well as shelf-life
testing and an assessment of bioburden, pyrogen, EtO residuals,
and sterility. |

1

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.

2

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

3

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

4

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_