The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not intended for use in coronary arteries.

Device Description

The Traxcess 14 Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The guidewire is coated with a lubricious hydrophilic coating.

AI/ML Overview

Acceptance Criteria and Device Performance for Traxcess 14 Guidewire

This document describes the acceptance criteria and study results for the Traxcess 14 Guidewire, as presented in the provided 510(k) summary. No AI/ML components are mentioned in this submission, therefore, sections related to AI/ML specific criteria (sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The Traxcess 14 Guidewire's performance was evaluated through a series of bench tests and biocompatibility assessments, with the predicate device (Traxcess 0.014" Hydrophilic Guidewire, K080863) serving as the primary benchmark for equivalence.

Bench Testing Category	Acceptance Criteria	Reported Device Performance	Conclusion
Physical & Dimensional	Meet specified dimensional requirements (OD, overall length, coil, SS, docking sections).	Test articles met specified dimensional requirements for OD, overall length, length of coil section, length of SS section, length of docking section.	Device met established dimensional and physical specifications.
Tensile Strength	Distal ≥ 3N; Proximal ≥ 70N	Tensile strength of distal ≥ 3N and of proximal ≥ 70N.	Device met established tensile strength.
Tip Flexibility	Force to deflect distal tip ≤ predicate.	Demonstrated force to deflect the distal tip is ≤ predicate.	Device tip flexibility is ≤ predicate.
Torque Strength	Equivalent or better than predicate (turns to failure).	Equivalent or better than predicate (turns to failure).	Equivalent to predicate.
Coating Adherence	Coating adherence maintained after advance/retract cycles.	Coating adherence maintained after advance/retract cycles.	Durability and lubricity of coating was comparable to predicate.
Torqueability	Torque response equal to or better than predicate.	Torque response was equal to or better than predicate.	Torque response was equal to or better than predicate.
Flexing & Fracture Resistance	No damage to test articles or coating after flexing and fracture test.	No damage to test articles or coating after flexing and fracture test.	Device able to withstand forces and stress during navigation in vasculature.
Radiopacity	Distal coil section visible under fluoroscopy.	Distal coil section visible under fluoroscopy.	Device radiopacity equivalent or better than predicate.
Tip Shapeability	Test articles able to maintain tip shape.	Test articles able to maintain tip shape.	Device tip shapeability equivalent or better than predicate.
In-vitro Simulated Use	Achieve rating ≥ 3 for prep of device, introduction, and tracking.	Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking.	Device performed as intended under simulated use.
Attachment with Docking Wire	Pull force of attachment equivalent or better than predicate.	Pull force of attachment was equivalent or better than predicate.	Device is compatible with docking wire.
Particulate Testing	Particle count ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns).	Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns).	Device does not generate particles under use.
Biocompatibility - Cytotoxicity	Non-cytotoxic (ISO 10993-5).	Cell culture exhibited slight reactivity (Grade 1).	Non-cytotoxic.
Biocompatibility - Sensitization/Irritation (Kligman)	Weak allergenic potential (0% reaction at challenge following induction phase) (ISO 10993-10).	Extracts of test article elicited no reaction at challenge (0%) following induction phase. (Grade 1).	Weak allergenic potential.
Biocompatibility - Sensitization/Irritation (Intracutaneous)	Non-irritant (no significantly greater biological reaction than control) (ISO 10993-10).	Extracts of test article did not show a significantly greater biological reaction than sites injected with the control.	Non-irritant.
Biocompatibility - Hemolysis	Non-hemolytic (ISO 10993-4).	Hemolysis index was 4.69% (direct) and 0.0% (indirect).	Non-hemolytic.
Biocompatibility - Coagulation	No effect on coagulation (no statistically significant difference compared to controls) (ISO 10993-4).	No statistically significant difference found between plasma exposed to test article, negative control, and untreated control.	No effect on coagulation.
Biocompatibility - Complement Activation	No effect on complement system (C3a and SC5b-9 not statistically higher than controls) (ISO 10993-4).	C3a and SC5b-9 in plasma exposed to test article was not statistically higher than the plasma exposed to negative and untreated controls.	No effect on complement system.
Biocompatibility - Thrombogenicity	No significant thrombosis (Grade 1-2 minimal thrombosis) (ISO 10993-4).	Minimal thrombosis for test article and control sites (Grade 1-2).	No significant thrombosis.
Biocompatibility - Systemic Toxicity	No toxic effects (no significantly greater biological reaction than control) (ISO 10993-11).	Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice.	No toxic effects.
Biocompatibility - Pyrogenicity	Non-pyrogenic (temperature increase 0.0° C from baseline) (ISO 10993-11).	Temperature increase was 0.0° C from baseline.	Non-pyrogenic.

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

The provided 510(k) summary does not specify the exact sample sizes (number of devices) used for each individual bench test or biocompatibility assessment. It refers to "test articles" being evaluated.

The data provenance is not explicitly stated as country of origin, however, the submitting company is MicroVention, Inc., located in Tustin, California, U.S.A., implying the studies were conducted under U.S. regulatory and testing standards. The tests appear to be prospective in nature, as they involve testing newly manufactured devices against predetermined criteria.

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

N/A. This is a medical device submission based on physical and biological testing, not on the interpretation of data by human experts to establish a "ground truth" in the context of diagnostic performance.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, which is not the case for the bench and biological tests described here. The conclusions are based on quantitative measurements and established ISO standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. No MRMC comparative effectiveness study was conducted as this is a physical medical device, not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study

N/A. This submission is for a physical medical device (guidewire), not a standalone algorithm.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" or reference standard was primarily engineering specifications and established ISO standards for biocompatibility. For comparative tests (e.g., tip flexibility, torque strength, coating adherence, docking wire attachment), the predicate device served as the reference for equivalence.

8. Sample Size for the Training Set

N/A. There is no "training set" as this device does not involve machine learning or AI.

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

N/A. Correspondingly, there is no ground truth for a training set.

Summary

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510(k) Summary

JUL 3 1 2014

K133725

Trade Name:	Traxcess 14 Guidewire
Generic Name:	Guidewire
Classification:Product Code:Submitted By:	Class II, 21 CFR 870.1330MOF, DQXMicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.Ph: 714-247-8000Fax: 714-247-8005
Contact:	Naomi Gong
Date:	December 4, 2013

Predicate Device:

Number	Description	Clearance Date
K080863	Traxcess 0.014" HydrophilicGuidewire	April 7, 2008

Device Description:

Indication For Use:

The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

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Technological Comparison:

	Predicate	Traxcess 14
Intended Use	The Traxcess 14 Guidewire is intendedfor general intravascular use, includingthe neuro and peripheral vasculature. Theguidewire can be steered to facilitate theselective placement of diagnostic ortherapeutic catheters. This device is notintended for use in coronary arteries.	Same
Diameter	Proximal = 0.014"Distal = 0.012"	Same
Overall Length	200 cm	Same
Distal Shaft Length(Shapeable Length)	1.4 cm	Same
Material	Core wire (proximal): Stainless steelCore wire (distal): Nickel titanium alloyCoil: Stainless steel and Platinum nickelalloyOther: Brazing material and solder	Same
Coating	Shaft: PTFE/siliconeCoil: Hydrophilic Coating(dimethylacramide-glycidyl methacrylatecopolymer)	Shaft and Coil: Hydrophilic Coating[SLIP-COAT]
Coating Length	Hydrophilic coating (distal) = 400 mmPTFE/silicone (proximal) ~1600 mm	Hydrophilic Coating = 1450 mm
Coil Length	40 cm	Same
Radiopaque Length	3 cm	Same
Distal tip thickness(core wire)	0.037 mm	Same
Proximal endconfiguration	Tapered to be compatible with Traxcessdocking wire	Same

・

Verification and Test Summary Table:

Bench Testing	Result	Conclusion
Physical and dimensional attributes	Test articles met specifieddimensional requirements forOD, overall length, length ofcoil section, length of SSsection, length of dockingsection.	Device met establisheddimensional and physicalspecifications.
Tensile strength (distal and proximal)	Tensile strength of distal ≥ 3Nand of proximal ≥ 70N	Device met established tensilestrength
Tip flexibility	Demonstrated force to deflectthe distal tip is ≤ predicate	Device tip flexibility is ≤predicate

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Bench Testing	Result	Conclusion
Torque strength	Equivalent or better thanpredicate (turns to failure)	Equivalent to predicate
Coating adherence	Coating adherence maintainedafter advance/retract cycles	Durability and lubricity ofcoating was comparable topredicate
Torqueability	Torque response was equal toor better than predicate	Torque response was equal toor better than predicate
Flexing and fracture resistance test	No damage to test articles orcoating after flexing andfracture test	Device able to withstandforces and stress duringnavigation in vasculature.
Radiopacity	Distal coil section visibleunder fluoroscopy	Device radiopacity equivalentor better than predicate
Tip shapeability	Test articles able to maintaintip shape	Device tip shapeabilityequivalent or better thanpredicate
In-vitro simulated use testing	Test articles achieved rating ≥3 for prep of device,introduction, and tracking	Device performed as intendedunder simulated use.
Attachment with docking wire	Pull force of attachment wasequivalent or better thanpredicate	Device is compatible withdocking wire
Particulate Testing	Particle count of test articles ≤25 particles (≥ 10 microns)and ≤ 3 particles (≥ 25microns)	Device does not generateparticles under use.

Biocompatibility	Result	Conclusion
Cytotoxicity - MEM Elution Test (ISO10993-5)	Cell culture exhibited slightreactivity (Grade 1)	Non-cytotoxic
Sensitization/Irritation - KligmanMaximization Test (ISO10993-10)	Extracts of test article elicitedno reaction at challenge (0%)following induction phase.(Grade 1)	Weak allergenic potential
Sensitization/Irritation - IntracutaneousInjection Test (ISO 10993-10)	Extracts of test article did notshow a significantly greaterbiological reaction than sitesinjected with the control	Non-irritant
Hemocompatibility - Hemolysis (Directand Indirect) (ISO 10993-4)	Hemolysis index was 4.69%(direct) and 0.0% (indirect)	Non-hemolytic
Hemocompatibility - UnactivatedPartial Thromboplastin Assay (ISO10993-4)	No statistically significantdifference found betweenplasma exposed to test article,negative control, and untreatedcontrol.	No effect on coagulation
Hemocompatibility - ComplementActivation (ISO 10993-4)	C3a and SC5b-9 in plasmaexposed to test article was notstatistically higher than theplasma exposed to negativeand untreated controls.	No effect on complementsystem
Hemocompatibility - DogThrombogenicity (ISO 10993-4)	Minimal thrombosis for testarticle and control sites (Grade1-2)	No significant thrombosis

and the contraction of the comments of the comments of

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Biocompatibility	Result	Conclusion
Systemic toxicity - Systemic InjectionTest (ISO 10993-11)	Extracts of test article did notinduce a significantly greaterbiological reaction than thecontrol extracts when injectedinto albino mice.	No toxic effects
Systemic toxicity - Rabbit Pyrogen Test(ISO 10993-11)	Temperature increase was 0.0°C from baseline.	Non-pyrogenic

Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Traxcess 14 Guidewire when compared with the predicate device.

1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The devices,

. Have the same intended use,
트 Use the same operating principle,
Incorporate the same basic design,
. Use similar construction and material,
Are packaged and sterilized using same material and processes. .

In summary, the Traxcess 14 Guidewire described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-9002

July 31, 2014

MicroVention, Inc. Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Ave. Tustin, CA 92780

Rc: K133725

Trade/Device Name: Traxcess 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Neurovasculature Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: June 27, 2014 Received: June 30, 2014

Dear Ms. Gong.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Naomi Gong

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133725

Device Name Traxcess 14 Guidewire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB 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.