Traxcess .007" Mini Guidewire is indicated 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 indicated for use in coronary arteries.

Device Description

Traxcess .007" Mini Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It consists of a proximal coated Stainless Steel core wire, and a distal coated Nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a Platinum/Nickel coil. The Platinum/Nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician. Traxcess .007" Mini Guidewire distal and proximal sections are coated with hydrophilic coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. A shaping mandrel, insertion tool, and torque device are also included with the device

AI/ML Overview

The provided document pertains to the 510(k) summary for the Traxcess .007" Mini Guidewire (K161803), which is a medical device. This document describes that the subject device is substantially equivalent to a predicate device, the Traxcess® 14 SELECT Guidewire (K153053). The core of the submission relies on demonstrating this substantial equivalence through various tests.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text, using the specified categories:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Performance Bench Testing
Dimensional Inspection (Visual)	Test article should meet specified dimensional requirements for: OD (Distal and Proximal), Overall Length, Length of distal Pt/Ni coil section, Length of hydrophilic coated section.	Device met established dimensional specification.
Tip Shapeability	Test article should be greater than or equal to existing tip shapeability specification.	Device met established tip shapeability specification.
Durability/Lubricity of Hydrophilic Coating	Test article should meet existing durability/lubricity of hydrophilic coating specification.	Device met established durability/lubricity of hydrophilic coating specification.
Tensile Strength	Test article should be greater than or equal to existing tensile strength specification for distal tip and proximal joint section.	Device met established distal tip and proximal joint tensile strength specification.
Corrosion Resistance	Test article should be corrosion resistant.	Device met established corrosion resistance.
Surface Contamination and Defects	Test article when examined at magnification, should meet existing surface contamination and defects specification.	Device met established surface contamination and defects specification.
Torque Strength	Test article should be greater than or equal to existing torque strength specification.	Device met established torque strength specification.
Torqueability	Test article should be equal to, or better than predicate device.	Subject device torque response better than predicate device.
Fracture resistance	Test article should not show signs of fracture. There should be no coating flaking off the guidewire.	Device met established fracture resistance specification.
Flexing test	Test article should not show signs of defect, fracture or other damage. There should be no coating flaking off the guidewire.	Device met established flexing test specification.
Distal Tip flexibility	Test article should be less than existing distal tip specification to deflect the distal tip of guidewire.	Device met established distal tip flexibility specification.
Particle Testing	Test article should meet established particle testing specification.	Device met established particle test specification.
Radiopacity	Test article should be visible under fluoroscopy.	Device met established radiopacity specification.
In-Vitro Simulated Use Testing	Test article should meet rating of 3 or greater when tested with compatible microcatheters.	Device met established simulated use testing specification.
Animal Testing
Trackability, friction and handling	Equal to or better than the predicate device.	Both subject device and predicate device were able to reach desired location in the animal study with no issues. No friction during insertion. Subject device trackability, friction and handling equivalent to predicate device.
Radiopacity	Must be visible under fluoroscopy.	Both subject device and predicate device were visible under fluoroscopy.
Compatibility with Microcatheter	Must be compatible with microcatheters.	Both subject device and predicate device were compatible with microcatheters.
Overall Assessment	Equal to or better than the predicate device.	Performance of both subject device and predicate device was satisfactory. Subject device overall assessment is equivalent to predicate device.
Biocompatibility Testing (on Predicate Device)
Cytotoxicity - L929 MEM Elution Test	Test article meets the requirements of the test if it does not show greater than a mild reactivity (Grade 2).	Test article exhibited a biological reactivity grade of 0 (Non-cytotoxic).
Sensitization/Irritation - Kligman Maximization Test	Test article meets the requirements of the test if it does not show a positive response in at least 10% of the test animals.	Test article exhibited 0% sensitization (Non-sensitizer).
Sensitization/Irritation - Intracutaneous Injection Test	Test article meets the requirements of the test if it does not produce irritation after intracutaneous injection in New Zealand White rabbits.	Test article did not show a significantly greater biological reaction than sites injected with the control article. The difference of the overall mean score between the test article and the control article was 0.0 (Non-irritant).
Hemocompatibility - Hemolysis - Direct and Indirect	Test article meets the requirements of the test if the hemolytic index above the negative control article is <5%.	Hemolysis index was above the negative control of 0.77% via direct contact method and 0.23% via indirect contact method (Non-hemolytic).
Hemocompatibility - Unactivated Partial Thromboplastin Time (UPTT) Assay - Direct Contact	Test article meets the requirements of the test if no statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control.	No statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control (Not considered to have an effect on coagulation of human plasma).
Hemocompatibility - C3A and SC5B-9 Complement Activation Test - Direct Contact	Test article meets the requirements of the test if the concentration of C3A and SC5B-9 in plasma exposed to test article does not statistically increase than the plasma exposed to negative and untreated controls.	The concentration of C3A and SC5B-9 in plasma exposed to test articles were not statistically increased than the plasma exposed to negative and untreated controls (Not considered to activate the complement system in human plasma).
Hemocompatibility - In Vitro Hemocompatibility Test - Direct Contact	Test article meets the requirements of the test if no statistical decrease (or increase/decrease for hematocrit and Mean corpuscular values) is found between blood exposed to test article and blood exposed to negative control or untreated control.	Test article did not have an effect on the WBCs, Platelet concentration and other hematological parameters in comparison to negative control and untreated control (No effect on selected hematological parameters).
Hemocompatibility - Dog Thrombogenicity	Test article meets the requirements of the test if there is minimal thrombosis for test article (Grade 0-2).	Minimal thrombosis (Grade 0-1) for test article and control sites (No significant thrombosis).
Systemic toxicity - Systemic Injection Test	Test article meets the requirements of the test if it does not induce a significantly greater biological reaction than the animal treated with the control articles when injected into albino mice.	Test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice (No toxic effects).
Systemic toxicity - Rabbit Pyrogen Test	Test article meets the requirements of the test for the absence of pyrogens, if no rabbit shows an individual temperature rise of 0.5°C or more above the baseline temperature.	Temperature increases for the test animals were all 0.0°C from baseline (Non-pyrogenic).

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Sizes: The document does not explicitly state numerical sample sizes for most of the bench tests. It generally refers to "test article" or "test samples." For some tests, there are references to "number of turns to guidewire failure" or "animal study" but without specific numbers of devices or animals.
- Animal Testing: The document mentions "animal study" for trackability, friction and handling, radiopacity, compatibility, and overall assessment. For Biocompatibility, "at least 10% of the test animals" is mentioned for sensitization/irritation, "New Zealand White rabbits" for intracutaneous injection, "albino mice" for systemic injection, and "rabbit" for pyrogen test. Crucially, animal testing for performance was comparative with the predicate device, but specific numbers were not provided. "Dog Thrombogenicity" is mentioned.
Data Provenance: The document does not specify the country of origin. The submission is from MicroVention, Inc. in Tustin, California, USA, implying the studies were likely conducted in the USA or by labs commissioned by them. The studies are prospective in the sense that they were conducted for this 510(k) submission to demonstrate equivalence.

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

This section is not applicable to this document. The submission is for a catheter guidewire, which relies on objective physical, chemical, and biological performance criteria, rather than subjective interpretation by human experts. The "ground truth" here is objective measurement against engineering specifications and biological safety standards, not expert consensus on qualitative data like medical images.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often with multiple readers, to resolve discrepancies. The tests described are objective, and the results are directly measured against predetermined criteria.

5. 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

This section is not applicable. This document is for a physical medical device (guidewire) and does not involve AI or human "readers" or subjective interpretation of cases. Therefore, an MRMC study related to AI assistance is not relevant.

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

This section is not applicable. As mentioned above, this is for a physical medical device and does not involve algorithms or AI.

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

The "ground truth" for the tests performed is primarily based on:

Engineering Specifications: Predetermined dimensional requirements, tensile strength, torque strength, shapeability specifications, etc., set for the device's physical performance.
Biological Safety Standards: Benchmarks derived from ISO standards (e.g., ISO 10993 series) for biocompatibility, such as acceptable levels of cytotoxicity, sensitization, hemolysis, pyrogenicity, etc.
Comparative Performance: For some tests (e.g., torqueability, animal study trackability), the predicate device served as a direct comparison, where the subject device had to be "equal to or better than" the predicate.

8. The sample size for the training set

This section is not applicable. The device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The "training" here would refer to the design and manufacturing process iteration, which is not quantified as a "sample size" in this context.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 30, 2016

MicroVention, Inc. Sapna Singh, MS, RAC Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K161803

Trade/Device Name: Traxcess .007" Mini Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 1, 2016 Received: September 2, 2016

Dear Ms. Singh:

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 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.

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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.

Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. 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 (if known) K161803

Device Name Traxcess .007" Mini Guidewire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY [K161803]

This 510(k) summary for Traxcess .007" Mini Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.

SUBMITTER [807.92(a)(1)]

MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.

Telephone:	(714) 247-8162
Fax:	(714) 247-8014

Contact Person:	Sapna Singh
Email:	sapna.singh@microvention.com
Date Prepared:	September 30, 2016

DEVICE [807.92(a)(2)]

Name of Device:	Traxcess .007" Mini Guidewire
Common or Usual Name:	Traxcess Guidewire
Classification Name:	Catheter Guidewire
Product Code:	MOF, DQX
Regulatory Class:	Class II
Submission Type:	Special 510(K)
Regulation Number:	21 CFR 870.1330
Reviewing Product Branch:	Division of Neurological and Physical Medicine Devices(Office of Device Evaluation, CDRH)

PREDICATE DEVICE [807.92(a)(3)]

Traxcess® 14 SELECT Guidewire (K153053)

DEVICE DESCRIPTION [807.92(a)(4)]

Traxcess .007" Mini Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It consists of a

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proximal coated Stainless Steel core wire, and a distal coated Nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a Platinum/Nickel coil. The Platinum/Nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician.

Traxcess .007" Mini Guidewire distal and proximal sections are coated with hydrophilic coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. A shaping mandrel, insertion tool, and torque device are also included with the device

INDICATIONS FOR USE [807.92(a)(5)]

Traxcess .007" Mini Guidewire is indicated 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 indicated for use in coronary arteries.

CONTRAINDICATION

The device is not indicated to be used in coronary arteries.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

Traxcess .007" Mini Guidewire has the following similarities to the predicate device, Traxcess® 14 SELECT Guidewire (K153053):

1. Same intended use
1. Same operating principle
1. Incorporate the same basic guidewire design
1. Incorporate the same guidewire construction material
1. Are packaged and sterilized using the same materials and processes

The small distal tip of the guidewire and the application of hydrophilic coating on the distal and proximal sections of the guidewire does not change the indications for use of the Traxcess guidewires and is not a change to the fundamental scientific technology. The performance data below shows the device will perform as well as the previously marketed device.

The Table I states the comparison between Traxcess® 14 SELECT Guidewire (Predicate Device, K153053) and Traxcess .007" Mini Guidewire (Subject Device, K161803).

Table I: Predicate Device vs Subiect Device Comparison Table

	Traxcess 14 SELECTGuidewire (Predicate Device,K153053)	Traxcess .007" MiniGuidewire (Subject Device,K161803)
Indications for Use

Indications for Use Statement	Traxcess Guidewire is intended forgeneral intravascular use, includingthe neuro and peripheralvasculature. The guidewire can besteered to facilitate the selectiveplacement of diagnostic ortherapeutic catheters. This deviceis not intended for use incoronary arteries.	Traxcess .007" Mini Guidewire isindicated for general intravascularuse, including the neuro andperipheral vasculature. Theguidewire can be steered tofacilitate the selective placement ofdiagnostic or therapeutic catheters.This device is not indicated foruse in coronary arteries.
Performance
Function	The steerable guidewire is usedto facilitate the selectiveplacement of diagnostic ortherapeutic catheters.	Same
Anatomical Location	General intravascular use,including the neuro and peripheralvasculature.	Same
Design
Overall Length	200 cm	210 cm
Diameter	Proximal = 0.014"Distal = 0.012"	Proximal = SameDistal = 0.007"
Core wire configuration	60 cm Nitinol welded to StainlessSteel	Same
Coil Length	40 cm	6 cm
Coil Configuration	3cm Platinum Nickel alloy and37cm Stainless Steel	6cm Platinum Nickel alloy
Distal Shaft Length (ShapeableLength)	1.4 cm	Same
Docking Wire Compatibility	Yes	No
Material
Material	Core wire (proximal): StainlesssteelCore wire (distal): Nickel titanium(Nitinol) alloyCoil: Platinum nickel alloy andStainless steel	Core wire (proximal): SameCore wire (distal): SameCoil: Platinum nickel alloy. NoStainless steel
Coating Material	Coil and distal stainless steelsection: Hydrophilic Coating[SLIP-COAT by Argon Medical]	Coil and distal stainless steelsection: SameNo PTFE Coating
	Proximal Stainless Steel Section:PTFE
Hydrophilic Coating Length	98 cm	158 cm
Other Attributes
Method of supply	Sterile and single use	Same
Sterilization method	Ethylene oxide gas	Same
Accessories	Shaping mandrel, Torque device,and Insertion tool	Same
Package configuration	Placed into a Dispenser hoop,Tyvek pouch, and Carton box	Same

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PERFORMANCE DATA [807.92(b)]

Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table II) indicate that Traxcess .007" Mini Guidewire (subject device, K161803) meets established performance requirements, and is substantially equivalent for its intended use.

Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
Dimensional Inspection (Visual):The dimensional attributes of the test samples were inspected.	Test article should meet specified dimensional requirements for:OD (Distal and Proximal) Overall Length Length of distal Pt/Ni coil section Length of hydrophilic coated section	Device met established dimensional specification.
Tip Shapeability:The test evaluates the shapeability and retention before and after simulated application of intraprocedural stresses.	Test article should be greater than or equal to existing tip shapeability specification.	Device met established tip shapeability specification.
Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
Durability/Lubricity ofHydrophilic Coating:The durability/lubricity of thecoated test samples areinspected by passing the samplethrough two silicone clamp pads.Machine starts pulling thecoated sample up through theclamping pads, recording thecoating lubricity friction (ingrams) until the sample iscompletely through.	Test article should meet existingdurability/lubricity of hydrophiliccoating specification.	Device met establisheddurability/lubricity ofhydrophilic coatingspecification.
Tensile Strength:The tensile strength of the distaltip and proximal section (nitinoland stainless steel weld) of theguidewire was measured to makesure it is sufficiently strong towithstand normal tensile loadingfor its intended use.	Test article should be greater than orequal to existing tensile strengthspecification for distal tip andproximal joint section.	Device met establisheddistal tip and proximal jointtensile strengthspecification.
Corrosion Resistance:The corrosion resistance of theguidewire is tested to make sureif the guidewire is corrosionresistance.	Test article should be corrosionresistant.	Device met establishedcorrosion resistance.
Surface Contamination andDefects:The surface contamination anddefect results of the guidewire istested to make sure it is freefrom contamination and defects.	Test article when examined atmagnification, should meet existingsurface contamination and defectsspecification.	Device met establishedsurface contamination anddefects specification.
Torque Strength:The Torque Strength test wasperformed to count the number ofturns to guidewire failure.	Test article should be greater than orequal to existing torque strengthspecification.	Device met establishedtorque strengthspecification.
Torqueability:The Torqueability test wasperformed to measure thedifference in input angle (turn atthe proximal end at a set amount)vs. the output angle and measurehow much the distal end turns.	Test article should be equal to, orbetter than predicate device.	Subject device torqueresponse better thanpredicate device.
Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
Fracture resistance:The Fracture Resistance Testwas performed to test for fractureon the guidewire after windingthe guidewire around a cylindricalformer, then unwound andexamined for fracture of theguidewire and the coating as well.	Test article should not show signs offracture. There should be no coatingflaking off the guidewire.	Device met establishedfracture resistancespecification.
Flexing test:The Flexing test was performedto test the guidewire (distal andproximal sections) underrepeated reverse bending andstraightening (flexing) andexamined for defects or damage.	Test article should not show signs ofdefect, fracture or other damage.There should be no coating flaking offthe guidewire.	Device met establishedflexing test specification.
Distal Tip flexibility:The distal tip flexibility testingwas performed to demonstratethe force required to deflect thedistal tip of the guidewire.	Test article should be less thanexisting distal tip specification todeflect the distal tip of guidewire.	Device met establisheddistal tip flexibilityspecification.
Particle Testing:The particle testing analysis wasperformed to quantify particulatematter in injections of theguidewire afteradvancement/retractionprocedures.	Test article should meet establishedparticle testing specification.	Device met establishedparticle test specification.
Radiopacity:The guidewire is placed underfluoroscopy and digital imagesare visually assessed for devicevisibility.	Test article should be visible underfluoroscopy.	Device met establishedradiopacity specification.
In-Vitro Simulated UseTesting:Samples underwent simulateduse testing that includedintroduction into and movementwithin the catheter, trackingguidewire/microcatheter systemin the model, system maximumdistal reach, overall performanceand any particles detected.	Test article should meet rating of 3 orgreater when tested with compatiblemicrocatheters.	Device met establishedsimulated use testingspecification.
Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
Trackability, friction and handlingof the guidewire to the targetlocation	Equal to or better than the predicatedevice.	Both subject device andpredicate device were ableto reach desired locationin the animal study with noissues. No friction duringinsertion.Subject device trackability,friction and handlingequivalent to predicatedevice.
Radiopacity	Must be visible under fluoroscopy.	Both subject device andpredicate device werevisible under fluoroscopy.
Compatibility with Microcatheter	Must be compatible withmicrocatheters.	Both subject device andpredicate device werecompatible withmicrocatheters.
Overall Assessment	Equal to or better than the predicatedevice.	Performance of bothsubject device andpredicate device wassatisfactory.Subject device overallassessment is equivalentto predicate device.

Table II: Performance Bench Testing and Animal Testing Summary

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Biocompatibility: The biocompatibility studies were not repeated on the subject device, Traxcess .007" Mini Guidewire since it is made from the same material, same manufacturing processes, same sterility assurance level and same packaging configuration as those utilized in the fabrication of predicate device, Traxcess® 14 SELECT Guidewire (K153053). The results from biocompatibility testing conducted on predicate device showed that the acceptance criteria were met. Table III summarizes the biocompatibility testing conducted on Traxcess® 14 SELECT Guidewire.

Table III: Biocompatibility Test Summary

Biocompatibility Test(ISO Standard)	Acceptance Criteria	Conclusion
Cytotoxicity - L929 MEM ElutionTest(ISO 10993-5)	Test article meets therequirements of the test if it doesnot show greater than a mildreactivity (Grade 2).	Test article exhibited abiological reactivity grade of 0(on a scale of 0 to 4).(Non-cytotoxic).
Sensitization/Irritation - KligmanMaximization Test(ISO10993-10)	Test article meets therequirements of the test if it doesnot show a positive response inatleast 10% of the test animals.	Test article exhibited 0%sensitization.(Non-sensitizer).
Biocompatibility Test(ISO Standard)	Acceptance Criteria	Conclusion
Sensitization/Irritation -Intracutaneous Injection Test(ISO 10993-10)	Test article meets therequirements of the test if it doesnot produce irritation afterintracutaneous injection in NewZealand White rabbits.	Test article did not show asignificantly greater biologicalreaction than sites injected withthe control article. Thedifference of the overall meanscore between the test articleand the control article was 0.0.(Non-irritant).
Hemocompatibility - Hemolysis -Direct and Indirect(ISO 10993-4)	Test article meets therequirements of the test if thehemolytic index above thenegative control article is <5%.	Hemolysis index was above thenegative control of 0.77% viadirect contact method and0.23% via indirect contactmethod.(Non-hemolytic).
Hemocompatibility - UnactivatedPartial Thromboplastin Time(UPTT) Assay - Direct Contact(ISO 10993-4)	Test article meets therequirements of the test if nostatistical decrease is foundbetween UPTT of the plasmaexposed to the test article andthat of plasma exposed tonegative control or untreatedcontrol.	No statistical decrease is foundbetween UPTT of the plasmaexposed to the test article andthat of plasma exposed tonegative control or untreatedcontrol.(Not considered to have aneffect on coagulation of humanplasma).
Hemocompatibility - C3A andSC5B-9 Complement ActivationTest - Direct Contact(ISO 10993-4)	Test article meets therequirements of the test if theconcentration of C3A and SC5B-9 in plasma exposed to testarticle does not statisticallyincrease than the plasmaexposed to negative anduntreated controls.	The concentration of C3A andSC5B-9 in plasma exposed totest articles were notstatistically increased than theplasma exposed to negativeand untreated controls.(Not considered to activate thecomplement system in humanplasma).
Hemocompatibility - In VitroHemocompatibility Test - DirectContact(ISO 10993-4)	Test article meets therequirements of the test if nostatistical decrease (orincrease/decrease for hematocritand Mean corpuscular values) isfound between blood exposed totest article and blood exposed tonegative control or untreatedcontrol.	Test article did not have aneffect on the WBCs, Plateletconcentration and otherhematological parameters incomparison to negative controland untreated control.(No effect on selectedhematological parameters).
Hemocompatibility - DogThrombogenicity(ISO 10993-4)	Test article meets therequirements of the test if thereis minimal thrombosis for testarticle (Grade 0-2).	Minimal thrombosis (Grade 0-1)for test article and control sites.(No significant thrombosis).
Systemic toxicity - SystemicInjection Test(ISO 10993-11)	Test article meets therequirements of the test if it doesnot induce a significantly greaterbiological reaction than theanimal treated with the controlarticles when injected into albinomice	Test article did not induce asignificantly greater biologicalreaction than the controlextracts when injected intoalbino mice.(No toxic effects).
Biocompatibility Test(ISO Standard)	Acceptance Criteria	Conclusion
Systemic toxicity - RabbitPyrogen Test(ISO 10993-11)	Test article meets therequirements of the test for theabsence of pyrogens, if no rabbitshows an individual temperaturerise of 0.5°C or more above thebaseline temperature.	Temperature increases for thetest animals were all 0.0° Cfrom baseline.(Non-pyrogenic).

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Packaging: The packaging validation, T=3 years accelerated aging was performed on predicate device, Traxcess® 14 SELECT Guidewire (K153053) and included testing devices via visual inspection, simulated use testing, sterile pouch seal strength testing, dye penetration testing and shipper box testing. The results from packaging testing conducted on predicate device showed that the acceptance criteria were met. The testing was not repeated on the subject device, Traxcess .007" Mini Guidewire since there is no change in the packaging material, packaging configuration, and method of supply or sterilization. The packaging still provides the same protection and sterile barrier requirements.

Sterilization: A product adoption study was performed on predicate device, Traxces® 14 SELECT Guidewire (K153053). The device is sterilized using 100% Ethylene Oxide (EtO) gas, per Cycle 11 to a sterility assurance level of 10 t in the same manner as our existing Headway 17 Microcatheter (K083343). The bacterial endotoxin testing was conducted on predicate device and found to be less than 0.011 EU/ml and met the acceptance criteria of no more than 2.15 EU/device. The sterilization testing was not repeated on subject device, Traxcess .007" Mini Guidewire since it is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as predicate device, Traxcess® 14 SELECT Guidewire (K153053). There are no changes in materials or other design attributes made to the subject device.

Shelf Life: The shelf life testing, T=3 years accelerated aging was performed on predicate device, Traxcess® 14 SELECT Guidewire (K153053) and included testing devices via simulated use, dimensional inspection, durability/lubricity of hydrophilic and PTFE coating, tensile strength, surface defects and contamination, torque response and particle testing. The results from shelf life testing conducted on predicate device showed that the acceptance criteria were met. The shelf life testing was not repeated on the subject device, Traxcess .007" Mini Guidewire since no new materials are added to the subject device. There will be no impact on device shelf life as material degradation rate is the same.

The conclusions drawn from the performance bench testing, biocompatibility, packaging, sterilization and shelf-life testing demonstrate compliance with the established testing acceptance criteria. Therefore, we can conclude that proposed device is substantially equivalent to legally marketed predicate device, Traxcess 14 SELECT Guidewire (K153053).

CONCLUSIONS

Based on the 510(k) summary and information provided herein, we conclude the subject device, Traxcess .007" Mini Guidewire, is substantially equivalent in its intended use, design, guidewire

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material, performance, and the underlying fundamental scientific technology used, to the predicate device, Traxcess® 14 SELECT Guidewire (K153053).

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.