Traxcess™ 7 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™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within 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™ 7 Mini Guidewire distal and proximal sections are coated with hydrophilic coating. There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Traxcess™ 7 Mini Guidewire." This is a medical device submission seeking substantial equivalence to a previously cleared device, not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in terms of traditional medical device performance testing, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI medical device:

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

Acceptance Criteria (Performance Requirement)	Reported Device Performance
Physical attributes: Met specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices.	Device met established dimensional specifications.
Surface Contamination: Test article, when examined at magnification, should meet existing surface contamination and defects specification.	Device was free from surface defects and contamination.
Corrosion Resistance: Test article should be corrosion resistant.	Device met established corrosion resistance.
Guidewire Coating adherence: Coating adherence maintained after advance/retract cycles.	Durability and lubricity of coating was maintained after advance/retract cycles.
Guidewire 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.
Guidewire tip shapeability: Test article should be greater than or equal to existing tip shapeability specification.	Device met established Guidewire tip shapeability specification.
Torque Strength: Test article should be greater than or equal to existing torque strength specification.	Device met established torque strength specification.
Torque Response: Test article should be equivalent to, or better than predicate device.	Subject device torque response equivalent to predicate device.
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.
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.
Simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking.	Device performed as intended under simulated use.
Particulate Testing: Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns).	Device has comparable particulate results to the predicate device.

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of guidewires tested for tensile strength). The data provenance is described as "Bench Testing," meaning these are laboratory-generated results on physical samples of the device, not patient data. Therefore, concepts like "country of origin of the data," "retrospective or prospective" do not apply in the context of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable to this type of device submission. The "ground truth" for these physical performance tests are objective engineering specifications and measurements, not expert interpretations of clinical data. For example, a guidewire's diameter is measured with instruments, not subject to expert consensus.

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

This question is not applicable as the tests are objective physical measurements and not subject to human adjudication of clinical findings.

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 question is not applicable. The device is a physical guidewire, not an AI-powered diagnostic or assistive tool that would involve human readers or affect their performance.

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

This question is not applicable, as the device is a physical guidewire, not an algorithm.

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

For the bench testing, the "ground truth" is defined by established engineering and device specifications (e.g., dimensional requirements, material properties, mechanical performance criteria). For the biocompatibility aspect, the ground truth for the reference device (Traxcess™ 14 SELECT Guidewire) would have been established through a series of biocompatibility tests according to ISO standards, which evaluate the biological response to the device material.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no training set for this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2020

MicroVention, Inc. Ganesh Balachandar Sr. Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656

Re: K201487

Trade/Device Name: Traxcess 7 Mini Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: June 1, 2020 Received: June 4, 2020

Dear Ganesh Balachandar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201487

Device Name Traxcess™ 7 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

This 510(k) summary of safety and effectiveness for the Traxcess™ 7 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.

I SUBMITTER [807.92(a)(1)]

MicroVention Inc. Tustin, California U.S.A

Telephone: (714)247-8201 Contact Name: Ganesh Balachandar E-mail address: ganesh.balachander(@microvention.com Date Prepared: 01-June-2020

II DEVICE [807.92(a)(2)]

Name of Device:	Traxcess TM 7 Mini Guidewire
Common or Usual Name:	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 Neurosurgical, Neurointerventional, and Neurodiagnostic Devices (Office of Product Evaluation and Quality)

III PREDICATE DEVICE [807.92(a)(3)]

Predicate Device: Traxcess 7 Mini Guidewire (K161803) Reference Device: Traxcess 14 SELECT Guidewire (K200547)

IV DEVICE DESCRIPTION [807.92(a)(4)]

Traxcess™ 7 Mini Guidewire distal and proximal sections are coated with hydrophilic coating.

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There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.

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

Traxcess™ 7 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.

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

Traxcess™ 7 Mini Guidewire has the following similarities to the predicate device, Traxcess™ 7 Mini Guidewire (K161803):

Have the same intended use ●
Use the same operating principle
Incorporate the same basic guidewire design ●
Incorporate the same guidewire construction material ●
Are packaged and sterilized using the same materials and processes ●

The change in core wire taper diameter profile for the Traxcess™ 7 Mini guidewire for better support and compatibility with microcatheters does not change the indications for use of the Traxcess™ 7 Mini Guidewire 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.

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The Table 1 states the comparison between Traxcess™ 7 Mini Guidewire (Predicate Device, K161803) and Traxcess™ 7 Mini Guidewire (Subject Device).

Description	Reference Device (Existing)	Predicate Device (Existing)	Subject Device (Modified)	Rationale for Difference (if any)
	Traxcess™ 14 SELECTGuidewire (K200547)	Traxcess™ 7 MiniGuidewire (K161803)	Traxcess™ 7 MiniGuidewire
Indications for Use	Traxcess™ 14 SELECTGuidewire is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. Theguidewire can be steered tofacilitate the selective placementof diagnostic or therapeuticcatheters. This device is notindicated for use in coronaryarteries.	Traxcess™ 7 Mini Guidewireis indicated for generalintravascular use, includingthe neuro and peripheralvasculature. The guidewirecan be steered to facilitate theselective placement ofdiagnostic or therapeuticcatheters. This device is notindicated for use in coronaryarteries.	Same	No difference
Intended Use	The Traxcess™ 14 SELECTguidewire is used in bothdiagnostic and interventionalprocedures where distal accessis necessary.	The Traxcess™ 7 MiniGuidewire is used in bothdiagnostic and interventionalprocedures where distal accessis necessary.	Same	No difference
Function	The steerable guidewire is usedto facilitate the selectiveplacement of diagnostic ortherapeutic catheters.	The steerable guidewire is usedto facilitate the selectiveplacement of diagnostic ortherapeutic catheters.	Same	No difference
AnatomicalLocation	General intravascular use,including the neuro andperipheral vasculature.	General intravascular use,including the neuro andperipheral vasculature.	Same	No difference
Wire Diameter	Proximal = 0.014"Distal = 0.012"	Proximal = 0.014"Distal = 0.007"	Same	No differencewith predicate
				device(K161803)
Device Length	200 cm	210 cm	Same	No differencewith predicatedevice(K161803)
Coil Length	40 cm	6 cm	Same	No differencewith predicatedevice(K161803)
Platinum/NickelCoil Length(Radiopaque)	3 cm	6 cm	Same	No differencewith predicatedevice(K161803)
Distal ShaftLength(ShapeableLength)	1.4 cm	1.4 cm	Same	No differencewith predicatedevice(K161803)
Corewireconfiguration	N/A	Diameter from 2-6cm:0.0033"Diameter from16-30 cm:0.01"	Diameter from 2-6cm:0.0038"Diameter from 16-30 cm:0.008"	Change in corewire diameterprofile incomparison to thepredicate device(K161803)
Docking wirecompatibility	Compatible with Traxcess™docking wire(K093647)	No	Same	No differencewith predicatedevice(K161803)
Material	Core wire (proximal):Stainless steelCore wire (distal):Nickel titanium (Nitinol)alloyCoil: Platinum nickel alloyand Stainless steelOther: Brazing materialand solder	Core wire (proximal):Stainless steelCore wire (distal):Nickel titanium (Nitinol)alloyCoil: Platinum nickel alloyand Stainless steelOther: Brazing material andsolder	Same	No differencewith predicatedevice(K161803)
CoatingMaterial	Proximal section:PTFEDistal section:Hydrophilic Coating [SLIP-COAT by Argon Medical]	Coil and distal/proximalstainless-steel section:Hydrophilic Coating [SLIP-COAT by Argon Medical]	Same	No differencewith predicatedevice(K161803)
Coating Length	Hydrophiliccoating = 980 mmPTFE = 1000 mm	Hydrophiliccoating = 1580 mm	Same	No differencewith predicatedevice(K161803)
Method ofsupply	Sterile and single use	Sterile and single use	Same	No differencewith predicatedevice(K161803)
Sterilizationmethod	Ethylene oxide gas	Ethylene oxide gas	Same	No differencewith predicatedevice(K161803)
Accessories	Shaping mandrel, torquedevice, and insertion tool	Shaping mandrels, torquedevice, and insertion tool	Same	No differencewith predicatedevice(K161803)
Packageconfiguration	Placed into a dispenser hoop,Tyvek pouch, and box carton.	Placed into a dispenser hoop,Tyvek pouch, and box carton.	Same	No differencewith predicatedevice(K161803)

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VII PERFORMANCE DATA [807.92(b)]

Results of the verification and validation testing in the table below indicate that the product meets established performance requirements and is safe and effective for its intended use.

Bench Testing	Result	Conclusion
Physical attributes	Test articles met specifieddimensional requirements forguidewire OD, overall length, lengthof Pt/Ni coil section, length of SSsection, length of PTFE coatedsection, length of hydrophilic coatedsection, length of proximal dockingsection and accessory devices.	Device met establisheddimensional specifications.
SurfaceContamination	Test article when examined atmagnification, should meet existingsurface contamination and defectsspecification.	Device was free from surfacedefects and contamination.
Corrosion Resistance	Test article should be corrosionresistant.	Device met establishedcorrosion resistance.
Guidewire Coatingadherence	Coating adherence maintained afteradvance/retract cycles.	Durability and lubricity ofcoating was maintained afteradvance/retract cycles.
Guidewire fractureresistance	Test article should not show signs offracture. There should be no coatingflaking off the guidewire.	Device met established fractureresistance specification.
Guidewire tipshapeability	Test article should be greater than orequal to existing tip shapeabilityspecification.	Device met establishedGuidewire tip shapeabilityspecification.
Torque Strength	Test article should be greater than orequal to existing torque strengthspecification.	Device met established torquestrength specification.
Torque Response	Test article should be equivalentto, or better than predicatedevice.	Subject device torque responseequivalent to predicate device.
Flexing test	Test article should not showsigns of defect, fracture or otherdamage. There should be nocoating flaking off the guidewire.	Device met established flexingtest specification.
Distal tip flexibility	Test article should be less thanexisting distal tip specification todeflect the distal tip of guidewire.	Device met established distaltip flexibility specification.
Tensile strength	Test article should be greaterthan or equal to existing tensilestrength specification for distaltip and proximal joint section.	Device met established distaltip and proximal joint tensilestrength specification.
Simulated use testing	Test articles achieved rating ≥ 3for prep of device, introduction,and tracking.	Device performed as intendedunder simulated use.
Particulate Testing	Particle count of test articles ≤25particles (≥ 10 microns) and ≤3 particles (≥ 25 microns).	Device has comparableparticulate results to thepredicate device.

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Biological Evaluation

The biocompatibility studies were not repeated as Traxcess™ 7 Mini Guidewire is made from the same material, same manufacturing processes, same sterility assurance level and same packaging configuration as those utilized in the fabrication of the reference device Traxcess™ 14 SELECT Guidewire (K200547). The biocompatibility testing conducted on the Traxcess™ 14 SELECT Guidewire (K200547) provides assurance that the guidewire has a safe biocompatibility profile and are safe to use.

VIII CONCLUSIONS

Based on the 510(k) summary and information provided herein, we conclude the subject device, Traxcess™ 7 Mini Guidewire, is substantially equivalent in its intended use, design, guidewire material, performance, and the underlying fundamental scientific technology used, to the predicate Traxcess™ 7 Mini Guidewire (K161803).

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.