K Number

Device Name

Traxcess 7 Mini XSoft Guidewire

Manufacturer

MicroVention, Inc.

Date Cleared

2016-12-09

(29 days)

Product Code

MOF DQX

Regulation Number

870.1330

Intended Use

Traxcess 7 Mini XSoft 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.

Device Description

Traxcess 7 Mini XSoft 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 aproximal 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 7 Mini XSoft 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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161803

Reference Devices

K153053

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and materials of the guidewire, with no mention of AI or ML.

Therapeutic

No
The device is described as a guidewire to facilitate the selective placement of diagnostic or therapeutic catheters, but it does not directly provide therapy itself.

Diagnostic

The device is a guidewire used to facilitate the selective placement of diagnostic or therapeutic catheters. While it can be used with diagnostic catheters, the guidewire itself does not perform diagnostic functions. It is a tool for guiding other instruments.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like a coiled wire, core wires, a coil, and includes accessories like a shaping mandrel, insertion tool, and torque device. It also mentions coatings and materials. This indicates a hardware-based medical device, not a software-only one.

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 describes the device as being used intravascularly to facilitate the placement of diagnostic or therapeutic catheters. This is an in vivo (within a living organism) use, not an in vitro (outside of a living organism) use.
Device Description: The description details a physical guidewire designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

Therefore, the Traxcess 7 Mini XSoft Guidewire is a medical device used within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Traxcess 7 Mini XSoft Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of therapeutic catheters. This device is not indicated for use in coronary arteries.

Product codes (comma separated list FDA assigned to the subject device)

MOF, DQX

Device Description

Traxcess 7 Mini XSoft 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

General intravascular use, including the neuro and peripheral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Bench Testing: Results of the performance bench testing (Table II) indicate that Traxcess 7 Mini XSoft Guidewire (subject device) meets established performance requirements, and is substantially equivalent for its intended use.

Summary of tests and conclusions:

Dimensional Inspection (Visual): Device met established dimensional specification.
Tip Shapeability: Device met established tip shapeability specification.
Durability/Lubricity of Hydrophilic Coating: Device met established durability/lubricity of hydrophilic coating specification.
Tensile Strength: Device met established distal tip and proximal joint tensile strength specification.
Corrosion Resistance: Device met established corrosion resistance.
Surface Contamination and Defects: Device met established surface contamination and defects specification.
Torque Strength: Device met established torque strength specification.
Torqueability: Subject device torque response better than predicate devices.
Fracture resistance: Device met established fracture resistance specification.
Flexing test: Device met established flexing test specification.
Distal Tip flexibility: Device met established distal tip flexibility specification.
Particle Testing: Device met established particle test specification.
Radiopacity: Device met established radiopacity specification.
In-Vitro Simulated Use Testing: Device met established simulated use testing specification.

Biocompatibility studies were not repeated on the subject device as it is made from the same material, same manufacturing processes, same sterility assurance level and same packaging configuration as the predicate device, Traxcess 7 Mini Guidewire (K161803). Biocompatibility testing conducted on Traxcess® 14 SELECT Guidewire (reference device) showed acceptance criteria were met for:

Cytotoxicity - L929 MEM Elution Test (ISO 10993-5): Non-cytotoxic.
Sensitization/Irritation - Kligman Maximization Test (ISO10993-10): Non-sensitizer.
Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10): Non-irritant.
Hemocompatibility - Hemolysis - Direct and Indirect (ISO 10993-4): Non-hemolytic.
Hemocompatibility - Unactivated Partial Thromboplastin Time (UPTT) Assay - Direct Contact (ISO 10993-4): Not considered to have an effect on coagulation of human plasma.
Hemocompatibility - C3A and SC5B-9 Complement Activation Test - Direct Contact (ISO 10993-4): Not considered to activate the complement system in human plasma.
Hemocompatibility - In Vitro Hemocompatibility Test - Direct Contact (ISO 10993-4): No effect on selected hematological parameters.
Hemocompatibility - Dog Thrombogenicity (ISO 10993-4): No significant thrombosis.
Systemic toxicity - Systemic Injection Test (ISO 10993-11): No toxic effects.
Systemic toxicity - Rabbit Pyrogen Test (ISO 10993-11): Non-pyrogenic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161803

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K153053

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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" 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

December 9, 2016

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

Re: K163154

Trade/Device Name: Traxcess 7 Mini XSoft Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: November 9, 2016 Received: November 10, 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.

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 同公

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

Enclosure

Indications for Use

510(k) Number (if known) K163154

Device Name Traxcess 7 Mini XSoft Guidewire

Indications for Use (Describe)

Traxcess 7 Mini XSoft Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of therapeutic catheters. This device is not indicated for use in coronary arteries.

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 for Traxcess 7 Mini XSoft 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:	December 07, 2016

DEVICE [807.92(a)(2)]

Name of Device:	Traxcess 7 Mini XSoft 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

PREDICATE DEVICE [807.92(a)(3)]

Traxcess® 7 Mini Guidewire (K161803)

REFERENCE DEVICE

Traxcess® 14 SELECT Guidewire (K153053)

DEVICE DESCRIPTION [807.92(a)(4)]

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

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

Traxcess 7 Mini XSoft Guidewire has the following similarities to predicate device, Traxcess 7 Mini Guidewire (K161803).

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 minor change in the distal corewire taper (distal to proximal) does not change the indications for use of the Traxcess 7 Mini XSoft 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 devices. The Table I states the comparison between subject device, Traxcess 7 Mini XSoft guidewire and predicate device, Traxcess 7 Mini Guidewire (K161803).

Table I: Reference Device vs Predicate Devices vs Subject Device Comparison Table
	Traxcess® 14 SELECT
Guidewire (K153053)	Traxcess® 7 Mini
Guidewire (K161803)	Traxcess 7 Mini XSoft
	[Reference Device]	[Predicate Device]	[Subject Device]
Indication For Use
Indication For Use
Statement	Traxcess 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.	Traxcess 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.	Traxcess 7 Mini XSoft
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.
Performance
Function	The steerable guidewire is
used to facilitate the
selective placement of
diagnostic or therapeutic
catheters.	Same	Same
Anatomical Location	General intravascular use,
including the neuro and
peripheral vasculature.	Same	Same
Design
Overall Length	200 cm	210 cm	210 cm
Diameter	Proximal = 0.014"
Distal = 0.012"	Proximal = 0.014"
Distal = 0.007"	Proximal = 0.014"
Distal = 0.007"
Corewire
Configuration	60 cm Nitinol welded to
Stainless Steel	Same	Same
Coil Length	40 cm	6 cm	6 cm
Coil Configuration	3 cm Platinum Nickel alloy
and 37 cm Stainless Steel	6cm Platinum Nickel alloy	6cm Platinum Nickel alloy
Distal Shaft Length
(Shapeable Length)	1.4 cm	Same	Same
Distal Corewire
Taper (distal to
proximal)	Diameter before flattening is
0.003"	Diameter before flattening is
0.0025"	Diameter before flattening is
0.0020"
	Length of distal 'paddle' and
taper: $17 ± 1.5$ mm	Length of distal 'paddle' and
taper: $14 ± 1.5$ mm	Length of distal 'paddle' and
taper: $14 ± 1.5$ mm
	Thickness of distal 'paddle' is
$0.037 ± 0.001$ mm	Thickness of distal 'paddle' is
$0.0356 ± 0.001$ mm	Thickness of distal 'paddle' is
$0.0254 ± 0.001$ mm
Docking Wire
Compatibility	Yes	No	No
Table I: Reference Device vs Predicate Devices vs Subject Device Comparison Table
Material
Material	Corewire (proximal):
Stainless Steel
Corewire (distal): Nitinol
Coil: Platinum Nickel alloy and
Stainless Steel	Corewire (proximal):
Stainless Steel
Corewire (distal): Nitinol
Coil: Platinum Nickel alloy. No
Stainless Steel	Corewire (proximal):
Stainless Steel
Corewire (distal):
Nitinol
Coil: Platinum Nickel
alloy. No Stainless Steel
Coating Material	Coil and distal stainless
steel section: Hydrophilic
Coating [SLIP-COAT by
Argon Medical]
Proximal Stainless Steel
section: PTFE	Coil and distal stainless
steel section: Hydrophilic
Coating [SLIP-COAT by
Argon Medical]
No PTFE Coating	Coil and distal
stainless steel
section: Hydrophilic
Coating [SLIP-
COAT by Argon
Medical]
No PTFE Coating
Hydrophilic Coating
Length	98 cm	158 cm	158 cm
Other Attributes
Method of supply	Sterile and single use	Same	Same
Sterilization method	Ethylene oxide gas	Same	Same
Accessories	Shaping Mandrel,
Torque Device, and
Insertion Tool	Same	Same
Package
configuration	Placed into a Dispenser
Hoop, Tyvek Pouch, and
Carton Box.	Same	Same

PERFORMANCE DATA [807.92(b)]

Table II: Performance Bench Testing Summary
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
•Accessory devices present	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.
Durability/Lubricity of
Hydrophilic Coating:
The durability/lubricity of the
coated test samples are
inspected by passing the sample
through two silicone clamp pads.
Machine starts pulling the
coated sample up through the
clamping pads, recording the
coating lubricity friction (in
grams) until the sample is
completely through.	Test article should meet existing
durability/lubricity of hydrophilic
coating specification.	Device met established
durability/lubricity of
hydrophilic coating
specification.
Tensile Strength:
The tensile strength of the distal
tip and proximal section (nitinol
and stainless steel weld) of the
guidewire was measured to make
sure it is sufficiently strong to
withstand normal tensile loading
for its intended use.	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:
The corrosion resistance of the
guidewire is tested to make sure
if the guidewire is corrosion
resistance.	Test article should be corrosion
resistant.	Device met established
corrosion resistance.
Table II: Performance Bench Testing Summary
Surface Contamination and
Defects:
The surface contamination and
defect results of the guidewire is
tested to make sure it is free
from 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:
The Torque Strength test was
performed to count the number of
turns to guidewire failure.	Test article should be greater than or
equal to existing torque strength
specification.	Device met established
torque strength
specification.
Torqueability:
The Torqueability test was
performed to measure the
difference in input angle (turn at
the proximal end at a set amount)
vs. the output angle and measure
how much the distal end turns.	Test article should be equal to, or
better than predicate devices.	Subject device torque
response better than
predicate devices.
Fracture resistance:
The Fracture Resistance Test
was performed to test for fracture
on the guidewire after winding
the guidewire around a cylindrical
former, then unwound and
examined for fracture of the
guidewire and the coating as well.	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:
The Flexing test was performed
to test the guidewire (distal and
proximal sections) under
repeated reverse bending and
straightening (flexing) and
examined for defects or damage.	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:
The distal tip flexibility testing
was performed to demonstrate
the force required to deflect the
distal tip of the guidewire.	Test article should be less than
existing distal tip specification to
deflect the distal tip of guidewire
and must be softer than
Traxcess 7 Mini.	Device met established
distal tip flexibility
specification.
Particle Testing:
The particle testing analysis was
performed to quantify particulate
matter in injections of the
guidewire after
advancement/retraction
procedures.	Test article should meet established
particle testing specification.	Device met established
particle test specification.
Table II: Performance Bench Testing Summary
Radiopacity:
The guidewire is placed under
fluoroscopy and digital images
are visually assessed for device
visibility.	Test article should be visible under
fluoroscopy.	Device met established
radiopacity specification.
In-Vitro Simulated Use
Testing:
Samples underwent simulated
use testing that included
introduction into and movement
within the catheter, tracking
guidewire/microcatheter system
in the model, system maximum
distal reach, overall performance
and any particles detected.	Test article should meet rating of 3 or
greater when tested with compatible
microcatheters.	Device met established
simulated use testing
specification.

There are no differences between the predicate and the reference device which would raise any different questions of safety and effectiveness. One can find the proposed device substantially equivalent to the predicate, Traxcess® 14 SELECT Guidewire (K153053).

Biocompatibility: The biocompatibility studies were not repeated on the subject device, as Traxcess 7 Mini XSoft 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 predicate device, Traxcess 7 Mini Guidewire (K161803). The results from biocompatibility testing conducted on Traxcess® 14 SELECT Guidewire 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 Elution
Test
(ISO 10993-5)	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
(on a scale of 0 to 4).
(Non-cytotoxic).
Sensitization/Irritation - Kligman
Maximization Test
(ISO10993-10)	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
(ISO 10993-10)	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).
Table III: Biocompatibility Test Summary
Biocompatibility Test
(ISO Standard)	Acceptance Criteria	Conclusion
Hemocompatibility - Hemolysis -
Direct and Indirect
(ISO 10993-4)	Test article meets the
requirements of the test if the
hemolytic index above the
negative control article is