Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and materials of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is a guidewire used to facilitate the placement of diagnostic catheters; it does not directly treat or alleviate a medical condition but rather assists in a diagnostic procedure.

Diagnostic

No

Explanation: The device description states that the guidewire "can be steered to facilitate the selective placement of diagnostic catheters." This indicates its role in assisting diagnostic procedures, not performing the diagnosis itself. The guidewire is a tool for navigation, not for collecting or analyzing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical guidewire made of metal and coated with a hydrophilic material, along with accessories like a shaping mandrel and torque device. This is a hardware medical device, not software.

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 is for "general intravascular use, including the neuro and peripheral vasculature" to "facilitate the selective placement of diagnostic catheters." This describes a device used within the body for a procedural purpose (guiding a catheter), not for testing samples outside the body to diagnose a condition.
Device Description: The description details a physical guidewire designed to be inserted into blood vessels. It does not mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.

Therefore, the Traxcess .007" Mini Guidewire is a medical device used for interventional procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

MOF, DQX

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

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 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.

Summary of Performance Bench Testing & Animal Testing:

Dimensional Inspection (Visual): Device met established dimensional specification for OD (Distal and Proximal), Overall Length, Length of distal Pt/Ni coil section, Length of hydrophilic coated section.
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 device.
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: Devices were visible under fluoroscopy.
In-Vitro Simulated Use Testing: Device met established simulated use testing specification.
Trackability, friction and handling of the guidewire to the target location (Animal Study): 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 (Animal Study): Both subject device and predicate device were visible under fluoroscopy.
Compatibility with Microcatheter (Animal Study): Both subject device and predicate device were compatible with microcatheters.
Overall Assessment (Animal Study): Performance of both subject device and predicate device was satisfactory. Subject device overall assessment is equivalent to predicate device.

Biocompatibility: Biocompatibility studies based on ISO 10993-5, ISO10993-10, ISO 10993-4, and ISO 10993-11 were not repeated as the device is made from the same material, same manufacturing processes, same sterility assurance level and same packaging configuration as the predicate device. The predicate device met acceptance criteria for these tests (Cytotoxicity, Sensitization/Irritation, Hemocompatibility, Systemic toxicity).

Packaging: Packaging validation, T=3 years accelerated aging was performed on predicate device and met acceptance criteria. Testing was not repeated on the subject device due to no change in packaging material, configuration, and method of supply or sterilization.

Sterilization: A product adoption study was performed on predicate device. Device sterilized using 100% Ethylene Oxide (EtO) gas to a sterility assurance level of 10-6. Bacterial endotoxin testing found to be less than 0.011 EU/ml and met acceptance criteria. Sterilization testing was not repeated due to no changes in materials or other design attributes related to sterilization.

Shelf Life: Shelf life testing, T=3 years accelerated aging was performed on predicate device and met acceptance criteria. Testing was not repeated on the subject device as no new materials were added, and material degradation rate is the same.

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.

K153053

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.

Not Found

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

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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.

1

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

2

Indications for Use

510(k) Number (if known) K161803

Device Name Traxcess .007" Mini Guidewire

Indications for Use (Describe)

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.

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

4

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 SELECT
Guidewire (Predicate Device,
K153053) | Traxcess .007" Mini
Guidewire (Subject Device,
K161803) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| | | |
| Indications for Use Statement | Traxcess 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. | 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. |
| Performance | | |
| Function | The steerable guidewire is used
to facilitate the selective
placement of diagnostic or
therapeutic catheters. | Same |
| Anatomical Location | General intravascular use,
including the neuro and peripheral
vasculature. | Same |
| Design | | |
| Overall Length | 200 cm | 210 cm |
| Diameter | Proximal = 0.014"
Distal = 0.012" | Proximal = Same
Distal = 0.007" |
| Core wire configuration | 60 cm Nitinol welded to Stainless
Steel | Same |
| Coil Length | 40 cm | 6 cm |
| Coil Configuration | 3cm Platinum Nickel alloy and
37cm Stainless Steel | 6cm Platinum Nickel alloy |
| Distal Shaft Length (Shapeable
Length) | 1.4 cm | Same |
| Docking Wire Compatibility | Yes | No |
| Material | | |
| Material | Core wire (proximal): Stainless
steel
Core wire (distal): Nickel titanium
(Nitinol) alloy
Coil: Platinum nickel alloy and
Stainless steel | Core wire (proximal): Same
Core wire (distal): Same
Coil: Platinum nickel alloy. No
Stainless steel |
| Coating Material | Coil and distal stainless steel
section: Hydrophilic Coating
[SLIP-COAT by Argon Medical] | Coil and distal stainless steel
section: Same
No 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 |

5

6

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 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.
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 device.	Subject device torque
response better than
predicate device.
Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
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.	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.
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.
Performance Bench Testing
Tests	Acceptance Criteria	Conclusion
Trackability, friction and handling
of the guidewire to the target
location	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.

Table II: Performance Bench Testing and Animal Testing Summary

7

8

9

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 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
atleast 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 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
(ISO 10993-4)	Test article meets the
requirements of the test if the
hemolytic index above the
negative control article is