TRAXCESS 14 GUIDEWIRE

K133725 · MicroVention, Inc. · MOF · Jul 31, 2014 · Cardiovascular

Device Facts

• Record ID: K133725
• Device Name: TRAXCESS 14 GUIDEWIRE
• Applicant: MicroVention, Inc.
• Product Code: MOF · Cardiovascular
• Decision Date: Jul 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Intravascular guidewire; 0.014" stainless steel shaft; tapered nitinol tip; platinum/stainless steel coils; hydrophilic coating. Used in neuro and peripheral vasculature; operated by physicians to steer and place diagnostic or therapeutic catheters. Provides mechanical support and navigation through vasculature; facilitates catheter access. Benefits patient by enabling minimally invasive access to target vessels for diagnosis or therapy.

Clinical Evidence

Bench testing only. Testing included physical/dimensional attributes, tensile strength, tip flexibility, torque strength, coating adherence, torqueability, flexing/fracture resistance, radiopacity, tip shapeability, in-vitro simulated use, attachment compatibility, and particulate testing. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, hemocompatibility, systemic toxicity, pyrogenicity). All results met specifications and were equivalent or superior to the predicate.

Technological Characteristics

Materials: stainless steel shaft, nitinol tip, platinum/stainless steel coils. Coating: hydrophilic [SLIP-COAT]. Dimensions: 0.014" proximal diameter, 0.012" distal diameter, 200 cm length. Mechanical navigation device; no energy source or software.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate selective placement of diagnostic or therapeutic catheters. Contraindicated for use in coronary arteries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Traxcess 0.014" Hydrophilic Guidewire (K080863)

Submission Summary (Full Text)

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510(k) Summary

JUL 3 1 2014

K133725

| Trade Name: | Traxcess 14 Guidewire |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | Guidewire |
| Classification:<br>Product Code:<br>Submitted By: | Class II, 21 CFR 870.1330<br>MOF, DQX<br>MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A.<br>Ph: 714-247-8000<br>Fax: [phone] |
| Contact: | Naomi Gong |
| Date: | December 4, 2013 |

## Predicate Device:

| Number | Description | Clearance Date |
|---------|------------------------------------------|----------------|
| K080863 | Traxcess 0.014" Hydrophilic<br>Guidewire | April 7, 2008 |

## Device Description:

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

### Indication For Use:

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

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# Technological Comparison:

.

| | Predicate | Traxcess 14 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Intended Use | The Traxcess 14 Guidewire is intended<br>for general intravascular use, including<br>the neuro and peripheral vasculature. The<br>guidewire can be steered to facilitate the<br>selective placement of diagnostic or<br>therapeutic catheters. This device is not<br>intended for use in coronary arteries. | Same |
| Diameter | Proximal = 0.014"<br>Distal = 0.012" | Same |
| Overall Length | 200 cm | Same |
| Distal Shaft Length<br>(Shapeable Length) | 1.4 cm | Same |
| Material | Core wire (proximal): Stainless steel<br>Core wire (distal): Nickel titanium alloy<br>Coil: Stainless steel and Platinum nickel<br>alloy<br>Other: Brazing material and solder | Same |
| Coating | Shaft: PTFE/silicone<br>Coil: Hydrophilic Coating<br>(dimethylacramide-glycidyl methacrylate<br>copolymer) | Shaft and Coil: Hydrophilic Coating<br>[SLIP-COAT] |
| Coating Length | Hydrophilic coating (distal) = 400 mm<br>PTFE/silicone (proximal) ~1600 mm | Hydrophilic Coating = 1450 mm |
| Coil Length | 40 cm | Same |
| Radiopaque Length | 3 cm | Same |
| Distal tip thickness<br>(core wire) | 0.037 mm | Same |
| Proximal end<br>configuration | Tapered to be compatible with Traxcess<br>docking wire | Same |

・

:

# Verification and Test Summary Table:

| Bench Testing | Result | Conclusion |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Physical and dimensional attributes | Test articles met specified<br>dimensional requirements for<br>OD, overall length, length of<br>coil section, length of SS<br>section, length of docking<br>section. | Device met established<br>dimensional and physical<br>specifications. |
| Tensile strength (distal and proximal) | Tensile strength of distal ≥ 3N<br>and of proximal ≥ 70N | Device met established tensile<br>strength |
| Tip flexibility | Demonstrated force to deflect<br>the distal tip is ≤ predicate | Device tip flexibility is ≤<br>predicate |

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| Bench Testing | Result | Conclusion |
|--------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Torque strength | Equivalent or better than<br>predicate (turns to failure) | Equivalent to predicate |
| Coating adherence | Coating adherence maintained<br>after advance/retract cycles | Durability and lubricity of<br>coating was comparable to<br>predicate |
| Torqueability | Torque response was equal to<br>or better than predicate | Torque response was equal to<br>or better than predicate |
| Flexing and fracture resistance test | No damage to test articles or<br>coating after flexing and<br>fracture test | Device able to withstand<br>forces and stress during<br>navigation in vasculature. |
| Radiopacity | Distal coil section visible<br>under fluoroscopy | Device radiopacity equivalent<br>or better than predicate |
| Tip shapeability | Test articles able to maintain<br>tip shape | Device tip shapeability<br>equivalent or better than<br>predicate |
| In-vitro simulated use testing | Test articles achieved rating ≥<br>3 for prep of device,<br>introduction, and tracking | Device performed as intended<br>under simulated use. |
| Attachment with docking wire | Pull force of attachment was<br>equivalent or better than<br>predicate | Device is compatible with<br>docking wire |
| Particulate Testing | Particle count of test articles ≤<br>25 particles (≥ 10 microns)<br>and ≤ 3 particles (≥ 25<br>microns) | Device does not generate<br>particles under use. |

| Biocompatibility | Result | Conclusion |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Cytotoxicity - MEM Elution Test (ISO<br>10993-5) | Cell culture exhibited slight<br>reactivity (Grade 1) | Non-cytotoxic |
| Sensitization/Irritation - Kligman<br>Maximization Test (ISO10993-10) | Extracts of test article elicited<br>no reaction at challenge (0%)<br>following induction phase.<br>(Grade 1) | Weak allergenic potential |
| Sensitization/Irritation - Intracutaneous<br>Injection Test (ISO 10993-10) | Extracts of test article did not<br>show a significantly greater<br>biological reaction than sites<br>injected with the control | Non-irritant |
| Hemocompatibility - Hemolysis (Direct<br>and Indirect) (ISO 10993-4) | Hemolysis index was 4.69%<br>(direct) and 0.0% (indirect) | Non-hemolytic |
| Hemocompatibility - Unactivated<br>Partial Thromboplastin Assay (ISO<br>10993-4) | No statistically significant<br>difference found between<br>plasma exposed to test article,<br>negative control, and untreated<br>control. | No effect on coagulation |
| Hemocompatibility - Complement<br>Activation (ISO 10993-4) | C3a and SC5b-9 in plasma<br>exposed to test article was not<br>statistically higher than the<br>plasma exposed to negative<br>and untreated controls. | No effect on complement<br>system |
| Hemocompatibility - Dog<br>Thrombogenicity (ISO 10993-4) | Minimal thrombosis for test<br>article and control sites (Grade<br>1-2) | No significant thrombosis |

and the contraction of the comments of the comments of

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| Biocompatibility | Result | Conclusion |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Systemic toxicity - Systemic Injection<br>Test (ISO 10993-11) | Extracts of test article did not<br>induce a significantly greater<br>biological reaction than the<br>control extracts when injected<br>into albino mice. | No toxic effects |
| Systemic toxicity - Rabbit Pyrogen Test<br>(ISO 10993-11) | Temperature increase was 0.0°<br>C from baseline. | Non-pyrogenic |

## Summary of Substantial Equivalence

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

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

The devices,

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

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

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Public Health Service

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

July 31, 2014

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

Rc: K133725

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

Dear Ms. Gong.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Naomi Gong

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Carlos L. Pena -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

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

510(k) Number (if known) K133725

Device Name Traxcess 14 Guidewire

Indications for Use (Describe)

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

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

### FOR FDA USE ONLY

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

Carlos L. Pena -S

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