Traxcess 7 Mini XSoft Guidewire

K163154 · MicroVention, Inc. · MOF · Dec 9, 2016 · Cardiovascular

Device Facts

• Record ID: K163154
• Device Name: Traxcess 7 Mini XSoft Guidewire
• Applicant: MicroVention, Inc.
• Product Code: MOF · Cardiovascular
• Decision Date: Dec 9, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

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 Story

Coiled guidewire designed for percutaneous microcatheter navigation through blood vessels; consists of proximal stainless steel core wire and distal nitinol core wire; distal tip tapered and contained within platinum/nickel coil. Physician-steerable; distal 1.4 cm shapeable. Hydrophilic coating provides lubricity. Used in neuro and peripheral vasculature to direct therapeutic/diagnostic catheters. Supplied with shaping mandrel, insertion tool, and torque device. Physician operates device under fluoroscopic guidance; output is physical navigation of catheter to target site. Benefits include improved access to complex vasculature.

Clinical Evidence

No clinical data. Bench testing only. Testing included dimensional inspection, tip shapeability, coating durability/lubricity, tensile strength, corrosion resistance, torque strength/ability, fracture resistance, flexing, distal tip flexibility, particle testing, radiopacity, and in-vitro simulated use. Biocompatibility testing (ISO 10993) performed on reference device (K153053) demonstrated non-cytotoxicity, non-sensitization, non-irritation, non-hemolysis, and no systemic toxicity.

Technological Characteristics

Materials: Stainless steel (proximal core), Nitinol (distal core), Platinum/Nickel alloy (coil). Hydrophilic coating (SLIP-COAT). Dimensions: 210 cm length, 0.014" proximal/0.007" distal diameter. Energy: Mechanical. Connectivity: None. Sterilization: Ethylene oxide (EtO).

Indications for Use

Indicated for general intravascular use, including neuro and peripheral vasculature, to facilitate selective placement of diagnostic or therapeutic catheters. Not indicated for 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® 7 Mini Guidewire (K161803)

Reference Devices

• Traxcess® 14 SELECT Guidewire (K153053)

Submission Summary (Full Text)

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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.

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

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

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# 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) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: | [phone] |
|------------|----------------|
| Fax: | [phone] |

| Contact Person: | Sapna Singh |
|-----------------|------------------------------|
| Email: | [e-mail] |
| 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<br>Branch: | Division of Neurological and Physical Medicine<br>Devices |

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

Traxcess® 7 Mini Guidewire (K161803)

#### REFERENCE DEVICE

Traxcess® 14 SELECT Guidewire (K153053)

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

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

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

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.

## 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
- 2. Same operating principle
- 3. Incorporate the same basic guidewire design
- 4. Incorporate the same guidewire construction material
- 5. 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).

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| Table I: Reference Device vs Predicate Devices vs Subject Device Comparison Table | | | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Traxcess® 14 SELECT<br>Guidewire (K153053) | Traxcess® 7 Mini<br>Guidewire (K161803) | Traxcess 7 Mini XSoft |
| | [Reference Device] | [Predicate Device] | [Subject Device] |
| Indication For Use | | | |
| Indication For Use<br>Statement | Traxcess Guidewire is<br>indicated for general<br>intravascular use, including<br>the neuro and peripheral<br>vasculature. The guidewire<br>can be steered to facilitate<br>the selective placement of<br>diagnostic or therapeutic<br>catheters. This device is not<br>indicated for use in coronary<br>arteries. | Traxcess Guidewire is<br>indicated for general<br>intravascular use, including<br>the neuro and peripheral<br>vasculature. The guidewire<br>can be steered to facilitate<br>the selective placement of<br>diagnostic or therapeutic<br>catheters. This device is not<br>indicated for use in coronary<br>arteries. | Traxcess 7 Mini XSoft<br>Guidewire is indicated for<br>general intravascular use,<br>including the neuro and<br>peripheral vasculature. The<br>guidewire can be steered to<br>facilitate the selective<br>placement of diagnostic or<br>therapeutic catheters. This<br>device is not indicated for<br>use in coronary arteries. |
| Performance | | | |
| Function | The steerable guidewire is<br>used to facilitate the<br>selective placement of<br>diagnostic or therapeutic<br>catheters. | Same | Same |
| Anatomical Location | General intravascular use,<br>including the neuro and<br>peripheral vasculature. | Same | Same |
| Design | | | |
| Overall Length | 200 cm | 210 cm | 210 cm |
| Diameter | Proximal = 0.014"<br>Distal = 0.012" | Proximal = 0.014"<br>Distal = 0.007" | Proximal = 0.014"<br>Distal = 0.007" |
| Corewire<br>Configuration | 60 cm Nitinol welded to<br>Stainless Steel | Same | Same |
| Coil Length | 40 cm | 6 cm | 6 cm |
| Coil Configuration | 3 cm Platinum Nickel alloy<br>and 37 cm Stainless Steel | 6cm Platinum Nickel alloy | 6cm Platinum Nickel alloy |
| Distal Shaft Length<br>(Shapeable Length) | 1.4 cm | Same | Same |
| Distal Corewire<br>Taper (distal to<br>proximal) | Diameter before flattening is<br>0.003" | Diameter before flattening is<br>0.0025" | Diameter before flattening is<br>0.0020" |
| | Length of distal 'paddle' and<br>taper: $17 ± 1.5$ mm | Length of distal 'paddle' and<br>taper: $14 ± 1.5$ mm | Length of distal 'paddle' and<br>taper: $14 ± 1.5$ mm |
| | Thickness of distal 'paddle' is<br>$0.037 ± 0.001$ mm | Thickness of distal 'paddle' is<br>$0.0356 ± 0.001$ mm | Thickness of distal 'paddle' is<br>$0.0254 ± 0.001$ mm |
| Docking Wire<br>Compatibility | Yes | No | No |
| Table I: Reference Device vs Predicate Devices vs Subject Device Comparison Table | | | |
| Material | | | |
| Material | Corewire (proximal):<br>Stainless Steel<br>Corewire (distal): Nitinol<br>Coil: Platinum Nickel alloy and<br>Stainless Steel | Corewire (proximal):<br>Stainless Steel<br>Corewire (distal): Nitinol<br>Coil: Platinum Nickel alloy. No<br>Stainless Steel | Corewire (proximal):<br>Stainless Steel<br>Corewire (distal):<br>Nitinol<br>Coil: Platinum Nickel<br>alloy. No Stainless Steel |
| Coating Material | Coil and distal stainless<br>steel section: Hydrophilic<br>Coating [SLIP-COAT by<br>Argon Medical]<br>Proximal Stainless Steel<br>section: PTFE | Coil and distal stainless<br>steel section: Hydrophilic<br>Coating [SLIP-COAT by<br>Argon Medical]<br>No PTFE Coating | Coil and distal<br>stainless steel<br>section: Hydrophilic<br>Coating [SLIP-<br>COAT by Argon<br>Medical]<br>No PTFE Coating |
| Hydrophilic Coating<br>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,<br>Torque Device, and<br>Insertion Tool | Same | Same |
| Package<br>configuration | Placed into a Dispenser<br>Hoop, Tyvek Pouch, and<br>Carton Box. | Same | Same |

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## PERFORMANCE DATA [807.92(b)]

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.

| Table II: Performance Bench Testing Summary | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Tests | Acceptance Criteria | Conclusion |
| Dimensional Inspection<br>(Visual):<br>The dimensional attributes of the<br>test samples were inspected. | Test article should meet specified<br>dimensional requirements for:<br>•OD (Distal and Proximal)<br>•Overall Length<br>•Length of distal Pt/Ni coil section<br>•Length of hydrophilic coated<br>section<br>•Accessory devices present | Device met established<br>dimensional specification. |
| Tip Shapeability:<br>The test evaluates the<br>shapeability and retention before<br>and after simulated application of<br>intraprocedural stresses. | Test article should be greater than or<br>equal to existing tip shapeability<br>specification. | Device met established tip<br>shapeability specification. |
| Durability/Lubricity of<br>Hydrophilic Coating:<br>The durability/lubricity of the<br>coated test samples are<br>inspected by passing the sample<br>through two silicone clamp pads.<br>Machine starts pulling the<br>coated sample up through the<br>clamping pads, recording the<br>coating lubricity friction (in<br>grams) until the sample is<br>completely through. | Test article should meet existing<br>durability/lubricity of hydrophilic<br>coating specification. | Device met established<br>durability/lubricity of<br>hydrophilic coating<br>specification. |
| Tensile Strength:<br>The tensile strength of the distal<br>tip and proximal section (nitinol<br>and stainless steel weld) of the<br>guidewire was measured to make<br>sure it is sufficiently strong to<br>withstand normal tensile loading<br>for its intended use. | Test article should be greater than or<br>equal to existing tensile strength<br>specification for distal tip and<br>proximal joint section. | Device met established<br>distal tip and proximal joint<br>tensile strength<br>specification. |
| Corrosion Resistance:<br>The corrosion resistance of the<br>guidewire is tested to make sure<br>if the guidewire is corrosion<br>resistance. | Test article should be corrosion<br>resistant. | Device met established<br>corrosion resistance. |
| Table II: Performance Bench Testing Summary | | |
| Surface Contamination and<br>Defects:<br>The surface contamination and<br>defect results of the guidewire is<br>tested to make sure it is free<br>from contamination and defects. | Test article when examined at<br>magnification, should meet existing<br>surface contamination and defects<br>specification. | Device met established<br>surface contamination and<br>defects specification. |
| Torque Strength:<br>The Torque Strength test was<br>performed to count the number of<br>turns to guidewire failure. | Test article should be greater than or<br>equal to existing torque strength<br>specification. | Device met established<br>torque strength<br>specification. |
| Torqueability:<br>The Torqueability test was<br>performed to measure the<br>difference in input angle (turn at<br>the proximal end at a set amount)<br>vs. the output angle and measure<br>how much the distal end turns. | Test article should be equal to, or<br>better than predicate devices. | Subject device torque<br>response better than<br>predicate devices. |
| Fracture resistance:<br>The Fracture Resistance Test<br>was performed to test for fracture<br>on the guidewire after winding<br>the guidewire around a cylindrical<br>former, then unwound and<br>examined for fracture of the<br>guidewire and the coating as well. | Test article should not show signs of<br>fracture. There should be no coating<br>flaking off the guidewire. | Device met established<br>fracture resistance<br>specification. |
| Flexing test:<br>The Flexing test was performed<br>to test the guidewire (distal and<br>proximal sections) under<br>repeated reverse bending and<br>straightening (flexing) and<br>examined for defects or damage. | Test article should not show signs of<br>defect, fracture or other damage.<br>There should be no coating flaking off<br>the guidewire. | Device met established<br>flexing test specification. |
| Distal Tip flexibility:<br>The distal tip flexibility testing<br>was performed to demonstrate<br>the force required to deflect the<br>distal tip of the guidewire. | Test article should be less than<br>existing distal tip specification to<br>deflect the distal tip of guidewire<br>and must be softer than<br>Traxcess 7 Mini. | Device met established<br>distal tip flexibility<br>specification. |
| Particle Testing:<br>The particle testing analysis was<br>performed to quantify particulate<br>matter in injections of the<br>guidewire after<br>advancement/retraction<br>procedures. | Test article should meet established<br>particle testing specification. | Device met established<br>particle test specification. |
| Table II: Performance Bench Testing Summary | | |
| Radiopacity:<br>The guidewire is placed under<br>fluoroscopy and digital images<br>are visually assessed for device<br>visibility. | Test article should be visible under<br>fluoroscopy. | Device met established<br>radiopacity specification. |
| In-Vitro Simulated Use<br>Testing:<br>Samples underwent simulated<br>use testing that included<br>introduction into and movement<br>within the catheter, tracking<br>guidewire/microcatheter system<br>in the model, system maximum<br>distal reach, overall performance<br>and any particles detected. | Test article should meet rating of 3 or<br>greater when tested with compatible<br>microcatheters. | Device met established<br>simulated use testing<br>specification. |

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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<br>(ISO Standard) | Acceptance Criteria | Conclusion |
| Cytotoxicity - L929 MEM Elution<br>Test<br>(ISO 10993-5) | Test article meets the<br>requirements of the test if it does<br>not show greater than a mild<br>reactivity (Grade 2). | Test article exhibited a<br>biological reactivity grade of 0<br>(on a scale of 0 to 4).<br>(Non-cytotoxic). |
| Sensitization/Irritation - Kligman<br>Maximization Test<br>(ISO10993-10) | Test article meets the<br>requirements of the test if it does<br>not show a positive response in<br>at least 10% of the test animals. | Test article exhibited 0%<br>sensitization.<br>(Non-sensitizer). |
| Sensitization/Irritation -<br>Intracutaneous Injection Test<br>(ISO 10993-10) | Test article meets the<br>requirements of the test if it does<br>not produce irritation after<br>intracutaneous injection in New<br>Zealand White rabbits. | Test article did not show a<br>significantly greater biological<br>reaction than sites injected with<br>the control article. The<br>difference of the overall mean<br>score between the test article<br>and the control article was 0.0.<br>(Non-irritant). |
| Table III: Biocompatibility Test Summary | | |
| Biocompatibility Test<br>(ISO Standard) | Acceptance Criteria | Conclusion |
| Hemocompatibility - Hemolysis -<br>Direct and Indirect<br>(ISO 10993-4) | Test article meets the<br>requirements of the test if the<br>hemolytic index above the<br>negative control article is <5%. | Hemolysis index was above the<br>negative control of 0.77% via<br>direct contact method and<br>0.23% via indirect contact<br>method.<br>(Non-hemolytic). |
| Hemocompatibility - Unactivated<br>Partial Thromboplastin Time<br>(UPTT) Assay - Direct Contact<br>(ISO 10993-4) | Test article meets the<br>requirements of the test if no<br>statistical decrease is found<br>between UPTT of the plasma<br>exposed to the test article and that<br>of plasma exposed to negative<br>control or untreated control. | No statistical decrease is found<br>between UPTT of the plasma<br>exposed to the test article and<br>that of plasma exposed to<br>negative control or untreated<br>control.<br>(Not considered to have an effect<br>on coagulation of human<br>plasma). |
| Hemocompatibility - C3A and<br>SC5B-9 Complement Activation<br>Test - Direct Contact<br>(ISO 10993-4) | Test article meets the<br>requirements of the test if the<br>concentration of C3A and SC5B-<br>9 in plasma exposed to test article<br>does not statistically increase than<br>the plasma exposed to negative<br>and untreated controls. | The concentration of C3A and<br>SC5B-9 in plasma exposed to<br>test articles were not<br>statistically increased than the<br>plasma exposed to negative<br>and untreated controls.<br>(Not considered to activate the<br>complement system in human<br>plasma). |
| Hemocompatibility - In Vitro<br>Hemocompatibility Test - Direct<br>Contact<br>(ISO 10993-4) | Test article meets the<br>requirements of the test if no<br>statistical decrease (or<br>increase/decrease for hematocrit<br>and Mean corpuscular values) is<br>found between blood exposed to<br>test article and blood exposed to<br>negative control or untreated<br>control. | Test article did not have an<br>effect on the WBCs, Platelet<br>concentration and other<br>hematological parameters in<br>comparison to negative control<br>and untreated control.<br>(No effect on selected<br>hematological parameters). |
| Hemocompatibility - Dog<br>Thrombogenicity<br>(ISO 10993-4) | Test article meets the<br>requirements of the test if there<br>is minimal thrombosis for test<br>article (Grade 0-2). | Minimal thrombosis (Grade 0-1)<br>for test article and control sites.<br>(No significant thrombosis). |
| Systemic toxicity - Systemic<br>Injection Test<br>(ISO 10993-11) | Test article meets the<br>requirements of the test if it does<br>not induce a significantly greater<br>biological reaction than the animal<br>treated with the control articles<br>when injected into albino mice | Test article did not induce a<br>significantly greater biological<br>reaction than the control<br>extracts when injected into<br>albino mice.<br>(No toxic effects). |
| Table III: Biocompatibility Test Summary | | |
| Biocompatibility Test<br>(ISO Standard) | Acceptance Criteria | Conclusion |
| Systemic toxicity - Rabbit<br>Pyrogen Test<br>(ISO 10993-11) | Test article meets the<br>requirements of the test for the<br>absence of pyrogens, if no rabbit<br>shows an individual temperature<br>rise of 0.5°C or more above the<br>baseline temperature. | Temperature increases for the<br>test animals were all 0.0° C<br>from baseline. (Non-pyrogenic). |

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Packaging: Traxcess 7 Mini XSoft packaging is similar to the FDA cleared predicate device, Traxcess 7 Mini Guidewire (K161803). The packaging validation, T=3 years accelerated aging was performed on the reference device, Traxcess® 14 SELECT Guidewire (K153053) and included testing devices via visual inspection, simulated use testing, sterile pouch seal strength testing, dye penetration testing and shipper box testing. The results from packaging testing conducted on Traxcess® 14 SELECT Guidewire showed that the acceptance criteria were met. The testing was not repeated on the subject device, Traxcess 7 Mini XSoft Guidewire since there is no change in the packaging material, packaging configuration, and method of supply or sterilization. The packaging still provides the same protection and sterile barrier requirements.

Sterilization: Traxcess 7 Mini XSoft is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate device, Traxcess 7 Mini Guidewire (K161803) Traxcess 7 Mini XSoft is sold sterile, for single use and single patient only. The product adoption study was performed and is documented. No changes in materials or other design attributes have been made to the subject device. Therefore, it was not necessary to repeat sterilization validation.

Shelf Life: Traxcess 7 Mini XSoft shelf life is same as FDA cleared predicate device. Traxcess 7 Mini Guidewire (K161803). No new materials are added to the Traxcess 7 Mini X.Soft. Therefore, there will be no impact on device shelf life since material degradation rate is the same.

The accelerated shelf life testing for Traxcess® 14 SELECT Guidewire has been conducted (T= 3 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the result, we can conclude that Traxcess 7 Mini XSoft will perform as intended per the Design Specification to recognized standards where applicable. Traxcess 7 Mini XSoft will be labeled for 3-year shelf life.

### CONCLUSIONS

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