(70 days)
The Traxcess® Pro 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 therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless steel section is coated with a hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of these surface coatings is to provide lubricity when the MicroVention guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
This document is a 510(k) summary for the Traxcess® Pro 14 Guidewire, which is a medical device. The information provided is for regulatory purposes to demonstrate substantial equivalence to a predicate device, not a typical study report for an AI/ML device. Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance data for the device based on the bench and biocompatibility testing.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Dimensional attributes: Device to meet specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices. | Device met established dimensional specifications (Test articles met specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices). |
| Tip shapeability: Performance relative to a specific angle retention. | ≥71% average for tip shape percent angle retention. Device met established tip shapeability. |
| Tensile strength: Distal ≥ 3N; Proximal ≥ 70N. | Device met established tensile strength (Tensile strength of distal ≥ 3N; Tensile strength of proximal ≥ 70N). |
| Torque strength: Equivalent or better than predicate (turns to failure). | Device torque strength comparable to predicate (Equivalent or better than predicate (turns to failure)). |
| Torqueability: Torque response equal to or better than predicate. | Device torque response comparable to predicate (Torque response was equal to or better than predicate). |
| Tip flexibility: Force to deflect the distal tip is ≤ predicate. | Device tip flexibility is ≤ predicate (Demonstrated force to deflect the distal tip is ≤ predicate). |
| Fracture resistance and Flexing test: No portion of the guidewire should show signs of defect, fracture or other damage. No coating flaking off the guidewire. | No defects, fractures, damage or signs of coating flaking. |
| Particle Testing: Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns). | Device does not generate particles under use (Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns)). |
| Radiopacity: Distal coil section visible under fluoroscopy. | Device radiopacity was comparable to predicate (Distal coil section visible under fluoroscopy). |
| Coating adherence: Coating adherence maintained after advance/retract cycles. | Durability and lubricity of coating was maintained after advance/retract cycles. |
| In-vitro simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking. | Device performed as intended under simulated use (Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking). |
| Acceptance Criteria (Biocompatibility) | Reported Device Performance |
|---|---|
| Cytotoxicity - MEM Elution Test (ISO 10993-5): Cell culture exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). No cytotoxic effect. | Non-cytotoxic (Cell culture exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). No cytotoxic effect). |
| Sensitization/Irritation - Kligman Maximization Test (ISO10993-10): Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10): | Non-sensitizer (Extracts of test article exhibited 0% sensitization).Non-irritant (Extracts of test article did not show a significantly greater biological reaction than sites injected with the control). |
| Hemocompatibility - Hemolysis (Direct and Indirect) (ISO 10993-4): | Non-hemolytic (Hemolysis index was above the negative control of 0.77% (direct contact)) and 0.23% (indirect contact)). |
| Hemocompatibility - Unactivated Partial Thromboplastin Assay (ISO 10993-4): No statistically significant difference found between plasma exposed to test article, negative control, and untreated control. | No effect on coagulation of human plasma (No statistically significant difference found between plasma exposed to test article, negative control, and untreated control). |
| Hemocompatibility - Complement Activation (ISO 10993-4): The concentration of C3a and SC5b-9 in plasma exposed to test article was not statistically increased than the plasma exposed to negative and untreated controls. | Not considered to have activated the complement system in human plasma (The concentration of C3a and SC5b-9 in plasma exposed to test article was not statistically increased than the plasma exposed to negative and untreated controls). |
| Hemocompatibility - In Vitro Hemocompatibility Test (Direct Contact) (ISO 10993-4): No effect on the WBCs, Platelet concentration and other hematological parameters in comparison to control. | No effect on selected hematological parameters (No effect on the WBCs, Platelet concentration and other hematological parameters in comparison to control). |
| Hemocompatibility - Dog Thrombogenicity (ISO 10993-4): Minimal thrombosis for test article and control sites (Grade 0-1). | No significant thrombosis (Minimal thrombosis for test article and control sites (Grade 0-1)). |
| Systemic toxicity - Systemic Injection Test (ISO 10993-11): Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice. | No toxic effects (Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice). |
| Systemic toxicity - Rabbit Pyrogen Test (ISO 10993-11): Temperature increase was 0.0°C from baseline. | Non-pyrogenic (Temperature increase was 0.0°C from baseline). |
Study Proving Device Meets Acceptance Criteria:
The "Design Verification and Validation Test Summary" (Table II) describes the testing performed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for individual bench or biocompatibility tests. The statement "Test articles" is used, implying multiple units were tested, but the exact number is not provided.
- Data Provenance: Not specified. This is a regulatory submission for a medical device; the tests are typically considered "prospective" in the sense that they are planned experiments conducted to qualify the device. Country of origin for data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This document describes physical and biological performance testing of a medical device, not a diagnostic algorithm that requires expert ground truth labeling. The "ground truth" for these tests comes from objective measurements and standardized protocols (e.g., ISO standards for biocompatibility).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human reader interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established through:
- Objective Measurements: e.g., dimensional attributes, tensile strength, particle counts.
- Standardized Test Protocols: e.g., ISO 10993 series for biocompatibility, and other unspecified internal bench test methods to ensure physical performance.
- Comparison to Predicate Device: For several tests (e.g., torque strength, torqueability, tip flexibility, radiopacity), the performance is assessed as being "comparable to" or "equivalent or better than" the predicate device, implying the predicate device's established performance serves as a benchmark for "ground truth" for those specific characteristics.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set or corresponding ground truth to establish for this type of device.
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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 a human figure with three faces in profile, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
MicroVention, Inc. Ms. Sapna Singh Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 72780
Re: K153053
Trade/Device Name: Traxcess Pro 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 3, 2015 Received: December 4, 2015
Dear Ms. Sapna 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 (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 yours,
William J. Heetderks -S
for 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) K153053
Device Name Traxcess® Pro 14 Guidewire
Indications for Use (Describe)
The Traxces® Pro 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 therapeutic catheters. This device is not intended 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 of safety and effectiveness for the Traxcess® Pro 14 Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.
I. SUBMITTER [807.92(a)(1)]
MicroVention, Inc. 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: October 19, 2015
II. DEVICE [807.92(a)(2)]
| Name of Device: | Traxcess® Pro 14 Guidewire |
|---|---|
| Common or Usual Name: | Guidewire |
| Classification Name: | Catheter Guidewire |
| Product Code: | MOF, DQX |
| Regulatory Class: | Class II |
| Submission Type: | Special 510(K) |
| Regulation Number: | 21 CFR 870.1330 |
| Reviewing Product Branch: | Division of Cardiovascular Devices (Office of DeviceEvaluation, CDRH) |
III. PREDICATE DEVICE [807.92(a)(3)]
Traxcess 14 Guidewire (K133725)
IV. DEVICE DESCRIPTION [807.92(a)(4)]
The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal
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coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil.
The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician.
The coil section of the guidewire and the distal stainless steel section is coated with a hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of these surface coatings is to provide lubricity when the MicroVention guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
V. INDICATIONS FOR USE [807.92(a)(5)]
The Traxcess® Pro 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The Traxcess® Pro 14 Guidewire has the following similarities to the predicate device. Traxcess 14 Guidewire (K133725):
-
- Have the same intended use
-
- Use the same operating principle
-
- Incorporate the same basic guidewire design
-
- Incorporate the same guidewire construction material
-
- Are packaged and sterilized using the same materials and processes
The change in the distal tip of the guidewire and the application of PTFE coating on the proximal stainless steel section 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 Guidewire (Predicate Device, K133725) and Traxcess® Pro 14 Guidewire (Subject Device).
Table I: Predicate Device vs Subject Device Comparison Table
| Traxcess 14 Guidewire(Predicate Device, K133725) | Traxcess® Pro 14 Guidewire(Subject Device) | |
|---|---|---|
| Intended Use | ||
| Intended Use Statement | The Traxcess 14 Guidewire is | Same |
| intended for generalintravascular use, including theneuro and peripheralvasculature. The wire can besteered to facilitate the selectiveplacement of diagnostic ortherapeutic catheters. Thisdevice is not intended for use incoronary arteries. | ||
| Performance | ||
| Function | The steerable guidewire is usedto facilitate the selectiveplacement of diagnostic ortherapeutic catheters. | Same |
| Anatomical Location | General intravascular use,including the neuro and peripheralvasculature. | Same |
| Design | ||
| Overall Length | 200 cm | Same |
| Diameter | Proximal = 0.014"Distal = 0.012" | Same |
| Coil Length | 40 cm | Same |
| Platinum/Nickel Coil Length(Radiopaque) | 3 cm | Same |
| Stainless Steel Coil Length | 37 cm | Same |
| Distal Shaft Length (ShapeableLength) | 1.4 cm | Same |
| Distal tip thickness(core wire) | 0.037 mm | Same |
| Proximal end configuration | Compatible with Traxcess dockingwire | Same |
| Material | ||
| Material | Core wire (proximal): StainlesssteelCore wire (distal): Nickeltitanium (Nitinol) alloyCoil: Platinum nickel alloy andStainless steelOther: Brazing material andsolder | Same |
| Coating Material | Coil and distal/proximal stainlesssteel section: Hydrophilic Coating[SLIP-COAT by Argon Medical] | Coil and distal stainless steelsection: Hydrophilic Coating[SLIP-COAT by Argon Medical] |
| Proximal Stainless steel section:PTFE | ||
| Coating Length | Hydrophilic Coating = 1450 mm | Hydrophilic coating = 980 mmPTFE = 1000 mm |
| 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 |
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VII. PERFORMANCE DATA [807.92(b)]
Results of the verification and validation testing (Table II) indicate that the product meets established performance requirements, and is safe and effective for its intended use.
| Bench Testing | Result | Conclusion |
|---|---|---|
| Dimensional attributes | Test articles met specifieddimensional requirements forguidewire OD, overall length,length of Pt/Ni coil section,length of SS section, length ofPTFE coated section, length ofhydrophilic coated section,length of proximal dockingsection and accessory devices | Device met establisheddimensional specifications |
| Tip shapeability | ≥71% average for tip shapepercent angle retention | Device met established tipshapeability |
| Tensile strength | Tensile strength of distal ≥ 3NTensile strength of proximal ≥70N | Device met established tensilestrength |
| Torque strength | Equivalent or better thanpredicate (turns to failure) | Device torque strengthcomparable to predicate |
| Torqueability | Torque response was equal toor better than predicate | Device torque responsecomparable to predicate |
| Tip flexibility | Demonstrated force to deflectthe distal tip is ≤ predicate | Device tip flexibility is ≤predicate |
| Fracture resistance and Flexingtest | No portion of the guidewireshould show signs of defect,fracture or other damage.There should be no coatingflaking off the guidewire | No defects, fractures, damageor signs of coating flaking |
Table II: Design Verification and Validation Test Summary
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| Bench Testing | Result | Conclusion |
|---|---|---|
| Particle Testing | Particle count of test articles ≤25 particles (≥ 10 microns) and ≤3 particles (≥ 25 microns) | Device does not generateparticles under use |
| Radiopacity | Distal coil section visible underfluoroscopy | Device radiopacity wascomparable to predicate |
| Coating adherence | Coating adherence maintainedafter advance/retract cycles | Durability and lubricity ofcoating was maintained afteradvance/retract cycles |
| n-vitro simulated use testing | Test articles achieved rating ≥ 3for prep of device, introduction,and tracking | Device performed as intendedunder simulated use |
| Biocompatibility | Result | Conclusion |
|---|---|---|
| Cytotoxicity - MEM Elution Test(ISO 10993-5) | Cell culture exhibited a biologicalreactivity grade of 0 (on a scaleof 0 to 4). No cytotoxic effect | Non-cytotoxic |
| Sensitization/Irritation - KligmanMaximization Test (ISO10993-10) | Extracts of test article exhibited0% sensitization | Non-sensitizer |
| Sensitization/Irritation -Intracutaneous Injection Test(ISO 10993-10) | Extracts of test article did notshow a significantly greaterbiological reaction than sitesinjected with the control | Non-irritant |
| Hemocompatibility - Hemolysis(Direct and Indirect) (ISO 10993-4) | Hemolysis index was above thenegative control of 0.77% (directcontact)) and 0.23% (indirectcontact) | Non-hemolytic |
| Hemocompatibility - UnactivatedPartial Thromboplastin Assay(ISO 10993-4) | No statistically significantdifference found betweenplasma exposed to test article,negative control, and untreatedcontrol. | No effect on coagulation ofhuman plasma |
| Hemocompatibility -Complement Activation (ISO10993-4) | The concentration of C3a andSC5b-9 in plasma exposed totest article was not statisticallyincreased than the plasmaexposed to negative anduntreated controls. | Not considered to haveactivated the complementsystem in human plasma |
| Hemocompatibility - In VitroHemocompatibility Test (DirectContact) (ISO 10993-4) | No effect on the WBCs, Plateletconcentration and otherhematological parameters incomparison to control | No effect on selectedhematological parameters |
| Hemocompatibility - DogThrombogenicity (ISO 10993-4) | Minimal thrombosis for testarticle and control sites (Grade0-1) | No significant thrombosis |
| Systemic toxicity - SystemicInjection Test (ISO 10993-11) | Extracts of test article did notinduce a significantly greaterbiological reaction than thecontrol extracts when injectedinto albino mice. | No toxic effects |
| Systemic toxicity - RabbitPyrogen Test (ISO 10993-11) | Temperature increase was 0.0°C from baseline. | Non-pyrogenic |
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VIII. CONCLUSIONS
Based on the 510(k) summary and information provided herein, we conclude the subject device, the Traxcess® Pro 14 Guidewire, is substantially equivalent in its intended use, design, guidewire material, performance, and the underlying fundamental scientific technology used, to the predicate Traxcess 14 Guidewire (K133725).
§ 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.