(29 days)
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.
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
The provided text describes the regulatory submission for a medical guidewire (Traxcess 7 Mini XSoft Guidewire). This document primarily details the performance bench testing and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device. It addresses the acceptance criteria and conclusions for these tests, which are typical for medical device regulatory submissions rather than AI/ML device studies.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) are not applicable as this is a physical medical device and not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Performance Bench Testing (Table II) | ||
| Dimensional Inspection (Visual) | Test article should meet specified dimensional requirements for: OD (Distal and Proximal), Overall Length, Length of distal Pt/Ni coil section, Length of hydrophilic coated section, Accessory devices present. | Device met established dimensional specification. |
| Tip Shapeability | Test article should be greater than or equal to existing tip shapeability specification. | Device met established tip shapeability specification. |
| Durability/Lubricity of Hydrophilic Coating | Test article should meet existing durability/lubricity of hydrophilic coating specification. | Device met established durability/lubricity of hydrophilic coating specification. |
| Tensile Strength | 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 | Test article should be corrosion resistant. | Device met established corrosion resistance. |
| Surface 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 | Test article should be greater than or equal to existing torque strength specification. | Device met established torque strength specification. |
| Torqueability | Test article should be equal to, or better than predicate devices. | Subject device torque response better than predicate devices. |
| Fracture resistance | 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 | 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 | Test article should be less than existing distal tip specification to deflect the distal tip of guidewire and must be softer than Traxcess 7 Mini. | Device met established distal tip flexibility specification. |
| Particle Testing | Test article should meet established particle testing specification. | Device met established particle test specification. |
| Radiopacity | Test article should be visible under fluoroscopy. | Device met established radiopacity specification. |
| In-Vitro Simulated Use Testing | Test article should meet rating of 3 or greater when tested with compatible microcatheters. | Device met established simulated use testing specification. |
| Biocompatibility Testing (Table III) | (Note: These tests were not repeated on the subject device but relied on data from the reference device, Traxcess® 14 SELECT Guidewire (K153053), due to identical materials, manufacturing, sterilization, and packaging.) | |
| Cytotoxicity - L929 MEM Elution Test | 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 | Test article meets the requirements of the test if it does not show a positive response in at least 10% of the test animals. | Test article exhibited 0% sensitization. (Non-sensitizer). |
| Sensitization/Irritation - Intracutaneous Injection Test | 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 | Test article meets the requirements of the test if the hemolytic index above the negative control article is <5%. | Hemolysis index was above the negative control of 0.77% via direct contact method and 0.23% via indirect contact method. (Non-hemolytic). |
| Hemocompatibility - Unactivated Partial Thromboplastin Time (UPTT) Assay - Direct Contact | Test article meets the requirements of the test if no statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control. | No statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control. (Not considered to have an effect on coagulation of human plasma). |
| Hemocompatibility - C3A and SC5B-9 Complement Activation Test - Direct Contact | Test article meets the requirements of the test if the concentration of C3A and SC5B-9 in plasma exposed to test article does not statistically increase than the plasma exposed to negative and untreated controls. | The concentration of C3A and SC5B-9 in plasma exposed to test articles were not statistically increased than the plasma exposed to negative and untreated controls. (Not considered to activate the complement system in human plasma). |
| Hemocompatibility - In Vitro Hemocompatibility Test - Direct Contact | Test article meets the requirements of the test if no statistical decrease (or increase/decrease for hematocrit and Mean corpuscular values) is found between blood exposed to test article and blood exposed to negative control or untreated control. | Test article did not have an effect on the WBCs, Platelet concentration and other hematological parameters in comparison to negative control and untreated control. (No effect on selected hematological parameters). |
| Hemocompatibility - Dog Thrombogenicity | Test article meets the requirements of the test if there is minimal thrombosis for test article (Grade 0-2). | Minimal thrombosis (Grade 0-1) for test article and control sites. (No significant thrombosis). |
| Systemic toxicity - Systemic Injection Test | Test article meets the requirements of the test if it does not induce a significantly greater biological reaction than the animal treated with the control articles when injected into albino mice. | Test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice. (No toxic effects). |
| Systemic toxicity - Rabbit Pyrogen Test | Test article meets the requirements of the test for the absence of pyrogens, if no rabbit shows an individual temperature rise of 0.5°C or more above the baseline temperature. | Temperature increases for the test animals were all 0.0° C from baseline. (Non-pyrogenic). |
| Packaging Validation | Acceptance criteria for visual inspection, simulated use testing, sterile pouch seal strength testing, dye penetration testing and shipper box testing were met. | The results from packaging testing conducted on Traxcess® 14 SELECT Guidewire (reference device) showed that the acceptance criteria were met. (Not repeated for subject device due to no change in packaging.) |
| Sterilization | Sterilization efficacy and integrity maintained. | Product adoption study performed and documented. (Not repeated for subject device due to no changes in materials or design.) |
| Shelf Life | All acceptance criteria for accelerated shelf life testing (T=3 years accelerated aging) were met. | The accelerated shelf life testing for Traxcess® 14 SELECT Guidewire (reference device) was conducted, and test results confirmed all acceptance criteria were met. (Not repeated for subject device due to no new materials and same degradation rate, concluding a 3-year shelf life). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a numerical value for each test (e.g., how many guidewires for tensile strength). The document refers to "Test article" and "Samples," implying a number sufficient for engineering bench testing which often relies on a small defined number of samples to represent the product (e.g., 3-5 devices per test).
- Data Provenance: This is an engineering bench test and lab-based biocompatibility study. The "country of origin" of data or "retrospective/prospective" nature is not applicable in the same way it would be for a clinical trial or AI study. The manufacturer is MicroVention, Inc., Tustin, California, U.S.A., implying the testing would have been conducted or overseen by them or contracted labs.
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)
- N/A. This is a physical device and not an AI/ML system that relies on expert interpretation of data for ground truth. "Ground truth" here is defined by meeting predefined engineering specifications and biological safety standards, which are evaluated objectively through physical and chemical tests, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective interpretations, often in clinical or image-based studies. These tests are objective pass/fail based on quantitative measurements and established scientific standards.
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
- N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established engineering specifications, material science principles, and international standards for biocompatibility (e.g., ISO 10993 standards). These are objective, quantifiable criteria for physical and biological performance, not subjective expert interpretations or clinical outcomes data in the context of an AI device.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
MicroVention, Inc. Sapna Singh, MS, RAC Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780
Re: K163154
Trade/Device Name: Traxcess 7 Mini XSoft Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: November 9, 2016 Received: November 10, 2016
Dear Ms. Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{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 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This 510(k) summary for Traxcess 7 Mini XSoft Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.
| Telephone: | (714) 247-8162 |
|---|---|
| Fax: | (714) 247-8014 |
| Contact Person: | Sapna Singh |
|---|---|
| Email: | sapna.singh@microvention.com |
| Date Prepared: | December 07, 2016 |
DEVICE [807.92(a)(2)]
| Name of Device: | Traxcess 7 Mini XSoft Guidewire |
|---|---|
| Common or Usual Name: | Traxcess Guidewire |
| Classification Name: | Catheter Guidewire |
| Product Code: | MOF, DQX |
| Regulatory Class: | Class II |
| Submission Type: | Special 510(K) |
| Regulation Number: | 21 CFR 870.1330 |
| Reviewing ProductBranch: | Division of Neurological and Physical MedicineDevices |
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).
-
- Same intended use
-
- 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 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 SELECTGuidewire (K153053) | Traxcess® 7 MiniGuidewire (K161803) | Traxcess 7 Mini XSoft | |
| [Reference Device] | [Predicate Device] | [Subject Device] | |
| Indication For Use | |||
| Indication For UseStatement | Traxcess Guidewire isindicated for generalintravascular use, includingthe neuro and peripheralvasculature. The guidewirecan be steered to facilitatethe selective placement ofdiagnostic or therapeuticcatheters. This device is notindicated for use in coronaryarteries. | Traxcess Guidewire isindicated for generalintravascular use, includingthe neuro and peripheralvasculature. The guidewirecan be steered to facilitatethe selective placement ofdiagnostic or therapeuticcatheters. This device is notindicated for use in coronaryarteries. | Traxcess 7 Mini XSoftGuidewire is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. Theguidewire can be steered tofacilitate the selectiveplacement of diagnostic ortherapeutic catheters. Thisdevice is not indicated foruse in coronary arteries. |
| Performance | |||
| Function | The steerable guidewire isused to facilitate theselective placement ofdiagnostic or therapeuticcatheters. | Same | Same |
| Anatomical Location | General intravascular use,including the neuro andperipheral vasculature. | Same | Same |
| Design | |||
| Overall Length | 200 cm | 210 cm | 210 cm |
| Diameter | Proximal = 0.014"Distal = 0.012" | Proximal = 0.014"Distal = 0.007" | Proximal = 0.014"Distal = 0.007" |
| CorewireConfiguration | 60 cm Nitinol welded toStainless Steel | Same | Same |
| Coil Length | 40 cm | 6 cm | 6 cm |
| Coil Configuration | 3 cm Platinum Nickel alloyand 37 cm Stainless Steel | 6cm Platinum Nickel alloy | 6cm Platinum Nickel alloy |
| Distal Shaft Length(Shapeable Length) | 1.4 cm | Same | Same |
| Distal CorewireTaper (distal toproximal) | Diameter before flattening is0.003" | Diameter before flattening is0.0025" | Diameter before flattening is0.0020" |
| Length of distal 'paddle' andtaper: $17 ± 1.5$ mm | Length of distal 'paddle' andtaper: $14 ± 1.5$ mm | Length of distal 'paddle' andtaper: $14 ± 1.5$ mm | |
| Thickness of distal 'paddle' is$0.037 ± 0.001$ mm | Thickness of distal 'paddle' is$0.0356 ± 0.001$ mm | Thickness of distal 'paddle' is$0.0254 ± 0.001$ mm | |
| Docking WireCompatibility | Yes | No | No |
| Table I: Reference Device vs Predicate Devices vs Subject Device Comparison Table | |||
| Material | |||
| Material | Corewire (proximal):Stainless SteelCorewire (distal): NitinolCoil: Platinum Nickel alloy andStainless Steel | Corewire (proximal):Stainless SteelCorewire (distal): NitinolCoil: Platinum Nickel alloy. NoStainless Steel | Corewire (proximal):Stainless SteelCorewire (distal):NitinolCoil: Platinum Nickelalloy. No Stainless Steel |
| Coating Material | Coil and distal stainlesssteel section: HydrophilicCoating [SLIP-COAT byArgon Medical]Proximal Stainless Steelsection: PTFE | Coil and distal stainlesssteel section: HydrophilicCoating [SLIP-COAT byArgon Medical]No PTFE Coating | Coil and distalstainless steelsection: HydrophilicCoating [SLIP-COAT by ArgonMedical]No PTFE Coating |
| Hydrophilic CoatingLength | 98 cm | 158 cm | 158 cm |
| Other Attributes | |||
| Method of supply | Sterile and single use | Same | Same |
| Sterilization method | Ethylene oxide gas | Same | Same |
| Accessories | Shaping Mandrel,Torque Device, andInsertion Tool | Same | Same |
| Packageconfiguration | Placed into a DispenserHoop, Tyvek Pouch, andCarton 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(Visual):The dimensional attributes of thetest samples were inspected. | Test article should meet specifieddimensional requirements for:•OD (Distal and Proximal)•Overall Length•Length of distal Pt/Ni coil section•Length of hydrophilic coatedsection•Accessory devices present | Device met establisheddimensional specification. |
| Tip Shapeability:The test evaluates theshapeability and retention beforeand after simulated application ofintraprocedural stresses. | Test article should be greater than orequal to existing tip shapeabilityspecification. | Device met established tipshapeability specification. |
| Durability/Lubricity ofHydrophilic Coating:The durability/lubricity of thecoated test samples areinspected by passing the samplethrough two silicone clamp pads.Machine starts pulling thecoated sample up through theclamping pads, recording thecoating lubricity friction (ingrams) until the sample iscompletely through. | Test article should meet existingdurability/lubricity of hydrophiliccoating specification. | Device met establisheddurability/lubricity ofhydrophilic coatingspecification. |
| Tensile Strength:The tensile strength of the distaltip and proximal section (nitinoland stainless steel weld) of theguidewire was measured to makesure it is sufficiently strong towithstand normal tensile loadingfor its intended use. | Test article should be greater than orequal to existing tensile strengthspecification for distal tip andproximal joint section. | Device met establisheddistal tip and proximal jointtensile strengthspecification. |
| Corrosion Resistance:The corrosion resistance of theguidewire is tested to make sureif the guidewire is corrosionresistance. | Test article should be corrosionresistant. | Device met establishedcorrosion resistance. |
| Table II: Performance Bench Testing Summary | ||
| Surface Contamination andDefects:The surface contamination anddefect results of the guidewire istested to make sure it is freefrom contamination and defects. | Test article when examined atmagnification, should meet existingsurface contamination and defectsspecification. | Device met establishedsurface contamination anddefects specification. |
| Torque Strength:The Torque Strength test wasperformed to count the number ofturns to guidewire failure. | Test article should be greater than orequal to existing torque strengthspecification. | Device met establishedtorque strengthspecification. |
| Torqueability:The Torqueability test wasperformed to measure thedifference in input angle (turn atthe proximal end at a set amount)vs. the output angle and measurehow much the distal end turns. | Test article should be equal to, orbetter than predicate devices. | Subject device torqueresponse better thanpredicate devices. |
| Fracture resistance:The Fracture Resistance Testwas performed to test for fractureon the guidewire after windingthe guidewire around a cylindricalformer, then unwound andexamined for fracture of theguidewire and the coating as well. | Test article should not show signs offracture. There should be no coatingflaking off the guidewire. | Device met establishedfracture resistancespecification. |
| Flexing test:The Flexing test was performedto test the guidewire (distal andproximal sections) underrepeated reverse bending andstraightening (flexing) andexamined for defects or damage. | Test article should not show signs ofdefect, fracture or other damage.There should be no coating flaking offthe guidewire. | Device met establishedflexing test specification. |
| Distal Tip flexibility:The distal tip flexibility testingwas performed to demonstratethe force required to deflect thedistal tip of the guidewire. | Test article should be less thanexisting distal tip specification todeflect the distal tip of guidewireand must be softer thanTraxcess 7 Mini. | Device met establisheddistal tip flexibilityspecification. |
| Particle Testing:The particle testing analysis wasperformed to quantify particulatematter in injections of theguidewire afteradvancement/retractionprocedures. | Test article should meet establishedparticle testing specification. | Device met establishedparticle test specification. |
| Table II: Performance Bench Testing Summary | ||
| Radiopacity:The guidewire is placed underfluoroscopy and digital imagesare visually assessed for devicevisibility. | Test article should be visible underfluoroscopy. | Device met establishedradiopacity specification. |
| In-Vitro Simulated UseTesting:Samples underwent simulateduse testing that includedintroduction into and movementwithin the catheter, trackingguidewire/microcatheter systemin the model, system maximumdistal reach, overall performanceand any particles detected. | Test article should meet rating of 3 orgreater when tested with compatiblemicrocatheters. | Device met establishedsimulated use testingspecification. |
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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(ISO Standard) | Acceptance Criteria | Conclusion |
| Cytotoxicity - L929 MEM ElutionTest(ISO 10993-5) | Test article meets therequirements of the test if it doesnot show greater than a mildreactivity (Grade 2). | Test article exhibited abiological reactivity grade of 0(on a scale of 0 to 4).(Non-cytotoxic). |
| Sensitization/Irritation - KligmanMaximization Test(ISO10993-10) | Test article meets therequirements of the test if it doesnot show a positive response inat least 10% of the test animals. | Test article exhibited 0%sensitization.(Non-sensitizer). |
| Sensitization/Irritation -Intracutaneous Injection Test(ISO 10993-10) | Test article meets therequirements of the test if it doesnot produce irritation afterintracutaneous injection in NewZealand White rabbits. | Test article did not show asignificantly greater biologicalreaction than sites injected withthe control article. Thedifference of the overall meanscore between the test articleand the control article was 0.0.(Non-irritant). |
| Table III: Biocompatibility Test Summary | ||
| Biocompatibility Test(ISO Standard) | Acceptance Criteria | Conclusion |
| Hemocompatibility - Hemolysis -Direct and Indirect(ISO 10993-4) | Test article meets therequirements of the test if thehemolytic index above thenegative control article is <5%. | Hemolysis index was above thenegative control of 0.77% viadirect contact method and0.23% via indirect contactmethod.(Non-hemolytic). |
| Hemocompatibility - UnactivatedPartial Thromboplastin Time(UPTT) Assay - Direct Contact(ISO 10993-4) | Test article meets therequirements of the test if nostatistical decrease is foundbetween UPTT of the plasmaexposed to the test article and thatof plasma exposed to negativecontrol or untreated control. | No statistical decrease is foundbetween UPTT of the plasmaexposed to the test article andthat of plasma exposed tonegative control or untreatedcontrol.(Not considered to have an effecton coagulation of humanplasma). |
| Hemocompatibility - C3A andSC5B-9 Complement ActivationTest - Direct Contact(ISO 10993-4) | Test article meets therequirements of the test if theconcentration of C3A and SC5B-9 in plasma exposed to test articledoes not statistically increase thanthe plasma exposed to negativeand untreated controls. | The concentration of C3A andSC5B-9 in plasma exposed totest articles were notstatistically increased than theplasma exposed to negativeand untreated controls.(Not considered to activate thecomplement system in humanplasma). |
| Hemocompatibility - In VitroHemocompatibility Test - DirectContact(ISO 10993-4) | Test article meets therequirements of the test if nostatistical decrease (orincrease/decrease for hematocritand Mean corpuscular values) isfound between blood exposed totest article and blood exposed tonegative control or untreatedcontrol. | Test article did not have aneffect on the WBCs, Plateletconcentration and otherhematological parameters incomparison to negative controland untreated control.(No effect on selectedhematological parameters). |
| Hemocompatibility - DogThrombogenicity(ISO 10993-4) | Test article meets therequirements of the test if thereis minimal thrombosis for testarticle (Grade 0-2). | Minimal thrombosis (Grade 0-1)for test article and control sites.(No significant thrombosis). |
| Systemic toxicity - SystemicInjection Test(ISO 10993-11) | Test article meets therequirements of the test if it doesnot induce a significantly greaterbiological reaction than the animaltreated with the control articleswhen injected into albino mice | Test article did not induce asignificantly greater biologicalreaction than the controlextracts when injected intoalbino mice.(No toxic effects). |
| Table III: Biocompatibility Test Summary | ||
| Biocompatibility Test(ISO Standard) | Acceptance Criteria | Conclusion |
| Systemic toxicity - RabbitPyrogen Test(ISO 10993-11) | Test article meets therequirements of the test for theabsence of pyrogens, if no rabbitshows an individual temperaturerise of 0.5°C or more above thebaseline temperature. | Temperature increases for thetest animals were all 0.0° Cfrom 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).
§ 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.