(44 days)
The Traxcess™ 14 SELECT 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 intended for use in coronary arteries.
The Traxcess™ 14 SELECT 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 PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
The provided text describes the acceptance criteria and a study demonstrating that the Traxcess™ 14 SELECT Guidewire meets these criteria. However, it's important to note that this document is for a medical device (guidewire), not an AI/ML powered device. Therefore, many of the requested categories (e.g., ground truth, experts, MRMC study, training set) typically associated with AI/ML device performance evaluation are not applicable or found in this context.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench/Biocompatibility Testing) | Reported Device Performance (Result & Conclusion) |
|---|---|
| Bench Testing: | |
| Physical attributes (dimensional requirements) | Device met established dimensional specifications |
| Surface Contamination (absence of defects/contamination) | Device was free from surface defects and contamination |
| Corrosion Resistance | Device met established corrosion resistance |
| Simulated use testing (prep, introduction, tracking rating ≥ 3) | Device performed as intended under simulated use |
| Guidewire Coating adherence (maintained after advance/retract cycles) | Durability and lubricity of coating was maintained after advance/retract cycles |
| Guidewire fracture resistance (no fracture, no coating flaking) | Device met established fracture resistance specification |
| Particulate Testing (≤ 6000 particles (≥ 10 microns) and ≤ 600 particles (≥ 25 microns)) | Device has comparable particulate results to the predicate device |
| Biocompatibility Testing: | |
| Cytotoxicity (ISO 10993-5:2009) (Scores of grade 0, 1, or 2) | The test articles are non-cytotoxic (grade 0) |
| Sensitization (ISO 10993-10:2010) (Grades of <1) | The test articles are not a sensitizer (grade <1) |
| Irritation (ISO 10993-10:2010) (Difference in mean score ≤ 1.0) | The test articles are considered non-irritating (the score ≤1) |
| Acute Systemic Toxicity (ISO 10993-11:2017) (No significantly greater biological reactivity, no death, no severe reactions, no excessive weight loss) | The test articles meet requirements of the test and it's nontoxic |
| Material-mediated Pyrogenicity (ISO 10993-11:2017) (No animal shows temperature rise ≥ 0.5 °C) | Not pyrogenic (temperature rise < 0.5 °C) |
| Haemo-compatibility - Hemolysis (ISO 10993-4:2017) (< 2.0% hemolytic index for non-hemolytic) | Non-hemolytic (1.48% hemolysis - Extract Method; 0.96% hemolysis - Direct Method) |
| Haemo-compatibility - Coagulation (ISO 10993-4:2017) (No statistically significant decrease in PTT) | The test article meets the requirement of the test and not an activator to the coagulation |
| Haemo-compatibility - Complement Activation (ISO 10993-4:2017) (No statistically significant increase in C3a or SC5b-9a) | The test articles are considered a 'Non-Activator of the Complement System' |
| Haemo-compatibility - Thrombus formation (ISO 10993-4:2017) (Mean percentage value of platelet cell counts 80-120% of negative control and ≥ 30% above positive control, no visible clot) | The test article meets the requirement of the test and does not cause thrombus formation |
| Haemo-compatibility – Thrombogenicity (ISO 10993-4:2017) (Thrombus formation score of 2 or less) | The test articles are considered thromboresistant (score <2) |
2. Sample sized used for the test set and the data provenance:
The document mentions "Test articles" for bench testing and "animals" for biocompatibility testing, but does not specify the exact sample sizes for each test. The provenance of the data is that it was generated from verification and validation testing on the Traxcess™ 14 SELECT Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes a physical medical device (guidewire) and its performance through bench and biocompatibility testing, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above. The tests performed are objective laboratory assessments.
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:
This information is not applicable as the document describes a physical medical device (guidewire), not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes a physical medical device (guidewire), 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 based on objective measurements and observations against established specifications and ISO standards for physical and biological properties. This includes dimensional measurements, visual inspection for defects, force resistance, coating integrity, and specific biological responses (e.g., cell viability, immune response, blood compatibility).
8. The sample size for the training set:
This information is not applicable as the document describes a physical medical device and its validation through testing, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 16, 2020
MicroVention, Inc. Ganesh Balachandar Sr. Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656
Re: K200547
Trade/Device Name: Traxcess™ 14 SELECT Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: March 5, 2020 Received: March 19, 2020
Dear Ganesh Balachandar:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200547
Device Name
Traxcess™ 14 SELECT Guidewire
Indications for Use (Describe)
The Traxcess™ 14 SELECT 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 intended for use in coronary arteries.
Type of Use (Select one or both, as applicable)
X 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™14 SELECT 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. Tustin, California U.S.A
Telephone: (714)247-8201 Contact Name: Ganesh Balachandar E-mail address: ganesh.balachander(@)microvention.com Date prepared: 15-April-2020
II DEVICE [807.92(a)(2)]
| Name of Device: | Traxcess™ 14 SELECT 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 Neurosurgical, Neurointerventional, andNeurodiagnostic Devices (Office of Product Evaluation andQuality) |
III PREDICATE DEVICE [807.92(a)(3)] Traxcess 14 SELECT Guidewire (K153053)
IV DEVICE DESCRIPTION [807.92(a)(4)]
The Traxcess™ 14 SELECT 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.
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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 PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT 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™ 14 SELECT 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 intended for use in coronary arteries.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The Traxcess™ 14 SELECT Guidewire has the following similarities to the
predicate device, Traxcess™ 14 SELECT Guidewire (KT53053):
- Have the same intended use 1.
-
- Use the same operating principle
- 3 Incorporate the same basic guidewire design
-
- Incorporate the same guidewire construction material
- റ് Are packaged and sterilized using the same materials and processes
The change in the alternative 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 1 states the comparison between Traxcess™ 14 SELECT Guidewire (Predicate Device, K153053) and Traxcess™14 SELECT Guidewire (Subject Device).
| Description | Predicate Device (Existing)Traxcess™ 14 SELECTGuidewire | Subject Device (Modified)Traxcess™ 14 SELECTGuidewire (K200547) | Rationale forDifferences (ifany) |
|---|---|---|---|
| Indications for Use | The Traxcess™ 14 SELECTGuidewire is intended forgeneral intravascular use,including the neuro andperipheral vasculature. Thewire can be steered tofacilitate the selectiveplacement of diagnostic ortherapeutic catheters. This | The Traxcess™ 14 SELECTGuidewire is indicated forgeneral intravascular use,including the neuro andperipheral vasculature. Theguidewire can be steered tofacilitate the selectiveplacement of diagnostic ortherapeutic catheters. This | Changed intendedto indicated in theIndications forUse statement |
| device is not intended for usein coronary arteries. | device is not intended for usein coronary arteries. | ||
| Intended Use | The Traxcess™ 14 SELECTguidewire is used in bothdiagnostic and interventionalprocedures where distalaccess is necessary. | Same | No differences |
| Function | The steerable guidewire isused to facilitate the selectiveplacement of diagnostic ortherapeutic catheters. | Same | No differences |
| Anatomical Location | General intravascular use,including the neuro andperipheral vasculature. | Same | No differences |
| Wire Diameter | Proximal = 0.014"Distal = 0.012" | Same | No differences |
| Device Length | 200 cm | Same | No differences |
| Coil Length | 40 cm | Same | No differences |
| Platinum/Nickel CoilLength (Radiopaque) | 3 cm | Same | No differences |
| Stainless Steel CoilLength | 37 cm | Same | No differences |
| Distal Shaft Length(Shapeable Length) | 1.4 cm | Same | No differences |
| Distal tip thickness(core wire) | 0.037 mm | Same | No differences |
| Proximal endconfiguration | Compatible with Traxcess™docking wire(K093647) | Same | No differences |
| Material | Core wire (proximal):Stainless steelCore wire (distal):Nickel titanium(Nitinol) alloyCoil: Platinum nickel alloyand Stainless steelOther: Brazing materialand solder | Same | No differences |
| Coating Material(Distal section) | Coil and distal/proximalstainless-steel section:Hydrophilic Coating [SLIP-COAT by Argon Medical] | Same | No differences |
| Coating Material(Proximal section) | ProximalStainless-steelsection: PTFE | Proximal Stainless-steelsection:PTFE | Change inSupplier of PTFEcoating |
| Coating Length(Distal section) | Hydrophiliccoating = 980 | Same | No differences |
| mm | |||
| Coating Length(Proximal section) | PTFE = 1000 mm | Same | No differences |
| Method of supply | Sterile and single use | Same | No differences |
| Sterilization method | Ethylene oxide gas | Same | No differences |
| Accessories | Shaping mandrel, Torquedevice, and Insertion tool | Same | No differences |
| Package configuration | Placed into a dispenser hoop,Tyvek pouch, and boxcarton. | Same | No differences |
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VII PERFORMANCE DATA [807.92(b)]
Results of the verification and validation testing (Table 2,3) indicate that the product meets established performance requirements and is safe and effective for its intended use.
Table 2: Design Verification and Validation Test Summary
| Bench Testing | Result | Conclusion |
|---|---|---|
| Physical attributes | Test articles met specified dimensionalrequirements for guidewire OD, overalllength, length of Pt/Ni coil section, length ofSS section, length of PTFE coated section,length of hydrophilic coated section, lengthof proximal docking section and accessorydevices | Device met establisheddimensional specifications |
| Surface Contamination | Test article when examined atmagnification, should meet existing surfacecontamination and defects specification. | Device was free from surfacedefects and contamination |
| Corrosion Resistance | Test article should be corrosion resistant. | Device met established corrosionresistance. |
| Simulated use testing | Test articles achieved rating ≥ 3for prep of device, introduction, andtracking | Device performed as intended undersimulated use |
| Guidewire Coatingadherence | Coating adherence maintained afteradvance/retract cycles | Durability and lubricity of coatingwas maintained afteradvance/retract cycles |
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| Guidewire fractureresistance | Test article should not show signs offracture. There should be no coating flakingoff the guidewire. | Device met established fractureresistance specification. |
|---|---|---|
| Particulate Testing | Particle count of test articles ≤ 6000 particles(≥ 10 microns) and ≤600 particles (≥ 25 microns) | Device has comparable particulateresults to the predicate device |
Table 3: Biocompatibility Test Summary
| Biocompatibility | Result | Conclusion |
|---|---|---|
| CytotoxicityCompliance withISO 10993-5:2009 | Scores of grade 0 (no cell lysis) or grade 1and 2 (slight to mild cytotoxic results) areconsidered passing and non-cytotoxic. | The test articles are non-cytotoxic(grade 0) |
| SensitizationCompliance withISO 10993-10:2010 | The test article is considered non-sensitizingif all of the animals receive grades of <1 atall time periods. | The test articles are not a sensitizer(grade <1) |
| IrritationCompliance withISO 10993-10:2010 | Considered to be non-irritating and passingwhen the difference between the test articlemean score (erythema and edema) is 1.0 orless than that of the negative (vehicle)control score. | The test articles are considerednon-irritating (the score ≤1) |
| Acute SystemicToxicityCompliance withISO 10993-11:2017 | The test is considered negative and non-acutesystemically toxic if none of the animalstreated with the test article showed asignificantly greater biological reactivitythan animals treated with the negativecontrol. If 2 or more test group animals diesor exhibit severe reactions (e.g. convulsions).or if 3 or more test group animals experienceweight loss greater than 10% of their originalmass, the article does not meet requirementsof the test | The test articles meet requirementsof the test and it's nontoxic. |
| Material-mediatedPyrogenicityCompliance withISO 10993-11:2017 | Considered non-pyrogenic if no animalshows an individual rise in temperature of0.5 °C or more above the baselinetemperature | Not pyrogenic ((temperature rise <0.5 °C) |
| Biocompatibility | Result | Conclusion |
| Haemo-compatibility -HemolysisCompliance with (ISO)10993-4: 2017 | A score of< 2.0% hemolytic index is classified as “non-hemolytic". Scores of ≥2% to ≤5%hemolytic index are “slightly hemolytic” andscores of >5% are "hemolytic". | The test article is considered non-hemolytic (1.48% hemolysis)Extract Method |
| A score of< 2.0% hemolytic index is classified as “non-hemolytic". Scores of ≥2% to ≤5%hemolytic index are “slightly hemolytic" andscores of >5% are "hemolytic". | Test article is consideration-hemolytic (0.96% hemolysis)).Direct Method | |
| Haemo-compatibility -CoagulationCompliance withISO 10993-4:2017 | Test article meets the requirements of thetest and is not considered to have an effect onthe PTT, if no statistically significantdecrease is found between the PTT of theplasma exposed to the test article and that ofthe plasma exposed to either the negativecontrol or the untreated control. Thebiological significance is also considered inthe evaluation of the results by comparing toa predicate device. | The test article meets therequirement of the test and not anactivator to the coagulation. |
| Haemo-compatibility- ComplementActivationCompliance with ISO10993-4: 2017 | No statistically significant increase in thereported level of C3a or SC5b-9a whencompared to both the Normal Human Serum(NHS) and the negative control at 60-minutetime point. | The test articles are considered a'Non-Activator of the ComplementSystem'. |
| Haemo-compatibility- ThrombusformationCompliance withISO 10993-4:2017 | The mean percentage value of the plateletcell counts is within 80 to 120% of thenegative control and is at least 30% abovethat of the positive control mean percentagevalue. The test article fails if the plateletcount is ≤50% of the negative control and /ora visible clot is produced | The test article meets therequirement of the test and doesnot cause thrombus formation |
| Haemo-compatibility– ThrombogenicityCompliance with ISO10993-4:2017 | Considered thromboresistant if the test articlehas a thrombus formation score of 2 or less | The test articles are consideredthromboresistant (score <2). |
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VIII CONCLUSIONS
Based on the 510(k) summary and information provided herein, we conclude the subject device, the Traxcess™ 14 SELECT Guidewire, is substantially
equivalent in its intended use, design, guidewire material, performance, and the underlying fundamental scientific technology used, to the predicate Traxcess™ 14 SELECT Guidewire (K153053).
§ 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.