(28 days)
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML capabilities.
No
Explanation: The device is a guidewire used to facilitate the placement of diagnostic catheters, which is a diagnostic rather than therapeutic function.
No
The device description clearly states "The guidewire can be steered to facilitate the selective placement of diagnostic catheters." This indicates the device is a tool to assist in diagnostic procedures, not a diagnostic device itself.
No
The device description clearly outlines physical components like stainless steel and nitinol core wires, a platinum/nickel coil, and included accessories like shaping mandrels and a torque device. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Traxcess™ 7 Mini Guidewire is a physical tool used to facilitate the placement of diagnostic catheters within blood vessels. It is a device used in vivo (within the body) to guide other instruments.
- Intended Use: The intended use clearly states it's for "general intravascular use" and to "facilitate the selective placement of diagnostic catheters." This describes a procedural tool, not a diagnostic test performed on a sample.
The information provided about the device description, performance studies (bench testing, biological evaluation), and predicate/reference devices all support its classification as an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
Traxcess™ 7 Mini 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 catheters. This device is not indicated for use in coronary arteries.
Product codes
MOF, DQX
Device Description
Traxcess™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within 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 Guidewire distal and proximal sections are coated with hydrophilic coating. There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General intravascular use, including the neuro and peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Physical attributes: 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. Conclusion: Device met established dimensional specifications.
- Surface Contamination: Test article when examined at magnification, should meet existing surface contamination and defects specification. Conclusion: Device was free from surface defects and contamination.
- Corrosion Resistance: Test article should be corrosion resistant. Conclusion: Device met established corrosion resistance.
- Guidewire Coating adherence: Coating adherence maintained after advance/retract cycles. Conclusion: Durability and lubricity of coating was maintained after advance/retract cycles.
- Guidewire fracture resistance: Test article should not show signs of fracture. There should be no coating flaking off the guidewire. Conclusion: Device met established fracture resistance specification.
- Guidewire tip shapeability: Test article should be greater than or equal to existing tip shapeability specification. Conclusion: Device met established Guidewire tip shapeability specification.
- Torque Strength: Test article should be greater than or equal to existing torque strength specification. Conclusion: Device met established torque strength specification.
- Torque Response: Test article should be equivalent to, or better than predicate device. Conclusion: Subject device torque response equivalent to predicate device.
- Flexing test: Test article should not show signs of defect, fracture or other damage. There should be no coating flaking off the guidewire. Conclusion: 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. Conclusion: Device met established distal tip flexibility specification.
- Tensile strength: Test article should be greater than or equal to existing tensile strength specification for distal tip and proximal joint section. Conclusion: Device met established distal tip and proximal joint tensile strength specification.
- Simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking. Conclusion: Device performed as intended under simulated use.
- Particulate Testing: Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns). Conclusion: Device has comparable particulate results to the predicate device.
Biological Evaluation:
The biocompatibility studies were not repeated as Traxcess™ 7 Mini 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 the reference device Traxcess™ 14 SELECT Guidewire (K200547). The biocompatibility testing conducted on the Traxcess™ 14 SELECT Guidewire (K200547) provides assurance that the guidewire has a safe biocompatibility profile and are safe to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2020
MicroVention, Inc. Ganesh Balachandar Sr. Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656
Re: K201487
Trade/Device Name: Traxcess 7 Mini Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: June 1, 2020 Received: June 4, 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
1
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 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 (QS) 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201487
Device Name Traxcess™ 7 Mini Guidewire
Indications for Use (Describe)
Traxcess™ 7 Mini 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 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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3
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Traxcess™ 7 Mini 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: 01-June-2020
II DEVICE [807.92(a)(2)]
| Name of Device: | Traxcess TM 7 Mini 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, and Neurodiagnostic Devices (Office of Product Evaluation and Quality) |
III PREDICATE DEVICE [807.92(a)(3)]
Predicate Device: Traxcess 7 Mini Guidewire (K161803) Reference Device: Traxcess 14 SELECT Guidewire (K200547)
IV DEVICE DESCRIPTION [807.92(a)(4)]
Traxcess™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within 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 Guidewire distal and proximal sections are coated with hydrophilic coating.
4
There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.
V INDICATIONS FOR USE [807.92(a)(5)]
Traxcess™ 7 Mini 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.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
Traxcess™ 7 Mini Guidewire has the following similarities to the predicate device, Traxcess™ 7 Mini Guidewire (K161803):
- 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 core wire taper diameter profile for the Traxcess™ 7 Mini guidewire for better support and compatibility with microcatheters does not change the indications for use of the Traxcess™ 7 Mini 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 device.
5
The Table 1 states the comparison between Traxcess™ 7 Mini Guidewire (Predicate Device, K161803) and Traxcess™ 7 Mini Guidewire (Subject Device).
| Description | Reference Device (Existing) | Predicate Device (Existing) | Subject Device (Modified) | Rationale for Difference (if any) |
|---|---|---|---|---|
| Traxcess™ 14 SELECT | ||||
| Guidewire (K200547) | Traxcess™ 7 Mini | |||
| Guidewire (K161803) | Traxcess™ 7 Mini | |||
| Guidewire | ||||
| Indications for Use | 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 | ||||
| indicated for use in coronary | ||||
| arteries. | Traxcess™ 7 Mini 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. | Same | No difference | ||
| Intended Use | The Traxcess™ 14 SELECT | |||
| guidewire is used in both | ||||
| diagnostic and interventional | ||||
| procedures where distal access | ||||
| is necessary. | The Traxcess™ 7 Mini | |||
| Guidewire is used in both | ||||
| diagnostic and interventional | ||||
| procedures where distal access | ||||
| is necessary. | Same | No difference | ||
| Function | The steerable guidewire is used | |||
| to facilitate the selective | ||||
| placement of diagnostic or | ||||
| therapeutic catheters. | The steerable guidewire is used | |||
| to facilitate the selective | ||||
| placement of diagnostic or | ||||
| therapeutic catheters. | Same | No difference | ||
| Anatomical | ||||
| Location | General intravascular use, | |||
| including the neuro and | ||||
| peripheral vasculature. | General intravascular use, | |||
| including the neuro and | ||||
| peripheral vasculature. | Same | No difference | ||
| Wire Diameter | Proximal = 0.014" | |||
| Distal = 0.012" | Proximal = 0.014" | |||
| Distal = 0.007" | Same | No difference | ||
| with predicate | ||||
| device(K161803) | ||||
| Device Length | 200 cm | 210 cm | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Coil Length | 40 cm | 6 cm | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Platinum/Nickel | ||||
| Coil Length | ||||
| (Radiopaque) | 3 cm | 6 cm | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Distal Shaft | ||||
| Length | ||||
| (Shapeable | ||||
| Length) | 1.4 cm | 1.4 cm | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Corewire | ||||
| configuration | N/A | Diameter from 2-6 | ||
| cm:0.0033" | ||||
| Diameter from16-30 cm: | ||||
| 0.01" | Diameter from 2-6 | |||
| cm:0.0038" | ||||
| Diameter from 16-30 cm: | ||||
| 0.008" | Change in core | |||
| wire diameter | ||||
| profile in | ||||
| comparison to the | ||||
| predicate device | ||||
| (K161803) | ||||
| Docking wire | ||||
| compatibility | Compatible with Traxcess™ | |||
| docking wire(K093647) | No | Same | No difference | |
| with predicate | ||||
| device(K161803) | ||||
| Material | Core wire (proximal): | |||
| Stainless steel | ||||
| Core wire (distal): | ||||
| Nickel titanium (Nitinol) | ||||
| alloy | ||||
| Coil: Platinum nickel alloy | ||||
| and Stainless steel | ||||
| Other: Brazing material | ||||
| and solder | Core wire (proximal): | |||
| Stainless steel | ||||
| Core wire (distal): | ||||
| Nickel titanium (Nitinol) | ||||
| alloy | ||||
| Coil: Platinum nickel alloy | ||||
| and Stainless steel | ||||
| Other: Brazing material and | ||||
| solder | Same | No difference | ||
| with predicate | ||||
| device(K161803) | ||||
| Coating | ||||
| Material | Proximal section: | |||
| PTFE | ||||
| Distal section: | ||||
| Hydrophilic Coating [SLIP- | ||||
| COAT by Argon Medical] | Coil and distal/proximal | |||
| stainless-steel section: | ||||
| Hydrophilic Coating [SLIP- | ||||
| COAT by Argon Medical] | Same | No difference | ||
| with predicate | ||||
| device(K161803) | ||||
| Coating Length | Hydrophilic | |||
| coating = 980 mm | ||||
| PTFE = 1000 mm | Hydrophilic | |||
| coating = 1580 mm | Same | No difference | ||
| with predicate | ||||
| device(K161803) | ||||
| Method of | ||||
| supply | Sterile and single use | Sterile and single use | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Sterilization | ||||
| method | Ethylene oxide gas | Ethylene oxide gas | Same | No difference |
| with predicate | ||||
| device(K161803) | ||||
| Accessories | Shaping mandrel, torque | |||
| device, and insertion tool | Shaping mandrels, torque | |||
| device, and insertion tool | Same | No difference | ||
| with predicate | ||||
| device(K161803) | ||||
| Package | ||||
| configuration | Placed into a dispenser hoop, | |||
| Tyvek pouch, and box carton. | Placed into a dispenser hoop, | |||
| Tyvek pouch, and box carton. | Same | No difference | ||
| with predicate | ||||
| device(K161803) |
6
7
8
VII PERFORMANCE DATA [807.92(b)]
Results of the verification and validation testing in the table below indicate that the product meets established performance requirements and is safe and effective for its intended use.
| Bench Testing | Result | Conclusion |
|---|---|---|
| Physical attributes | 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. | Device met established | |
| dimensional specifications. | ||
| Surface | ||
| Contamination | Test article when examined at | |
| magnification, should meet existing | ||
| surface contamination and defects | ||
| specification. | Device was free from surface | |
| defects and contamination. | ||
| Corrosion Resistance | Test article should be corrosion | |
| resistant. | Device met established | |
| corrosion resistance. | ||
| Guidewire Coating | ||
| adherence | Coating adherence maintained after | |
| advance/retract cycles. | Durability and lubricity of | |
| coating was maintained after | ||
| advance/retract cycles. | ||
| Guidewire 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. | ||
| Guidewire tip | ||
| shapeability | Test article should be greater than or | |
| equal to existing tip shapeability | ||
| specification. | Device met established | |
| Guidewire tip shapeability | ||
| specification. | ||
| Torque Strength | Test article should be greater than or | |
| equal to existing torque strength | ||
| specification. | Device met established torque | |
| strength specification. | ||
| Torque Response | Test article should be equivalent | |
| to, or better than predicate | ||
| device. | Subject device torque response | |
| equivalent to predicate device. | ||
| 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. | Device met established distal | |
| tip flexibility 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. | ||
| Simulated use testing | Test articles achieved rating ≥ 3 | |
| for prep of device, introduction, | ||
| and tracking. | Device performed as intended | |
| under simulated use. | ||
| Particulate Testing | Particle count of test articles ≤ | |
| 25particles (≥ 10 microns) and ≤ | ||
| 3 particles (≥ 25 microns). | Device has comparable | |
| particulate results to the | ||
| predicate device. |
9
Biological Evaluation
The biocompatibility studies were not repeated as Traxcess™ 7 Mini 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 the reference device Traxcess™ 14 SELECT Guidewire (K200547). The biocompatibility testing conducted on the Traxcess™ 14 SELECT Guidewire (K200547) provides assurance that the guidewire has a safe biocompatibility profile and are safe to use.
VIII CONCLUSIONS
Based on the 510(k) summary and information provided herein, we conclude the subject device, Traxcess™ 7 Mini Guidewire, is substantially equivalent in its intended use, design, guidewire material, performance, and the underlying fundamental scientific technology used, to the predicate Traxcess™ 7 Mini Guidewire (K161803).