(44 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the selective placement of diagnostic or therapeutic catheters; it is not itself a therapeutic device.
Yes.
The "Intended Use / Indications for Use" section states: "The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters." This indicates that the device can be used in conjunction with "diagnostic" catheters.
No
The device description clearly describes a physical guidewire made of stainless steel and nitinol, with various coatings and included accessories like a shaping mandrel and torque device. There is no mention of software as a component of the device itself.
Based on the provided information, the Traxcess™ 14 SELECT Guidewire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use, including the neuro and peripheral vasculature" to "facilitate the selective placement of diagnostic or therapeutic catheters." This describes a device used within the body for procedural guidance, not for testing samples outside the body.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels. This aligns with an interventional medical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Traxcess™ 14 SELECT Guidewire's function is purely mechanical guidance within the vasculature.
N/A
Intended Use / Indications for Use
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.
Product codes
MOF, DQX
Device Description
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.
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)
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:
- 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.
- Simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking. Conclusion: Device performed as intended under simulated use.
- 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.
- Particulate Testing: Particle count of test articles ≤ 6000 particles (≥ 10 microns) and ≤ 600 particles (≥ 25 microns). Conclusion: Device has comparable particulate results to the predicate device.
Table 3: Biocompatibility Test Summary
Biocompatibility:
- Cytotoxicity Compliance with ISO 10993-5:2009: Scores of grade 0 (no cell lysis) or grade 1 and 2 (slight to mild cytotoxic results) are considered passing and non-cytotoxic. Conclusion: The test articles are non-cytotoxic (grade 0).
- Sensitization Compliance with ISO 10993-10:2010: The test article is considered non-sensitizing if all of the animals receive grades of 5% are "hemolytic". Conclusion: The test article is considered non-hemolytic (1.48% hemolysis) Extract Method. A score of 5% are "hemolytic". Conclusion: Test article is consideration-hemolytic (0.96% hemolysis)). Direct Method.
- Haemo-compatibility - Coagulation Compliance with ISO 10993-4:2017: Test article meets the requirements of the test and is not considered to have an effect on the PTT, if no statistically significant decrease is found between the PTT of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. The biological significance is also considered in the evaluation of the results by comparing to a predicate device. Conclusion: The test article meets the requirement of the test and not an activator to the coagulation.
- Haemo-compatibility - Complement Activation Compliance with ISO 10993-4: 2017: No statistically significant increase in the reported level of C3a or SC5b-9a when compared to both the Normal Human Serum (NHS) and the negative control at 60-minute time point. Conclusion: The test articles are considered a 'Non-Activator of the Complement System'.
- Haemo-compatibility - Thrombus formation Compliance with ISO 10993-4:2017: The mean percentage value of the platelet cell counts is within 80 to 120% of the negative control and is at least 30% above that of the positive control mean percentage value. The test article fails if the platelet count is ≤50% of the negative control and /or a visible clot is produced. Conclusion: The test article meets the requirement of the test and does not cause thrombus formation.
- Haemo-compatibility – Thrombogenicity Compliance with ISO 10993-4:2017: Considered thromboresistant if the test article has a thrombus formation score of 2 or less. Conclusion: The test articles are considered thromboresistant (score
§ 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.
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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
1
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
2
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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3
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, and |
| Neurodiagnostic Devices (Office of Product Evaluation and | |
| Quality) |
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.
4
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 SELECT
Guidewire | Subject Device (Modified)
Traxcess™ 14 SELECT
Guidewire (K200547) | Rationale for
Differences (if
any) |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for Use | The Traxcess™ 14 SELECT
Guidewire is intended for
general intravascular use,
including the neuro and
peripheral vasculature. The
wire can be steered to
facilitate the selective
placement of diagnostic or
therapeutic catheters. This | 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 | Changed intended
to indicated in the
Indications for
Use statement |
| | device is not intended for use
in coronary arteries. | device is not intended for use
in coronary arteries. | |
| Intended Use | The Traxcess™ 14 SELECT
guidewire is used in both
diagnostic and interventional
procedures where distal
access is necessary. | Same | No differences |
| Function | The steerable guidewire is
used to facilitate the selective
placement of diagnostic or
therapeutic catheters. | Same | No differences |
| Anatomical Location | General intravascular use,
including the neuro and
peripheral 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 Coil
Length (Radiopaque) | 3 cm | Same | No differences |
| Stainless Steel Coil
Length | 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 end
configuration | Compatible with Traxcess™
docking wire(K093647) | Same | No differences |
| 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 | Same | No differences |
| Coating Material
(Distal section) | Coil and distal/proximal
stainless-steel section:
Hydrophilic Coating [SLIP-
COAT by Argon Medical] | Same | No differences |
| Coating Material
(Proximal section) | Proximal
Stainless-steel
section: PTFE | Proximal Stainless-steel
section:
PTFE | Change in
Supplier of PTFE
coating |
| Coating Length
(Distal section) | Hydrophilic
coating = 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, Torque
device, and Insertion tool | Same | No differences |
| Package configuration | Placed into a dispenser hoop,
Tyvek pouch, and box
carton. | Same | No differences |
5
6
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 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. | ||
| Simulated use testing | Test articles achieved rating ≥ 3 | |
| for prep of device, introduction, and | ||
| tracking | Device performed as intended under | |
| simulated use | ||
| Guidewire Coating | ||
| adherence | Coating adherence maintained after | |
| advance/retract cycles | Durability and lubricity of coating | |
| was maintained after | ||
| advance/retract cycles |
7
| 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. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Particulate Testing | Particle count of test articles ≤ 6000 particles
(≥ 10 microns) and ≤
600 particles (≥ 25 microns) | Device has comparable particulate
results to the predicate device |
Table 3: Biocompatibility Test Summary
| Biocompatibility | Result | Conclusion |
|---|---|---|
| Cytotoxicity | ||
| Compliance with | ||
| ISO 10993-5:2009 | Scores of grade 0 (no cell lysis) or grade 1 | |
| and 2 (slight to mild cytotoxic results) are | ||
| considered passing and non-cytotoxic. | The test articles are non-cytotoxic | |
| (grade 0) | ||
| Sensitization | ||
| Compliance with | ||
| ISO 10993-10:2010 | The test article is considered non-sensitizing | |
| if all of the animals receive grades of 5% are "hemolytic". | The test article is considered non- | |
| hemolytic (1.48% hemolysis) | ||
| Extract Method | ||
| A score of | ||
| 5% are "hemolytic". | Test article is consideration- | |
| hemolytic (0.96% hemolysis)). | ||
| Direct Method | ||
| Haemo-compatibility - | ||
| Coagulation | ||
| Compliance with | ||
| ISO 10993-4:2017 | Test article meets the requirements of the | |
| test and is not considered to have an effect on | ||
| the PTT, if no statistically significant | ||
| decrease is found between the PTT of the | ||
| plasma exposed to the test article and that of | ||
| the plasma exposed to either the negative | ||
| control or the untreated control. The | ||
| biological significance is also considered in | ||
| the evaluation of the results by comparing to | ||
| a predicate device. | The test article meets the | |
| requirement of the test and not an | ||
| activator to the coagulation. | ||
| Haemo-compatibility |
- Complement
Activation
Compliance with ISO
10993-4: 2017 | No statistically significant increase in the
reported level of C3a or SC5b-9a when
compared to both the Normal Human Serum
(NHS) and the negative control at 60-minute
time point. | The test articles are considered a
'Non-Activator of the Complement
System'. |
| Haemo-compatibility - Thrombus
formation
Compliance with
ISO 10993-4:2017 | The mean percentage value of the platelet
cell counts is within 80 to 120% of the
negative control and is at least 30% above
that of the positive control mean percentage
value. The test article fails if the platelet
count is ≤50% of the negative control and /or
a visible clot is produced | The test article meets the
requirement of the test and does
not cause thrombus formation |
| Haemo-compatibility
– Thrombogenicity
Compliance with ISO
10993-4:2017 | Considered thromboresistant if the test article
has a thrombus formation score of 2 or less | The test articles are considered
thromboresistant (score