(70 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device description and intended use state that it is a guidewire used to facilitate the selective placement of therapeutic catheters, but it does not directly provide a therapeutic effect itself.
No
The device is a guidewire used to facilitate the placement of therapeutic catheters, not to diagnose a condition.
No
The device description clearly details a physical guidewire made of stainless steel and nitinol, with various coatings and included physical tools (shaping mandrel, torque device, insertion tool). This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general intravascular use" and is used to "facilitate the selective placement of therapeutic catheters." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels. This is consistent with an interventional medical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting 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 the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This guidewire does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Traxces® Pro 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of therapeutic catheters. This device is not intended for use in coronary arteries.
Product codes
MOF, DQX
Device Description
The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil.
The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician.
The coil section of the guidewire and the distal stainless steel section is coated with a hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of these surface coatings is to provide lubricity when the MicroVention guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
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 and Biocompatibility testing were performed.
Bench Testing:
- Dimensional 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.
- Tip shapeability: >=71% average for tip shape percent angle retention. Conclusion: Device met established tip shapeability.
- Tensile strength: Tensile strength of distal >= 3N, Tensile strength of proximal >= 70N. Conclusion: Device met established tensile strength.
- Torque strength: Equivalent or better than predicate (turns to failure). Conclusion: Device torque strength comparable to predicate.
- Torqueability: Torque response was equal to or better than predicate. Conclusion: Device torque response comparable to predicate.
- Tip flexibility: Demonstrated force to deflect the distal tip is = 10 microns) and = 25 microns). Conclusion: Device does not generate particles under use.
- Radiopacity: Distal coil section visible under fluoroscopy. Conclusion: Device radiopacity was comparable to predicate.
- Coating adherence: Coating adherence maintained after advance/retract cycles. Conclusion: Durability and lubricity of coating was maintained after advance/retract cycles.
- in-vitro simulated use testing: Test articles achieved rating >= 3 for prep of device, introduction, and tracking. Conclusion: Device performed as intended under simulated use.
Biocompatibility:
- Cytotoxicity - MEM Elution Test (ISO 10993-5): Cell culture exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). No cytotoxic effect. Conclusion: Non-cytotoxic.
- Sensitization/Irritation - Kligman Maximization Test (ISO10993-10): Extracts of test article exhibited 0% sensitization. Conclusion: Non-sensitizer.
- Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10): Extracts of test article did not show a significantly greater biological reaction than sites injected with the control. Conclusion: Non-irritant.
- Hemocompatibility - Hemolysis (Direct and Indirect) (ISO 10993-4): Hemolysis index was above the negative control of 0.77% (direct contact)) and 0.23% (indirect contact). Conclusion: Non-hemolytic.
- Hemocompatibility - Unactivated Partial Thromboplastin Assay (ISO 10993-4): No statistically significant difference found between plasma exposed to test article, negative control, and untreated control. Conclusion: No effect on coagulation of human plasma.
- Hemocompatibility - Complement Activation (ISO 10993-4): The concentration of C3a and SC5b-9 in plasma exposed to test article was not statistically increased than the plasma exposed to negative and untreated controls. Conclusion: Not considered to have activated the complement system in human plasma.
- Hemocompatibility - In Vitro Hemocompatibility Test (Direct Contact) (ISO 10993-4): No effect on the WBCs, Platelet concentration and other hematological parameters in comparison to control. Conclusion: No effect on selected hematological parameters.
- Hemocompatibility - Dog Thrombogenicity (ISO 10993-4): Minimal thrombosis for test article and control sites (Grade 0-1). Conclusion: No significant thrombosis.
- Systemic toxicity - Systemic Injection Test (ISO 10993-11): Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice. Conclusion: No toxic effects.
- Systemic toxicity - Rabbit Pyrogen Test (ISO 10993-11): Temperature increase was 0.0° C from baseline. Conclusion: Non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
MicroVention, Inc. Ms. Sapna Singh Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 72780
Re: K153053
Trade/Device Name: Traxcess Pro 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 3, 2015 Received: December 4, 2015
Dear Ms. Sapna Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 yours,
William J. Heetderks -S
for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153053
Device Name Traxcess® Pro 14 Guidewire
Indications for Use (Describe)
The Traxces® Pro 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of therapeutic catheters. This device is not intended for use in coronary arteries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | □Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Traxcess® Pro 14 Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.
I. SUBMITTER [807.92(a)(1)]
MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.
| Telephone: | (714) 247-8162 |
|---|---|
| Fax: | (714) 247-8014 |
Contact Person: Sapna Singh Email: sapna.singh@microvention.com Date Prepared: October 19, 2015
II. DEVICE [807.92(a)(2)]
| Name of Device: | Traxcess® Pro 14 Guidewire |
|---|---|
| Common or Usual Name: | Guidewire |
| Classification Name: | Catheter Guidewire |
| Product Code: | MOF, DQX |
| Regulatory Class: | Class II |
| Submission Type: | Special 510(K) |
| Regulation Number: | 21 CFR 870.1330 |
| Reviewing Product Branch: | Division of Cardiovascular Devices (Office of Device |
| Evaluation, CDRH) |
III. PREDICATE DEVICE [807.92(a)(3)]
Traxcess 14 Guidewire (K133725)
IV. DEVICE DESCRIPTION [807.92(a)(4)]
The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal
4
coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil.
The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician.
The coil section of the guidewire and the distal stainless steel section is coated with a hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of these surface coatings is to provide lubricity when the MicroVention guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
V. INDICATIONS FOR USE [807.92(a)(5)]
The Traxcess® Pro 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The Traxcess® Pro 14 Guidewire has the following similarities to the predicate device. Traxcess 14 Guidewire (K133725):
-
- Have the same intended use
-
- Use the same operating principle
-
- Incorporate the same basic guidewire design
-
- Incorporate the same guidewire construction material
-
- Are packaged and sterilized using the same materials and processes
The change in the distal tip of the guidewire and the application of PTFE coating on the proximal stainless steel section of the guidewire does not change the indications for use of the Traxcess guidewires and is not a change to the fundamental scientific technology. The performance data below shows the device will perform as well as the previously marketed device.
The Table I states the comparison between Traxcess 14 Guidewire (Predicate Device, K133725) and Traxcess® Pro 14 Guidewire (Subject Device).
Table I: Predicate Device vs Subject Device Comparison Table
| | Traxcess 14 Guidewire
(Predicate Device, K133725) | Traxcess® Pro 14 Guidewire
(Subject Device) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use | | |
| Intended Use Statement | The Traxcess 14 Guidewire is | Same |
| | intended for 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
device is not intended for use in
coronary arteries. | |
| Performance | | |
| Function | The steerable guidewire is used
to facilitate the selective
placement of diagnostic or
therapeutic catheters. | Same |
| Anatomical Location | General intravascular use,
including the neuro and peripheral
vasculature. | Same |
| Design | | |
| Overall Length | 200 cm | Same |
| Diameter | Proximal = 0.014"
Distal = 0.012" | Same |
| Coil Length | 40 cm | Same |
| Platinum/Nickel Coil Length
(Radiopaque) | 3 cm | Same |
| Stainless Steel Coil Length | 37 cm | Same |
| Distal Shaft Length (Shapeable
Length) | 1.4 cm | Same |
| Distal tip thickness
(core wire) | 0.037 mm | Same |
| Proximal end configuration | Compatible with Traxcess docking
wire | Same |
| Material | | |
| 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 |
| Coating Material | Coil and distal/proximal stainless
steel section: Hydrophilic Coating
[SLIP-COAT by Argon Medical] | Coil and distal stainless steel
section: Hydrophilic Coating
[SLIP-COAT by Argon Medical] |
| | | Proximal Stainless steel section:
PTFE |
| Coating Length | Hydrophilic Coating = 1450 mm | Hydrophilic coating = 980 mm
PTFE = 1000 mm |
| Other Attributes | | |
| Method of supply | Sterile and single use | Same |
| Sterilization method | Ethylene oxide gas | Same |
| Accessories | Shaping mandrel, Torque device,
and Insertion tool | Same |
| Package configuration | Placed into a Dispenser hoop,
Tyvek pouch, and Carton box | Same |
5
6
VII. PERFORMANCE DATA [807.92(b)]
Results of the verification and validation testing (Table II) indicate that the product meets established performance requirements, and is safe and effective for its intended use.
| Bench Testing | Result | Conclusion |
|---|---|---|
| Dimensional attributes | Test articles met 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 | ||
| Tip shapeability | ≥71% average for tip shape | |
| percent angle retention | Device met established tip | |
| shapeability | ||
| Tensile strength | Tensile strength of distal ≥ 3N | |
| Tensile strength of proximal ≥ | ||
| 70N | Device met established tensile | |
| strength | ||
| Torque strength | Equivalent or better than | |
| predicate (turns to failure) | Device torque strength | |
| comparable to predicate | ||
| Torqueability | Torque response was equal to | |
| or better than predicate | Device torque response | |
| comparable to predicate | ||
| Tip flexibility | Demonstrated force to deflect | |
| the distal tip is ≤ predicate | Device tip flexibility is ≤ | |
| predicate | ||
| Fracture resistance and Flexing | ||
| test | No portion of the guidewire | |
| should show signs of defect, | ||
| fracture or other damage. | ||
| There should be no coating | ||
| flaking off the guidewire | No defects, fractures, damage | |
| or signs of coating flaking |
Table II: Design Verification and Validation Test Summary
7
| Bench Testing | Result | Conclusion |
|---|---|---|
| Particle Testing | Particle count of test articles ≤ | |
| 25 particles (≥ 10 microns) and ≤ | ||
| 3 particles (≥ 25 microns) | Device does not generate | |
| particles under use | ||
| Radiopacity | Distal coil section visible under | |
| fluoroscopy | Device radiopacity was | |
| comparable to predicate | ||
| Coating adherence | Coating adherence maintained | |
| after advance/retract cycles | Durability and lubricity of | |
| coating was maintained after | ||
| advance/retract cycles | ||
| n-vitro simulated use testing | Test articles achieved rating ≥ 3 | |
| for prep of device, introduction, | ||
| and tracking | Device performed as intended | |
| under simulated use |
| Biocompatibility | Result | Conclusion |
|---|---|---|
| Cytotoxicity - MEM Elution Test | ||
| (ISO 10993-5) | Cell culture exhibited a biological | |
| reactivity grade of 0 (on a scale | ||
| of 0 to 4). No cytotoxic effect | Non-cytotoxic | |
| Sensitization/Irritation - Kligman | ||
| Maximization Test (ISO10993- |
-
| Extracts of test article exhibited
0% sensitization | Non-sensitizer |
| Sensitization/Irritation -
Intracutaneous Injection Test
(ISO 10993-10) | Extracts of test article did not
show a significantly greater
biological reaction than sites
injected with the control | Non-irritant |
| Hemocompatibility - Hemolysis
(Direct and Indirect) (ISO 10993-
4) | Hemolysis index was above the
negative control of 0.77% (direct
contact)) and 0.23% (indirect
contact) | Non-hemolytic |
| Hemocompatibility - Unactivated
Partial Thromboplastin Assay
(ISO 10993-4) | No statistically significant
difference found between
plasma exposed to test article,
negative control, and untreated
control. | No effect on coagulation of
human plasma |
| Hemocompatibility -
Complement Activation (ISO
10993-4) | The concentration of C3a and
SC5b-9 in plasma exposed to
test article was not statistically
increased than the plasma
exposed to negative and
untreated controls. | Not considered to have
activated the complement
system in human plasma |
| Hemocompatibility - In Vitro
Hemocompatibility Test (Direct
Contact) (ISO 10993-4) | No effect on the WBCs, Platelet
concentration and other
hematological parameters in
comparison to control | No effect on selected
hematological parameters |
| Hemocompatibility - Dog
Thrombogenicity (ISO 10993-4) | Minimal thrombosis for test
article and control sites (Grade
0-1) | No significant thrombosis |
| Systemic toxicity - Systemic
Injection Test (ISO 10993-11) | Extracts of test article did not
induce a significantly greater
biological reaction than the
control extracts when injected
into albino mice. | No toxic effects |
| Systemic toxicity - Rabbit
Pyrogen Test (ISO 10993-11) | Temperature increase was 0.0°
C from baseline. | Non-pyrogenic |
8
VIII. CONCLUSIONS
Based on the 510(k) summary and information provided herein, we conclude the subject device, the Traxcess® Pro 14 Guidewire, is substantially equivalent in its intended use, design, guidewire material, performance, and the underlying fundamental scientific technology used, to the predicate Traxcess 14 Guidewire (K133725).