(48 days)
Not Found
No
The description focuses on the physical components and intended use of a guidewire and docking wire, with no mention of AI or ML capabilities.
No
Explanation: The device is described as being used to facilitate the placement of diagnostic or therapeutic catheters, but it is not itself a therapeutic device. It is a guidewire, which is an accessory used in procedures, not a device that directly delivers therapy.
No
The intended use statement says "The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters," meaning the device itself is not diagnostic but aids in placing diagnostic tools.
No
The device description clearly details physical components made of stainless steel, nitinol, and coatings, indicating it is a hardware device, not software-only.
Based on the provided information, 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" 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 to diagnose conditions.
- Device Description: The description details the physical components of a guidewire and docking wire, which are tools used in medical procedures. It does not describe reagents, test kits, or equipment used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information based on laboratory testing.
The device is a medical device used for guiding other instruments within the vasculature, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Traxcess Guidewire and Traxcess Docking Wire 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 device is not intended for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Traxcess 14EX Guidewire consists of a 0.014" stainless steel shaft and a tapered The Traxcess 14EA Guidewire consisted organism and stainless steel coils. The distal coil minton the contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE and silicone.
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It The Traxess Docking Which an use assist with a nitinol pipe and is coated with PTFE and silicone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 | Result |
|---|---|
| Physical attributes | Pass |
| Distal tip tensile strength | Pass |
| Tip flexibility | Pass |
| Distal tip torque strength | Pass |
| Coating adherence | Pass |
| Torqueability | Pass |
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |
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
1093397
510(k) Summary
DEC 1 7 2009
| Trade Name: | Traxcess 14EX Guidewire and Traxcess Docking Wire |
|---|---|
| Generic Name: | Guidewire |
| Classification: | Class II, 21 CFR 807.1330 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Naomi Gong |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K080863 | Traxcess 0.014" Hydrophilic Guidewire | April 7, 2008 |
| K080563 | Runthrough NS Extension Wire | March 20, 2008 |
Device Description:
The Traxcess 14EX Guidewire consists of a 0.014" stainless steel shaft and a tapered The Traxcess 14EA Guidewire consisted organism and stainless steel coils. The distal coil minton the contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE and silicone.
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It The Traxess Docking Which an use assist with a nitinol pipe and is coated with PTFE and silicone.
Indication For Use:
The Traxcess Guidewire and Traxcess Docking Wire 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 device is not intended for use in coronary arteries.
1
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Physical attributes | Pass |
| Distal tip tensile strength | Pass |
| Tip flexibility | Pass |
| Distal tip torque strength | Pass |
| Coating adherence | Pass |
| Torqueability | Pass |
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Traxcess 14EX Guidewire and Traxcess Docking Wire when compared with the predicate devices.
The devices,
- I Have the same intended use,
- 트 Use the same operating principle,
- 메 Incorporate the same basic design,
- I Use similar construction and material,
- Are packaged and sterilized using same material and processes.
In summary, the Traxcess 14EX Guidewire and Traxcess Docking Wire described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird-like figure, possibly representing a dove or other bird, with its wings spread. The bird is composed of three curved lines, giving it a sense of movement and flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Microvention Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
DEC 1 7 2009
Re: K093397
Trade Device Name: Traxcess 14EX Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 11, 2009 Received: December 14, 2009
Dear Ms. Gong:
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.
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.
3
Page 2 - Ms. Naomi Gong
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 of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k), Traxcess EX
MicroVention, Inc.
Indications for Use
510(k) Number (if known): _ K 0 93397
Traxcess 14EX Guidewire and Traxcess Docking Wire Device Name:
Indications For Use:
The Traxcess Guidewire and Traxcess Docking Wire 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 device is not intended for use in coronary arteries.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kog 3397
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