(20 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 AI or ML.
No
The device is used to facilitate the placement of diagnostic or therapeutic catheters, but it is not itself a therapeutic device. It helps in the delivery of other devices that might be therapeutic.
No
Explanation: The device is a guidewire used to facilitate the placement of catheters, which can be diagnostic or therapeutic. The guidewire itself does not perform any diagnostic function.
No
The device description clearly outlines physical components (stainless steel shaft, nitinol tip, platinum and stainless steel coils, coatings) and performance studies focus on physical characteristics and animal testing, indicating a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Traxcess 0.014" Hydrophilic Guidewire clearly indicate it is a medical device used within the body (intravascularly) to facilitate the placement of catheters. It is a tool used during a medical procedure, not a test performed on a sample outside the body.
The information provided aligns with a Class II or Class III medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Traxcess 0.014" Hydrophilic 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 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 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The distal coil section contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE. The Guidewire is available in a variety of coil tip and overall lengths to suit the needs of the clinician.
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)
Nonclinical testing was completed in accordance with the FDA guidance document entitled "Coronary and Cerebrovascular Guidewire Guidance, January 1995". In summary, physical tests were performed to characterize that the tensile strength, torque strength, torqueability, tip flexibility, coatings, biocompatibility, and catheter compatibility were suitable for its intended use. In addition, animal testing was performed to confirm guidewire performance.
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
510(k) Summary
| Trade Name: | Traxcess 0.014" Hydrophilic Guidewire | APR 17 20 |
|---|---|---|
| Generic Name: | Guidewire | |
| Classification: | Class II, 807.1330 | |
| Submitted By: | MicroVention, Inc. | |
| 75 Columbia, Suite A | ||
| Aliso Viejo, CA 92656 | ||
| Contact: | Kevin E. Daly | |
| Predicate Devices: | Runthrough NS (K063695) | |
| Transend EX Platinum Guidewire (K971254) | ||
| Radifocus Glidewire GT with Gold Coil (K955801) |
Device Description:
The Traxcess 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The distal coil section contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE. The Guidewire is available in a variety of coil tip and overall lengths to suit the needs of the clinician.
Indications for Use:
The Traxcess 0.014" Hydrophilic 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 device is not intended for use in coronary arteries.
Nonclinical Testing:
Nonclinical testing was completed in accordance with the FDA guidance document entitled "Coronary and Cerebrovascular Guidewire Guidance, January 1995". In summary, physical tests were performed to characterize that the tensile strength, torque strength, torqueability, tip flexibility, coatings, biocompatibility, and catheter compatibility were suitable for its intended use. In addition, animal testing was performed to confirm guidewire performance.
Summary:
Based upon the technical and performance attributes of the Traxcess 0.014" Hydrophilic Guidewire, this device is substantially equivalent to the cited predicate devices.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Regulatory Technology Services LLC c/o Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313
Re: K080863
Traxcess 0.014" Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: March 27, 2008 Received: March 28, 2008
Dear Mr. Job:
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 such 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.
2
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
er R. Vachner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ¥090863
Device Name: Traxcess 0.014" Hydrophilic Guidewire
Indications for Use:
The Traxcess 0.014" Hydrophilic 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 device is not intended for use in coronary arteries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. de Anus
(Division Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices
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