(91 days)
Not Found
No
The summary describes a physical medical device (a wire) and its intended use and performance through bench testing. There is no mention of software, algorithms, image processing, AI, or ML.
No.
The "Intended Use / Indications for Use" states that the device "can be used with Traxcess guidewires to facilitate the placement of diagnostic or therapeutic catheters," identifying it as an accessory to aid in the placement of therapeutic devices, rather than being a therapeutic device itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the device "can be used with Traxcess guidewires to facilitate the placement of diagnostic or therapeutic catheters," but the device itself is an accessory (docking wire) that extends a guidewire, rather than performing a diagnostic function directly.
No
The device description explicitly states it consists of a stainless steel shaft with a nitinol pipe, indicating it is a physical 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 "general intravascular use" to "facilitate the placement of diagnostic or therapeutic catheters." This describes a device used within the body for a procedural purpose, not a device used to examine samples outside the body to diagnose a condition.
- Device Description: The description details a physical wire used for extending another wire, consistent with an interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Traxcess Docking Wire can be used with Traxcess guidewires to facilitate the placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Product codes
DQX
Device Description
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It consists of a stainless steel shaft 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
Bench Testing:
- Attachment with docking wire: Pass
- Docking wire tensile strength: Pass
- Simulated use testing (Tracking, supportability, microcatheter compatibility/exchange, repositioning): Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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FEB 2 4 2010 1093647
510(k) Summary
| Trade Name: | Traxcess Docking Wire |
|---|---|
| Generic Name: | Guidewire |
| Classification: | Class II, 21 CFR 870.1330 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Naomi Gong |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K080563 | Runthrough NS Extension Wire | March 20, 2008 |
Device Description:
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It consists of a stainless steel shaft with a nitinol pipe and is coated with PTFE and silicone.
Indication For Use:
The 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.
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Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |
| Simulated use testing |
- Tracking, supportability, microcatheter compatibility/exchange, repositioning | Pass |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Traxcess Docking Wire when compared with the predicate device.
The device
- Uses the same operating principle, .
- Incorporates the same basic design,
- Uses similar construction and material, ■
- Is packaged and sterilized using same material and processes. .
In summary, the 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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Microvention. Inc. Ms. Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
FEB 2 4 2010
Re: K093647
Trade/Device Name: Traxcess Docking Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2010 Received: January 15, 2010
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Gong
forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
R. hamer
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_Kuji5647
Device Name: Traxcess Docking Wire
Indications For Use:
ﺘﻨ ﺗ
The Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Traxcess Docking Wire can be used with Traxcess guidewires to facilitate the 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)
NURSERY Rhymes
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K093647
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