(17 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any computational processing of data.
No.
The device is intended to facilitate other procedures and devices (introduce and position catheters and interventional devices, facilitate alignment, function as a measurement tool) rather than directly treat a condition or disease itself.
No
Explanation: The device is a guidewire used to introduce and position catheters and devices, facilitate alignment, and function as a measurement tool within the vasculature. Its primary functions are interventional and procedural, not diagnostic.
No
The device description clearly lists physical components such as a stainless steel corewire, coilwire, marker bands, and PTFE coating, indicating it is a physical medical 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 the device is for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. This is an in-vivo (within the living body) application.
- Device Description: The description details the physical components of a guidewire used in interventional procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with structures within the body during a procedure.
N/A
Intended Use / Indications for Use
The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.
Product codes
DQX
Device Description
The device description of the ATW Marker Wire Steerable Guidewire is as follows.
• Stainless Steel Corewire,
• Radiopaque platinum / nickel coilwire,
• Radiopaque Marker Bands with optional spacing (See package labeling), and
• PTFE coating on shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994358, Wizdom Marker Wire Steerable Guidewire, Stabilizer Marker Wire Steerable Guidewire, ST Steerable Guidewire
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.
0
Attachment 4
AN 13 2000
Attachment 4
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: ATW Marker Wire Steerable Guidewire
Common/Classification Name: Catheter Guide Wire |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Wizdom Marker Wire Steerable Guidewire
Stabilizer Marker Wire Steerable Guidewire
ST Steerable Guidewire |
| Classification | Class II |
| Performance
Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established
performance standards. |
| Intended Use
and Device
Description | The Cordis ATW Marker Wire Steerable Guidewires are intended for use in
angiographic procedures to introduce and position catheters and interventional devices
within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker
Wire Steerable Guidewires are intended to facilitate the alignment of interventional
devices and function as a measurement tool. |
| | The device description of the ATW Marker Wire Steerable Guidewire is as follows.
• Stainless Steel Corewire,
• Radiopaque platinum / nickel coilwire,
• Radiopaque Marker Bands with optional spacing (See package labeling), and
• PTFE coating on shaft. |
| Biocompatibility | All materials used in the ATW Marker Wire Steerable Guidewires are biocompatible. |
| Summary of
Substantial
Equivalence | The ATW Marker Wire Steerable Guidewires are substantially equivalent to the
previously cleared ST Steerable Guidewire, Wizdom Marker Wire, and Stabilizer
Marker Wire Steerable Guidewires. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Mr. Dennis Griffin Manager, Requlatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Re: K994358 Trade Name: ATW Marker Wire Steerable Guidewire Regulatory Class: II Product Code: DQX December 20, 1999 Dated: Received: December 27, 1999
Dear Mr. Griffin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
2
Page 2 - Mr. Dennis Griffin
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the requlation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.tda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ouitopm. Al-for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indications for Use Statement
| 510(k) Number
| (if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | ATW Marker Wire Steerable Guidewire |
| Indications for | |
| Use | The Cordis guidewires are intended for use in angiographic procedures to introduce |
| and position catheters and interventional devices within the coronary and peripheral | |
| vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are | |
| intended to facilitate the alignment of interventional devices and function as a | |
| measurement tool. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
for Witten
Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K994358