(210 days)
Not Found
No
The device description focuses on the physical construction and mechanical properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended to facilitate the navigation and placement of other medical devices, not to directly treat a medical condition or disease.
No
The device is described as facilitating the navigation and placement of other devices, indicating an interventional or supportive role, not a diagnostic one.
No
The device description clearly details a physical guidewire constructed from stainless steel and gold alloy, with specific dimensions and coatings. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details the physical construction of a guidewire designed for insertion into blood vessels. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
Therefore, the IVT 0.014" Railwire™ is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
Product codes
Not Found
Device Description
The IVT 0.014" Railwire™ is constructed from a stainless steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2 * in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are secured together at two points. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. This design provides both unibody integrity and flexibility. The IVT Railwire™ will be manufactured in various lengths ranging from 100 to 300 cms. All Railwire™s will receive a final parylene (polypara-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the Railwire™ allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Biocompatibility and physical performance testing demonstrates the Railwire™ product to be safe and effective. Information provided in the 510(k) submission supports the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS DATA 9 .
InterVentional Technologies Inc. (IVT) SUBMITTER :
September 28, 1995 DATE:
Guidewire DEVICE NAME:
0.014" Railwire™ PROPRIETARY NAME:
Michael E. Klicpera, Esq. CONTACT : Corporate Counsel
Guidewires classified under 21 CFR 870.1330 CLASSIFICATION :
PREDICATED DEVICES:
IVT is claiming substantial equivalence to the following predicate medical devices:
DEVICE DESCRIPTION: 1.
The IVT 0.014" Railwire™ is constructed from a stainless steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible.
The core is nominally 0.0136" in diameter. The coil, approximately 1.2 * in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are The core is inserted into the coil secured together at two points. lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb.
51
jy
1
This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core This design provides both unibody using a silver alloy solder. integrity and flexibility.
The IVT Railwire™ will be manufactured in various lengths ranging from 100 to 300 cms. All Railwire™s will receive a final parylene (polypara-xylyene) coating prior to packaging and sterilization.
Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the Railwire™ allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.
2. INTENDED USE:
The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
SUBSTANTIAL EQUIVALENCE: 3.
The intended use of the IVT 0.014" Railwire™ is the same as that for other predicate quidewire devices. The materials and design of the Railwire™ are similar to these previously FDA cleared guidewires. The technical characteristics of the Railwire™ do not introduce new questions regarding safety or effectiveness of cardiovascular guidewires. The labeling Railwire™ provides similar information with the as the associated predicate devices.
Biocompatibility demonstrates and physical performance testing the Railwire™ product to be safe and effective. Information provided in the 510(k) submission supports the determination of substantial equivalence.
In summary IVT has provided evidence that shows the Railwire™ device to be safe and effective. This guidewire is considered to be substantially equivalent to similar marketed devices.