(135 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the placement of other therapeutic devices (balloon dilatation catheters) but is not itself performing a therapeutic function.
No
The device is a guide wire used to facilitate the placement of other catheters. Its intended use is mechanical/operational for a medical procedure, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like a core wire, tip coil, and surface coatings, and the performance studies involve physical tests like tensile strength and bend strength, 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 is to "facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA)." This describes a device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. It does not describe a device used to examine specimens taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly within the body.
N/A
Intended Use / Indications for Use
The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes
DQX
Device Description
The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.
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
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS) to the unmodified device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445).
- . Dimensional Inspection
- Tip sliding resistance test
- Tensile strength of tip .
- Tip butting load ●
- Tensile strength of shaft .
- Wire stability in holder loop .
- Bend strength ●
- Seal strength of packaging .
- Reshapability .
- Torque Strength ●
- Torqueability .
- Tip Flexibility .
- Coating Adherence/Integrity .
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.
0
Kd63695
SECTION II. 510(K) SUMMARY
A. Device Name
APR 2 7 2007
| Proprietary Name | Runthrough NS |
|---|---|
| Classification Name | Wire, Guide, Catheter |
| Common Name | Guide Wire |
B. Intended Use
The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Note: This is the same intended use as the predicate device - Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.
C. Device Description
The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.
D. Principle Of Operation / Technology
The Runthrough NS is operated manually or by a manual process.
1
E. Design / Materials
Differences in materials between the modified device and the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil cleared under K961445 raise no new issues of safety and effectiveness.
F. Specifications
| Feature | Modified Runthrough NS | Unmodified Device
Radifocus® Glidewire
for Coronary Use with
Platinum or Gold Coil
cleared under K961445 |
|--------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Available diameter | 0.014" ( 0.36mm ) | 0.014" ( 0.36mm ) |
| Available length | 180cm, 300cm | 180cm, 300cm |
| Tip marker length | 30mm | 20mm |
| Accessory Devices | Torque Device, Inserter,
Stylet | Torque Device, Inserter |
| Shelf life | 36 months | 24 months |
2
G. Performance
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS) to the unmodified device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445).
- . Dimensional Inspection
- Tip sliding resistance test
- Tensile strength of tip .
- Tip butting load ●
- Tensile strength of shaft .
- Wire stability in holder loop .
- Bend strength ●
- Seal strength of packaging .
- Reshapability .
- Torque Strength ●
- Torqueability .
- Tip Flexibility .
- Coating Adherence/Integrity .
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The guide wire is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (