(434 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the guidewire, with no mention of AI/ML or related concepts.
Yes
The device is used to aid in the selective placement of catheters during "therapeutic procedures."
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used "during diagnostic and/or therapeutic procedures," indicating it can be used for diagnostic purposes.
No
The device description clearly states it is a physical guidewire constructed of Nitinol and other materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HyTek Guidewire is for "general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details the physical construction of a guidewire, including materials and coatings, which are typical for an invasive medical device.
- 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 examination.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The HyTek Guidewire's function is purely mechanical and procedural within the vascular system.
N/A
Intended Use / Indications for Use
The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
Product codes
Not Found
Device Description
The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral and visceral 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
The HyTek Guidewire successfully underwent all functional and safety testing including tensile strength, torqueability and torque strength, tip flexibility and coating adhesion testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Microvena Corporation. The logo features a stylized "M" symbol on the left, followed by the word "MICROVENA" in bold, sans-serif font. Below "MICROVENA" is the word "CORPORATION" in a smaller font size. A thick black line extends from the top of the "M" symbol over the word "MICROVENA".
510(k) SUMMARY
| Contact/Submitter: | Christine M. Busch, Regulatory Affairs Associate |
|---|---|
| Date Prepared: | December 12, 1996 |
| Trade Name: | The “HyTek” Hydrophilic Guidewire |
| Common Name: | Guidewire |
| Classification Name: | Wire Guide Catheter (per 21 CFR 870.1330) |
| Predicate Devices: | HydroTorque™ Guide Wire (K935232) |
| ACS HI-TORQUE Guidewires | |
| The “NINER” .009” PTCA Guidewire (K952860) |
Device Description: The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.
The M-PATH PTCA Guidewire (K946356)
The HyTek Guidewire is intended for general intravascular use to Intended Use: aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
Functional/Safety
The HyTek Guidewire successfully underwent all functional and Testing: safety testing including tensile strength, torqueability and torque strength, tip flexibility and coating adhesion testing.
Conclusion: The HyTek Guidewire is substantially equivalent to the predicate devices based on the results of the functional testing.