(88 days)
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No
The document describes a physical guidewire and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guidewire, designed to assist in the delivery of a balloon dilatation catheter or stent, not to provide therapy itself.
No
The device description indicates its purpose is to physically reach and cross stenotic lesions for catheter insertion, not to identify or diagnose conditions.
No
The device description clearly states it is a physical guidewire made of stainless steel with a radiopaque tungsten spring coil, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter" and "prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical guidewire made of stainless steel with a flexible tip and radiopaque coil. This is consistent with a medical device used for navigation within blood vessels, not a device for analyzing biological samples.
- Anatomical Site: The anatomical site is "coronary," referring to the arteries of the heart. This further supports the use of the device within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are typically used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural, facilitating the delivery of other devices within the coronary arteries.
N/A
Intended Use / Indications for Use
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The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter.
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Schneider steerable stont support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device.
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Any use other than that intended is not recommended.
Product codes
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Device Description
The HANNIBAL " Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, HIHE coated proximal shatt, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coll. which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The dietal part of the coil is very flexible and shapeable.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Equivalence in technological characteristics was substantiated by comparative performance lesting including bond strength, tip flexibility, coating adhesion, torque and compatibility with interventional devices. Because matcrials used were the same as those used in other Schneider guidewires, a reduced biocompatibility battery, consisting of hemnlysis and cytotoxicity, was conducted.
The results of all testing indicated that the HANNIBAL™ guidewire is equivalent to the ACS I li-Torque Extra S'port " guidewire and is, therefore, safe for the intended use.
Key Metrics
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Predicate Device(s)
ACS Hi-Torque Extra S'port™ Guidewire, C-Thru Coronary Guidewire
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Summary for HANNIBAL™ Guidewire
MAY - 9 1997
This summary of 510(k) safety and effectivencess information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The sesigned 510(k) number is K97049.4
February 4, 1997 Date propared:
| Sponsor: | |
|---|---|
| ---------- | -- |
Schneider (Europe) AG Ackerstrusse 6 PO Box CH-8180 Bulach, Switzerland
Contact:
Rudolf Ott V.P. Clinical and Regulatory Affairs Phone: 011-411-8721179
| Trade/Proprietary Name: | HANNIBAL™ Guidewire |
|---|---|
| Classification: | Class II |
| Equivalent Devices: | ACS Hi-Torque Extra S'port™ Guidewire (performance) |
| C-Thru Coronary Guidewire (materials, sterilization, packaging) |
Device Description
The HANNIBAL " Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, HIHE coated proximal shatt, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coll. which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The dietal part of the coil is very flexible and shapeable.
Intended Use
-
The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter.
-
Schneider steerable stont support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device.
-
Any use other than that intended is not recommended.
Technological characteristics
Equivalence in technological characteristics was substantiated by comparative performance lesting including bond strength, tip flexibility, coating adhesion, torque and compatibility with interventional devices. Because matcrials used were the same as those used in other Schneider guidewires, a reduced biocompatibility battery, consisting of hemnlysis and cytotoxicity, was conducted.
The results of all testing indicated that the HANNIBAL™ guidewire is equivalent to the ACS I li-Torque Extra S'port " guidewire and is, therefore, safe for the intended use.