(187 days)
ACS® Hi Torque Floppy II® Guide Wire, Scimed® Sceptor™ Floppy Guide Wire
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No
The description focuses on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML technologies.
No
The device is a guide wire used to introduce and place interventional catheters, which are therapeutic devices, but the guide wire itself does not perform therapy.
No
Explanation: The Medtronic® MUSTANG™ Steerable Guide Wire is used to introduce and place interventional catheters. It is a tool for therapy delivery, not for diagnosing conditions or generating diagnostic information.
No
The device description clearly describes a physical guide wire with specific material properties, coatings, and a spring, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA)." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is a surgical/interventional tool, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents, calibrators, or controls
This device is an interventional medical device used in a surgical procedure.
N/A
Intended Use / Indications for Use
The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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
coronary
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was performed to assess the biocompatibility of the device. Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACS® Hi Torque Floppy II® Guide Wire, Scimed® Sceptor™ Floppy Guide Wire
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 20 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
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- The trade or proprietary name of the device is the Medtronio® MUSTANG™ Steerable Guide Wire. The common or classification name is Coronary Guidewire.
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- The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
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- The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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- In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was performed to assess the biocompatibility of the device.
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- Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use. The MUSTANG™ is considered to be substantially equivalent to the following devices:
ACS® Hi Torque Floppy II® Guide Wire
Scimed® Sceptor™ Floppy Guide Wire