(88 days)
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No
The summary describes a mechanical guidewire and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a guidewire used to introduce and position other interventional devices, rather than directly treating a disease or condition itself.
No
Explanation: The device is a guidewire used to introduce and position catheters and interventional devices, which are therapeutic actions, not diagnostic. While it is used in angiographic procedures, the guidewire itself does not perform any diagnostic function.
No
The device description clearly states it is a "Steerable Guidewire," which is a physical medical device used in procedures, not a software-only application.
Based on the provided information, the Cordis STABILIZER Plus XS Steerable Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used within the body during a medical procedure, not a test performed outside the body on biological samples.
- Device Description: The description details a physical guidewire used for navigation and support within blood vessels. This is consistent with an invasive medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cordis STABILIZER Plus XS Steerable Guidewire does not fit this description.
N/A
Intended Use / Indications for Use
The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Product codes
74DQX
Device Description
The Cordis STABILIZER Plus XS Steerable Guidewire is an extra support version of the Cordis WIZDOM Steerable Guidewire. The extra support versions of the WIZDOM Steerable Guidewire utilize slightly larger diameter corewires and different tapers compared to the conventional WIZDOM guidewire in order to provide the extra support required for bulkier device (such as a stent) introduction.
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 and peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
PREMARKET NOTIFICATION Cordis Corporation STABILIZER™ Plus XS Steerable Guidewire
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
Common or Usual Name: Catheter Guide Wire
Proprietary Name: Cordis STABILIZER Plus XS Steerable Guidewire
II. Name of Predicate Devices
Cordis WIZDOM Steerable Guidewire (K953760) Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997) Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire
III. Classification
Catheter Guide Wire, Class II - 21 CFR 870.1330 74DQX - Cardiovascular
IV. Performance Standards
Performance standards have hot been established by the FDA under section 514 of the Food. Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Cordis STABILIZER Plus XS Steerable Guidewire is an extra support version of the Cordis WIZDOM Steerable Guidewire. The extra support versions of the WIZDOM Steerable Guidewire utilize slightly larger diameter corewires and different tapers compared to the conventional WIZDOM guidewire in order to provide the extra support required for bulkier device (such as a stent) introduction.
VI. Biocompatibility
The materials incoporated into the STABILIZER Plus XS are exactly the same as the materials used for the currently marketed WIZDOM Steerable Guidewire.