(91 days)
No
The summary describes a traditional guidewire and makes no mention of AI, ML, or related concepts.
No
The device is described as intended for the "introduction and positioning of catheters and interventional devices," which are typically diagnostic or interventional tools, not therapeutic in themselves. Its function is to facilitate other procedures, not to directly treat a condition.
No
The device is a guidewire, which is used for the introduction and positioning of other medical devices (catheters and interventional devices), not for diagnosing. Its function is to facilitate the delivery of other devices.
No
The device description clearly states "The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires," indicating a physical, hardware-based medical device.
Based on the provided information, the ESSENCE™ Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the guidewire is for "introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems." This describes a device used within the body for medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description focuses on its physical characteristics and similarity to other steerable guidewires used in interventional procedures.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on laboratory analysis.
Therefore, the ESSENCE™ Guidewire is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ESSENCE™ Guidewires are intendedfor the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The mid value a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.
Product codes
Not Found
Device Description
The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neurovascular systems
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cordis Endovascular Systems, Inc. Instinct® Steerable Guidewire (K930982), Cordis Corporation Reflex Steerable Guidewire (K905432), Target Therapeutics Dasher Guidewire (K914030)
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
PREMARKET NOTIFICATION 510(k) Cordis Endovascular Systems, Inc. ESSENCE™ Stainless Steel Guidewire
0-00015
SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 1 1964
General Provisions: I.
Steerable Guidewire Common or Usual Name:
ESSENCE™ Guidewire Proprietary Name:
Name of Predicate Devices II.
Cordis Endovascular Systems, Inc. Instinct® Steerable Guidewire (K930982)
Cordis Corporation Reflex Steerable Guidewire (K905432)
Target Therapeutics Dasher Guidewire (K914030)
Classification: III.
Class II
Image /page/0/Picture/25 description: The image shows a black and white close-up of what appears to be a person's head and shoulder. The person's face is not visible, and the image is mostly black. The background is white, which creates a high contrast with the dark figure.
Performance Standards: IV.
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description V.
The ESSENCE™ Guidewires are intendedfor the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The mid value a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.
VI. Biocompatibility
All appropriate biocompatibility tests were successfully performed on the Cordis Endovascular Systems, Inc. ESSENCE™ Guidewire.
VII. Summary of Substantial Equivalence
The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.
Image /page/0/Picture/23 description: The image shows a black blob on a white background. The blob is roughly oval-shaped, with a slightly irregular edge. The blob is solid black, with no visible texture or detail. The white background is plain and featureless. The blob is positioned on the left side of the image.
Image /page/0/Picture/24 description: The image shows a black and white silhouette of a bush or shrub. The bush is dense and has an irregular shape. The background is white, which helps to highlight the dark silhouette of the bush.