(85 days)
CINCH® 3 Steerable Guidewire Extension
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is designed to extend guidewires for catheter exchange, which is a procedural aid rather than a direct therapeutic intervention.
No
The document describes a guidewire extension used to exchange catheters, which is a procedural function, not a diagnostic one.
No
The device description clearly states it is a "flexible stainless steel wire coated with DURAGLIDETM", indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to extend a guidewire to facilitate catheter exchange within the body. This is an invasive procedure, not a test performed on samples taken from the body.
- Device Description: The description details a physical wire used for medical procedures, not a reagent, instrument, or system intended for the examination of specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to diagnose diseases or conditions. This device is clearly used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter
Product codes
Not Found
Device Description
The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
CINCH® 3 Steerable Guidewire Extension
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
NOV - 7 1996
Image /page/0/Picture/1 description: The image shows a series of numbers and a letter, all in a bold, black font. The characters are 'K963171'. The numbers are unevenly spaced and appear to be handwritten or stamped. The background is white.
PREMARKET NOTIFICATION 510(k) Cordis Corporation Cinch® QR Steerable Guidewire Extension
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
Common or Usual Name: Catheter Guide Wire (Accessory) Proprietary Name: Cordis CINCH® QR Steerable Guidewire Extension
II. Name of Predicate Devices
CINCH® 3 Steerable Guidewire Extension
III. Classification
Catheter Guide Wire Accessory, Class II - 21 CFR 870.1330
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter
The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.
VI. Biocompatibility
Biocompatibility testing was not repeated since the CINCH® QR and the currently marketed CINCH® 3 (K914863) Steerable Guidewire Extensions are made of the same materials. The DURAGLIDE™ coating and method of application have also been cleared for use with the WIZDOM™ Steerable Guidewire (K953760).