(89 days)
No
The device description and intended use focus on the physical characteristics and function of a guidewire, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a guidewire used to introduce and position other medical devices, not to treat a disease or condition itself.
No
The device is a guidewire, used to introduce and position other devices during angiographic procedures, not to diagnose a condition itself.
No
The device description clearly states it incorporates physical components like a stainless steel corewire, radiopaque coil, and PTFE coating, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details the physical components of a guidewire used in interventional procedures (corewire, coil, coating). This aligns with a medical device used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Cordis ST 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 ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
NOV 13
02...00023??
963214
PREMARKET NOTIFICATION Cordis Corporation ST Steerable Guidewire
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Common or Usual Name: Catheter Guide Wire
Proprietary Name: Cordis ST Steerable Guidewire
Name of Predicate Devices II.
Cordis WIZDOM Steerable Guidewire (K953760) ACS HI-TORQUE FLOPPY/FLOPPY II/Intermediate/Standard Guide Wire (K881897)
III. Classification
Catheter Guide Wire, Class II - 21 CFR 870.1330 74DQX - Cardiovascular Devices
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 ST 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 ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.
VI. Biocompatibility
All materials have been tested as specified by the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). All material demonstrated compatibility with biological tissue by meeting the acceptance requirements stipulated in the test protocols.