(152 days)
Not Found
No
The summary describes a physical medical device (guide wires) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
Explanation: The device is a guide wire intended to facilitate the placement of other catheters, not to directly treat a condition or disease itself. Guide wires are considered accessory devices in medical procedures.
No
The device, a guide wire, is intended to facilitate the placement of other catheters, not to diagnose medical conditions by providing information or measurements about the patient's health.
No
The device description clearly describes physical hardware components (guide wires, spring coil, core wire) and their physical properties (size, length, coating). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the guide wires are used within the body ("within the peripheral or coronary vasculature") to facilitate the placement of other devices (balloon catheters). This is an in vivo application, not in vitro.
- Lack of Diagnostic Purpose: The guide wires themselves do not perform any diagnostic testing on bodily specimens. Their purpose is purely mechanical – to guide other devices.
Therefore, based on the provided information, this device is a medical device used for interventional procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
Product codes
Not Found
Device Description
The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral or coronary 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
510(k) Summary
APR - 9 1996
Submitter's Name:
Contact Person:
510(k) Summary Date:
Device Names:
Classification Name:
Predicate Device:
Biocompatibles Limited
Brunel Science Park
Kingston Lane
Uxbridge
Middlesex UB8 3PQ
England
Tel. +44 1895 274481
Mr. Neil McLacian
Regulatory Affairs Manager
November 9, 1995
0.014" Floppy Guide Wire with
Phosphorylcholine Polymer (PCP) Coating and
0.014" Intermediate Guide Wire with Phosphorylcholine
Polymer (PCP) Coating
Catheter Guide Wire (21 CFR 870.1330)
Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque
Floppy II® Guide Wire and 0.014" Hi-Torque Intermediate®
Guide Wire
Device Description:
The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.
Intended Use:
The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
000001