(263 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a guidewire, with no mention of AI or ML technologies.
No
The device is a guidewire used to facilitate the placement of other percutaneous intervention devices and does not directly provide therapy.
No
Explanation: The device, a guidewire, is intended to facilitate the placement of other interventional devices and aid in navigating vasculature, not to diagnose a condition. Its use is prior to percutaneous intervention, indicating a preparatory rather than diagnostic role.
No
The device description clearly details a physical guidewire, handle control, and support accessory, all of which are hardware components. It is not solely software.
Based on the provided information, the CiTop™ Guidewire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "angiographic procedures to facilitate the intra-luminal placement of the wire... in the peripheral vasculature prior to further percutaneous intervention." This describes a device used within the body for a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical guidewire designed for navigation within blood vessels, including features for torque, tip shaping, and visualization under fluoroscopy. These are characteristics of an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used with biological specimens (blood, tissue, etc.) or providing diagnostic information based on the analysis of such specimens.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CiTop™ Guidewire's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Product codes
DQX
Device Description
The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm.
The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy.
The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire .
The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization.
The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
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
Biocompatibility of the CiTop™ 0.014" Guidewire materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (
§ 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 CiTop™ 0.014" Guidewire
Date: August 29, 2007
Submitter Information:
JCI 1 2 /007
OVALUM Ltd. 10. Plaut St. Rabin Industrial Park, Rehovot Israel 76706 Tel: (972)-8-9315679 Fax: (972)-8-9318107
Contact Person:
Naáma Oren Director of QA and Regulatory Affairs
Device Identification
| Trade Name: | CiTop™ 0.014" Guidewire |
|---|---|
| Device Common Name: | Catheter Guide Wire |
| Classification Name: | Catheter Guide Wire |
| Classification: | Class II (74 DQX/21CFR 870.1330) |
Predicate devices:
The CiTop™ 0.014" Guidewire is substantially equivalent to the following predicate devices:
- · Asahi PTCA & PTA guidewire Confianza Pro cleared under K041531
- · Cordis STEER-IT Guidewire cleared under K040592;
- · LuMend Frontrunner CTO Catheter and Accessories K013284
Device Description:
The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm.
The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy.
The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates
1
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as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire .
The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization.
The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
Intended Use
The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Technological Characteristics
The components of the CiTop™ 0.014" Guidewire are similar in basic materials. design, construction and performance to the predicate devices. The distal tip has been designed to improve performance characteristics in passing total occlusions (i.e. tip flexibility, tip shaping and shape retention / relaxation).
Safety and Performance Testing
Biocompatibility of the CiTop™ 0.014" Guidewire materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (