TVC Insight™

Basic Information

• Brand Name: TVC Insight™
• Primary DI: 00857595006203
• Version / Model: TVC-C195-20
• Catalog Number: TVC-C195-20
• Company Name: INFRAREDX, INC.
• Labeler DUNS: 124065421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 5
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 565abbe7-5f5e-4713-8b08-7ff43e15c342

Device Description

Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer. Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857595006203	GS1
Package	00857595006302	GS1	Carton	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123108	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Shaft Diameter 3.6 French
Device Size Text, specify			Entry Diameter 2.4 French
Length	160	Centimeter
Device Size Text, specify			Crossing Profile 3.2 French
Device Size Text, specify			Max Guidewire Diameter 0.014 inch
Device Size Text, specify			Guide Catheter Inner Diameter 1.70mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.