(81 days)
Not Found
No
The description focuses on the physical characteristics and performance of a micro catheter, with no mention of AI or ML.
No
The device is described as a micro catheter intended for the controlled selective infusion of physician-specified therapeutic agents, but it is not itself a therapeutic agent or device that provides therapy. Its function is to deliver therapeutic agents.
No
The device is a micro catheter intended for accessing vasculature and infusing therapeutic or diagnostic agents. While it can deliver diagnostic materials like contrast media, the catheter itself does not perform diagnostic functions. It is a delivery tool, not a diagnostic device.
No
The device description clearly describes a physical catheter, which is a hardware component. The performance studies also focus on physical properties and biocompatibility of the catheter.
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 accessing vasculature for the infusion of therapeutic and diagnostic agents. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter designed for insertion into blood vessels. This aligns with an in vivo medical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside the body, which is the core function of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to deliver substances into the body.
N/A
Intended Use / Indications for Use
The MTI Nautica™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
Product codes
74 KRA
Device Description
The MTI Nautica™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-specified
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
In-vitro performance testing of the MTI Nautica™ Micro Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. The biocompatibility of the MTI Nautica™ Micro Catheter was verified in accordance with ISO 10993-1. Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter was tested as an external communicating, blood contact, limited exposure (
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
MTI Confidential
MAR 0 7 2003
510(k) Summary 4.
Micro Therapeutics, Inc.
Nautica™ Micro Catheter December 12, 2002
Special 510(k) (modifications to K022003)
Prepared December 13, 2002 Nautica™ Micro Catheter TRADE NAME Catheter, Continuous Flush GENERIC NAME Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 CLASSIFICATION SUBMITTED BY Micro Therapeutics, Inc. CONTACT M 2 Goodyear Regulatory Affairs (949) 837-3700 Irvine, CA 92618 PREDICATE MTI Titan™ Micro Catheter (K022003) DEVICE(S) MTI Rebar® Micro Catheter (K993672) The MTI Nautica™ Micro Catheter is an end-hole, single-lumen DEVICE catheter designed to be introduced over a steerable guidewire into the DESCRIPTION vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity. INDICATIONS The MTI Nautica™ Micro Catheter is intended to access peripheral FOR USE and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature. TESTING In-vitro performance testing of the MTI Nautica™ Micro Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. The biocompatibility of the MTI Nautica™ Micro Catheter was verified in accordance with ISO 10993-1. Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter was tested as an external communicating, blood contact, limited exposure (