(86 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter and injector, with no mention of AI or ML.
No.
The devices are designed for controlled infusion of therapeutic agents, not for the therapeutic effect itself.
No
Explanation: The device is intended for the controlled selective infusion of therapeutic agents or contrast media, which are therapeutic or interventional functions, not diagnostic ones. Neither the device description nor the intended use mentions any diagnostic capabilities like imaging, signal acquisition for analysis, or disease detection.
No
The device description clearly details physical hardware components: a micro catheter and an injector, with no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled selective infusion of therapeutic agents or contrast media into the vasculature. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The device is a micro catheter and an injector designed for delivering substances directly into the body's blood vessels. This aligns with an in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
Therefore, the MTI Titan Micro Catheter and MTI HD Injector are medical devices intended for therapeutic or imaging procedures performed within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Titan Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The MTI HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan™ Micro Catheter.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DQF
Device Description
The MTI Titan™ 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. The catheter is provided with a removable adapter for attachment to either standard luer fitting devices or the MTI HD Injector.
The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing needle. The connector at the distal end of the injector is threaded for connecting to the MTI Titan™ Micro Catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature of the peripheral and neuro anatomy
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)
In-vitro performance testing of the MTI Titan™ Micro Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. The accessory MTI HD Injector underwent in-vitro performance testing including dimensional inspection, injection rate, thread engagement, clip movement, needle detachment, integrity of attachment to Titan Micro Catheter, fit of piston in barrel and leakage. The biocompatibility of the MTI Titan™ Micro Catheter and accessory MTI HD Injector was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter and injector when tested as an external communicating, blood contact, limited exposure (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Micro Therapeutics, Inc.
Traditional 510(k) (modifications to K993672 and K011535) Titan™ Micro Catheter and MTI HD Injector Syringe June 18, 2002
4. 510(k) Summary
| Prepared June 18, 2002 | |||
|---|---|---|---|
| TRADE NAME | |||
| GENERIC NAME | |||
| CLASSIFICATION | Titan™ Micro Catheter and accessory HD Injector | ||
| Catheter, Continuous Flush and Syringe | |||
| Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 | |||
| SUBMITTED BY | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, CA 92618 | CONTACT | Bill Hyatt | |
| Regulatory Affairs | |||
| (949) 837-3700 | |||
| PREDICATE | |||
| DEVICE(S) | MTI Rebar™ Micro Catheter (K993672) | ||
| MTI Cadence Precision Injector (K011535) | |||
| DEVICE | |||
| DESCRIPTION | The MTI Titan™ 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. The catheter is provided with a removable adapter for | |||
| attachment to either standard luer fitting devices or the MTI HD Injector. | |||
| The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing | |||
| needle. The connector at the distal end of the injector is threaded for connecting to | |||
| the MTI Titan™ Micro Catheter. | |||
| INDICATIONS FOR | |||
| USE | The Titan Micro Catheter is intended for the controlled selective infusion of | ||
| physician-specified therapeutic agents or contrast media into the vasculature of the | |||
| peripheral and neuro anatomy. | |||
| The MTI HD Injector is intended for the infusion of physician-specified fluids with | |||
| the MTI Titan™ Micro Catheter | |||
| TESTING | In-vitro performance testing of the MTI Titan™ Micro Catheter included | ||
| dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, | |||
| torque tests and performance under simulated conditions. The accessory | |||
| MTI HD Injector underwent in-vitro performance testing including dimensional | |||
| inspection, injection rate, thread engagement, clip movement, needle detachment, | |||
| integrity of attachment to Titan Micro Catheter, fit of piston in barrel and leakage. | |||
| The biocompatibility of the MTI Titan™ Micro Catheter and accessory | |||
| MTI HD Injector was verified in accordance with ISO 10993-1, Biological | |||
| Evaluation of Medical Devices. Test results confirmed biocompatibility of the | |||
| catheter and injector when tested as an external communicating, blood contact, | |||
| limited exposure ( |