(23 days)
No
The device description and intended use focus on the physical characteristics and function of a micro catheter for infusion, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a micro catheter intended for infusing therapeutic agents, not a therapeutic agent itself or a device that performs therapy.
No
The device is intended for the infusion of therapeutic agents or contrast media, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter with a lumen, shaft, radiopaque markers, and coating, indicating it is a hardware device.
No, 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 a therapeutic and diagnostic procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into the body's vasculature. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the MTI Echelon™ Micro Catheter is a medical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The MTI Echelon™ 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. This is the same intended use as predicate device Rebar® Micro Catheter K993672.
Product codes
KRA
Device Description
The MTI Echelon™ 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
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
In-vitro performance testing of the MTI Echelon™ 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 Echelon™ 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
Micro Therapeutics, Inc. Special 510(k) (modifications to K993672) Echelon™ Micro Catheter
February 28, 2003
Image /page/0/Picture/1 description: The image shows the text "K030688" in a handwritten style. Below this text, the date "MAR 2 8 2003" is printed in a sans-serif font. The date indicates that the image or document associated with this text was created or processed on March 28, 2003. The handwritten text likely serves as an identifier or code for the document.
510(k) Summary 4.
| TRADE NAME
GENERIC NAME
CLASSIFICATION | Echelon™ Micro Catheter
Catheter, Continuous Flush
Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| SUBMITTED BY | Micro Therapeutics, Inc.
2 Goodyear
Irvine, CA 92618 | Marilyn R. Pourazar
Regulatory Affairs
(949) 837-3700 |
| PREDICATE
DEVICE(S) | MTI Rebar® Micro Catheter (K993672) | |
| DEVICE
DESCRIPTION | The MTI Echelon™ 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. | |
| INDICATIONS
FOR USE | The MTI Echelon™ 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. This
is the same intended use as predicate device Rebar® Micro Catheter
K993672. | |
| TESTING | In-vitro performance testing of the MTI Echelon™ 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 Echelon™ 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 (