(21 days)
Not Found
No
The description focuses on the physical characteristics and performance of a micro catheter, with no mention of AI or ML capabilities.
No
The device is described as a micro catheter intended to deliver therapeutic agents or diagnostic materials, but it is not itself a therapeutic agent or treatment method.
No
Explanation: The device is intended for the infusion of therapeutic and diagnostic materials, not for the diagnosis of a medical condition itself. It facilitates the delivery of diagnostic materials (like contrast media), but it is a delivery tool, not a diagnostic device.
No
The device description clearly describes a physical catheter with a lumen, shaft, luer adapter, radiopaque markers, and coating, indicating it is a hardware device.
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 materials within the body. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in-vivo (within the body) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Tip-Shape Echelon™ Micro Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tip-Shape Echelon™ 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Tip-shape Echelon Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. 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
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 Tip Shape Echelon™ Micro Catheter included Dimensional and Visual Analysis, Tip Tensile Strength, Pressure Testing, Guidewire Friction, Coil Friction, Tip Reshape-ability and Retention, Tip offset distances measurement and Tip length measurement specification. The biocompatibility of the MTI Tip Shape 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) (modification to K030688 and K031992) Tip-Shape Echelon™ Micro Catheter August 6, 2004
SEP = 2 2004
510(k) Summary 4.
| TRADE NAME | Tip-Shape Echelon™ Micro Catheter | |
|---|---|---|
| GENERIC NAME | Catheter, Continuous Flush | |
| CLASSIFICATION | Class II (21 CFR 870.1210) and Class II (21 CFR 870.4450) | |
| SUBMITTED BY | Micro Therapeutics, Inc. | |
| 2 Goodyear | ||
| Irvine, CA 92618 | Marilyn R. Pourazar | |
| Regulatory Affairs | ||
| (949) 837-3700 x293 | ||
| PREDICATE | ||
| DEVICE(S) | MTI Echelon™ Micro Catheter (K030688) | |
| MTI Echelon™ Micro Catheter (K031992) | ||
| DEVICE | ||
| DESCRIPTION | The Tip-shape Echelon Micro Catheter is an endhole, single-lumen | |
| catheter designed to be introduced over a steerable guidewire into the | ||
| vasculature. The proximal end of the catheter incorporates a standard | ||
| luer adapter to facilitate the attachment of accessories. 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 Echelon ™ 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. | ||
| This is the same intended use as predicate devices Echelon Micro | ||
| Catheter K030688 and K031992. | ||
| TESTING | In-vitro performance testing of the MTI Tip Shape Echelon™ Micro | |
| Catheter included Dimensional and Visual Analysis, Tip Tensile | ||
| Strength, Pressure Testing, Guidewire Friction, Coil Friction, Tip | ||
| Reshape-ability and Retention, Tip offset distances measurement and | ||
| Tip length measurement specification. | ||
| The biocompatibility of the MTI Tip Shape 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 ( |