(166 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a micro catheter, 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 described as a catheter "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." The catheter itself is a delivery mechanism for therapeutic agents, but it is not a therapeutic device on its own.
No
The device is intended for the infusion of therapeutic and diagnostic materials, not for diagnostic analysis itself. While it can deliver diagnostic materials like contrast media, it doesn't process or interpret data to diagnose a condition.
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. The performance studies also focus on physical properties and biocompatibility.
No, 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 is consistent with an in vivo device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis on specimens.
The device described 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 MTI 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
KRA
Device Description
The 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
physician
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 Echelon™ Micro Catheter included dimensional inspection, visual analysis, tensile strength tests, tip tensile strength, burst pressure tests, flow rate tests, torque tests, tip reshape-ability /retention, tip offset distances measurement, tip length measurement specification, guidewire friction, coil friction 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.
Kos/990
Traditional 510(k) (modification to K030688, K031992 and K042187) Echelon™ Micro Catheter Family July 20, 2005
510(k) Summary 4.
| Prepared July 21, 2005 | ||
|---|---|---|
| TRADE NAME | ||
| GENERIC NAME | ||
| CLASSIFICATION | Echelon™ Micro Catheter | |
| 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: Marilyn R. Pourazar | |
| Manager, Regulatory Affairs | ||
| (949) 837-3700 x1293 | ||
| PREDICATE | ||
| DEVICE(S) | MTI K993672 MTI Rebar® Micro Catheter decision date 4-Jan-2000 | |
| MTI K030688, MTI Echelon Micro Catheter decision date March 27, 2003 | ||
| MTI K031992, MTI Echelon Micro Catheter decision date August 3, 2003 | ||
| DEVICE | ||
| DESCRIPTION | The 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. | ||
| TESTING | In-vitro performance testing of the MTI Echelon™ Micro Catheter | |
| included dimensional inspection, visual analysis, tensile strength tests, | ||
| tip tensile strength, burst pressure tests, flow rate tests, torque tests, | ||
| tip reshape-ability /retention, tip offset distances measurement, tip | ||
| length measurement specification, guidewire friction, coil friction 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 ( Trade Name: MTI Echelon Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 30, 2005 Received: December 01, 2005 |
Dear Ms. Pourazar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Marilyn R. Pourazar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R. Richter
Image /page/3/Picture/5 description: The image shows the name and title of Bram D. Zuckerman, M.D. He is the Director of the Division of Cardiovascular Devices. The division is part of the Office of Device Evaluation. The office is part of the Center for Devices and Radiological Health.
Enclosure
4
Indications for Use
510(k) Number (if known): K051990
Device Name:
Indications For Use:
The MTI 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_≤ 05 19 90
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