(166 days)
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.
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.
The provided document is a 510(k) summary for a medical device (MTI Echelon Micro Catheter) and does not describe acceptance criteria or a study proving the device meets those criteria in the way typically required for AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility testing for a physical catheter. The "acceptance criteria" here are implied by the successful completion and comparison of these physical tests to the predicate device, not statistical performance metrics of an algorithm.
Therefore, many of the requested categories for AI/SaMD studies are not applicable to this 510(k) submission. I will address only the relevant information from the provided text.
Relevant Information from the 510(k) Summary for the MTI Echelon™ Micro Catheter Family (K051990):
1. Table of acceptance criteria and the reported device performance:
The document lists the types of in-vitro performance tests conducted rather than explicit acceptance criteria with numerical performance data. The implicit acceptance criterion is that the new device performs comparably to the predicate devices in these tests.
| Test Category | Reported Device Performance |
|---|---|
| Dimensional Inspection | Performed (details not provided, but implies measurements were within specifications or comparable to predicate). |
| Visual Analysis | Performed (details not provided, but implies visual characteristics were acceptable or comparable to predicate). |
| Tensile Strength Tests | Performed (details not provided, but implies tensile strength was within specifications or comparable to predicate). |
| Tip Tensile Strength | Performed (details not provided, but implies tip tensile strength was within specifications or comparable to predicate). |
| Burst Pressure Tests | Performed (details not provided, but implies burst pressure was within specifications or comparable to predicate). |
| Flow Rate Tests | Performed (details not provided, but implies flow rates were within specifications or comparable to predicate). |
| Torque Tests | Performed (details not provided, but implies torque characteristics were within specifications or comparable to predicate). |
| Tip Reshape-ability/Retention | Performed (details not provided, but implies tip could be reshaped and retained shape as expected or comparable to predicate). |
| Tip Offset Distances Measurement | Performed (details not provided, but implies offset distances were within specifications or comparable to predicate). |
| Tip Length Measurement Specification | Performed (details not provided, but implies tip length met specifications or was comparable to predicate). |
| Guidewire Friction | Performed (details not provided, but implies guidewire friction was acceptable or comparable to predicate). |
| Coil Friction | Performed (details not provided, but implies coil friction was acceptable or comparable to predicate). |
| Performance under Simulated Conditions | Performed (details not provided, but implies the device performed acceptably in simulated use conditions or comparably to predicate). |
| Biocompatibility | Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility as an external communicating, blood contact, limited exposure (<24 hrs) device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for each of the in-vitro tests.
- The data provenance is not stated, but the testing would have been in-vitro (laboratory-based) performance testing, not involving human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device, and the "ground truth" for in-vitro performance tests is determined by validated test methods and measurement equipment, not expert human assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical studies with human assessors, not in-vitro physical performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/SaMD device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical "ground truth." For the in-vitro performance tests, the "ground truth" is derived from established engineering test methods, material specifications, and comparisons to predicate device performance.
8. The sample size for the training set:
- Not applicable. There is no "training set" for an AI algorithm for this physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or associated ground truth for an AI algorithm for this physical device.
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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 NAMEGENERIC NAMECLASSIFICATION | 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 GoodyearIrvine, CA 92618 | Contact: Marilyn R. PourazarManager, Regulatory Affairs(949) 837-3700 x1293 |
| PREDICATEDEVICE(S) | MTI K993672 MTI Rebar® Micro Catheter decision date 4-Jan-2000MTI K030688, MTI Echelon Micro Catheter decision date March 27, 2003MTI K031992, MTI Echelon Micro Catheter decision date August 3, 2003 | |
| DEVICEDESCRIPTION | The Echelon Micro Catheter is an endhole, single-lumen catheterdesigned to be introduced over a steerable guidewire into thevasculature. The proximal end of the catheter incorporates a standardluer adapter to facilitate the attachment of accessories. The catheterhas a semi-rigid proximal shaft which transitions into the flexibledistal shaft to facilitate the advancement of the catheter in theanatomy. Dual radiopaque markers at the distal end facilitatefluoroscopic visualization. The outer surface of the catheter is coatedto increase lubricity. | |
| INDICATIONS FORUSE | The Echelon ™ Micro Catheter is intended to access peripheral andneuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and ofdiagnostic materials such as contrast media. | |
| TESTING | In-vitro performance testing of the MTI Echelon™ Micro Catheterincluded 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, tiplength measurement specification, guidewire friction, coil friction andperformance under simulated conditions. | |
| The biocompatibility of the MTI Echelon™ Micro Catheter wasverified in accordance with ISO 10993-1, Biological Evaluation ofMedical Devices. Test results confirmed biocompatibility of thecatheter was tested as an external communicating, blood contact,limited exposure (<24 hrs) device. | ||
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The MTI Echelon™ Micro Catheters are substantially equivalent tothe predicate devices in intended use and principles of operation. |
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Micro Therapeutics, Inc. Traditional 510(k) (modification to K030688, K031992 and K042187) Echelon™ Micro Catheter Family July 20, 2005
ડ. Truthful and Accuracy Certification
Pursuant to 21 CFR 807.87(j), I Marilyn R Pourazar, certify that to the best of my know!edge and belief and based upon the data and information submitted to me in the course of my responsibilities as Regulatory Affairs Manager of Micro Therapeutics, Inc., and in reliance thereupon, the data and information submitted in this Premarket notification are truthful and accurate and that no facts material for a review of the substantial equivalence of this device have been knowingly omitted from this submission.
Marilyn R. Pourazar
Manager, Regulatory Affairs Micro Therapeutics, Inc.
7-20-05
Date
Date
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 4
Micro Therapeutics, Inc c/o Ms. Marilyn R. Pourazar Manager of Regulatory Affairs 2 Goodyear Irvine, CA 92618
Re: K051990
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.
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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
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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
Page 1 of 1
§ 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).