(41 days)
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.
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.
The provided text describes a 510(k) submission for the Echelon™ Micro Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through in-vitro performance testing and biocompatibility testing.
Medical device submissions like this typically involve engineering performance testing rather than studies involving AI algorithms, human readers, or complex ground truth establishment as would be seen in software as a medical device (SaMD) or AI/ML-based diagnostic tools. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of device and submission.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The general acceptance criteria for medical devices like this typically involve meeting pre-defined mechanical, chemical, and biological performance specifications that ensure safety and effectiveness. The reported performance confirms that the device met these criteria for various in-vitro tests and biocompatibility. Specific numerical acceptance criteria and their corresponding reported performance values are not provided in this summary document, but the fact that the device was deemed "substantially equivalent" implies these criteria were met.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In-vitro Performance Testing | Included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests, and performance under simulated conditions. (Specific numeric criteria and results are not detailed in this summary, but the device passed these tests to achieve substantial equivalence). |
| Biocompatibility Testing | 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 (<24 hrs) device. (Specific numeric criteria and results are not detailed in this summary, but the device passed these tests to achieve substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The text states "In-vitro performance testing" and "Biocompatibility testing" were conducted. For in-vitro mechanical tests, samples typically involve multiple units of the device to ensure consistency and statistical significance. Biocompatibility tests also involve a specified number of samples for each test (e.g., cytotoxicity, irritation, sensitization). However, the specific number of samples for each test is not mentioned in this summary.
- Data Provenance: The testing was "in-vitro" (laboratory-based) and conducted by the manufacturer, Micro Therapeutics, Inc., located in Irvine, CA. This constitutes prospective testing conducted specifically for the regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This submission is for a physical medical device (catheter) and relies on objective, measurable engineering and biological performance metrics rather than interpretation of data by clinical experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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/ML device or a diagnostic imaging device requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device refers to established engineering standards, specifications, and biological safety limits (e.g., ISO 10993-1 for biocompatibility). The device's performance was measured against these objective criteria rather than subjective expert consensus or clinical outcomes.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
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Micro Therapeutics, Inc. wwo. So 110rup Subscribed on to K030688)
Special 510(k) (modification to K030688)
Echelon™ Micro Catheter
June 26, 2003
AUG - 7 2003
510(k) Summary 4.
| TRADE NAME | 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. | Marilyn R. Pourazar |
| 2 Goodyear | Regulatory Affairs | |
| Irvine, CA 92618 | (949) 837-3700 | |
| PREDICATEDEVICE(S) | MTI Echelon™ Micro Catheter (K030688) | |
| DEVICEDESCRIPTION | The MTI Echelon™ Micro Catheter is an end-hole, single-lumencatheter designed to be introduced over a steerable guidewire into thevasculature. The catheter has a semi-rigid proximal shaft whichtransitions into the flexible distal shaft to facilitate the advancementof the catheter in the anatomy. Dual radiopaque markers at the distalend facilitate fluoroscopic visualization. The outer surface of thecatheter is coated to increase lubricity. | |
| INDICATIONSFOR USE | 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.This is the same intended use as predicate device Echelon MicroCatheter K030688. | |
| TESTING | In-vitro performance testing of the MTI Echelon™ Micro Catheterincluded dimensional inspection, tensile strength tests, burst pressuretests, flow rate tests, torque tests and performance under simulatedconditions.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 Catheter is substantially equivalent to thepredicate devices in intended use and principles of operation. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
AUG - 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micro Therapeutics, Inc. c/o Ms. Marilyn Pourazar Manager of Regulatory Affairs 2 Goodyear Irvine, CA 92618
Re: K031992
Echelon™ Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: June 26, 2003 Received: June 27, 2003
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.
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
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Page 2 - Ms. Marilyn Pourazar
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 (OS) 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 vour 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
KQeith
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Micro Therapeutics, Inc. Special 510(k) (modification to K030688) Echelon™ Micro Catheter June 26, 2003
Indications for Use Statement 6.
510(k) Number (if known): K031992
Device Name:
MTI Echelon™ Micro Catheter
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
Nde Certn
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031992
§ 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).