(23 days)
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.
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 Special 510(k) submission for the Echelon™ Micro Catheter, which is a modification to the previously cleared Rebar® Micro Catheter (K993672). As such, the submission focuses on demonstrating substantial equivalence to the predicate device through performance testing rather than establishing de novo clinical efficacy for a novel device. Therefore, many of the requested categories related to clinical studies, AI performance, and expert ground truth are not applicable to this type of submission.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes in-vitro performance testing and biocompatibility testing. The "acceptance criteria" themselves are not explicitly detailed as quantitative thresholds in the provided text, but rather implied by successful completion of these tests to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional specifications met | Dimensional inspection performed (results not detailed, but implied met for clearance) |
| Tensile strength within acceptable limits | Tensile strength tests performed (results not detailed, but implied met for clearance) |
| Burst pressure within acceptable limits | Burst pressure tests performed (results not detailed, but implied met for clearance) |
| Flow rate within acceptable limits | Flow rate tests performed (results not detailed, but implied met for clearance) |
| Torque characteristics within acceptable limits | Torque tests performed (results not detailed, but implied met for clearance) |
| Performance under simulated conditions equivalent to predicate | Performance under simulated conditions tested (results not detailed, but implied met for clearance) |
| Biocompatibility in accordance with ISO 10993-1 | Biocompatibility verified as an external communicating, blood contact, limited exposure (<24 hrs) device. Test results confirmed biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each in-vitro test. The data provenance is in-vitro testing conducted by Micro Therapeutics, Inc. The location or timeline of these tests (retrospective/prospective) is not explicitly stated, but in-vitro tests are typically prospective for a device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in-vitro performance and biocompatibility study, not a clinical study involving expert interpretation of data for ground truth. The "ground truth" for these tests would be the established engineering specifications and ISO standards for biocompatibility.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical data requiring adjudication.
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 a medical catheter, not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be the established engineering specifications, design requirements, and applicable industry standards for medical catheters. For biocompatibility, the ground truth was based on the requirements of ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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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 NAMEGENERIC NAMECLASSIFICATION | Echelon™ Micro CatheterCatheter, Continuous FlushClass II (21 CFR 870.1210) and Class II 21 CFR870.4450 | |
|---|---|---|
| SUBMITTED BY | Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618 | Marilyn R. PourazarRegulatory Affairs(949) 837-3700 |
| PREDICATEDEVICE(S) | MTI Rebar® Micro Catheter (K993672) | |
| 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 MTI Echelon™ Micro Catheter is intended for the controlledselective infusion of physician-specified therapeutic agents or contrastmedia into the vasculature of the peripheral and neuro anatomy. Thisis the same intended use as predicate device Rebar® Micro CatheterK993672. | |
| 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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Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the profiles to resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Micro Therapeutics, Inc. c/o Ms. Marilyn R. Pourazar Manager, Regulatory Affairs 2 Goodyear Irvine, CA 92618
Re: K030688
Trade Name: Echelon™ Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: February 28, 2003 Received: March 5, 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.
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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 (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 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 (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,
Neele TL
ram 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) (modifications to K993672) Echelon™ Micro Catheter February 28, 2003
6. Indications for Use Statement
510(k) Number (if known): 长630888
Device Name:
MTI Echelon™ Micro Catheter
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.
(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) | X |
|---|---|
| OR | Over the Counter Use |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K030688 |
|---|---|
| --------------- | --------- |
§ 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).