(32 days)
The Echelon Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or 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 Echelon Micro Catheter is packaged with an ev3 Syringe Adapter. This device, attached to an ev3 1ml syringe filled with Onyx®, will reduce the dead space within the micro catheter luer hub. Reducing the dead space within the hub is intended to minimize the potential mixing of Onyx® and DMSO in the hub of the catheter during connection and injection.
The provided document is a 510(k) Premarket Notification for a medical device, specifically a micro catheter, and its accessory. It focuses on demonstrating substantial equivalence to existing predicate devices. This type of document does not contain the detailed information required to answer most of your questions about acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance.
Here's why and what information can (and cannot) be extracted:
- Device Type: The Echelon Micro Catheter is a physical medical device (catheter) used for infusion. It is not an AI/ML device or a diagnostic device that produces images or interpretations. Therefore, concepts like "acceptance criteria for device performance" in terms of sensitivity, specificity, accuracy, or expert ground truth are not applicable in the way you've framed them for AI.
- Study Focus: The "Performance Data" section explicitly states: "Because the Echelon catheter itself has not changed, the scope of design verification focused on performance and compatibility of the Syringe Adapter accessory device." This means the studies performed were engineering/design verification tests on the physical properties and functionality of the catheter and its new accessory (e.g., dimensional checks, luer fitting integrity, pressure tests), not clinical trials or diagnostic performance studies involving human readers or AI.
Given this context, I will address your questions to the best of my ability based only on the provided text, explaining why certain information is absent.
Acceptance Criteria and Study for K090870 (Echelon Micro Catheter with Syringe Adapter)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Study Type) | Reported Device Performance (Summary) |
|---|---|
| Dimensional | Met design specifications |
| Luer Fitting Integrity | Maintained integrity |
| Onyx Infusion Pressure | Performed as intended during infusion |
| Catheter Dead Space Volume | Reduced dead space as intended |
| Radiopacity of Onyx Injection | Maintained radiopacity |
| Static Burst Pressure | Withstood pressure without bursting |
Note: The document provides general categories of verification studies but does not detail specific quantitative acceptance criteria values (e.g., "burst pressure > X psi") or precise reported performance values. It states these studies were conducted and, implicitly, that the device met these criteria to achieve substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The studies were "design verification" tests, likely involving multiple units or repetitions, but the exact sample sizes are not given.
- Data Provenance: Not specified. These are engineering design verification tests typically conducted by the manufacturer (Micro Therapeutics dba ev3 Neurovascular, located in Irvine, CA, USA). They would be considered prospective in the sense that they were conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical instrument (catheter and accessory), not a diagnostic tool requiring expert interpretation as ground truth. The "ground truth" for the performance studies would be objective engineering measurements and specified design parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus builds a "ground truth," typically in diagnostic imaging or clinical trials. These were engineering 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 document describes a physical medical device, not an AI or diagnostic imaging system. No MRMC study was performed, and no AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Material Properties: The "ground truth" for these design verification studies would be based on established engineering specifications, material properties, and functional performance requirements for medical devices of this type. For example, a "Luer Fitting Integrity" test would verify the fitting meets ISO standards for Luer connections.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" as it's a physical device, not an AI model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.
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Special 510(k) Premarket Notification
510(k) Summarv
Applicant - Manufacturer Name and Address
Micro Therapeutics dba ev3 Neurovascular 9775 Toledo Way Irvine. CA 92618 Establishment Registration No. 2029214
MAY - 1 2009
March20, 2009 Date
Contact Information
Tom Daughters Director, Regulatory Affairs
Proprietary Device Model & Trade Name
Model: 105-5092-150SA, Echelon Micro Catheter (.014) Model: 145-5092-150SA, Echelon Micro Catheter (.014 Pre-Shape) Model: 190-5092-150SA, Echelon Micro Catheter (.014 Pre-Shape) Model: 103-(5095) 1207 Syringe Adapter Accessory
Device Classification & Common Name
Classification Code: KRA, 21CFR Part 870.1210 Common Name: Catheter, Continuous Flush Classification: Class II
Predicate Devices - 510(k) References
K030688 Model: Echelon Micro Catheter (.014) K031992 Model: Echelon Micro Catheter (.010) K042187 Models: Echelon Micro Catheter (.010; .014) - Pre-Shaped Tips K051990 Models: Echelon Catheters (.010, .014) - Revised Contraindication
Description of the Device Subject to Premarket Notification
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 Echelon Micro Catheter is packaged with an ev3 Syringe Adapter. This device, attached to an ev3 1ml syringe filled with Onyx®, will reduce the dead space within the micro catheter luer hub. Reducing the dead space within the hub
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is intended to minimize the potential mixing of Onyx® and DMSO in the hub of the catheter during connection and injection.
Indications for Use
The Echelon Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media.
Performance Data
Because the Echelon catheter itself has not changed, the scope of design verification focused on performance and compatibility of the Syringe Adapter accessory device. Verification studies included:
Dimensional Luer Fitting Integrity Onyx Infusion Pressure Catheter Dead Space Volume Radiopacity of Onyx Injection Static Burst Pressure
Substantial Equivalence
The risk assessment for the Echelon catheter and the Syringe Adapter accessory was reviewed to identify any new or unique risks. No new risks were identified. The indications for use, the scientific technology and the performance data demonstrate the Echelon Microcatheter with the Syringe Adapter is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micro Therapeutics dba ev3 Neurovascular c/o Mr. Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine. CA 92618
Re: K090870
Echelon Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 20, 2009 Received: March 30, 2009
Dear Mr. Daughters:
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 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 - Mr. Tom Daughters
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Statement of Indications for Use
Indications for Use
510(k) Number (if known): _ K090870
Device Name: Echelon Micro Catheter
Indications for Use:
The Echelon Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K090870
Page
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§ 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).