(21 days)
The Tip-Shape 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 Tip-shape 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 text describes a 510(k) premarket notification for a medical device, the Tip-Shape Echelon™ Micro Catheter. This is a submission for substantial equivalence to existing predicate devices, not typically a submission that would include a detailed study with acceptance criteria and AI performance metrics as these are more common for novel algorithms or AI/ML-driven devices.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document lists "Testing" that was performed, which includes various in-vitro performance tests and biocompatibility verification. However, it does not explicitly state specific acceptance criteria (e.g., "Tip Tensile Strength > X N") or directly report quantitative device performance against these criteria. It only lists the types of tests conducted and concludes that biocompatibility was "verified."
| Acceptance Criteria (Implicit from "Testing" section) | Reported Device Performance |
|---|---|
| Dimensional and Visual Analysis | N/A (Not explicitly stated) |
| Tip Tensile Strength | N/A (Not explicitly stated) |
| Pressure Testing | N/A (Not explicitly stated) |
| Guidewire Friction | N/A (Not explicitly stated) |
| Coil Friction | N/A (Not explicitly stated) |
| Tip Reshape-ability and Retention | N/A (Not explicitly stated) |
| Tip offset distances measurement | N/A (Not explicitly stated) |
| Tip length measurement specification | N/A (Not explicitly stated) |
| Biocompatibility (in accordance with ISO 10993-1) | Confirmed biocompatibility |
2. Sample sizes used for the test set and the data provenance
The document does not mention sample sizes for any of the in-vitro performance tests. Data provenance is not applicable as this concerns physical device testing, not data generated by a test set.
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 submission for a physical medical catheter, not an AI/ML device requiring expert ground truth for image analysis or similar tasks.
4. Adjudication method for the test set
Not applicable, as this is related to expert consensus on ground truth, which is not relevant to this device submission.
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 device is not an AI-driven tool and therefore no MRMC study involving AI assistance would be performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
For the in-vitro performance tests, the "ground truth" would be the engineering specifications and tolerances for the device's physical properties. For biocompatibility, the ground truth is established by the results of tests conducted according to ISO 10993-1. These are physical measurements and biological assays, not expert consensus or diagnostic outcomes in the typical sense.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
{0}------------------------------------------------
Micro Therapeutics, Inc. Special 510(k) (modification to K030688 and K031992) Tip-Shape Echelon™ Micro Catheter August 6, 2004
SEP = 2 2004
510(k) Summary 4.
| TRADE NAME | Tip-Shape 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.2 GoodyearIrvine, CA 92618 | Marilyn R. PourazarRegulatory Affairs(949) 837-3700 x293 |
| PREDICATEDEVICE(S) | MTI Echelon™ Micro Catheter (K030688)MTI Echelon™ Micro Catheter (K031992) | |
| DEVICEDESCRIPTION | The Tip-shape Echelon Micro Catheter is an endhole, single-lumencatheter designed 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. | |
| 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 devices Echelon MicroCatheter K030688 and K031992. | |
| TESTING | In-vitro performance testing of the MTI Tip Shape Echelon™ MicroCatheter included Dimensional and Visual Analysis, Tip TensileStrength, Pressure Testing, Guidewire Friction, Coil Friction, TipReshape-ability and Retention, Tip offset distances measurement andTip length measurement specification.The biocompatibility of the MTI Tip Shape Echelon™ MicroCatheter was verified in accordance with ISO 10993-1, BiologicalEvaluation of Medical Devices. Test results confirmedbiocompatibility of the catheter was tested as an externalcommunicating, blood contact, limited exposure (<24 hrs) device. | |
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The MTI Tip Shape Echelon™ Micro Catheter is substantiallyequivalent to the predicate devices in intended use and principles ofoperation. |
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2004
Ms. Marilyn R. Pourazar Manager of Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618
Re: K042187
Tip-Shape Echelon Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: August 6, 2004 Received: August 12, 2004
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.
{2}------------------------------------------------
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 (301) 594-4648. 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,
Dvina R. Vochner
Bram D. Zuckerman, M.D. (S Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K042187
Device Name: MTI Tip-Shape Echelon™ Micro Catheter
Indications For Use:
The Tip-Shape 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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. Wachner
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_E04 2183
§ 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).