(81 days)
The MTI Nautica™ 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. Not intended for use in the coronary vasculature.
The MTI Nautica™ 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.
This document is a 510(k) Pre-market Notification for a medical device called the MTI Nautica™ Micro Catheter, dated December 12, 2002. It outlines the device description, indications for use, and a summary of substantial equivalence to predicate devices. The document also includes the FDA's acceptance letter from March 7, 2003, confirming the substantial equivalence.
Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are described as follows:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In-vitro Performance Testing | |
| Dimensional Inspection | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Tensile Strength Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Burst Pressure Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Flow Rate Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Torque Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Performance under Simulated Conditions | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Biocompatibility | |
| Compliance with ISO 10993-1 | Verified in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices). |
| Biocompatibility of an external communicating, blood contact, limited exposure (<24 hrs) device | Confirmed. |
| Substantial Equivalence (Overall Acceptance Criteria for 510(k)) | |
| Intended Use | Substantially equivalent to predicate devices (MTI Titan™ Micro Catheter (K022003) and MTI Rebar® Micro Catheter (K993672)). |
| Principles of Operation | Substantially equivalent to predicate devices (MTI Titan™ Micro Catheter (K022003) and MTI Rebar® Micro Catheter (K993672)). |
Study Details:
The provided document describes the regulatory submission for a Class II medical device, specifically a 510(k) Pre-market Notification. For this type of submission, extensive clinical studies with human participants are often not required if the device can demonstrate "substantial equivalence" to a legally marketed predicate device. The "study" in this context primarily refers to the bench testing and biocompatibility testing performed to support the claim of substantial equivalence.
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Sample sizes 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 the in-vitro performance tests (e.g., how many catheters were tested for tensile strength or burst pressure).
- The data provenance is not explicitly stated as country of origin, but the testing was conducted by Micro Therapeutics, Inc. (Irvine, CA, USA) and reviewed by the FDA (USA). The testing is prospective for the device being submitted.
- For biocompatibility, the testing was conducted in accordance with ISO 10993-1. Sample sizes for specific biocompatibility tests (e.g., cytotoxicity, sensitization) are not provided in this summary.
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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):
- This question is not directly applicable to the type of testing described in this 510(k) summary. The "ground truth" for bench testing is defined by engineering specifications and industry standards (e.g., ISO 10993-1 for biocompatibility). There were no human expert assessments of images or patient outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this involves bench testing and biocompatibility assessment, not clinical image interpretation or patient outcome adjudication.
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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:
- No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or described. This submission is for a catheter, a physical medical device, not a diagnostic or AI-powered imaging tool.
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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 or software-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in-vitro performance tests, the "ground truth" is defined by established engineering and performance specifications, often derived from industry standards or internal design requirements for similar devices.
- For biocompatibility, the "ground truth" is compliance with the requirements and acceptance criteria of ISO 10993-1.
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The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of device submission.
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MTI Confidential
MAR 0 7 2003
510(k) Summary 4.
Micro Therapeutics, Inc.
Nautica™ Micro Catheter December 12, 2002
Special 510(k) (modifications to K022003)
Prepared December 13, 2002 Nautica™ Micro Catheter TRADE NAME Catheter, Continuous Flush GENERIC NAME Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 CLASSIFICATION SUBMITTED BY Micro Therapeutics, Inc. CONTACT M 2 Goodyear Regulatory Affairs (949) 837-3700 Irvine, CA 92618 PREDICATE MTI Titan™ Micro Catheter (K022003) DEVICE(S) MTI Rebar® Micro Catheter (K993672) The MTI Nautica™ Micro Catheter is an end-hole, single-lumen DEVICE catheter designed to be introduced over a steerable guidewire into the DESCRIPTION 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. INDICATIONS The MTI Nautica™ Micro Catheter is intended to access peripheral FOR USE 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. Not intended for use in the coronary vasculature. TESTING In-vitro performance testing of the MTI Nautica™ Micro Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. The biocompatibility of the MTI Nautica™ Micro Catheter was 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. The MTI Nautica™ Micro Catheter is substantially equivalent to the SUMMARY OF SUBSTANTIAL predicate devices in intended use and principles of operation. EQUIVALENCE
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
Micro Therapeutics, Inc. c/o Ms. Marilyn R. Pourazar 2 Goodyear Irvine, CA 92618
Re: K024122
MTI Nautica™ Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: 74 KRA Dated: December 12, 2002 Received: December 16, 2002
Dear Ms. Marilyn:
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 (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,
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) (modifications to K022003) Nautica™ Micro Catheter December 12, 2002
Indications for Use Statement 6.
510(k) Number (if known): _ K-024122
Device Name:
MTI Nautica™ Micro Catheter
Indications for Use:
The MTI Nautica™ 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. Not intended for use in the coronary vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over the Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | ||||
| Division of Cardiovascular Devices | ||||
| 510(k) Number | K024122 |
§ 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).