NAUTICA MICRO CATHETER, MODEL 105-5094-153

K024122 · Micro Therapeutics, Inc. · KRA · Mar 7, 2003 · Cardiovascular

Device Facts

• Record ID: K024122
• Device Name: NAUTICA MICRO CATHETER, MODEL 105-5094-153
• Applicant: Micro Therapeutics, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended 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.

Device Story

Nautica™ Micro Catheter is an end-hole, single-lumen catheter designed for navigation through peripheral and neuro vasculature. Device features semi-rigid proximal shaft transitioning to flexible distal shaft; dual radiopaque markers for fluoroscopic visualization; lubricious outer coating. Operated by physicians under fluoroscopic guidance. Introduced over steerable guidewire to target site. Enables controlled selective infusion of therapeutic agents or contrast media. Benefits include precise delivery of embolics or diagnostics to specific vascular locations.

Clinical Evidence

Bench testing only. In-vitro performance testing included dimensional inspection, tensile strength, burst pressure, flow rate, torque, and simulated use. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device.

Technological Characteristics

End-hole, single-lumen catheter. Semi-rigid proximal shaft, flexible distal shaft. Dual radiopaque markers. Lubricious outer coating. Biocompatibility per ISO 10993-1. Mechanical device; no energy source or software.

Indications for Use

Indicated for accessing peripheral and neuro vasculature for controlled selective infusion of therapeutic agents (e.g., embolization materials) or diagnostic materials (e.g., contrast media). Contraindicated for use in coronary vasculature.

Regulatory Classification

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.

Predicate Devices

• MTI Titan™ Micro Catheter (K022003)
• MTI Rebar® Micro Catheter (K993672)

Submission Summary (Full Text)

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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 [phone] 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 [phone]. 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 [phone] or [phone] 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> | OR | Over the Counter Use | <span style="text-decoration: overline;"></span> |
|------------------------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |
| (Division Sign-Off) | | | | |
| Division of Cardiovascular Devices | | | | |
| 510(k) Number | K024122 | | | |