TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305

K022003 · Micro Therapeutics, Inc. · DYB · Sep 13, 2002 · Cardiovascular

Device Facts

• Record ID: K022003
• Device Name: TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305
• Applicant: Micro Therapeutics, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titan 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 HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan™ Micro Catheter.

Device Story

Titan Micro Catheter is an end-hole, single-lumen catheter for vascular access; features semi-rigid proximal shaft transitioning to flexible distal shaft; includes dual radiopaque markers for fluoroscopic visualization; lubricious coating. HD Injector is a 1 mL syringe with threaded plunger and vial septum-piercing needle; connects to catheter via threaded adapter. Used in clinical settings by physicians for infusion of therapeutic agents or contrast media. Device facilitates targeted delivery of fluids into peripheral and neuro anatomy; benefits patient through controlled, selective administration of diagnostic or therapeutic substances.

Clinical Evidence

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

Technological Characteristics

Single-lumen catheter with lubricious coating and dual radiopaque markers. HD Injector is a 1 mL syringe with threaded plunger and septum-piercing needle. Biocompatibility per ISO 10993-1. Mechanical device; no energy source or software.

Indications for Use

Indicated for controlled selective infusion of therapeutic agents or contrast media into peripheral and neuro vasculature. For use by physicians.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• MTI Rebar™ Micro Catheter (K993672)
• MTI Cadence Precision Injector (K011535)

Submission Summary (Full Text)

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Micro Therapeutics, Inc.
Traditional 510(k) (modifications to K993672 and K011535) Titan™ Micro Catheter and MTI HD Injector Syringe June 18, 2002

#### 4. 510(k) Summary

| Prepared June 18, 2002 | | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------|
| TRADE NAME<br>GENERIC NAME<br>CLASSIFICATION | Titan™ Micro Catheter and accessory HD Injector<br>Catheter, Continuous Flush and Syringe<br>Class II (21 CFR 870.1210) and Class II 21 CFR870.4450 | | |
| SUBMITTED BY | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT | Bill Hyatt<br>Regulatory Affairs<br>[phone] |
| PREDICATE<br>DEVICE(S) | MTI Rebar™ Micro Catheter (K993672)<br>MTI Cadence Precision Injector (K011535) | | |
| DEVICE<br>DESCRIPTION | The MTI Titan™ Micro Catheter is an end-hole, single-lumen catheter designed to<br>be introduced over a steerable guidewire into the vasculature. The catheter has a<br>semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate<br>the advancement of the catheter in the anatomy. Dual radiopaque markers at the<br>distal end facilitate fluoroscopic visualization. The outer surface of the catheter is<br>coated to increase lubricity. The catheter is provided with a removable adapter for<br>attachment to either standard luer fitting devices or the MTI HD Injector.<br>The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing<br>needle. The connector at the distal end of the injector is threaded for connecting to<br>the MTI Titan™ Micro Catheter. | | |
| INDICATIONS FOR<br>USE | The Titan Micro Catheter is intended for the controlled selective infusion of<br>physician-specified therapeutic agents or contrast media into the vasculature of the<br>peripheral and neuro anatomy.<br>The MTI HD Injector is intended for the infusion of physician-specified fluids with<br>the MTI Titan™ Micro Catheter | | |
| TESTING | <i>In-vitro</i> performance testing of the MTI Titan™ Micro Catheter included<br>dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests,<br>torque tests and performance under simulated conditions. The accessory<br>MTI HD Injector underwent <i>in-vitro</i> performance testing including dimensional<br>inspection, injection rate, thread engagement, clip movement, needle detachment,<br>integrity of attachment to Titan Micro Catheter, fit of piston in barrel and leakage.<br>The biocompatibility of the MTI Titan™ Micro Catheter and accessory<br>MTI HD Injector was verified in accordance with ISO 10993-1, Biological<br>Evaluation of Medical Devices. Test results confirmed biocompatibility of the<br>catheter and injector when tested as an external communicating, blood contact,<br>limited exposure (<24 hrs) device. | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The MTI Titan™ Micro Catheter and the accessory HD Injector are substantially<br>equivalent to the predicate devices in intended use and principles of operation. | | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 3 2002

Micro Therapeutics, Inc. c/o Mr. Bill Hyatt 2 Goodyear Irvine, CA 92618

Re: K022003

MTI Titan™ Micro Catheter MTI HD Injector Regulation Number: 870.1340, 870.1650 Regulation Name: Catheter Introducer. Angiographic Injector and Syringe Regulatory Class: Class II (two) Product Code: DYB, DQF Dated: June 18, 2002 Received: June 19, 2002

Dear Mr. Hyatt:

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.

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.

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Page 2 - Mr. Bill Hyatt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Kela Tule

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.

K022003

Traditional 510(k) (modifications to K993672 and K011535) Titan™ Micro Catheter and MTI HD Injector Syringe June 18, 2002

### Indications for Use Statement 6.

## 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

MTI Titan™ Micro Catheter MTI HD Injector

Indications for Use:

The Titan 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 HD Injector is intended for the infusion of physicianspecified fluids with the MTI Titan™ Micro Catheter.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use__________ OR Prescription Use_ (Per 21 CFR 801.109) Division of Cardiova

510(k) Number