TRULINE REINFORCED VALVED INFUSION CATHETER

K021139 · Micro Therapeutics, Inc. · FOZ · Apr 17, 2002 · General Hospital

Device Facts

• Record ID: K021139
• Device Name: TRULINE REINFORCED VALVED INFUSION CATHETER
• Applicant: Micro Therapeutics, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.

Device Story

Single-lumen plastic catheter; introduced over guidewire into vasculature. Proximal end features standard luer lock adapter for delivery of pharmacological agents or contrast media. Distal and proximal radiopaque markers facilitate fluoroscopic visualization. Used by physicians in clinical settings for controlled selective infusion. Benefits include precise delivery of therapeutic agents or contrast media to target vascular sites.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (ISO 10993-1) for external communicating, blood contact, limited exposure (<24 hrs) device; in-vitro performance testing including dimensional inspection, tensile strength, burst pressure, flow rate, and cyclic fatigue.

Technological Characteristics

Single-lumen plastic catheter; radiopaque markers for fluoroscopic visualization; luer lock adapter. Biocompatibility verified per ISO 10993-1. Mechanical testing includes tensile, burst, flow, and cyclic fatigue.

Indications for Use

Indicated for controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• TruLine™ Reinforced Valved Infusion Catheters (K021139)

Submission Summary (Full Text)

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Micro Therapeutics, Inc.

Special 510(k): TruLine™ Reinforced Valved Infusion Catheter

K021139

## Attachment 4

| | 510(k) Summary |
|----------------|--------------------------------------------------|
| Prepared: | April 5, 2002 |
| TRADE NAME | TruLine ™ |
| GENERIC NAME | Catheter, Intravascular, Therapeutic, Short-Term |
| CLASSIFICATION | Class II (21 CFR 880.5200) |
| SUBMITTED BY | Micro Therapeutics, Inc. |
| | 2 Goodyear |
| | Irvine, CA 92618 |

| CONTACT | Tom Daughters |
|---------|--------------------|
| | Regulatory Affairs |
| | [phone] |

| PREDICATE DEVICE | TruLine™ Reinforced Valved Infusion Catheters |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE DESCRIPTION | The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths. |
| INDICATIONS FOR USE | The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. |
| TESTING | Biocompatibility of the MTI TruLine™ Reinforced Valved Infusion Catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter when tested as an external communicating, blood contact, limited exposure (<24 hrs) device. In-vitro performance testing of the MTI TruLine™ Reinforced Infusion Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, cyclic fatigue tests and performance under simulated conditions. All testing yielded acceptable results. |
| SUMMARY OF SUBSTANTIAL EQUIVALENCE | The MTI TruLine™ Reinforced Infusion Catheter is substantially equivalent to the predicate device in intended use and principles of operation. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 7 2002

Mr. Tom Daughters Director, Regulatory Affairs Micro Therapeutics, Incorporated 2 Goodyear Irvine, California 92618

Re: K021139

Trade/Device Name: TruLine™ Reinforced Valved Infusion Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 5, 2002 Received: April 9, 2002

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 such additional controls. Existing major regulations affecting vour 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.

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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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Micro Therapeutics, Inc.

Special 510(k): TruLine™ Reinforced Valved Infusion Catheter

Attachment 2

Indications for Use Statement

510(k) Number (if known): 5021139

Device Name:

TruLine™ Reinforced Valved Infusion Catheter

Indications for Use:

The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of pharmacologic physician-specified agents or radiopaque contrast media general the into vasculature.

Patrica Currente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over the Counter Use_

(Per 21 CFR 801.109)