TRULINE INFUSION CATHETERS

K011937 · Micro Therapeutics, Inc. · FOZ · Aug 28, 2001 · General Hospital

Device Facts

• Record ID: K011937
• Device Name: TRULINE INFUSION CATHETERS
• Applicant: Micro Therapeutics, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 28, 2001
• 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

The MTI Reinforced Infusion Catheter is a single-lumen plastic catheter designed for introduction over a guidewire into the general vasculature. It features distal and proximal radiopaque markers for fluoroscopic visualization. Pharmacological agents or contrast media are delivered through a standard luer lock adapter at the proximal end. The device is used by physicians in clinical settings to facilitate targeted delivery of fluids. By providing controlled infusion, the catheter assists in therapeutic or diagnostic procedures, benefiting patients through precise agent administration.

Clinical Evidence

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

Technological Characteristics

Single-lumen plastic catheter; includes luer lock adapter and radiopaque markers. Biocompatibility tested per ISO 10993-1. No software or electronic components.

Indications for Use

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

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

• MTI Infusion Catheter

Submission Summary (Full Text)

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| AUG | 2 |
|-----|------|
| 8 | 2001 |

#### Micro Therapeutics, Inc. Special 510(k): Reinforced Infusion Catheter

K011937

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# Attachment 5

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### 510(k) Summary

## Prepared June 20, 2001

| TRADE NAME | TruLine™ Infusion Catheters | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------------------------------|
| GENERIC NAME | Catheter, Intravascular, Therapeutic, Short-Term | | |
| CLASSIFICATION | Class II (21 CFR 880.5200) | | |
| SUBMITTED BY | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT | Eben Gordon<br>Regulatory Affairs<br>[phone] |
| PREDICATE<br>DEVICE | MTI Infusion Catheter | | |
| DEVICE<br>DESCRIPTION | The MTI Reinforced Infusion Catheter is a single-lumen plastic catheter<br>designed to be introduced over a guidewire into the vasculature. Once<br>positioned, various pharmacological agents may be delivered through a<br>standard luer lock adapter at the proximal end. The infusion area of the<br>Reinforced Infusion Catheter is indicated by distal and proximal radiopaque<br>markers to facilitate fluoroscopic visualization. The Reinforced Infusion<br>Catheters are available in a variety of infusion lengths. | | |
| INDICATIONS FOR<br>USE | The MTI Reinforced Infusion Catheter is intended to be used for the<br>controlled selective infusion of physician-specified pharmacologic agents<br>or radiopaque contrast media into the general vasculature. | | |
| TESTING | Biocompatibility of the MTI Reinforced Infusion Catheter was verified in<br>accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test<br>results confirmed biocompatibility of the catheter when tested as an external<br>communicating, blood contact, limited exposure (<24 hrs) device.<br><br>In-vitro performance testing of the MTI Reinforced Infusion Catheter included<br>dimensional inspection, tensile strength tests, burst pressure tests, flow rate<br>tests, and performance under simulated conditions. All testing of the product<br>yielded acceptable results. | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The MTI Reinforced Infusion Catheter is substantially equivalent to the<br>predicate device in intended use and principles of operation. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized wave-like shapes, which are likely meant to represent the flow of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2001

Mr. Eden Gordon Director of QA/RA Micro Therapeutics, Incorporated 2 Goodyear Irvine, California 92618

K011937 Re : Truline Infusion Catheters Trade/Device Name: 880.5200 Regulation Number: Requlatory Class: II Product Code: FOZ Dated: August 9, 2001 Received: August 13, 2001

Dear Mr. Gordon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Gordon

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in yitro diaqnostic 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 807.97). Other qeneral 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,

K. Altrist

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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## Attachment 2

#### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

MTI Reinforced Infusion Catheter

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.

Patricia Crescenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 5 1 O(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 v

Over the Counter Use_

(Per 21 CFR 801.109)

OR