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 Description

The MTI 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 of the Reinforced Infusion Catheter is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The Reinforced Infusion Catheters are available in a variety of infusion lengths.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Micro Therapeutics, Inc. Reinforced Infusion Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criteria	Device Performance
Biocompatibility (in accordance with ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device)	Test results confirmed biocompatibility of the catheter.
In-vitro Performance Testing:
- Dimensional Inspection	Yielded acceptable results.
- Tensile Strength Tests	Yielded acceptable results.
- Burst Pressure Tests	Yielded acceptable results.
- Flow Rate Tests	Yielded acceptable results.
- Performance under Simulated Conditions	Yielded acceptable results.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any of its performance testing. The description is quite general about "in-vitro performance testing" and biocompatibility.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This information is not provided in the document. The tests performed are laboratory-based physical and biological evaluations, rather than those requiring expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. The testing described does not involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on the physical and biological characteristics of the device, not its use by human readers in a diagnostic capacity.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical medical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility testing, the "ground truth" was established based on the criteria outlined in ISO 10993-1. For the in-vitro performance testing (dimensional inspection, tensile strength, burst pressure, flow rate, simulated conditions), the "ground truth" would be the predetermined engineering specifications and performance requirements for a safe and effective catheter.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/machine learning product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned.

Summary

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AUG	2
8	2001

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

K011937

Attachment 5

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.2 GoodyearIrvine, CA 92618	CONTACT	Eben GordonRegulatory Affairs(949) 837-3700
PREDICATEDEVICE	MTI Infusion Catheter
DEVICEDESCRIPTION	The MTI Reinforced Infusion Catheter is a single-lumen plastic catheterdesigned to be introduced over a guidewire into the vasculature. Oncepositioned, various pharmacological agents may be delivered through astandard luer lock adapter at the proximal end. The infusion area of theReinforced Infusion Catheter is indicated by distal and proximal radiopaquemarkers to facilitate fluoroscopic visualization. The Reinforced InfusionCatheters are available in a variety of infusion lengths.
INDICATIONS FORUSE	The MTI Reinforced Infusion Catheter is intended to be used for thecontrolled selective infusion of physician-specified pharmacologic agentsor radiopaque contrast media into the general vasculature.
TESTING	Biocompatibility of the MTI Reinforced Infusion Catheter was verified inaccordance with ISO 10993-1, Biological Evaluation of Medical Devices. Testresults confirmed biocompatibility of the catheter when tested as an externalcommunicating, blood contact, limited exposure (<24 hrs) device.In-vitro performance testing of the MTI Reinforced Infusion Catheter includeddimensional inspection, tensile strength tests, burst pressure tests, flow ratetests, and performance under simulated conditions. All testing of the productyielded acceptable results.
SUMMARY OFSUBSTANTIALEQUIVALENCE	The MTI Reinforced Infusion Catheter is substantially equivalent to thepredicate 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).