ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65

K981191 · Intratherapeutics, Inc. · DQY · Apr 7, 1999 · Cardiovascular

Device Facts

• Record ID: K981191
• Device Name: ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
• Applicant: Intratherapeutics, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature

Device Story

ITI IntraMAX™ guide catheter is a single-lumen percutaneous catheter used to access distal vasculature. Operated by physicians in clinical settings, the device facilitates the delivery of diagnostic, therapeutic, or interventional devices into the extracranial vasculature. It is used in conjunction with a guidewire. The device is available in 6, 7, and 8 French sizes, with lengths ranging from 65-110 cm and various distal stem configurations to accommodate physician handling preferences. The device provides a pathway for interventional tools, aiding in clinical procedures by allowing precise navigation through the vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Bench tests included tensile, introducer resistance, kink resistance, torque, body stock stiffness, stem shape recovery, and back-up support. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Single-lumen percutaneous catheter. Available in 6, 7, and 8 French sizes; 65-110 cm lengths. Multiple distal stem configurations. Provided sterile. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for intravascular introduction of diagnostic, therapeutic, and interventional devices into the extracranial vasculature. Prescription use only.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Cordis Vista Brite Tip®
• Mallinckrodt Trax Craven
• SciMed Cyber guide catheters

Submission Summary (Full Text)

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4-7-99

K981191/

IntraTherapeutics, Inc. 651 Campus Drive St. Paul, MN 55112 USA

phone [phone] fax [phone]

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## Intra Therapenties

## 510(k) Summary

Product Name: ITI IntraMAX™ guide catheter Common Name: percutaneous catheter

Submitter's Name:

IntraTherapeutics, Inc. 651 Campus Drive St. Paul, MN 55112

Official Contact: Amy Peterson Vice President RA and QA Tel. [phone] Fax [phone]

Summary Preparation Date: September 1, 1998

This summary is provide in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.

The ITI IntraMAX™ guide catheter is a Class II product classified as a percutaneous catheter (21 CFR \$870.1250). Substantial equivalence is claimed to the Cordis Vista Brite Tip®, Mallinckrodt Trax Craven, and SciMed Cyber guide catheters.

The ITI IntraMAX™ guide catheters are single lumen devices designed to aid the physician in the access of distal vasculature with the aid of a guidewire. The ITI IntraMAX™ guide catheters are a family of catheters currently manufactured in three French sizes (6, 7 and 8 FR), in lengths 65-110 cm and with multiple distal stem configurations ("style features"). The style features are offered with differing handling characteristics to allow flexibility in meeting physician preferences within the indication for use.

The intended use is "for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature ".

Technological characteristics were assessed through comparison bench tests and results demonstrated, at minimum, equivalence performance characteristics between the ITI IntraMAX™ guide catheter and predicate devices. Bench tests included tensile, introducer resistance, kink resistance, torque, body stock stiffness, stem shape recovery and back-up support. All appropriate biocompatibility tests for a guide catheter were successfully completed per ISO 10993-1. The guide catheter is provided sterile.

The composite results of these tests indicate the ITI IntraMAX™ guide catheter is safe for the intended use with a shelf life of two years.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 1999

Ms. Amy Peterson Vice Presidrent RA and QA Intra Therapeutics, Inc. 651 Campus Drive St. Paul, MN 55112

Re : K981191 Trade Name: ITI IntraMAX™ Guide Catheter Regulatory Class: II Product Code: DQY Dated: January 7, 1999 Received: January 8, 1999

Dear Ms. Peterson:

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 leqally 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 regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have

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Page 2 - Ms. Amy Peterson

under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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_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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if know): _____________________________________________________________________________________________________________________________________________________ K981191

Device Name: ITI IntraMAX™ 91, 78, and 65

Indication For Use:

The ITI IntraMAX™ Guide Catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher Klore for TJC

ardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _