(370 days)
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No
The document describes a physical guide catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device description states it is a guide catheter intended for intravascular introduction of diagnostic, therapeutic and interventional devices, meaning it is used to introduce other devices, not to perform therapy itself.
No
The device, a guide catheter, is intended for the introduction of diagnostic, therapeutic, and interventional devices, but it is not itself a diagnostic device.
No
The device description clearly states it is a physical catheter, a hardware device, and the performance studies focus on physical characteristics and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a single-lumen catheter designed to aid in accessing vasculature. This aligns with an interventional or diagnostic tool used in vivo, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the ITI IntraMAX™ Guide Catheter is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ITI IntraMAX™ Guide Catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature.
Product codes
DQY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extracranial vasculature
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Cordis Vista Brite Tip®, Mallinckrodt Trax Craven, and SciMed Cyber guide catheters.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
4-7-99
IntraTherapeutics, Inc. 651 Campus Drive St. Paul, MN 55112 USA
phone (651) 697-9797 fax (651) 697-2080
Image /page/0/Picture/4 description: The image is a black square with white text inside. The text consists of a capital Greek letter "Gamma" (Γ) followed by a lowercase italicized "i". The text is centered within the square.
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. 612-697-2076 Fax 612-697-2085
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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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
2
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 (301) 594-4586. 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
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
3
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 _