(55 days)
Not Found
No
The summary describes a guide catheter, a mechanical device for accessing vasculature. There is no mention of software, image processing, AI, ML, or data analysis that would suggest the use of AI/ML technology.
No
The device description states that the IntraMax™ guide catheter is "intended for intravascular introduction of diagnostic, therapeutic and interventional devices." This indicates that it is a tool used to deliver other devices, not a therapeutic device itself.
No
The device is a guide catheter intended for intravascular introduction of other devices, not for diagnosing conditions itself. While it facilitates the use of diagnostic devices, it is not diagnostic in nature.
No
The device description clearly describes a physical catheter, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature." This describes a device used within the body for delivering other tools, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter designed to aid in accessing vasculature with a guidewire. This aligns with an interventional or diagnostic tool delivery system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the IntraMax™ guide catheter is a medical device used for accessing and delivering other devices within the body, not an IVD.
N/A
Intended Use / Indications for Use
The IntraMax™ guide catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional* devices into the extracranial vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The IntraMax™ is single lumen devices designed to aid the physician in the access of distal vasculature with the aid of a quidewire. The IntraMax™ is a family of catheters currently manufactured in three French sizes (6, 7 and 8 FR), multiple distal stem configurations, lengths and side holes ("style features"). Per French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences within the indication for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extracranial vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions. Biocompatibility tests per ISO 10993 were also performed and were in compliance with ISO and GLP requirements. All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) Summary
IntraMax™ Guide Catheter Product Name: quide or guiding catheter Common Name: IntraTherapeutics, Inc, Submitter's Name: 651 Campus Drive St. Paul, MN 55112 Amv Peterson Official Contact: VP Requlatory Affairs & Quality Assurance Tel. 651-697-2076 Fax 651-697-2080
Summary Preparation Date: July 27, 1999
This summary is provide in compliance with section 513(l)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.
The product trade and common name are IntraMax™ Guide Catheter and guide/guiding catheter, respectively. This is a Class II product classified under 21 CFR §870.1250 as a percutaneous catheter. Substantial equivalence* is claimed to IntraTherapeutics, Inc. 171 IntraMax™ Guide Catheter (K981191).
The IntraMax™ is single lumen devices designed to aid the physician in the access of distal vasculature with the aid of a quidewire. The IntraMax™ is a family of catheters currently manufactured in three French sizes (6, 7 and 8 FR), multiple distal stem configurations, lengths and side holes ("style features"). Per French size, catheters will be 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".
Summary of technological characteristics: functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions. Biocompatibility tests per ISO 10993 were also performed and were in compliance with ISO and GLP requirements. All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose.
The IntraMax™ remains substantially equivalent* to the predicate guide catheter for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature.
As demonstrated the IntraMax™ is identical for indication for use and equivalent in materials and technological characteristics. Performance functional testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the IntraMax™ Guide Catheter meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 36 of the US Code.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract representation of a human figure or symbol, possibly suggesting care or support.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Ms. Amy Peterson Vice President Regulatory Affairs & Quality Assurance Intra Therapeutics, Inc. 651 Campus Drive St. Paul, MN 55112
Re : K992622 IntraMax™ Guide Catheter Trade Name: Regulatory Class: II Product Code: DQY September 9, 1999 Dated: Received: September 10, 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 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 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 regulation may result in regulatory 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 under sections 531 through 542 of the Act for devices
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Page 2 - Ms. Amy Peterson
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. Callahan
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): K992622
Device Name: IntraMax™ Guide Catheter
Indication For Use: The 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 - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological 510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________