(370 days)
The ITI IntraMAX™ Guide Catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional devices into the extracranial vasculature.
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 provided document is a 510(k) Summary for the ITI IntraMAX™ guide catheter and an FDA clearance letter. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on bench testing and biocompatibility assessments. It is not a study that provides acceptance criteria and performance data in the format requested.
Therefore, I cannot extract the specific information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, number of experts, adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only states the following regarding performance and acceptance criteria:
- Acceptance Criteria Mentioned: "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."
- Performance Reported: "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."
This information indicates that the acceptance criteria were based on achieving "at minimum, equivalence performance characteristics" to predicate devices across a series of bench tests. However, the exact quantitative acceptance thresholds for each test (e.g., specific tensile strength values, kink resistance thresholds) and the specific quantitative results achieved by the ITI IntraMAX™ are not detailed in this summary.
In summary, based on the provided text, I can only state:
- Acceptance Criteria: Equivalence or better performance compared to predicate devices for various bench tests (tensile, introducer resistance, kink resistance, torque, body stock stiffness, stem shape recovery, back-up support) and successful completion of biocompatibility tests per ISO 10993-1.
- Reported Device Performance: The device "demonstrated, at minimum, equivalence performance characteristics" in the listed bench tests and "successfully completed" all appropriate biocompatibility tests. It was also deemed "safe for the intended use with a shelf life of two years."
No other requested information (sample sizes, expert details, MRMC study, standalone performance, ground truth details for training/test sets) is available in the provided text.
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4-7-99
IntraTherapeutics, Inc. 651 Campus Drive St. Paul, MN 55112 USA
phone (651) 697-9797 fax (651) 697-2080
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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. 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.
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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 (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
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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 _
§ 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).