(55 days)
The IntraMax™ guide catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional* devices into the extracranial vasculature.
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 provided text describes the 510(k) summary for the IntraMax™ Guide Catheter, focusing on its substantial equivalence to a predicate device rather than a study demonstrating the device meets specific acceptance criteria in the manner you've requested (e.g., performance metrics against established thresholds).
Therefore, much of the information you've asked for (e.g., detailed acceptance criteria table with performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not available in the provided document.
The document indicates that "functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions" and "All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose." However, specific quantitative acceptance criteria or detailed results of these functional tests are not provided. The focus is on demonstrating substantial equivalence to a previously cleared device (IntraTherapeutics, Inc. IntraMax™ Guide Catheter, K981191) based on identical intended use, equivalent materials, and technological characteristics.
Here's a summary of the available information based on your request, highlighting what is not explicitly stated in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Function according to intended use instructions. | "functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions." and "All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose." (No specific quantitative performance metrics are provided, but the statement implies successful completion of functional tests.) |
| Biocompatibility in compliance with ISO 10993 and GLP requirements. | "Biocompatibility tests per ISO 10993 were also performed and were in compliance with ISO and GLP requirements." (This indicates successful compliance with specific standards, but details of the tests and results are not given.) |
| Substantial equivalence to predicate device (K981191) in materials. | "The IntraMax™ is identical for indication for use and equivalent in materials and technological characteristics." (No specific material composition details are provided, but equivalence to the predicate is asserted.) |
| Substantial equivalence to predicate device (K981191) in technological characteristics. | "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." (Details of the specific technological characteristics and the comparative "bench" tests are not provided, only the assertion of equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated. The document refers to "functional testing" but does not provide details on the number of devices tested.
- Data provenance: The tests described (functional and biocompatibility) are laboratory/bench tests and not human clinical data. Their origin is internal to the manufacturer (IntraTherapeutics, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to the type of testing described (functional and biocompatibility bench tests) for establishing substantial equivalence. No human "ground truth" was established in this context.
4. Adjudication method for the test set
- Not applicable, as it was not a human-reader study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This device is a guide catheter and not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a medical device (catheter) and not an algorithm.
7. The type of ground truth used
- For functional testing, the "ground truth" would be engineering specifications and functional requirements (e.g., flow rate, flexibility, tensile strength, pushability, torqueability, lubricity, etc.), though these specific metrics are not detailed.
- For biocompatibility testing, the "ground truth" is compliance with ISO 10993 standards and Good Laboratory Practice (GLP) requirements, as determined by laboratory analysis.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the IntraMax™ Guide Catheter to a predicate device through functional and biocompatibility testing. It does not contain the detailed quantitative acceptance criteria, specific performance metrics, or study design information (like sample sizes, expert qualifications, or ground truth methods) that would be present in a submission for a novel device or a device requiring clinical performance evaluation with human data.
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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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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 _________________________________________________________________________________________________________________________________________________________
§ 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).