(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.
§ 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).