(22 days)
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.
The Flexor® Radial Hydrophilic Introducer Access Set is an introducer set, supplied with an introducer sheath, dilator, wire guide and access needle. The introducers are available in whole French sizes from 4.0 through 7.0 French and in lengths of 7, 13 and 23 centimeters. The sets are compatible with the supplied 0.018" wire guide. The sets are supplied sterile and intended for one-time use.
This document describes a 510(k) premarket notification for the "Flexor® Radial Hydrophilic Introducer Access Set" and its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria and performance data in the format requested.
The document states that the Flexor® Radial Hydrophilic Introducer Access Set met applicable design and performance requirements and that predetermined acceptance criteria were met for acute performance, check-flo valve leakage, and biocompatibility. However, it does not provide the specific numerical acceptance criteria or the reported device performance metrics.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, training set sample size, or how training set ground truth was established, as this information is not present in the provided text.
The closest information available is:
- Device: Flexor® Radial Hydrophilic Introducer Access Set
- Intended Use: To introduce diagnostic and interventional devices in radial artery access procedures.
- Predicate Device: Flexor® Radial Hydrophilic Introducer Access Set (cleared under 510(k) number K132592).
- Reason for new submission: Modification of the check-flo valve in response to physician feedback.
- Tests performed:
- Acute Performance
- Check-Flo valve liquid leakage testing
- Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance in conformance with ISO 10993-1:2009).
- Outcome of tests: Predetermined acceptance criteria were met for all tests, supporting a determination of substantial equivalence.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).