(15 days)
The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.
The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy.
An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly).
A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s).
The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.
This document, a 510(k) Summary for the RadialSeal™ Introducer Kit (K181855), focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria specific to algorithm performance. Therefore, many of the requested categories related to AI model evaluation will not be applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a tabular format for each test, nor does it provide specific numerical results for the RadialSeal™ Introducer Kit for most tests. Instead, it generally states that "results indicated that no new issues of safety and effectiveness were raised and the results were within the predetermined acceptance criteria" and that "The devices performed equivalently."
However, it does list the types of performance tests conducted and the standards they followed. A summary of the reported performance is general equivalency to the predicate device.
| Test Category | Method / Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sheath Performance Testing | Implied to meet relevant ISO 11070 requirements and internal standards, showing no new safety/effectiveness issues. | Performed equivalently to predicate device. Results within predetermined acceptance criteria. | |
| Surface | ISO 11070 Sec 4.3 | N/A (implied to meet standard) | Equivalency to predicate. |
| Corrosion Resistance | ISO 11070 Sec 4.4 | N/A (implied to meet standard) | Equivalency to predicate. |
| Radio-detectability | ISO 11070 Sec 4.5 | N/A (implied to meet standard) | Equivalency to predicate. |
| Dimensions- Size Designation | ISO 11070 Sec 7.2 | N/A (implied to meet standard) | Equivalency to predicate. |
| Sheath Introducer leakage | ISO 11070 Sec 7.3 | N/A (implied to meet standard, freedom from leakage) | Equivalency to predicate. |
| Hemostasis | ISO 11070 Sec 7.4 | N/A (implied to meet standard, freedom from leakage through valve) | Equivalency to predicate. |
| Peak Tensile Force | ISO 11070 Sec 7.6 | N/A (implied to meet standard) | Equivalency to predicate. |
| Sheath to dilator fit, rollback test, Puncture model test, Kink Angle, Radius of Curvature | ISO 11070 Sec A.1 | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| Valve Insertion Force | Internal Standard | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| Introducer Insertion Force | Internal Standard | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| External surface sliding force | Internal Standard | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| Hydrophilic coating separation resistance (cycle testing) | Internal Standard | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| Hydrophilic coating particulate evaluation (In vitro particulate test) | FDA Guidance, USP 788 | N/A (implied to meet standard) | Side by side testing showed equivalent performance to predicate. |
| Dimensional Verification | ISO 11070 Sec 7.2 | N/A (implied to meet standard) | Equivalency to predicate. |
| Hub | ISO 11070 Sec 7.5, ISO 594-1, ISO 594-2 | N/A (implied to meet standard) | Equivalency to predicate. |
| Stainless Steel Needle Performance Testing | Implied to meet relevant ISO 11070 requirements. | N/A (implied to meet relevant ISO standards for all needle tests) | |
| IV Catheter Performance Testing | Implied to meet relevant ISO 11070 and ISO 594-1 standards. | N/A (implied to meet relevant ISO standards for all catheter tests) | |
| IV Needle Performance Testing | Implied to meet relevant ISO 11070 and ISO 594-2 standards. | N/A (implied to meet relevant ISO standards for all IV needle tests) | |
| Plastic Guidewire Performance Testing | Implied to meet relevant ISO 11070 standards. | N/A (implied to meet relevant ISO standards for all plastic guidewire tests) | |
| Stainless Steel Guidewire Performance Testing | Implied to meet relevant ISO 11070 standards. | N/A (implied to meet relevant ISO standards for all SS guidewire tests) | |
| Dilator Performance Testing | Implied to meet relevant ISO 11070 and ISO 594-2 standards. | N/A (implied to meet relevant ISO standards for all dilator tests) | |
| Biocompatibility | ISO 10993-1 | No new issues of safety or effectiveness. | Testing completed per ISO 10993-1. Device classified as externally communicating, circulating blood, limited contact ( |
§ 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).