(70 days)
The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
The Medikit Super Sheath Introducer XL Sheaths and Super Sheath XL Introducer Sheath Sets are similar to the 4-9F sheaths with the addition of four French sizes to the sheath line. The Super Sheath XL Introducer Sheaths are available in 10F, 11F, 12F and 14F sizes and available in lengths ranging from 11 to 25 cm. The devices are provided sterile and are intended for one procedure use only. The Medikit Super Sheath XL Introducer Sheath is packaged with a dilator. The Super Sheath Introducer XL Sheath Set consists of a sheath, a dilator and a mini guidewire, with inserter. The mini guidewires with inserter were cleared to market in K052557 (January 17, 2006). The construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and fluorinated ethylene propylene FEP (Teflon). The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration as well as blood sampling. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. The dilators are 0.038" and a 0.035" guidewire compatible. The dilator tubes are made of fluorinated ethylene propylene (FEP). The dilator tubes are attached to the dilator hub using an epoxy resin. The sheath hub and the dilator hub lock using a rotating motion.
The provided text is a 510(k) premarket notification for a medical device (introducer sheaths) and does not describe acceptance criteria or a study that proves a device meets those criteria in the context of an AI/ML clinical validation study. Instead, it details the non-clinical (bench) testing performed to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested categories are not applicable to the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document describes several non-clinical tests but does not explicitly state acceptance criteria in a quantitative format or report performance against specific thresholds. It generally states that "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for each test. General goal: "meet product specification" and be "adequate for their intended use." | Verified as "adequate for their intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual non-clinical tests.
- Data Provenance: N/A (non-clinical bench testing, not human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. Ground truth in this context would be test standards/specifications, not expert interpretation of data.
4. Adjudication method for the test set:
N/A. This is relevant for diagnostic studies, not bench testing.
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:
N/A. This document describes a medical device, not an AI/ML diagnostic system, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance standards for introducer sheaths, which are not detailed in this summary but are referred to as "product specification."
8. The sample size for the training set:
N/A. No training set is applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
N/A. No training set.
Summary of Device-Specific Information from the Text:
The document describes the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets, which are indicated for the introduction of diagnostic and interventional devices into the human vasculature.
Study Type: Non-clinical (bench) testing was performed to verify that the device met product specifications and to establish substantial equivalence to a predicate device (Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets, K052557).
Tests Performed:
- Sheath Shaft Tensile test
- Sheath Kink Test
- Sheath Hub to Shaft Tensile Test
- Hemostatic Valve Integrity/Sheath Pressure Test
- Sheath Valve Integrity/Sheath Pressure Test
- Dilator Shaft Tensile Test
- Dilator Hub to Shaft Tensile Test
- Real Time Product Shelf Lift Testing
- (Also referenced from predicate device testing: Lubricity, radiopacity, sheath/dilator corrosion resistance testing, biocompatibility, and package test reports).
Conclusion of Testing: "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use. Based on a comparison of intended use, design and the results of bench testing, Medikit 10F, 11F, 12F, and 14F Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets have been shown to be substantially equivalent to the predicate (K052557) device."
§ 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).