(113 days)
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
The provided document describes the 510(k) premarket notification for the PICC WAND® Peelable Safety Introducer. The information primarily focuses on establishing substantial equivalence to a predicate device through biocompatibility and performance testing. There is no information regarding AI-based devices or studies that would involve AI models. Therefore, many of the requested categories are not applicable to this submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "Biocompatibility testing... has been completed to demonstrate the biological safety... Test results indicate that the device is equivalent to the predicate device." |
| Biomechanical Performance/Mechanical Requirements | "in vitro bench testing has been completed to demonstrate the... biomechanical performance characteristics... Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use." |
| Sterility | "Provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-6." |
| Substantial Equivalence (Overall Conclusion) | "The results of testing demonstrate that the PICC WAND® Peelable Safety Introducer is substantially equivalent to the predicate device in design, function, and indications for use." |
Study Details (Focus on Safety and Performance, Not AI)
-
Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the biocompatibility or in vitro bench testing. The data provenance is not explicitly mentioned (e.g., country of origin), but it is implied to be from studies conducted by Access Scientific, Inc. for regulatory submission in the USA. These tests are prospective. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are laboratory/bench tests and biocompatibility assessments, not clinical studies requiring expert ground truth for interpretation of medical images or data. -
Adjudication method for the test set:
This information is not applicable as the studies are not clinical trials that would require adjudication for outcomes. -
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:
Not applicable. This is a medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. No MRMC study was performed. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm or AI. -
The type of ground truth used:
For biocompatibility, the ground truth would be established by validated test methods adhering to ISO standards (e.g., ISO 10993 series) for biological safety, with results compared against predetermined safety thresholds. For biomechanical performance, the ground truth would be established by engineering specifications and performance requirements derived from the predicate device and intended use, measured through in vitro bench testing. -
The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/ML product. -
How the ground truth for the training set was established:
Not applicable (no training set).
§ 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).