(206 days)
The InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System (Heparin Coated) is indicated for the following usages: Percutaneous vascular access.
The Radially Expanding Vascular Access System (Heparin Coated) consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected ver a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments. This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the sleeve while leaving the sleeve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.
This document is a 510(k) premarket notification for the InnerDyne Radially Expanding Vascular Access System (Heparin Coated). The FDA's review of 510(k) submissions primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be associated with novel, high-risk devices.
Therefore, many of the typical elements requested in your prompt regarding acceptance criteria and detailed study information are not present or not applicable in this type of submission. The key finding is "substantial equivalence" based on design, function, materials, and indications for use being similar to a predicate device, with an added heparin coating and an expanded sheath diameter range noted as the primary differences.
Here's an attempt to address your points based on the provided text, highlighting where information is absent or not relevant to a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to a predicate device in terms of safety and effectiveness, based on similar technological characteristics and intended use. Performance data in the context of specific quantitative measures with defined thresholds is typically not required for 510(k) clearance unless there are new technological features posing different risks.
The document states: "From the foregoing, we conclude that the Radially Expanding Vascular Access System (Heparin Coated) device is as safe and effective as currently marketed devices for the stated indications." This is the broad "performance" claim, achieved by comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission relies on a comparison to a predicate device, not on new clinical performance data from a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. No "test set" in the sense of patient data requiring expert ground truth assessment is described as part of this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable/provided.
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
This information is not applicable. This device is a physical medical device (vascular access system), not an AI algorithm or imaging device that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The Type of Ground Truth Used
This information is not applicable/provided. The basis for clearance is substantial equivalence to an existing legally marketed device (the predicate). The "truth" in this context is that the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no mention of a "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided.
§ 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).