(118 days)
These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.
The various SDM Percutaneous Catheter Introducer/Set range in dilator tubing sized from 4 Fr to 13 Fr and in dilator lengths from 100mm to 340mm. Sheaths paired with the dilators are tapered and close fitting to facilitate maximum ease of insertion. The sheaths are offered in both FEP and Pebax depending on customer preference. The sheath hemostasis valve contains a silicone seal and is offered both with a sideport and plain. An 18ga needle and guidewire of appropriate size will also be included with each set. Dilator luers are marked with a numeral and sheath caps are colored coded to indicate french size. These sets will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids. A more economical, reduced version of the set will also be offered containing just a dilator and sheath without hemostasis valve packaged in a Tyvek/Poly chevron pouch
The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device called the "SDM Percuglide Percutaneous Catheter Introducer/Set." This document is a 510(k) Premarket Notification.
It's crucial to understand that a 510(k) summary (like the one provided) does not typically contain acceptance criteria or detailed study results proving a device meets them. The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not about proving clinical efficacy or safety through rigorous studies as would be required for a PMA (Premarket Approval).
Therefore, based solely on the provided text, I cannot describe acceptance criteria or a study proving the device meets those criteria in the way you've requested. The document focuses on demonstrating substantial equivalence by comparing the new device to existing predicate devices based on intended use, materials, dimensions, and mechanical properties.
Here's what I can infer from the text regarding your questions, and what is explicitly missing:
Summary of Findings from the Provided Text:
The document states that the SDM Percuglide Percutaneous Catheter Introducer/Set is substantially equivalent to currently marketed introducer sets.
The rationale for substantial equivalence is based on:
- Intended Use: "for use in percutaneous introduction of various catheters and/or guidewires into the vasculature." - This is the same as predicate devices.
- Materials: "generically the same as those present in the substantially equivalent devices."
- Dimensions: "chosen to match commonly accepted industry standards and to replicate several of the predicate devices."
- Mechanical Properties: "chosen to match commonly accepted industry standards and to replicate several of the predicate devices."
The document mentions that Biocompatibility Evaluation testing (per ISO Standard 10993, Part I) is "currently underway" and "This data will be provided to the office of Device Evaluation prior to completion of review." This indicates that, at the time of this summary, the biocompatibility data was not yet complete or submitted.
Addressing Your Specific Questions Based on the Provided Text:
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A table of acceptance criteria and the reported device performance:
- Not available in the provided text. The document describes the device's characteristics (e.g., dilator sizes, materials, components) and states they are chosen to "match commonly accepted industry standards and to replicate several of the predicate devices." It does not provide specific, quantifiable acceptance criteria (e.g., "tensile strength > X N") nor does it report specific device performance data against such criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text. No specific test sets, sample sizes, or data provenance information is mentioned for performance studies. The rationale for substantial equivalence is based on design choices to match predicate devices, not on direct comparative testing results described in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/available. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation, clinical outcomes evaluated by experts). The provided text describes a physical medical device and its components, and doesn't mention any such expert evaluations for establishing ground truth of a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/available. See point 3.
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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/available. This device is a physical catheter introducer set, not an AI-powered diagnostic or assistive tool. No MRMC studies would be relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/available. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/available. For a physical device like this, "ground truth" would typically relate to objective physical and mechanical properties (e.g., material strength, dimensions, flow rates), which are assessed against engineering specifications, not expert consensus or pathology in this context. The document states materials, dimensions, and functionality "match commonly accepted industry standards" and "replicate" predicate devices.
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The sample size for the training set:
- Not applicable/available. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable/available. See point 8.
Conclusion:
The provided document is a 510(k) summary focusing on demonstrating substantial equivalence, not a detailed report of studies proving a device meets specific performance criteria. It asserts that the device's design, materials, and intended use are similar to existing predicate devices. Information regarding specific acceptance criteria, detailed performance studies, sample sizes, expert involvement, or AI-related data is not included in this type of document. The only mention of ongoing testing is for biocompatibility, with data to be submitted later.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).