(58 days)
The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.
The product is a portable suction pump for general purpose drainage or for the promotion of wound healing when used with various accessory wound sealing kits.
This 510(k) submission (K052456) is a Special 510(k) for a modification to an already cleared device, the Versatile 1™ Wound Vacuum System (predicate K042134).
Therefore, the submission does not present a new clinical study to prove the device meets acceptance criteria. Instead, it relies on the principle of substantial equivalence to its predicate device. This means the manufacturer is asserting that the modifications made do not significantly affect the safety or efficacy of the device, and thus, the device still meets the criteria previously established for the predicate device.
Here's an analysis based on the provided text:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the Special 510(k) submission for K052456. Since it's a modification, the acceptance criteria would have been established and met during the clearance of the original predicate device (K042134). The current submission states that "The proposed modifications in materials and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." This implicitly means the modified device is expected to perform at the same level as the predicate in meeting its original acceptance criteria.
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Sample size used for the test set and the data provenance: Not applicable. No new clinical or performance studies using a test set are presented in this Special 510(k). The modifications were related to "materials and labeling."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment was used.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. The device is a wound vacuum system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a wound vacuum system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for K052456. The original predicate device's clearance would have relied on appropriate testing (e.g., bench testing, biocompatibility, electrical safety) to demonstrate its performance relative to its intended use.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
Summary:
This 510(k) is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device. The core of such a submission is to demonstrate that the modifications do not significantly affect the safety or effectiveness of the device. Therefore, it does not typically involve new extensive clinical studies or the establishment of new acceptance criteria. The claim is that the device, with the modifications, still meets the safety and effectiveness profile established during the clearance of its predicate device (K042134). The specific acceptance criteria and the studies that originally proved the predicate device met them would be found in the documentation for K042134.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.