(112 days)
The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
The XLR8 Plus (XLR8+) Wound Vacuum System is portable, rechargeable battery powered wound suction pump with the intention to deliver negative pressure to the wound. The XLR8 Plus (XLR8 +) is a modification to the existing A4-XLR8 wound vacuum system with exactly the same internal components and accessories. The XLR8+ is a lightweight, portable wound suction device. It has a rechargeable battery, LCD screen for clear viewing, membrane overlay with buttons to control the device. It has 2 therapy options, continuous therapy and variable intermittent therapy. It consists of 5 alerts to notify the users of unwanted events, i.e. leakage in the dressing, blockage in the tubing, canister is full, low battery status.
The provided text is a 510(k) summary for the Genadyne XLR8 Plus (XLR8+) Wound Vacuum System, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new device is as safe and effective as a legally marketed device, rather than rigorously proving performance against pre-defined acceptance criteria through extensive studies in the way an AI/ML device submission might.
Therefore, the information required for acceptance criteria and the study proving it typically found in AI/ML device descriptions is not present in this document. This document details a special 510(k), which implies minor modifications to an existing device, and thus relies heavily on the equivalence of the modified device to the predicate device, rather than new performance studies.
Here's a breakdown of why each requested point cannot be fully addressed by this document:
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A table of acceptance criteria and the reported device performance: This document doesn't define quantitative acceptance criteria for performance in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it compares technical characteristics and intended use to a predicate device. The "performance" reported is essentially that it matches the predicate.
Table based on available comparative information (technical characteristics):
Characteristic Acceptance Criteria (Predicate Device) Reported Device Performance (XLR8 Plus) Suction Capacity 3.5 liters per minute 3.5 liters per minute Max Vacuum 230 mmHg 230 mmHg Power Requirements 30W 30W Battery Type Rechargeable Li-Ion Rechargeable Li-Ion Dimensions 5.9" x 4" x 2.4" 5.9" x 4" x 3.4" (larger depth) Weight 1.5 lbs 1.65 lbs Canister Sizes 200, 400, 600, 800 ml 200, 400, 600, 800 ml Reusable No No Sterile Non Sterile Non Sterile Indications for Use Matches predicate Matches predicate Contraindications Matches predicate Matches predicate Precautions Matches predicate Matches predicate Compliance (Standards) IEC 60601-1, IEC 60601-1-2 IEC 60601-1, IEC 60601-1-2 Storage/Transport Temp -18°C to +43°C -18°C to +43°C Storage/Transport RH 10% to 95% 10% to 95% Storage/Transport Atm 700 - 1060 mbar 700 - 1060 mbar Operation Temp 18°C to 34°C 18°C to 34°C Operation RH 10% to 95% 10% to 95% Operation Atm 700 - 1060 mbar 700 - 1060 mbar -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned. The device's substantial equivalence is primarily based on comparisons of its technical specifications to the predicate device, not on new clinical performance data from a test set. This is a common approach for "Special 510(k)" submissions for minor modifications.
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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. There is no mention of a test set requiring expert-established ground truth for the performance claims.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As there's no mention of a test set requiring ground truth, no adjudication method is described.
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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. This device is a wound vacuum system, not an AI/ML imaging or diagnostic device. There is no concept of "human readers" or "AI assistance" in its function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of clinical validation for AI/ML devices is not relevant here. The "truth" for this submission is that its physical and functional characteristics are substantially equivalent to the predicate.
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The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.
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How the ground truth for the training set was established: Not applicable.
Summary of the Study (as described in the document):
The "study" or justification for substantial equivalence is a comparison of technological characteristics and indications for use between the new device (XLR8 Plus) and its predicate device (A4-XLR8). The document emphasizes that "Everything in the XLR8 Plus (XLR8+) Wound Vacuum System is exactly the same as the predicate device... with the exception of an increment in depth of 1" to the back cover housing." This suggests that the "study" was primarily an engineering and design comparison, demonstrating that the minor physical change does not alter the fundamental safety and effectiveness or performance parameters of the device. The compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-2) for both devices further supports this claim of equivalence.
§ 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.