(14 days)
The Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
The Renasys EZ is a powered suction pump with accessory wound dressing kits, disposable canister and filter designed for Negative Pressure Wound Therapy (NPWT). The Renasys EZ is designed for use with various Smith & Nephew wound dressing kits to deliver a recommended therapeutic range of 40-80 mmHg of continuous or internittent topical negative pressure to a wound site for the purposes of wound healing.
The provided text is a 510(k) Summary for the Renasys™ EZ Negative Pressure Wound Therapy system. This document focuses on establishing substantial equivalence to a predicate device based on indications for use, materials, technology, product specifications, and energy requirements. It does not contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement in a clinical effectiveness study that would typically be associated with performance claims for AI-driven devices.
Therefore, I cannot provide a response that includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details of standalone algorithm performance studies.
- Sample size for training sets or how ground truth for training sets was established.
This is because the provided document is a regulatory submission for a medical device (a suction pump), not an AI/ML-driven device, and thus the type of performance evaluation information requested is not relevant or present in this context.
§ 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.