(22 days)
The RENASYS EZ PLUS is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and grafts.
The Renasys EZ PLUS NPWT device is a lightweight, suction device intended for wound management via application of continual or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ PLUS is suitable for use in either a hospital or homecare setting. Renasys EZ PLUS is compatible with existing Smith & Nephew wound dressing kits currently on the market.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Renasys™ EZ PLUS Negative Pressure Wound Therapy device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with UL 60601-1 and IEC 60601-1 | Testing in accordance with UL 60601-1 and IEC 60601-1 was conducted and found satisfactory. |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 | Testing in accordance with IEC 60601-1-2 was conducted and found satisfactory. |
| Design Specifications: Meeting design specifications | Testing was conducted to verify the changes in the Renasys EZ PLUS met design specifications. |
| Substantial Equivalence: To predicate device (K091470 - Renasys™ EZ) for intended use. | Performance testing and electrical safety testing successfully demonstrated substantial equivalence to the marketed predicate device and safety and effectiveness for intended use. The FDA concurred with this determination. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The conducted testing appears to be primarily non-clinical bench testing.
- Data Provenance: The data provenance is from bench testing conducted by the manufacturer, Smith & Nephew, Inc. No information on country of origin for clinical or patient data is provided, as no clinical study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the provided document describes non-clinical (bench) testing, not a clinical study involving human patients where "ground truth" would be established by experts. The "ground truth" in this context is adherence to established engineering and safety standards.
4. Adjudication Method for the Test Set
- This question is not applicable as there is no human adjudication process described for the non-clinical bench testing. The evaluation is against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC study was done. This device is a negative pressure wound therapy (NPWT) device, which is a physical medical device, not an AI or imaging-related diagnostic tool. Therefore, the concept of "human readers" and "AI assistance" does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical medical device for wound therapy, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to established engineering standards and design specifications (e.g., UL 60601-1, IEC 60601-1-2, internal design specifications) rather than clinical ground truth like pathology or outcomes data. The primary "ground truth" for substantial equivalence is the performance and safety profile of the predicate device (Renasys™ EZ).
8. The Sample Size for the Training Set
- This question is not applicable as this device is a physical medical device and does not involve machine learning algorithms with a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no "training set" for this type of device.
§ 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.