(59 days)
The RENASYS EZ PLUS NPWT 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.
Appropriate wound types include:
- Chronic
- Acute
- · Traumatic
- Sub-acute and dehisced wounds
- · Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- Flaps and grafts
RENASYS EZ PLUS professional healthcare facility model (REF 66800697) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
The RENASYS EZ PLUS Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction device intended for wound management via application of continuous 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.
The provided text describes a 510(k) premarket notification for a medical device called the RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device. This notification aims to demonstrate substantial equivalence to a predicate device, the RENASYS EZ MAX Negative Pressure Wound Therapy Device (K142979).
The document details the device description, indications for use, and a summary comparison between the subject and predicate devices. It also outlines the non-clinical (bench) tests conducted to verify that the modifications to the RENASYS EZ PLUS NPWT meet design specifications and demonstrate substantial equivalence.
Important Note: The provided text does not include information about acceptance criteria, reported device performance in a statistical table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. This document is a regulatory submission for a non-AI/ML medical device where the primary goal is demonstrating substantial equivalence to a predicate device through bench testing, not through clinical or AI performance metrics.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of the available information and, where information is not present, an explanation of why:
1. Table of Acceptance Criteria and Reported Device Performance
Rationale: The provided text describes the regulatory clearance of a Negative Pressure Wound Therapy (NPWT) device. This is a traditional medical device, not an AI/ML powered device. The "acceptance criteria" and "reported device performance" in the context of this document refer to the successful completion of a series of non-clinical (bench) tests designed to demonstrate that the device meets its design specifications and is substantially equivalent to a predicate device. These are functional and safety performance metrics, not diagnostic accuracy metrics typically reported for AI/ML.
Since this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" as typically presented for AI/ML devices (e.g., sensitivity, specificity, AUC) is not applicable here. The document focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance thresholds in a clinical study for a novel AI algorithm.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Successful Testing) | Reported Device Performance (Summary from Text) |
|---|---|---|
| Functional Equivalence | - Pumping capacity equivalent to predicate device. |
- Delivers negative pressure at individual pressure settings, identical to predicate device.
- Delivers continuous and intermittent NPWT identical to predicate device. | - "Pumping capacity is equivalent to the predicate device."
- "Device provides negative pressure at individual pressure settings, identical to the predicate device."
- "Verification that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device." |
| Alarm Functionality | - Canister Full alarm functions correctly using simulated wound fluid. | - "Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate." (Implies successful verification) |
| Robustness & Safety | - System performance in foreseeable fault conditions is maintained. - System performance with high air leaks at the dressing site is maintained.
- System performance in worst-case scenarios (exudate viscosity/protein) is maintained. | - "Verification of system performance in foreseeable fault conditions." (Implies successful verification)
- "Verification of system performance when running with high air leaks at the dressing site." (Implies successful verification)
- "Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content." (Implies successful verification). The overall conclusion states: "Performance testing has been successfully completed to demonstrate that the RENASYS EZ PLUS NPWT device and canisters are substantially equivalent to the predicate devices for the intended use." |
| Standards Compliance | - Compliance with relevant ISO, IEC, BS EN, and UL standards (e.g., ISO13485, ISO 14971, IEC 60601-1-2). | - "Device complies with the following standards: ISO13485:2003, ISO 14971:2012, ISO 15223-1:2012, ISO 15223-2:2010, BS EN 980:2008, BS EN 1041:2008 +A1:2013, IEC 60601-1-2:2007, IEC 60601-1: :1988 + A1:1991 + A2:1995, UL 60601-1." |
2. Sample size used for the test set and the data provenance
Sample Size for Test Set: Not applicable in the context of this type of device. The "test set" here refers to the conditions and samples used in the bench testing. The document states "wound fluid designed to simulate chemistry and protein content of real exudate" and mentions "worst case scenarios with ranges of exudate viscosity and protein content", but does not specify numerical sample sizes for these test materials.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The data provenience is from non-clinical bench testing conducted to verify design specifications and substantial equivalence, not from clinical patient data. The manufacturer is Smith & Nephew, Inc., located in St. Petersburg, FL, USA, suggesting the testing was likely overseen by them, but the specific location of the bench testing is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated labels for patient data. For this device, the "truth" is established by engineering and performance specifications and comparison to the predicate device, not by expert interpretation of patient data.
Qualifications of Experts: Not applicable. The verification and validation of such a device are typically performed by engineers, quality assurance personnel, and regulatory affairs specialists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of ground truth in AI/ML studies. This is not relevant for bench testing of a physical medical device.
5. 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
MRMC Study: No. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Standalone Study: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Type of Ground Truth: For the bench testing, the "ground truth" equates to the established engineering specifications, performance parameters of the predicate device, and compliance with recognized industry standards. For example, the "ground truth" for pumping capacity would be the specified output pressure range, and the "truth" for alarm functionality would be the correct activation of alarms under specific fault conditions as per design. It is not clinical "ground truth" such as pathology or outcomes data.
8. The sample size for the training set
Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or a training set.
§ 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.