Search Results

The RENASYS GO 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

The RENASYS GO NPWT device is a modification to predicate device K088375. It is a lightweight suction pump 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 RENASYS GO NPWT device is designed to deliver negative pressure wound therapy to a closed environment over a wound in order to drain exudates from the wound site to help promote wound healing.

The closed environment over the wound is created by applying a sterile foam or gauze wound dressing to the wound site and connecting the sealed wound to the suction pump via a tube that connects to the disposable canister. The suction pump delivers negative pressure wound therapy and removes the exudates from the wound site to the disposable canister.

The device provides negative pressure wound therapy to the wound at a range of pressure settings between 40-200mmHg. The device can operate either by a mains power supply or internal battery.

RENASYS GO uses an integral waste canister that is supplied non-sterile, single-use with a volume capacity of 300ml or 750ml. The waste canister is attached to the pump device by two clips on either side of the canister. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Safety features include a 1.0 micron filter in the top of the canister to resist fluid penetration into the device, as well as a 0.2 micron bacterial filter to prevent the passage of airborne bacteria. Each sealed canister contains a solidifier which acts as a gelling agent to the exudate.

A tube is permanently attached to the bottom of the waste canister through an inlet port. A connector attached to the distal end of the canister tube attaches to the corresponding tubing included in each Smith & Nephew NPWT dressing kit.

The RENASYS GO device is compatible with RENASYS Foam and Gauze dressing kits with Soft Port which were cleared under 510(k) K142979.

The provided text describes modifications to an existing negative pressure wound therapy (NPWT) device, the RENASYS GO, and the testing conducted to demonstrate its substantial equivalence to a predicate device (K083375). As this is a 510(k) submission, the focus is on substantial equivalence rather than establishing novel acceptance criteria for a new device. Therefore, the "acceptance criteria" here largely refer to demonstrating that the modified device performs comparably to the predicate and meets relevant safety and performance standards.

Here's an analysis based on your request, understanding that "acceptance criteria" are implied by the scope of a 510(k) modification rather than explicitly listed as performance targets in the same way a new device might have:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing ("Non-Clinical Tests (Bench)") and verification testing. It does not specify sample sizes (e.g., number of devices tested for each condition). The testing appears to be conducted by the manufacturer, Smith & Nephew, Inc., and therefore the "data provenance" would be internal company testing. There is no mention of external data sources or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This document pertains to bench and verification testing for a device modification, demonstrating substantial equivalence. The "ground truth" for these tests relates to engineering specifications and performance against known standards or the predicate device, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As the testing mentioned is bench and verification testing against engineering specifications and standards, there is no mention or need for a medical expert adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that "Non-Clinical Tests (Bench)" were performed. It does not describe any human reader studies or MRMC comparative effectiveness studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a negative pressure wound therapy pump, not an AI/algorithm-based diagnostic or therapeutic device. The "performance" described is the functioning of the pump and its alarm systems, which is inherently standalone in its operation (i.e., the pump operates without continuous human "in-the-loop" interaction for its core function, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for the tests described is primarily:

• Engineering specifications and design requirements: For aspects like pumping capacity, negative pressure range, O-ring durability, and performance in various conditions.
• Predicate device performance: To demonstrate equivalence in core functionalities.
• Regulatory and consensus standards: Such as IEC 60601 series for electrical safety, usability, and alarm systems, and ISO standards for risk management.
• Simulated wound fluid chemistry: For testing alarm functionality.

8. The Sample Size for the Training Set

N/A. This document describes a medical device (a pump) and its modifications, not a machine learning or AI algorithm that requires a training set. The "software modifications" mentioned relate to alarm functionality and compliance with standards, implying traditional software engineering and testing, not AI model training.

9. How the Ground Truth for the Training Set Was Established

N/A. See point 8.

Ask a specific question about this device

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.

• 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.

Ask a specific question about this device