Search Results

The Nisus Touch Negative Pressure Wound Therapy Pump 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.

Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic.

The components included within the Cork Nisus Touch NPWT Pump are:

• Nisus Touch Negative Pressure Wound Therapy Pump
• Nisus Touch Pump Battery Charger

Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022).

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. These components are used in coniunction with the pump to ensure safe transfer of the wound debris to the canister. The NPWT Accessories were previously provided clearance on K132004. Our application for the Nisus Touch NPWT system includes no revisions to these previously cleared components.

This document describes the Nisus Touch Negative Pressure Wound Therapy Pump, a device that facilitates wound healing by removing exudates, infectious material, and tissue debris.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the device underwent "bench performance testing to establish basic functionality" and that "The testing results show the Nisus Touch NPWT pump functioned as expected."

Based on the "NONCLINICAL TESTS" section, here are the tests conducted and the general performance reported:

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

The document refers to "bench performance testing" using "simulated wound exudate" and a "wound test bed fixture." No specific sample size (e.g., number of devices tested, number of simulated scenarios) is mentioned for this testing. The data provenance is from non-clinical bench testing, not from human subjects or clinical data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.

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

Not applicable. The ground truth for this device's performance was established through engineering specifications and bench testing against those specifications. No human expert consensus was used to establish ground truth for this type of performance testing.

4. Adjudication Method for the Test Set:

Not applicable. As the testing was bench performance testing against engineering specifications, there was no need for an adjudication method by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing required to support this 510(k) submission. No clinical testing has been performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Given that this is a physical medical device (a negative pressure wound therapy pump) and not an AI/software algorithm intended for diagnostic or prognostic purposes, the concept of "standalone (algorithm only)" performance does not directly apply. The performance evaluated was the device's physical and software-controlled functionality.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on engineering specifications and expected functional behavior of a negative pressure wound therapy pump, including adherence to established electrical safety, EMC, and usability standards. For example, alarms for leakage or blockage are expected to activate under specific simulated conditions according to design specifications.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device with integrated software for control, not a machine learning or AI algorithm that requires a "training set" in the context of learning data. The software within the device operates based on pre-programmed logic.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for a machine learning algorithm. The software functionality is based on established engineering principles and medical device requirements.

Ask a specific question about this device