(27 days)
The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.
When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The ACTIV.A.C.TM Therapy Unit is a component of the ACTIV.A.C.TM Negative Pressure Wound Therapy System, also referred to as the ACTIV.A.C.TM Therapy System. The ACTIV.A.C.TM Therapy System consists of: an ACTIV.A.C.TM Therapy Unit (the subject of this submission), a disposable canister which collects wound exudate, a wound interface dressing, a semi-occlusive wound drape, and a sensing pad and lumen. The ACTIV.A.C.TM Therapy Unit is a portable, battery-powered, reusable, software-controlled therapy unit that can provide continuous or intermittent applications of negative pressure to the wound bed in the selectable range of -25mmHg to -200mmHg. The ACTV.A.C.TM Therapy Unit is designed for the application of negative pressure wound therapy in the home, acute or extended care setting. The open cells of the dressing, to which the therapy unit is connected via pad and lumen, enables distribution of the negative pressure across the surface of the wound bed, while the tubing transfers fluids removed from the wound to the canister. The therapy unit's software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.
Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that contains preset therapy settings based on wound type, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via USB data port and a Log Tool for recording canister changes, dressing changes and dressing pieces used.
The provided text describes a 510(k) premarket notification for the ACTIV.A.C.™ Negative Pressure Wound Therapy System. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K183543) based on minor modifications. As such, the information provided does not detail a clinical study with specific acceptance criteria related to a diagnostic or prognostic performance (like sensitivity, specificity, accuracy) of the device in a medical use case. Instead, the "acceptance criteria" discussed are related to the engineering performance and safety of the device's modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an engineering modification submission, the "acceptance criteria" are compliance with established engineering and regulatory performance standards. The reported performance is that the device met these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Software Modifications: Compliance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA-recognized standard IEC 62304:2006/Amd 1:2015. | Software modifications were developed, tested, and assessed according to the specified guidance and standard. |
| Modified Power Button Component (Pre/Post a predetermined number of cycles): |
- Force/Displacement: ASTM F2592-16
- Circuit Resistance: ASTM F1680-07a(2014)
- Contact Bounce: ASTM F1661-09(2015)
- Visual Inspection: ASTM F1595-00(2012)
- Contact Closure Cycling: ASTM F1578-07(2014) | "In all instances, test results indicate that the subject device complies with its predetermined specifications and the applicable FDA guidance and standards." |
| Usability Assessment (for device modifications): Compliance with FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016) and FDA-recognized standards: IEC 62366-1:2015 and ANSI/AAMI HE75:2009. | A usability assessment was conducted, concluding the device modifications do not require additional usability testing, implying compliance. |
2. Sample size used for the test set and the data provenance
The document describes bench testing for engineering parameters. It does not refer to a "test set" in the context of patient data or clinical samples. The testing was conducted on the modified device components themselves.
- Sample Size: Not explicitly stated for each test, but generally refers to a sufficient number of device units or components to validate the specified engineering parameters.
- Data Provenance: The data is generated from controlled laboratory bench tests conducted by the manufacturer, KCI USA, Inc. This is prospective data from engineering validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of information presented. The "ground truth" here is compliance with engineering standards and predetermined specifications, which is typically assessed by engineers and quality assurance personnel with expertise in device testing and regulatory requirements, not medical experts establishing a clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, typically involving multiple medical experts reviewing patient cases. Here, compliance is determined by comparing device performance to established technical standards.
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
Not applicable. This device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool requiring human reader assistance. There is no mention of AI or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device (pump, dressings, etc.) for wound therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is compliance with established engineering standards and predetermined device specifications. It's not based on expert clinical consensus, pathology, or patient outcomes data in the traditional sense, as this particular submission concerns minor device modifications and engineering validation.
8. The sample size for the training set
Not applicable. This submission does not describe an AI or machine learning model that would require a "training set." It details engineering validation of a physical device.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.