(90 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 closed environment and removing exudates via the application of negative pressure wound therapy.
The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) System. The ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) system consists of:
- ACTIV.A.C. TM Therapy Unit (the subject of this submission)
- disposable canister which collects wound exudate
- a wound interface dressing
- . semi-occlusive wound drape
- sensing pad and lumen
The ACTIV.A.C. ™ 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.™ 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 accumulated fluids to the canister. The 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 the ACTIV.A.C.™ Therapy Unit, a negative pressure wound therapy (NPWT) system. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to pre-existing devices (predicates K063692 and K120033) rather than defining specific, quantifiable acceptance criteria with numerical performance targets in the context of a "device performance" column. Instead, the "reported device performance" is described as the device functioning "as intended" and all test results being "as expected."
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Conformance to General Requirements for Basic Safety and Essential Performance (60601-1 standards) | The ACTIV.A.C.™ Therapy Unit functioned as intended and met these standards. |
| Software assessment (per FDA Guidance, May 11, 2005) | The ACTIV.A.C.™ Therapy Unit software was assessed and functioned as intended. |
| Maintenance of negative pressure within specifications and fluid exudate management without unexpected alarms | The ACTIV.A.C.™ Therapy Unit maintained negative pressure within specifications and managed fluid exudate without unexpected alarms. |
| Functionality in wider temperature specifications (Extreme Environmental Storage Conditions test) | The ACTIV.A.C.™ Therapy Unit functioned as intended when exposed to wider temperature specifications. |
| User interface and use environment similarity to predicate | Human factors engineering testing was not required; the device has the same user interface and use environment as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing for the ACTIV.A.C.™ Therapy Unit. It does not refer to a "test set" in the context of patient data or clinical trials. The tests conducted are:
- Conformance to 60601-1 standards: This likely involved laboratory testing of the device itself.
- Software assessment: This involved reviewing the software against FDA guidance.
- Negative Pressure Maintenance System Test: This involved testing the device's ability to maintain negative pressure and manage fluid.
- Extreme Environmental Storage Conditions test: This involved subjecting the device to various temperatures.
Therefore, there is no patient-specific sample size for a test set, and no data provenance in terms of country of origin or retrospective/prospective study design as these were non-clinical, in-vitro tests of the device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. As described above, this was non-clinical engineering and software testing. Ground truth in this context would be defined by engineering specifications and regulatory standards, not by expert medical opinion on patient data.
4. Adjudication Method for the Test Set:
Not applicable. There was no need for adjudication of patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This document describes a 510(k) submission for a medical device (ACTIV.A.C.™ Therapy Unit), which focuses on demonstrating substantial equivalence through non-clinical performance and technological characteristics. It does not involve a multi-reader multi-case (MRMC) study or evaluate the improvement of human readers with or without AI assistance. The device is a physically applied NPWT unit, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
No. The ACTIV.A.C.™ Therapy Unit is a hardware and software system, not an algorithm. The software is integral to the device's function (e.g., controlling pressure, alarms). Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests described would be based on:
- Engineering specifications and design requirements: For tests like negative pressure maintenance and environmental conditions.
- Regulatory standards: Specifically, IEC 60601-1 for basic safety and essential performance.
- FDA guidance documents: For software assessment.
This is primarily engineering and regulatory compliance-based ground truth, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
Not applicable. This is a medical device, not a machine learning algorithm that requires a training set of data. The "software" mentioned refers to the operational software embedded in the device, not an AI model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
§ 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.