(116 days)
The V.A.C.VIA™ Therapy System is an integrated wound management system for use in acute, extended and home care settings.
When used on open wounds, the V.A.C.VIA™ 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 by removing exudates and infectious material. Open wound types include: chronic, acute, traunatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, the V.A.C.VIA™ is intended to manage the environment of surgical incisions that continue to drain following sutured closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The negative pressure technology for the subject device is the same as that of the predicate device.
The therapy unit is a component of the therapy system which provides negative pressure wound therapy to the wound site for up to 7 days.
Negative pressure is created by the therapy unit by means of one software-controlled diaphragm pump which allows for a lightweight, single use therapy unit that provides for negative pressure wound therapy at either -75 or -125 mmHg. Negative pressure is delivered to the wound site through tubing to a dressing placed over the wound site.
This FDA 510(k) Summary describes a medical device, the V.A.C.VIA™ Negative Pressure Wound Therapy Unit, and its substantial equivalence to a predicate device. As such, the information provided is limited to what is relevant for a 510(k) submission, which focuses on demonstrating equivalence rather than comprehensive performance studies with detailed acceptance criteria typically found in clinical trials for novel devices.
Therefore, many of the requested elements (detailed performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established) are not explicitly present in the provided document.
Here's an overview based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Bench testing demonstrated that the V.A.C.VIA™ Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input during a 3 and 7-day test."
Specific numerical acceptance criteria for pressure delivery, air leak rate, or fluid input are not provided. However, the device is considered to have met the performance expectations by demonstrating "substantial equivalence" to the predicate device under these challenging conditions.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|
| Negative Pressure Delivery | Delivery of continuous negative pressure at -125 mmHg within specifications. | Demonstrated substantial equivalence to the predicate therapy unit in delivering continuous negative pressure at -125 mmHg within specifications. |
| Air Leak Rate | Performance maintained under worst-case air leak rate conditions. | Performed within specifications under worst-case air leak rate conditions. |
| Fluid Input | Performance maintained under worst-case fluid input conditions. | Performed within specifications under worst-case fluid input conditions. |
| Duration of Therapy | Performance maintained during 3 and 7-day test periods. | Performed within specifications during 3 and 7-day test periods. |
| Electrical Safety | Compliance with various IEC/ANSI/AAMI standards (e.g., ES60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11). | Confirmed to meet the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text); IEC 60601-1-2 Ed. 4.0 2014-02; IEC 60601-1-6 Ed. 3.1 2013-10; IEC 60601-1-8 Ed. 2.1 2012-11; IEC 60601-1-11 Ed. 2.0 2015-01. |
| Electromagnetic Emissions | Compliance with IEC 60601-1-2. | Confirmed to meet IEC 60601-1-2 Edition 4.0 2014-02. |
| Usability | No change to user interface or Instructions for Use, therefore no usability testing required. | No usability testing was deemed necessary. |
| Battery Safety | Compliance with IEC 62133 Edition 2.0 2012-12 for the new lithium battery. | New lithium battery verified to meet IEC 62133 Edition 2.0 2012-12. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "worst case conditions of air leak rate and fluid input" for the bench testing.
- Data Provenance: The study was "bench testing." No country of origin is specified for the data, and it is inherently prospective as it involves testing the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study was bench testing of physical performance parameters (negative pressure, air leak, fluid input, electrical safety). There was no "ground truth" in the clinical sense established by human experts.
4. Adjudication Method:
Not applicable, as there was no expert review or human assessment of clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was bench testing of a physical device. A MRMC study is relevant for diagnostic or AI-assisted interpretation tasks.
6. Standalone Performance:
Yes, the performance testing was standalone in the sense that it measured the device's physical performance parameters directly, without human intervention in the continuous delivery of negative pressure, the management of air leaks, or fluid input during the test duration. However, it's not "standalone" in the AI sense of an algorithm operating without human oversight, as this is a mechanical pump.
7. Type of Ground Truth Used:
For the performance aspects, the "ground truth" was based on engineering specifications and recognized international standards (e.g., for electrical safety, battery safety). For the "delivery of continuous negative pressure," the ground truth would be the expected pressure output based on the device's design and a reference standard measurement.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
In summary of the study:
The study involved bench testing to demonstrate that the updated V.A.C.VIA™ Negative Pressure Wound Therapy Unit is substantially equivalent to its predicate device (K132741). The testing focused on the device's ability to maintain continuous negative pressure (-125 mmHg) under simulated "worst-case" conditions for air leaks and fluid input over 3 and 7-day periods. Additionally, the device was confirmed to meet various electrical safety and performance standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11) and the new lithium battery met IEC 62133. No clinical or usability testing was deemed necessary due to the nature of the changes (internal components and external power supply updates) and the unchanged user interface and instructions for use.
§ 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.