Search Results

The Invia® Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds it creates 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.

When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Integrated Dressing is appropriate for the following indications:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Integrated Dressing is a sterile NPWT dressing, consisting of: a pad area designed to evenly distribute the negative pressure and to draw off the exudate, a perforated silicone adhesive wound contact layer to provide a gentle but secure adhesion to the skin, and a double lumen tubing with Quick-connector to connect the dressing to the Invia NPWT pumps.

The Invia Integrated Dressing is available in three different sizes as shown below.

The Invia Integrated Dressing is designed to be compatible with the Invia Negative Pressure Wound Therapy Systems (Invia® Liberty NPWT suction pump, cleared via K142626 and K172145) and Invia® Motion (cleared via K161128 and K172145) and Invia® Ease suction pumps (K214112).

For wounds greater than 0.5 cm in depth, it is likely that a wound filler needs to be used with the Invia Integrated Dressing to ensure adequate treatment of all the wound surfaces. The Invia Integrated Dressing can be used with the wound filler accessory, Invia Black Foam NPWT. The Invia Black Foam NPWT is available in one size as shown below.

The provided text is a 510(k) summary for the Medela AG Invia® Integrated Dressing, a negative pressure wound therapy (NPWT) dressing. This document establishes that no clinical studies were required or performed for the substantial equivalence determination of this device. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance, including details like sample size, expert qualifications, and adjudication methods, cannot be fully answered from this regulatory document.

Specifically:

• No clinical studies were conducted to prove device performance or establish acceptance criteria related to a specific clinical outcome. The acceptance criteria are based on non-clinical (bench, human factors, and animal) testing and similarity to a predicate device.

Here's what can be extracted and inferred from the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted, direct "reported device performance" against clinical acceptance criteria is not available in the provided text. The performance reported below is from non-clinical studies demonstrating equivalence to the predicate device and compliance with safety standards.

Information Not Available (or not applicable due to lack of clinical study):

2. Sample size used for the test set and the data provenance: Not applicable for clinical performance as no clinical test set was used for proving efficacy. Non-clinical studies would have their own sample sizes (e.g., number of animals for animal testing, number of participants for human factors, etc.), but these details are not provided in the summary beyond mentioning that studies were conducted. Data provenance for non-clinical tests is typical manufacturing/testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
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 an NPWT dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
7. The type of ground truth used: For the non-clinical animal study, the ground truth was animal tissue observation (macroscopic and histopathological findings) for adverse reactions due to prolonged dressing application. For other non-clinical tests, it was compliance with specifications and standards.
8. The sample size for the training set: Not applicable as no machine learning/AI model was developed.
9. How the ground truth for the training set was established: Not applicable.

In summary, the K223388 submission relies entirely on non-clinical testing to demonstrate that the Invia® Integrated Dressing is substantially equivalent to existing predicate devices and meets safety and performance requirements without introducing new questions of safety or effectiveness.

Ask a specific question about this device