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The Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as:

• · Chronic Wounds e.g. Leg ulcers
• · Acute Wounds
• · Subacute and dehisced wounds
• Traumatic wounds
• · Flaps & Grafts
• · Surgically closed incision sites

Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

The Avelle Negative Pressure Wound Therapy (NPWT) System consists of:

• a disposable battery powered pump
• absorbent wound dressing which is connected to the pump via tubing and luer-lock fittings
• adhesive fixation strips

The Avelle System is intended for single-patient use.

The Avelle pump is disposable, portable and battery-powered. The internal software of the pump limits the use to 30 days. The pump requires 3 AAA lithium batteries to operate. Testing shows that the 3 batteries will power the pump for a minimum of 15.6 days based on testing. A total of 6 AAA lithium batteries (2 sets) are provided with the pump which will power the device for its entire 30-day lifetime. The disposable battery-powered pump unit is attached to the dressing via the supplied tubing and luer-lock fittings.

The Avelle dressing is comprised of gelling fiber (Hydrofiber®) to absorb wound exudate with negative pressure applied indirectly to the dressing via the Avelle pump. The dressing is applied to the wound and secured around its periphery via its adhesive border and adhesive fixation strips are applied to ensure an adequate seal. The dressing's adhesive surface is protected by a split release liner system comprising of 2 or 3 sections of Low Density Polyethylene (LDPE) release liner (depending on dressing size), which are removed prior to dressing application.

The pump is turned on to apply and maintain a nominal negative pressure of -80mmHg to the dressing. The pump will draw excess wound exudate and infectious materials away from the wound bed and into the Hydrofiber® layers as demonstrated in a simulated use test with a moderately exuding flow of 82 mL over 3 days and a second simulated use test with a low exuding flow of 102 mL over 7 days.

The system will deliver up to 30 days' single patient use for the pump component, and up to 7 days' wear time for the dressing. Each dressing may be used for up to 7 days but may require more frequent changes due to clinical situations. After 30 days of use the pump must be discarded and treatment must be stopped.

The pump unit is provided non-sterile. The Absorbing Dressing (with adhesive fixation strips) is provided sterile via ethylene oxide (EtO) sterilization.

This document, a 510(k) summary for the AVELLE Negative Pressure Wound Therapy System, describes non-clinical performance testing rather than clinical studies with human participants. Therefore, many of the requested elements for clinical study data (such as sample size for test sets, ground truth establishment for test sets, expert qualifications, adjudication methods, and MRMC studies) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes that "The AVELLE NPWT meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device." Specific quantitative acceptance criteria are not provided in this summary, but the successful completion of the listed tests implies that the device met their pre-defined criteria.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test. The tests are "bench testing" and "simulated use tests," meaning they were conducted in a laboratory setting, not on human patients. The data provenance is ConvaTec Limited (the applicant).

3. Number of experts used to establish the ground truth for the test set and their qualifications

Not applicable. These were non-clinical, bench and simulated use tests, not diagnostic studies requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable for non-clinical bench testing.

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 is a medical device (NPWT system), not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned. The document explicitly states "Clinical Data is not included in this 510(k)."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a physical system (pump, dressing, tubing), not an algorithm-only device. "Standalone" performance would refer to the device's functional operation, which was assessed through the various bench and simulated use tests.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards for material properties, sterility, performance, and safety. For example, bacterial barrier testing would have a known standard for barrier effectiveness as its "ground truth."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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