(113 days)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.
This document describes the FDA 510(k) clearance for the Molnlycke Health Care US, LLC Avance Foam Dressing Kit - XL. This is an add-on to an existing Negative Pressure Wound Therapy (NPWT) system. As such, the submission focuses on demonstrating that the new component (the XL foam dressing) does not negatively impact the overall system's safety and effectiveness compared to the previously cleared system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with acceptance criteria values and reported device performance. It generally states that "all predefined acceptance criteria were met" for the bench tests conducted.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the bench tests. It only mentions that "Bench testing has been performed." The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software. No experts were used to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software.
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
This information is not applicable. No MRMC study was conducted as this is not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established engineering and functional specifications for the NPWT system's ability to transport fluid and deliver pressure. The document implicitly states that these functional requirements were met.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
Summary of Device Acceptance Criteria and Study:
The Avance Foam Dressing Kit - XL is an addition to an existing Negative Pressure Wound Therapy (NPWT) system. The acceptance criteria focus on demonstrating that this new, larger dressing component does not negatively affect the overall system's functional performance and biocompatibility.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
The document does not provide specific numerical acceptance criteria or performance metrics but states compliance.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993 | Shown to be biocompatible for the intended use. |
| Ability to transport fluid away from the wound | Performed as intended; predefined acceptance criteria were met. |
| Ability to deliver pressure in accordance with pump settings | Performed as intended; predefined acceptance criteria were met. |
Study Details:
- Type of Study: Non-clinical bench testing.
- Sample Size: Not specified for the bench tests.
- Data Provenance: Not specified.
- Ground Truth Establishment: For bench testing, the ground truth would be based on engineering specifications and validated test methods for fluid transport and pressure delivery within NPWT systems.
- Clinical Data: No clinical data was required or submitted to support substantial equivalence.
- AI/Machine Learning Specifics: Not applicable; this device is a physical medical dressing, not an AI 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.