(260 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 exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
The subject device of this submission, the Avance Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® is an offering of components developed for negative pressure wound therapy. These dressing kits which are intended 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 exudates and infectious materials. The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac ViewPad™ and Mepitel® is a combination of different components developed and arranged to meet the needs of the clinician for specific size and types of wounds.
The provided document is a 510(k) summary for the Avance® Foam Dressing Kits. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance criteria for a novel device. As such, it does not contain the information requested in points 1-9 of your prompt.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, nor data provenance details.
- Information on experts used to establish ground truth.
- Details on any adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Results from a standalone algorithm-only performance study.
- Details on the type of ground truth used (e.g., pathology, outcomes data).
- The sample size for a training set.
- How ground truth for a training set (if any) was established.
Instead, the document states:
- Performance Data: "The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac® ViewPad™and Mepitel® perform in the same manner as the predicate device kits (K122132) and are compatible with a similar type of pump. The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior. The fluid was efficiently transported from the wound model without lockage or problems. The system was tested over the time period of 73 hours without any problems or errors."
- Clinical Testing: "No clinical data was required."
- Conclusion: The device is substantially equivalent to the predicate device(s) identified with respect to intended use, materials (with the exception of ViewPad™ Materials), design and technological characteristics.
To obtain the detailed information requested regarding acceptance criteria and specific study results (especially for performance metrics, sample sizes, and ground truth establishment), you would typically need to consult a full 510(k) submission or a scientific publication related to the device, which are not provided in this excerpt. This document is a summary designed to state substantial equivalence, not to provide deep technical validation details.
§ 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.