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NovoPore™ is intended to be used as part of a Negative Pressure Wound Therapy (NPWT) system. When used in conjunction with a NPWT system, it is intended to remove excess exudate, infectious material, and tissue debris from wounds which may promote wound healing. NPWT systems are indicated for use on chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), explored fistulas, flaps, and grafts.

Device Description

The NovoPore™ Dressing is a polyurethane foam wound dressing used as an accessory to powered suction pumps. The single-use dressing is packaged in a peelable oriented polyamide / polyethylene bag and is sterilized by gamma irradiation. The NovoPore™ Dressing is available in one size: medium.

AI/ML Overview

The NovoPore™ Dressing is a polyurethane foam wound dressing intended for use with Negative Pressure Wound Therapy (NPWT) systems. The study provided focuses on establishing substantial equivalence to predicate devices (KCI GranuFoam® and Genadyne A4-XLR8 Foam Dressing) through non-clinical performance data and does not involve human clinical trials for efficacy or effectiveness.

Here’s a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by demonstrating performance that is "substantially equivalent" or comparable to the predicate devices. For mechanical properties, the device aimed to show similar or better performance compared to the predicates.

Acceptance Criteria (Implied by Predicate Equivalence)	NovoPore™ Dressing Performance	Predicate (GranuFoam™) Performance	Predicate (A4-XLR8 Foam) Performance
Material Composition
Dressing Composition	Porous, open-celled polyurethane foam	Porous, open-celled polyurethane foam	Porous, open-celled polyurethane foam
Material	Polyurethane	Polyurethane	Polyurethane
Physical Characteristics
Form	Foam	Foam	Foam
Method to achieve Open-Celled Foam	Crushing the foam	Reticulating the foam	Reticulating the foam
Color	White	Black	Green
Dimensions (medium), cm	18 x 12.5 x 3	18 x 12.5 x 3.2	18 x 12.5 x 3.3
Foam Density	66.1 kg/m³	23.0 kg/m³	21.1 kg/m³
Open Pore Size	100 - 600 microns	400 - 600 microns	Not available
Mechanical Properties Under Pressure (Wet)
Cyclic Compression - Mean Upper Compressive Stress (0 min)	20.7 ± 3.2 kPa	13.4 ± 0.4 kPa	12.8 ± 1.3 kPa
Cyclic Compression - Mean Upper Compressive Stress (1 hr)	21.4 ± 3.4 kPa	12.5 ± 0.6 kPa	11.5 ± 0.9 kPa
Cyclic Compression - Mean Upper Compressive Stress (2 hrs)	20.3 ± 3.4 kPa	12.8 ± 0.9 kPa	11.6 ± 0.9 kPa
Cyclic Compression - Mean Upper Compressive Stress (4 hrs)	18.0 ± 2.7 kPa	13.4 ± 1.0 kPa	12.0 ± 1.0 kPa
Cyclic Compression - Mean Upper Compressive Stress (6 hrs)	17.2 ± 2.3 kPa	13.9 ± 1.1 kPa	12.6 ± 1.2 kPa
Resilience Change (0 min)	0.0 ± 0 %	0.0 ± 0 %	0.0 ± 0 %
Resilience Change (1 hr)	2.0 ± 0 %	8.9 ± 1.6 %	10.3 ± 1.2 %
Resilience Change (2 hrs)	2.0 ± 0 %	10.3 ± 1.6 %	11.9 ± 1.4 %
Resilience Change (4 hrs)	2.0 ± 0 %	12.3 ± 2.1 %	14.4 ± 2.1 %
Resilience Change (6 hrs)	2.0 ± 0 %	14.2 ± 2.2 %	16.7 ± 3.1 %
Mean Change in Thickness after 6 hours (1350 cycles)	Decrease by avg of 1.5 ± 0.5%	Decrease by avg of 7.6 ± 2.6%	Decrease by avg of 8.0 ± 2.4%
Durability after 1350 compressive cycles, wet	No Damage	No Damage	No Damage
Vacuum Bench Test
Pressure Distribution	Evenly Distributed at each time point	Evenly Distributed at each time point	Not Tested
Fluid Flow (at T=0, 24h, 48h, 72h)	25 ml fluid drawn through within 30 seconds at every time point	25 ml fluid drawn through within 30 seconds at every time point	Not Tested
Dimensional change after 72h

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