(167 days)
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.
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.
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 |
§ 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.