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510(k) Data Aggregation
(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 | <10% change in dimensions | <10% change in dimensions | Not Tested |
| Material Strength | |||
| Tensile Strength | 223 ± 17 kPa | 105 ± 13 kPa | Not Tested |
| Tensile Elongation at Break | 225 ± 11 % | 185 ± 24 % | Not Tested |
| Tear Strength | 399 ± 32 | 733 ± 76 | Not Tested |
| Sterilization & Shelf-Life | |||
| Single-Use | Yes | Yes | Yes |
| Supplied Sterile | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | EO |
| Shelf Life | Two (2) years | Three (3) years | Three (3) years |
Study Proving Acceptance Criteria:
The study used to prove the device met acceptance criteria was a non-clinical bench testing program comparing the NovoPore™ Dressing to two legally marketed predicate devices: KCI GranuFoam™ and Genadyne A4-XLR8 Foam Dressing. The submission uses the term "substantially similar performance" and "met all acceptance criteria" for the mechanical and vacuum tests. The acceptance criteria were implicitly defined by the performance characteristics of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific non-clinical mechanical test. However, results are provided with standard deviations (e.g., 20.7 ± 3.2 kPa), indicating that multiple samples were tested for each measurement.
- Data Provenance: The data is "retrospective" in the sense that it's laboratory bench test data collected by the manufacturer to support a 510(k) submission. The country of origin of the data is the location where the testing was performed, which is implied to be Australia, given the submission sponsor's location (PolyNovo Biomaterials Pty Ltd, Victoria Australia).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The study is a non-clinical bench test. "Ground truth" in this context refers to the measured physical and mechanical properties of the devices, not expert interpretations.
4. Adjudication Method for the Test Set
This is not applicable. The study involved objective measurements of physical and mechanical properties, not subjective expert assessment or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a non-clinical bench effectiveness study, not an MRMC comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (wound dressing), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" was based on objective, quantitative measurements of physical and mechanical properties (e.g., compressive stress, resilience, fluid flow, tensile strength, density) of the NovoPore™ Dressing and the predicate devices. These measurements are considered the 'truth' of the device's performance characteristics.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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