(167 days)
Not Found
No
The summary describes a passive wound dressing and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended to remove excess exudate, infectious material, and tissue debris from wounds, which may promote wound healing. This activity of promoting wound healing falls under the definition of a therapeutic device.
No
The device is a wound dressing intended to remove excess exudate and promote wound healing as part of a Negative Pressure Wound Therapy (NPWT) system. It does not diagnose any condition or disease.
No
The device description explicitly states that NovoPore™ is a polyurethane foam wound dressing, which is a physical component, not software.
Based on the provided information, the NovoPore™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NovoPore™ Function: The description clearly states that NovoPore™ is a wound dressing used as part of a Negative Pressure Wound Therapy (NPWT) system. Its function is to physically remove exudate, infectious material, and tissue debris from wounds.
- No Sample Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis. It is a physical component of a wound treatment system.
Therefore, NovoPore™ falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (chronic, acute, traumatic, subacute and dehisced), partial-thickness burns, ulcers (such as diabetic or pressure), explored fistulas, flaps, and grafts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Mechanical properties of NovoPore™ Dressing were evaluated and compared with the predicates V.A.C. GranuFoam™ Dressing and A4-XLR8 Foam Dressing.
Key tests performed:
- Biocompatibility: Tested for Cytotoxicity, Mutagenicity (In Vitro Mouse Lymphoma Assay), Bacterial Reverse Mutation (AMES test), Intracutaneous Reactivity, Skin Sensitisation (polar and non-polar), Subcutaneous implantation, and Pyrogenicity. Results showed no negative impacts from materials.
- Shelf-life: Stability established for two (2) years.
- Package Stability: Confirmed sealing and seal system suitable to maintain integrity and microbial barrier. LAL testing used to verify acceptable low levels of endotoxin contamination.
- Mechanical testing: Involved cyclic compressive stress at various time points, resilience under cyclic compressive testing, durability under accelerated cyclic compression, and performance under vacuum. Concluded that NovoPore™ Dressings met all acceptance criteria for Mean USC, Mean SZL, Mean percentage Change in Thickness, and degree of damage, and were substantially equivalent to GranuFoam™ and XLR8 in terms of cyclic mechanical properties. Also concluded that NovoPore™ dressings showed substantially similar performance to GranuFoam dressings during and after 72 hours of 17 kPa vacuum non-clinical bench testing.
- Risk Management: Conducted according to ISO 14971, outcomes considered acceptable, all potential risks mitigated.
Clinical Performance Data: Human clinical trials are not applicable; device types have been on the market for many years with no significant incidents of safety or efficacy for predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
for
NovoPore™ Dressing
1. Submission Sponsor
PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne, 3207 Victoria Australia Phone: 613 8681 4086 Fax: 613 8681 5099 Contact: Dr. Tim Moore, Principal Scientist
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
February 25, 2014
4. Device Identification
| Trade/Proprietary Name: | NovoPore™ Dressing |
|---|---|
| Common/Usual Name: | Negative Pressure Wound Therapy Foam |
| Classification Name: | Negative Pressure Wound Therapy Powered Suction Pump and |
| Accessories | |
| Classification Regulation: | 878.4780 |
| Product Code: | OMP |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
5. Legally Marketed Predicate Device(s)
Kinetic Concepts, Inc. (KCI) GranuFoam®, 510 (k) Number K032310 Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing, 510 (k) Number K092992
1
6. 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.
7. Indication for Use Statement
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.
8. Substantial Equivalence Discussion
The following table compares the NovoPore™ Dressing device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Device Manufacturer | PolyNovo Biomaterials | THET BLE
Kinetic Concepts, Inc. | Genadyne |
|---------------------|-----------------------------|------------------------------------|----------------------------|
| | Pty Ltd | (KCI) | Blotechnologies, Inc. |
| | | GranuFoam™ | |
| Device Trade Name | NovoPore™ Dressing | | A4-XLR8 Foam |
| | | | Dressing |
| 510(k) Number | K132936 | K032310 | K092992 |
| Regulation Number | 878.4780 | 878.4780
878.4780 | |
| Product Code | OMP | OMP
OMP | |
| Common/Usual Name | Negative Pressure Wound | Negative Pressure Wound | Negative Pressure Wound |
| | Therapy Foam | Therapy Foam | Therapy Foam |
| Regulation Name | Negative Pressure Wound | Negative Pressure Wound | Negative Pressure Wound |
| | Therapy Powered Suction | Therapy Powered Suction | Therapy Powered Suction |
| | Pump and Accessories | Pump and Accessories | Pump and Accessories |
| Indications for Use | NovoPore™ is intended to | The V.A.C.® family of | Genadyne A4-XLR8 Foam |
| | be used as part of a | devices are feedback- | Dressing is intended to be |
| | Negative Pressure Wound | controlled negative | used In conjunction with |
| | Therapy (NPWT) system. | pressure devices used to | the Genadyne A4 Wound |
| | When used in conjunction | help promote wound | Vacuum System |
| | with a NPWT system, it is | healing, through means | (K082676) to deliver |
| | intended to remove | Including vacuum assisted | negative pressure wound |
| | excess exudate, infectious | drainage and removal of | therapy to the wound. |
| | material, and tissue debris | infectious material or | Genadyne A4 Wound |
| | from wounds which may | other fluids, under the | Vacuum System is |
| | promote wound healing. | influence of continuous | indicated for patients who |
| | NPWT systems are | and/or intermittent | would benefit from a |
| | indicated for use on | suction pressures, | suction device, |
| | chronic, acute, traumatic, | particularly for patients | particularly as the device |
| | subacute and dehisced | with chronic, acute, | may promote wound |
| | wounds, partial-thickness | traumatic, subacute and | healing by the removal of |
Table 5A - Comparison of Characteristics
2
:
| Device Manufacturer | PolyNovo Biomaterials
Pty Ltd | Kinetic Concepts, Inc.
(KCI) | Genadyne
Biotechnologies, Inc. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | NovoPore™ Dressing | GranuFoam™ | A4-XLR8 Foam |
| | | | Dressing |
| | burns, ulcers (such as
diabetic or pressure),
explored fistulas, flaps,
and grafts. | dehisced wounds, partial-
thickness burns, ulcers
(such as diabetic or
pressure), flaps and
grafts. Feedback control is
achieved by measuring
the level of negative
pressure at the wound
site. | excess exudates,
infectious material and
tissue debris.
A4-XLR8 Foam Dressing is
appropriate for use on the
following wounds:
• Pressure ulcers
• Diabetic/Neuropathi
c Ulcers
• Venous insufficiency
ulcers
• Traumatic wounds
• Post-operative and
dehisced surgical
wounds
• Comparative Bench
Caution: Federal law
restricts this device to sale
by or on the order of a |
| | | | physician. |
| Dressing Composition | Porous, open-celled
polyurethane foam | Porous, open-celled
polyurethane foam | Porous, open-celled
polyurethane foam |
| Form | Foam | Foam | Foam |
| Material | Polyurethane | Polyurethane | Polyurethane |
| Method to achieve | Crushing the foam | Reticulating the foam | Reticulating the foam |
| Open-Celled Foam | | | |
| Color | White | Black | Green |
| Dimensions (medium),
cm | 18 × 12.5 × 3 | 18 × 12.5 × 3.2 | 18 × 12.5 × 3.3 |
| Recommended | -50 to -175 | -125 plus or minus | -50 to -230 |
| pressure range | | increments of 25-75 as | |
| (mmHg) | | needed, up to -250. | |
| Cyclic compression - | 0 min: 20.7±3.2 kPa | 0 min: 13.4±0.4kPa | 0 min: 12.8±1.3 kPa |
| Mean Upper | 1 hr: 21.4 ±3.4 kPa | 1 hr: 12.5 ±0.6 kPa | 1 hr: 11.5 ±0.9 kPa |
| Compressive Stress
and Standard | 2 hrs: 20.3±3.4 kPa | 2 hrs: 12.8±0.9 kPa | 2 hrs: 11.6±0.9 kPa |
| deviation at 0, 1, 2, 4 | 4 hrs: 18.0 ± 2.7 kPa | 4 hrs: 13.4 ± 1.0 kPa | 4 hrs: 12.0 ± 1.0 kPa |
| and 6 hours, wet | 6 hrs: 17.2±2.3 kPa | 6 hrs: 13.9 ±1.1 kPa | 6 hrs: 12.6± 1.2 kPa |
| Cyclic compression - | 0 min: 0.0±0 % | 0 min: 0.0± 0 % | 0 min: 0.0± 0 % |
| Resillence change at 0, | 1 hr: 2.0 ± 0 % | 1 hr: 8.9 ±1.6 % | 1 hr: 10.3 ± 1.2 % |
| 1, 2, 4, and 6 hours,
wet | 2 hrs: 2.0±0 % | 2 hrs: 10.3± 1.6 % | 2 hrs: 11.9 ± 1.4 % |
| | 4 hrs: 2.0± 0 % | 4 hrs: 12.3 ± 2.1 % | 4 hrs: 14.4 ± 2.1 % |
| | 6 hrs: 2.0± 0 % | 6 hrs: 14.2 ± 2.2 % | 6 hrs: 16.7± 3.1 % |
| Mean Change in
Thickness after 6
hours, wet (1350
cycles) | Decrease by an average of
1.5 ± 0.5% | Decrease by an average of
7.6 ± 2.6% | Decrease by an average of
8.0 ± 2.4% |
・
3
| Device Manufacturer | PolyNovo Blomaterials
Pty Ltd | Kinetic Concepts, Inc.
(KCI) | Genadyne
Biotechnologies; Inc. |
|-----------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------|
| Device Trade Name | NovoPore™ Dressing | GranuFoam™ | A4-XLR8 Foam
Dressing |
| 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 |
| Vacuum Bench Test -
Fluid Flow (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 |
| Vacuum Bench Test -
Dimensional change
after 72h |