NOVOPORE DRESSING

K132936 · Polynovo Biomaterials Pty, Ltd. · OMP · Mar 4, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132936
• Device Name: NOVOPORE DRESSING
• Applicant: Polynovo Biomaterials Pty, Ltd.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NovoPore™ Dressing is a single-use, porous, open-celled polyurethane foam wound dressing designed as an accessory for powered negative pressure wound therapy (NPWT) suction pumps. The dressing is placed into the wound bed to facilitate the removal of excess exudate, infectious material, and tissue debris under continuous or intermittent suction. By maintaining a moist wound environment and removing inhibitory factors, the dressing promotes wound healing. It is intended for clinical use by healthcare professionals on various wound types, including chronic, acute, and traumatic wounds. The device is supplied sterile via gamma irradiation. Clinicians apply the foam to the wound site and connect it to an NPWT pump system; the foam's mechanical properties, such as compressive stress and resilience, ensure consistent pressure distribution and fluid flow during therapy. The dressing is replaced periodically as part of standard wound care management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993), mechanical performance (cyclic compressive stress, resilience, vacuum pressure distribution, fluid flow), and shelf-life/package stability testing.

Technological Characteristics

Porous, open-celled polyurethane foam; medium size (18 x 12.5 x 3 cm); white color; density 66.1 kg/m³; pore size 100-600 microns. Sterilized by gamma irradiation. Single-use. Complies with ISO 10993 (biocompatibility), ISO 11607 (packaging), and ASTM F1980-07 (shelf-life).

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (diabetic or pressure), explored fistulas, flaps, and grafts requiring negative pressure wound therapy.

Regulatory Classification

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.

Predicate Devices

• Kinetic Concepts, Inc. (KCI) GranuFoam® (K032310)
• Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing (K092992)

Submission Summary (Full Text)

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# 510(k) Summary

# for

# NovoPore™ Dressing

# 1. Submission Sponsor

PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne, 3207 Victoria Australia Phone: [phone] Fax: [phone] Contact: Dr. Tim Moore, Principal Scientist

# 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Carrie Hetrick, Senior Consultant, RA Email: [e-mail]

### 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<br>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

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### 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<br>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<br>878.4780 | |
| Product Code | OMP | OMP<br>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

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:

| Device Manufacturer | PolyNovo Biomaterials<br>Pty Ltd | Kinetic Concepts, Inc.<br>(KCI) | Genadyne<br>Biotechnologies, Inc. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | NovoPore™ Dressing | GranuFoam™ | A4-XLR8 Foam |
| | | | Dressing |
| | burns, ulcers (such as<br>diabetic or pressure),<br>explored fistulas, flaps,<br>and grafts. | dehisced wounds, partial-<br>thickness burns, ulcers<br>(such as diabetic or<br>pressure), flaps and<br>grafts. Feedback control is<br>achieved by measuring<br>the level of negative<br>pressure at the wound<br>site. | excess exudates,<br>infectious material and<br>tissue debris.<br>A4-XLR8 Foam Dressing is<br>appropriate for use on the<br>following wounds:<br>• Pressure ulcers<br>• Diabetic/Neuropathi<br>c Ulcers<br>• Venous insufficiency<br>ulcers<br>• Traumatic wounds<br>• Post-operative and<br>dehisced surgical<br>wounds<br>• Comparative Bench<br>Caution: Federal law<br>restricts this device to sale<br>by or on the order of a |
| | | | physician. |
| Dressing Composition | Porous, open-celled<br>polyurethane foam | Porous, open-celled<br>polyurethane foam | Porous, open-celled<br>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),<br>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<br>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,<br>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<br>Thickness after 6<br>hours, wet (1350<br>cycles) | Decrease by an average of<br>1.5 ± 0.5% | Decrease by an average of<br>7.6 ± 2.6% | Decrease by an average of<br>8.0 ± 2.4% |

・

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| Device Manufacturer | PolyNovo Blomaterials<br>Pty Ltd | Kinetic Concepts, Inc.<br>(KCI) | Genadyne<br>Biotechnologies; Inc. |
|-----------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------|
| Device Trade Name | NovoPore™ Dressing | GranuFoam™ | A4-XLR8 Foam<br>Dressing |
| Durability after 1350<br>compressive cycles,<br>wet | No Damage | No Damage | No Damage |
| Vacuum Bench Test -<br>Pressure distribution | Evenly Distributed at each<br>time point | Evenly Distributed at each<br>time point | Not Tested |
| Vacuum Bench Test -<br>Fluid Flow (T=0, 24h,<br>48h, 72h) | 25 ml fluid drawn through<br>within 30 seconds at<br>every time point | 25 ml fluid drawn through<br>within 30 seconds at<br>every time point | Not Tested |
| Vacuum Bench Test -<br>Dimensional change<br>after 72h | <10% change in<br>dimensions | <10% change in<br>- dimensions | Not Tested |
| Tensile Strength | $223 \pm 17$ kPa | $105 \pm 13$ kPa | Not Tested |
| Tensile Elongation at<br>Break | $225 \pm 11$ % | $185 \pm 24$ | Not Tested |
| Tear Strength | $399 \pm 32$ | $733 \pm 76$ | Not Tested |
| 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 |
| 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 |

# 9. 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. The following testing has been performed to support substantial equivalence:

- . Biocompatibility - Biocompatibility testing of the NovoPore™ Dressing was conducted in accordance with the ISO 10993-1 "Biological evaluation of medical devices" standards and FDA/CDRH/ODE Blue Book Memorandum G95-1, "Use of International Standard ISO 10993", 'Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing' using a representative device. Based on ISO 10993-1, NovoPore™ Dressing is intended for use in direct contact with wounds, and the finished device is used in the human body for 24 (twenty-four) hours to 30 (thirty) days. The NovoPore™ Dressing was tested for Cytotoxicity per ISO 10993-5: Mutagenicity (In Vitro Mouse Lymphoma Assay) per ISO 10993-3; Bacterial Reverse Mutation (AMES test) per ISO 10993-3; Intracutaneous Reactivity, Skin Sensitisation (polar and non-polar) per ISO 10993-1, ISO 10993-10, and ISO 10993-12; per ISO 10993-1; Subcutaneous implantation per ISO 10993-1, ISO 10993-6, and ISO 10993-12; and Pyrogenicity per Ph. Eur. 7th edition. The results for the biocompatibility testing showed that there are no negative impacts from materials that are used in the NovoPore™ Dressing.
- . Shelf-life - Stability of the subject device was established from the results of physical testing data using a protocol. Based on the evaluation of the results of the physical

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testing data, the expiring date has been set at two (2) years in accordance with ISO 11607 and ASTM F1980-07.

- Package Stability Based on the results, these tests confirm the sealing and seal system . (selection of materials) of the tested packages are suitable to maintain the integrity and therefore the microbial barrier of packages for medical devices as required by ISO 11607-1. LAL testing is routinely used to verify acceptable low levels of endotoxin contamination per AAMI ST72.
- . Mechanical testing -The tests involved cyclic compressive stress at various time points, resilience under cyclic compressive testing, durability under accelerated cyclic compression, and performance under vacuum, testing. It was concluded that the NovoPore™ Dressings met all acceptance criterion for Mean USC, Mean SZL, and Mean percentage Change in Thickness, and degree of damage, hence are substantially equivalent to GranuFoam™ and XLR8 in terms of cyclic mechanical properties. It was also concluded that the NovoPore™ dressings showing substantially similar performance to GranuFoam dressings during and after the 72 hours of 17 kPa vacuum non-clinical bench testing.
- . Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.

As part of demonstrating safety and effectiveness of NovoPore™ Dressing and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, PolyNovo Biomaterials Pty Ltd completed a number of tests. The NovoPore™ Dressing meets all the requirements for overall design, sterilization, and biocompatibility confirms that the output meets the design inputs and specifications. The NovoPore™ Dressing passed all testing stated above as shown by the acceptable results obtained.

The NovoPore™ Dressing complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

# 10. Clinical Performance Data

Human clinical trials are not applicable as there are no new innovative aspects that have been introduced. These types of products have been on the market for many years with no significant incidents of safety or efficacy for the predicate devices. The design, development and testing of the NovoPore™ Dressing has not resulted in the need for any clinical trials.

# 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the

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predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the NovoPore™ Dressing and the predicate devices do not raise any questions regarding its safety and effectiveness. The NovoPore™ Dressing, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2014

PolyNovo Biomaterials Pty Ltd % Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K132936

Trade/Device Name: NovoPore Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 30, 2014 Received: January 31, 2014

Dear Ms. Hetrick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Carrie Hetrick

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

、

Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K132936

#### Device Name NovoPore™ Dressing

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <span></span> Recreation Use (21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart G) |
|-----------------------------------------------------|-----------------------------------------------------------|
|-----------------------------------------------------|-----------------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# Please do not write below this line - continue on a separate page if needed.

FOR FDA USE ONLY 1 4 2011 11:21 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# David K