NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)

K172140 · Polynovo Biomaterials Pty, Ltd. · QSZ · Aug 11, 2017 · SU

Device Facts

• Record ID: K172140
• Device Name: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
• Applicant: Polynovo Biomaterials Pty, Ltd.
• Product Code: QSZ · SU
• Decision Date: Aug 11, 2017
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is for single use only.

Device Story

NovoSorb™ BTM is a biodegradable wound dressing consisting of a 2mm thick porous polyurethane foam bonded to a fenestrated, transparent polyurethane sealing membrane. The membrane physiologically closes the wound to limit evaporative water loss during foam integration. The device is applied to the wound site; the sealing membrane and adhesive layer are removed once integration occurs, leaving the foam to biodegrade. Supplied in various sizes (4cm² to 800cm²), the device is terminally sterilized and intended for single use. It is used by clinicians in clinical settings to manage various wound types, facilitating healing by providing a temporary barrier and a scaffold for tissue integration.

Clinical Evidence

No clinical tests were performed. Substantial equivalence was determined based on design, material composition, and mechanical bench testing.

Technological Characteristics

Biodegradable polyurethane foam; polyurethane adhesive layer; fenestrated transparent polyurethane sealing membrane. 2mm thickness. Supplied in sizes 4cm² to 800cm². Terminally sterilized. Single-use. Mechanical properties verified via bench testing.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/diabetic/chronic/vascular ulcers, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric, dehiscence), trauma wounds (abrasions, second-degree burns, skin tears), and draining wounds in patients requiring wound management.

Regulatory Classification

Identification

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Predicate Devices

• BTM Wound Dressing (K142879)

Submission Summary (Full Text)

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December 15, 2022

PolyNovo Biomaterials Pty Ltd. Ms. Sue Cho Regulatory Affairs Manager Unit 2, 320 Lorimer Street Port Melbourne, Victoria 3207 Australia

Re: K172140

Trade/Device Name: NovoSorb™ BTM Wound Dressing (2cm x 2cm), NovoSorb™ BTM Wound Dressing (10cm x 10cm), NovoSorb™ BTM Wound Dressing (10cm x 20cm), NovoSorb™ BTM Wound Dressing (20cm x 40cm) Regulatory Class: Unclassified Product Code: OSZ

Dear Ms. Sue Cho:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 11, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Sincerely,

# Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

August 11, 2017

PolyNovo Biomaterials Pty Ltd Ms. Sue Cho Regulatory Affairs Manager Unit 2, 320 Lorimer Street Port Melbourne, Victoria 3207 Australia

Re: K172140

Trade/Device Name: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2017 Received: July 17, 2017

Dear Ms. Cho:

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, listing 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 device

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# David Krause -S

- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K172140

Device Name

NovoSorb BTM Wound Dressing

#### Indications for Use (Describe)

The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is for single use only.

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

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### Section 6. 510(k) Summary

Date Prepared: 13 July 2017

## APPLICANT INFORMATION:

| Applicant/Submitter: | PolyNovo Biomaterials Pty Ltd<br>2/320 Lorimer Street<br>Port Melbourne<br>Victoria, Australia 3207 |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone]<br>Establishment Registration Number: 3007886187 |
| Contact Person: | Sue Cho<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Alternate Contact Person: | Joseph DePaolo<br>Director of Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| | Ivan Jasenko<br>Regulatory & Quality Systems Manager<br>Phone: [phone]<br>Email: [e-mail] |

## SUBJECT DEVICE INFORMATION:

| Trade Name: | NovoSorb™ BTM Wound Dressing |
|----------------------|------------------------------|
| Device Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |

Product Code: FRO

- Product Classification: Unclassified
## PREDICATE DEVICE INFORMATION:

Predicate Device: BTM Wound Dressing, K142879

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# 6.1 Device Description

The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients.

NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard envelope.

# 6.2 Indications for Use

The NovoSorb™ BTM Wound Dressing device is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device is for single use only.

## 6.3 Technological Characteristics Comparison

The NovoSorb™ BTM Wound Dressing device is a modification of the existing predicate device BTM Wound Dressing, K142879. The predicate and the subject device have the same technological characteristics, however the subject device is supplied to the user fenestrated, thereby removing the need for users to manually fenestrate the device prior to use.

# 6.4 Non-Clinical Tests

Mechanical testing was performed on the subject device. Results of the tests demonstrate that the mechanical properties of the subject device requirements and that the subject device is substantially equivalent to the predicate device.

# 6.5 Clinical Tests

No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data.

## 6.7 Conclusion

PolyNovo believes the modified NovoSorb BTM Wound Dressing device is substantially equivalent to the legally marketed predicate device, BTM Wound Dressing (K142879), because its design and materials used, methods of operation and technological characteristics are either identical or substantially equivalent to the existing marketed predicate. It has the same intended use and maintains the same safety and effectiveness as its premarket cleared predicate device. Any differences that exist between the devices do not affect the intended use or alter the fundamental scientific technology of the device.